Health and Social Development, Faculty of (Okanagan)
Health and Exercise Sciences, School of (Okanagan)
DSpace
UBCO
Dineen, Tineke Ellen
Doctor of Philosophy - PhD
University of British Columbia
Type two diabetes (T2D) is one of the fastest growing chronic conditions worldwide and has negative health consequences and high costs for healthcare systems. Prediabetes, which precedes T2D, offers an opportunity for early intervention to delay and/or prevent progression to T2D. Diet and exercise are the cornerstones of diabetes prevention and have a large research base demonstrating their efficacy at reducing T2D risk. To combat the rising prevalence of T2D worldwide, diabetes prevention programs need to be implemented in practice within real-world settings. Moving research to practice (real-world) is notoriously slow’. Successful real-world examples exist, but reporting on implementation variables is limited. Implementation science focuses on understanding how and why programs work in real-world settings. Understanding how and why programs work is important because real-world settings have substantially more variables influencing interventions compared to controlled trials. Thus, this dissertation used an implementation science lens to examine the translation of diabetes prevention programs to the real world. Chapters 2-4 examined implementation of the Small Steps for Big Changes (SSBC) diabetes prevention program. Specifically, Chapter 2-3 examined the implementation outcome, fidelity. Chapter 2 evaluated the effectiveness of the in-person Small Steps for Big Changes training for fitness facility staff using the 4-level Kirkpatrick training evaluation model. Chapter 3 examined the delivery of, and engagement with, an evidence-based diet and exercise diabetes prevention program when delivered by fitness facility staff within a community organization. Chapter 4 reported the implementation strategies used and identified implementation determinants through a qualitative examination of implementation process as SSBC was implemented into two local community sites. Finally, through an in-depth systematic search and review, Chapter 5 identified implementation strategies, outcomes, and determinants when diabetes prevention programs were implemented in real-world settings. Together, results from this dissertation establish the foundation for future scale-up of the SSBC program and can inform future implementation projects. Overall, this work made important practical, theoretical, and methodological contributions to implementation science and diabetes prevention fields.
EXAMINING THE IMPLEMENTATION OF DIABETES PREVENTION PROGRAMS IN THE COMMUNITY by Tineke Ellen Dineen M.Sc., Wageningen University, 2015 B.Sc., University of Guelph, 2013 A DISSERTATION SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY in THE COLLEGE OF GRADUATE STUDIES (Kinesiology) THE UNIVERSITY OF BRITISH COLUMBIA (Okanagan) January 2024 © Tineke Dineen, 2024 ii The following individuals certify that they have read, and recommend to the College of Graduate Studies for acceptance, a dissertation entitled: EXAMINING THE IMPLEMENTATION OF DIABETES PREVENTION PROGRAMS IN THE COMMUNITY submitted by Tineke Dineen in partial fulfillment of the requirements of the degree of Doctor of Philosophy. Dr. Mary E Jung, School of Health and Exercise Science Supervisor Dr. Corliss Bean, Brock University Co-Supervisor Dr. Kathleen Martin Ginis, School of Health and Exercise Science Supervisory Committee Member Dr. Tanya Forneris, School of Health and Exercise Science Supervisory Committee Member Dr. Elizabeth Keys, School of Nursing University Examiner Dr. Nicole Culos-Reed, University of Calgary, Faculty of Kinesiology External Examiner iii Abstract Type two diabetes (T2D) is one of the fastest growing chronic conditions worldwide and has negative health consequences and high costs for healthcare systems. Prediabetes, which precedes T2D, offers an opportunity for early intervention to delay and/or prevent progression to T2D. Diet and exercise are the cornerstones of diabetes prevention and have a large research base demonstrating their efficacy at reducing T2D risk. To combat the rising prevalence of T2D worldwide, diabetes prevention programs need to be implemented in practice within real-world settings. Moving research to practice (real-world) is notoriously slow’. Successful real-world examples exist, but reporting on implementation variables is limited. Implementation science focuses on understanding how and why programs work in real-world settings. Understanding how and why programs work is important because real-world settings have substantially more variables influencing interventions compared to controlled trials. Thus, this dissertation used an implementation science lens to examine the translation of diabetes prevention programs to the real world. Chapters 2-4 examined implementation of the Small Steps for Big Changes (SSBC) diabetes prevention program. Specifically, Chapter 2-3 examined the implementation outcome, fidelity. Chapter 2 evaluated the effectiveness of the in-person Small Steps for Big Changes training for fitness facility staff using the 4-level Kirkpatrick training evaluation model. Chapter 3 examined the delivery of, and engagement with, an evidence-based diet and exercise diabetes prevention program when delivered by fitness facility staff within a community organization. Chapter 4 reported the implementation strategies used and identified implementation determinants through a qualitative examination of implementation process as SSBC was implemented into two local community sites. Finally, through an in-depth systematic search and review, Chapter 5 identified implementation strategies, outcomes, and determinants when diabetes prevention programs were implemented in real-world settings. Together, results from this dissertation establish the foundation for future scale-up of the SSBC program and can iv inform future implementation projects. Overall, this work made important practical, theoretical, and methodological contributions to implementation science and diabetes prevention fields. v Lay Summary Diabetes affects one in three Canadians. Diabetes is a harmful health problem for many Canadians, and it costs a lot to treat. Diabetes prevention programs reduce the risk of type 2 diabetes. Adapting research programs for communities is challenging, and there is not much research on this topic. This research looked at how to move diabetes prevention research programs to community programs. First, I looked at a specific case, the Small Steps for Big Changes program. I looked at how the entire project went from the planning process to 6-months into the community organization running the program, how we trained community coaches, and how well the coaches ran the program. Then, I looked at research from around the world about how diabetes prevention programs are implemented. My research helps understand how to make the Small Steps for Big Changes program work better in community sites and can help others when they want to implement similar programs. vi Preface I declare that the contents of this dissertation is the result of my own work. In the case of coauthored work, all sources have been acknowledged and contributions to each study are detailed below. All experimental chapters in this thesis were approved by the research ethics board at the University of British Columbia (Okanagan). Data collection, data analysis, and manuscript writing for all published works included in this dissertation were conducted at the University of British Columbia (Okanagan). Chapter 2 Dineen, T. E., Bean, C., Cranston, K. D., MacPherson, M. M., & Jung, M. E. (2021). Fitness Facility Staff Can Be Trained to Deliver a Motivational Interviewing-Informed Diabetes Prevention Program. Frontiers in Public Health, 9, 728612. https://doi.org/10.3389/fpubh.2021.728612 Tineke’s role in Chapter 2: • Conceived the research question • Completed all data analysis and interpretation • Primary author of manuscript, drafted manuscript, led revisions Co-authors role in Chapter 2: • Bean and Jung provided guidance for all stages of the project • Cranston and MacPherson assisted in data analysis Ethics Approval: This study protocol was approved by The University of British Columbia Okanagan Research Services Behavioural Research Ethics Board (H16-02028). Chapter 3 vii Dineen, T. E., Banser, T., Bean, C., & Jung, M. E. (2021). Fitness facility staff demonstrate high fidelity when implementing an evidence-based diabetes prevention program. Translational Behavioral Medicine, 11(10), 1814–1822. https://doi.org/10.1093/tbm/ibab039 Tineke’s role in Chapter 3: • Conceived the research question and study design • Completed analysis and interpretation • Primary author of manuscript, drafted manuscript, led revisions Co-authors role in Chapter 3: • Bean and Jung provided guidance for all stages of the project • Banser assisted in data input and analysis • All authors read and approved the final manuscript Ethics Approval: This study protocol was approved by The University of British Columbia Okanagan Research Services Behavioural Research Ethics Board (H16-02028). Chapter 4 Dineen T.E., Bean C. & Jung M.E. (2022). Implementation of a diabetes prevention program within two community sites: A qualitative assessment. Implementation Science Communications, 3(1), 11. https://doi.org/10.1186/s43058-022-00258-6 Tineke’s role in Chapter 4: • Conceived the research question and study design • Completed data collection, analysis and interpretation • Primary author of manuscript, drafted manuscript, led revisions viii Co-authors role in Chapter 4: • Bean and Jung provided guidance for all stages of the project • Bean and Jung assisted in the analysis and interpretation of the data • All authors read and approved the final manuscript Ethics Approval: This study protocol was approved by The University of British Columbia Okanagan Research Services Behavioural Research Ethics Board (H16-02028). Chapter 5 Dineen T. E., Bean C., Bohlouli, A., Percival, S., Vis-Dunbar, M. & Jung M.E. (revised & resubmitted). Implementation of diabetes prevention programs into real-world settings: A systematic search and review. Implementation Science. Tineke’s role in Chapter 5: • Conceived the research question and protocol • Conceived systematic search and review search and methods • Completed study screening, data extraction, and charting • Completed data analysis and interpretation • Primary author of manuscript, drafted manuscript Co-authors role in Chapter 5: • Bean and Jung provided guidance for all stages of the project • Vis-Dunbar and Dineen created the search strategy • Bohlouli and Percival assisted in study screening and data extraction • All authors read and approved the manuscript for submission ix Additional manuscripts completed during the degree program, but are not included in the thesis include: Cranston D. K.,Grieve N., Dineen T. E., & Jung M.E. (accepted). Digitalization of diabetes prevention program coach training: an integrated knowledge translation approach to the needs analysis, development, and usability testing of an online training platform. JMIR Formative Research, http://doi.org/10.2196/preprints.50942 Dineen T. E., Bean C. & Jung M.E. (2022). Successes and challenges from a motivational-interviewing informed diabetes prevention program situated in the community. Health Promotion Practice, 15248399221115066. Advance online publication. https://doi.org/10.1177/15248399221115066 Dineen T. E., Bean C., Vis-Dunbar M. & Jung M.E. (2021). Implementation of diabetes prevention programs into real-world settings: A systematic search and review protocol. Open Science Framework, https://doi.org/10.17605/OSF.IO/CBZJA Dineen T. E., Locke S., Cranston K., Beauchamp M. & Jung M.E. (2021). Self-regulatory efficacy and long-term physical activity engagement: Examining mediators from a randomized trial. Psychology of Sport and Exercise, 56, 102001. https://doi.org/10.1016/j.psychsport.2021.102001 Bean C., Dineen T. E., Locke S., Bouvier B., & Jung M.E. (2021). An evaluation of reach and effectiveness of a diabetes prevention behaviour change program in the community. Canadian Journal of Diabetes. 45(4), 360–368. https://doi.org/10.1016/j.jcjd.2020.10.006 x MacPherson M., Dineen T. E., Cranston K., & Jung M.E. (2020). Identifying behaviour change techniques and motivational interviewing techniques in a diabetes prevention program situated in a community site. Canadian Journal of Diabetes, 44(8), 719-726 https://doi.org/10.1016/j.jcjd.2020.09.001 Bean C., Dineen T. E. & Jung M.E. (2020). “It’s a life thing, not a few months thing”: Profiling patterns of the physical activity change process and associated strategies of women with prediabetes over 1-year. Canadian Journal of Diabetes, 44(8), 701-710 https://doi.org/10.1016/j.jcjd.2020.09.001 Bean C., Dineen T. E. & Jung M.E. (2020). Lessons learned in supporting women with prediabetes through maintaining diet and exercise behavior changes beyond a diabetes-prevention counseling program. Case Studies in Sport and Exercise Psychology, 4(1), 21-31. https://doi.org/10.14288/1.0389757 Gainforth H., Dineen T. E., Giroux E. & Forneris T. (2020). Teaching behaviour change theory in Canada: Establishing consensus on behaviour change theories that are recommended to be taught to undergraduate students in courses addressing health behaviour change. Pedagogy in Health Promotion, 7(1), 51-59. https://doi.org/10.1177/2373379920906178 xi Table of Contents Abstract .................................................................................................................................... iii Lay Summary ............................................................................................................................ v Preface ...................................................................................................................................... vi Table of Contents ..................................................................................................................... xi List of Tables ......................................................................................................................... xvii List of Figures ...................................................................................................................... xviii Abbreviations ......................................................................................................................... xix Acknowledgements ............................................................................................................... xxi Dedication ............................................................................................................................ xxiii Chapter 1: Introduction ............................................................................................................ 1 1.1 The Burden of Diabetes ............................................................................................ 1 1.2 Landmark Diabetes Prevention Programs ................................................................ 2 1.3 Translating Landmark Trials into Real-World Solutions ............................................. 3 1.4 Examining the Efficacy-Effectiveness-Implementation Continuum ............................ 5 1.5 Theoretical Tenets of Implementation Research ....................................................... 6 1.5.1 Overview of Three Theoretical Approaches within Implementation Science ........ 7 1.5.1.1 Process Framework .................................................................................... 7 1.5.1.2 Explanatory Frameworks ............................................................................. 8 1.5.1.3 Evaluation Frameworks ............................................................................... 9 1.5.2 Intricacies of Implementation Research .............................................................. 9 1.5.2.1 Levels of Analysis ..........................................................................................11 1.5.2.2 Implementation Strategies .............................................................................12 1.6 Small Steps for Big Changes ...................................................................................12 1.7 Dissertation Aims .....................................................................................................15 xii 1.8.5 Summary ...........................................................................................................16 Chapter 2: Fitness Facility Staff Can Be Trained to Deliver A Motivational Interviewing-Informed Diabetes Prevention Program ................................................................................ 17 2.1 Introduction ..............................................................................................................17 2.1.1 Background and Rationale .................................................................................19 2.1.2 Case Description................................................................................................21 2.2 Methods ...................................................................................................................22 2.2.1 Participants .......................................................................................................22 2.2.1.1 Staff and Clients .........................................................................................22 2.2.2 Data Collection ..................................................................................................22 2.2.2.1 Level 1: Reaction .......................................................................................23 2.2.2.2 Level 2: Learning ........................................................................................23 2.2.2.3 Level 3: Behaviour .....................................................................................24 2.2.2.4 Level 4: Training Outcomes ........................................................................25 2.2.3 Data Analysis .....................................................................................................25 2.3 Results ....................................................................................................................26 2.3.1 Level 1: Reaction ...............................................................................................26 2.3.2 Level 2: Learning ...............................................................................................26 2.3.3 Level 3: Behaviour .............................................................................................27 2.3.4 Level 4: Training Outcomes ...............................................................................27 2.4 Discussion ...............................................................................................................27 2.4.1 Limitations..........................................................................................................30 2.4.2 Lessons Learned ...............................................................................................31 2.4.3 Conclusion .........................................................................................................32 Chapter 3: Fitness Facility Staff Demonstrate High Fidelity When Implementing an Evidence-Based Diabetes Prevention Program .................................................................... 37 xiii 3.1 Introduction ..............................................................................................................37 3.2 Methods ...................................................................................................................39 3.2.1 Program Description ..........................................................................................39 3.2.1.1 Staff Training ..............................................................................................40 3.3.1 Data Collection ..................................................................................................41 3.3.1.1 Staff and Clients .........................................................................................41 3.3.1.2 Staff Self-Reported Session Fidelity ...........................................................41 3.3.1.3 Independent Coder Counseling Session Fidelity Check .............................42 3.3.1.4 Independent Coder Goal Fidelity Check .....................................................43 3.4.1 Data Analysis .....................................................................................................45 3.3 Results .....................................................................................................................45 3.3.1 Staff Self-Reported Fidelity ................................................................................45 3.3.2 Independent Coder Counselling Session Fidelity Check ....................................45 3.3.3 Independent Coder Goal Enactment Fidelity Check ...........................................46 3.4 Discussion ...............................................................................................................46 3.4.1 Limitations and Future Directions .......................................................................50 3.4.2 Conclusion .........................................................................................................51 Chapter 4: Implementation of a Diabetes Prevention Program within Two Community Sites: A Qualitative Assessment ............................................................................................56 4.1 Background .............................................................................................................56 4.2 Methods ...................................................................................................................59 4.2.1 Program Description and Study Setting .............................................................59 4.2.2 Paradigmatic Position ........................................................................................61 4.2.3 Participants and Data Collection ........................................................................61 4.2.3.1 Semi-structured Interviews .........................................................................61 4.2.3.2 Focus Group- .............................................................................................62 xiv 4.2.4 Data Analysis .....................................................................................................63 4.3 Results ....................................................................................................................64 4.3.1 Process ..............................................................................................................64 4.3.2 Intervention Characteristics ................................................................................65 4.3.3 Outer Setting ......................................................................................................66 4.3.4 Inner Setting ......................................................................................................67 4.3.5 Individual Characteristics ...................................................................................68 4.3.6 Modifications for Increased Sustainability ..........................................................69 4.3.6.1 Intervention Chracteristics ..........................................................................69 4.3.6.2 Inner Setting ...............................................................................................69 4.4 Discussion ...............................................................................................................70 4.4.1 Limitations and Future Directions .......................................................................74 4.4.2 Conclusions .......................................................................................................77 Chapter 5: Implementation of Diabetes Prevention Programs into Real-World Settings: A Systematic Search and Review .............................................................................................91 5.1 Background .............................................................................................................91 5.2 Methods ...................................................................................................................94 5.2.2 Study Selection ..................................................................................................96 5.2.3 Study Quality Assessment .................................................................................96 5.2.4 Data Extraction and Analysis .............................................................................96 5.3 Results ....................................................................................................................98 5.3.1 Study (N = 166) Characteristics .........................................................................98 5.3.2 Program (n = 94) Characteristics .......................................................................98 5.3.3 Implementation Strategies .................................................................................99 5.3.4 Implementation Determinants and Outcomes .................................................. 100 5.3.5 Theoretical Frameworks ................................................................................... 101 xv 5.4 Discussion ............................................................................................................. 101 5.4.1 Strengths,Limitations and Future Directions ..................................................... 108 5.4.2. Conclusions ..................................................................................................... 109 Chapter 6: General Discussion ............................................................................................ 143 6.1 Theoretical Contributions ....................................................................................... 144 6.1.1 Advanced Research on Treatment Fidelity....................................................... 144 6.1.1.1 Training Evaluation .................................................................................. 145 6.1.1.2 Treatment Delivery, Receipt, and Enactment ........................................... 147 6.1.1.3 Favourable Conditions to Support Fidelity ................................................ 150 6.1.2 Used A Common Determinant Framework to Contextualize Results ................ 151 6.1.3 Identified Implementation Strategies within the SSBC Project .......................... 151 6.2 Methodological Contributions ................................................................................. 153 6.2.1 Used a Self-Determination Theory Measure to Investigate Motivational Interviewing ................................................................................................................. 153 6.2.2 Applied Novel Methodology to Access Client Receipt and Engagement .......... 154 6.3 Practical Implications ............................................................................................. 156 6.3.1 Demonstrating Community Organization Are Feasible Resources to Supply Evidence Based Counselling Programs ....................................................................... 156 6.3.2 Informed the Small Steps for Big Changes Scale-Up Project ........................... 157 6.3.2.1 Tailoring SSBC For Sustainable Scale-up ................................................ 157 6.3.2.3 Implementation Strategies Developed for Scale-Up ................................. 158 6.3.2.3 Generalizability Biases ............................................................................. 159 6.4 Strengths and Limitations ...................................................................................... 161 6.5 Future Research .................................................................................................... 163 6.6 Conclusion ............................................................................................................. 168 Bibliography .......................................................................................................................... 170 xvi Appendices ........................................................................................................................... 205 Appendix A: Supplementary File for Chapter 2: Client satisfaction with program quality (program and structures) ................................................................................................. 205 Appendix B: Supplementary File for Chapter 2: Average Motivational Interviewing Competency Assessment (MICA) scores by sub-scale per staff ...................................... 206 Appendix C: Supplementary File for Chapter 4: TIDieR Checklist ................................... 208 Appendix D: Additional File for Chapter 5: PRISMA Checklist ......................................... 215 Appendix E: Additional File for Chapter 5: Codebook for Implementation Strategies ....... 218 Appendix F: Additional File from Chapter 5: Implementation Strategies per program ...... 297 xvii List of Tables Table 1: Overview of measurement timepoints..........................................................................33 Table 2: The mean and standard deviation for staff satisfaction with the 3-day training program. .................................................................................................................................................34 Table 3: Helpful response questionnaire (HRQ) and Motivational Interviewing Competency Assessment (MICA) scores per staff .........................................................................................35 Table 4: The mean and standard deviation for client responses to the learning climate questionnaire ............................................................................................................................36 Table 5: Descriptive statistics for fidelity checklist data per session and sub-scale (N = 26). .....52 Table 6: Agreement between staff and independent coder on delivery of intervention components ..............................................................................................................................53 Table 7: SMART goal coding (n = 275) .....................................................................................55 Table 8: Identification and description of implementation strategies used in SSBC ...................78 Table 9: Sample interview guide questions ...............................................................................83 Table 10: Overview of CFIR constructs linked to inductive themes ...........................................84 Table 11: Program characteristics ........................................................................................... 112 Table 12: Frequency of implementation strategies represented within programs .................... 138 Table 13: Overview of thematic clusters represented within this review .................................. 141 Table 14: Overview of importance and feasibility quadrants represented within this review .... 142 xviii List of Figures Figure 1: PRISMA flow diagram .............................................................................................. 111 xix Abbreviations List of Abbreviations BCT: Behaviour Change Technique BCTTv1: the Behaviour Change Technique Taxonomy v1 CBPR: Community-Based Participatory Research CFIR: Consolidated Framework for Implementation Research COM-B: Capability, Opportunity, Motivation – Behaviour model DPP: Diabetes Prevention Program ERIC: Expert Recommendations for Implementing Change project’s Compilation of Implementation Strategies HbA1c: Haemoglobin A1c HIIT: High Intensity Interval Training HRQ: Helpful Response Questionnaire ICC: Interclass Correlation Coefficients ISLAGIATT: it seemed like a good idea at the time KTA: Knowledge to Action Framework mHealth: mobile health MI: Motivational Interviewing MICA: Motivational Interviewing Competency Assessment MICT: Moderate Intensity Continuous Training MRC: Medical Research Council MVPA: moderate to vigorous physical activity NIH BCC: National Institute of Health Behaviour Change Consortium OARS: open-ended questions, affirmations, reflections, and summary statements PA: Physical activity PABAK: prevalence and bias adjusted kappa xx PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analysis PICOS: population, intervention, comparison, outcomes and study type PIPE: penetration, implementation, participation, and effectiveness RE-AIM: Reach, Effectiveness, Adoption, Implementation, Maintenance framework SMART: Specific, Measurable, Attainable, Realistic, Time-Bound SSBC: Small Steps for Big Changes STARI: Standards for Reporting Implementation Studies T2D: Type 2 Diabetes TDF: Theoretical Domains Framework TIDieR: Template for Intervention Description and Replication xxi Acknowledgements I humbly acknowledge that I completed this dissertation on the traditional, ancestral, and unceded territories of the Sylix Okanagan Nation. I am mindful that I am here as an uninvited guest on these lands and that I have benefited from the colonial system, which has simultaneously disadvantaged the traditional caretakers of these lands. I am committed to ongoing learning, reflection, and contributing to the reconciliation process with Indigenous communities. I truly could not have done this work without the incredible support that I received over the years. I constantly reflect on my experiences while at UBCO and I am filled with inspiration for the future. My journey through my PhD has been a profound period of growth, and I owe much of who I am today to the guidance and support of numerous individuals I met along the way. Mary and Corliss, thank you for your expertise, encouragement and commitment. You are both exceptional mentors. You challenged me to make my work better, think big, be creative, and try new things. You also reminded me to acknowledge the incredible achievements we have made and not undersell. Thank you for fostering my growth. Many of the strengths I've gained over these years can be attributed to your mentorship, support and willingness to provide me the opportunity to develop, refine and put my skills into action. Thank you for supporting my development. I leave as a stronger, more resilient and self-assured researcher and individual. Small Steps team and the entire DPRG lab, thank you for being there to support both research and life events. Every member of the team contributes significantly to the program's daily success. My work benefitted from so many great minds, whether from quick conversations in the lab, shared ideas during meetings, or purposeful collaboration on various projects.Thank xxii you! Special thanks to Alex, Megan and Kaela. I feel like our journey began together and it’s remarkable to see how far we have come! I have loved having you three by my side over the years and know I can count on you always. Kaela, I don’t think I could have finished my PhD without you. Thank you for being my side-kick, my person to bounce all my ideas off of, my favourite cycling buddy and just overall incredible friend. YMCA, thank you for being such a great partner. I have so many fond memories of working alongside you all. From the staff who participated in my projects, to the smiles I received at the front desk, you made my work so enjoyable. Social Sciences and Humanities Research Council, thank you for the financial support. The generous support relieved so much financial stress, enabled me to focus on pursuing my goals, engage in meaningful research, and granted me the opportunity to start a family during my PhD. Last but certainly not least, I'm immensely grateful to my family for their unwavering love and support throughout the years. They've been my source of encouragement, even when they knew it would take me away from home. Thank you to my husband’s family, for welcoming me with open arms, giving Michael and I shelter when the smoke comes to Kelowna, and for the much needed childcare support! Michael, you are my anchor. Thank you for bringing me to Kelowna! Thank you for giving my life so much meaning!. I appreciate all the help you have provided, from fetching me a glass of water, taking care of Oliver so I could work, and being there for me no matter what. I can’t wait for more life adventures with you. Oliver, thank you for being so joyful. You brighten my day, everyday. To the life that grows within me, I can’t wait to meet you! xxiii Dedication To my family – the one that raised me, the one that welcomed me when I married in, and the one that I will raise. I love you all. 1 Chapter 1: Introduction 1.1 The Burden of Diabetes Diabetes has become one of the world’s fastest growing health emergencies [1]. Over half a billion people are living with diabetes worldwide and this number is expected to rise another 46% by 2045, reaching 783 million people [1]. Between 2000-2019, mortality rates from diabetes rose by 3% worldwide [2]. During the same period, the worldwide probability of dying from any of the four leading noncommunicable diseases (cardiovascular disease, cancer, chronic respiratory disease, or diabetes) decreased by 22% worldwide. Clearly, there is a need to focus on the prevention and treatment of type 2 diabetes (T2D). Type 2 diabetes is a chronic condition where blood glucose levels are elevated, often associated with metabolic disruption from excess body weight and physical inactivity [3]. Of all forms of diabetes, greater than 95% of cases are individuals with T2D [2]. There is a continuum between normal glucose levels, levels indicative of prediabetes, and levels used to diagnose T2D. Prediabetes is where blood glucose levels are higher than normal but lower than the threshold for a T2D diagnosis [3]. Excess blood glucose (hyperglycemia) results from disruptions in insulin secretion (impaired fasting glycemia; IFG) or a lack of insulin action within the body (impaired glucose tolerance; IGT), or both [4]. Both IFG and IGT can be diagnosed with a blood test and are two of the three methods used to diagnose prediabetes or T2D. The final method is using glycated hemoglobin (HbA1c), a reflection of chronic hyperglycemia and the most common and stable of the three diagnostic tools [3]. Prediabetes and T2D can be asymptomatic, making it hard to detect. In Canada, approximately 20% of T2D cases are undiagnosed [5] and it is estimated that as much as 90% of prediabetes cases are undiagnosed [6]. By the time an individual is diagnosed with T2D, there may have been years of elevated blood glucose levels – albeit not at a T2D level. 2 Detecting individuals in the prediabetes range at an earlier stage facilitates treatment, as untreated cases typically experience a persistent rise in HbA1c scores [3, 5]. Therefore, early detection and management of prediabetes is imperative. Elevated blood glucose is associated with all-cause mortality [7] and increases the risk for microvascular (e.g., retinopathy, nephropathy, neuropathy) and macrovascular (e.g., cardiovascular disease) complications [8]. Globally, $966 billion is spent annually on direct costs associated with diabetes [1]. In Canada, diabetes-related expenditures total approximately $4800 USD per person, per year [1]. The escalating prevalence of T2D places an immense burden on healthcare systems, thus prevention and early intervention are needed. 1.2 Landmark Diabetes Prevention Programs A substantial body of research supports diet and/or exercise modifications as potent methods to reduce one’s risk of developing T2D [9-12]. The US Diabetes Prevention Program randomized over 3000 participants with elevated blood glucose levels to three groups, a group focused on achieving weight loss through diet and exercise changes, a medication group (metformin), and a control group. Participants in the diet and exercise group benefited from a 58% risk reduction of T2D at an average of 2.8 years follow-up compared to the control group [9]. Participants in the medication group also experienced risk reduction of T2D, albeit to a lesser extent, 31% [9]. These impressive results were replicated by two other large clinical trials published around the same time. The Finnish Diabetes Prevention Study (DPS) enrolled over 500 participants with IGT into either an intervention group focused on making diet and exercise changes to support weight loss or a control group. Individuals in the intervention group reduced their T2D risk by 58% over 4 years [10]. Finally, the Da Qing Impaired Glucose Tolerance (IGT) and Diabetes Study was conducted in China and randomized almost 600 individuals into four groups: a diet only group, an exercise only group, a combined diet and exercise group or a control group [11, 12]. The diet, exercise, and combined group reduced individual’s risk of 3 developing T2D by 31%, 46%, and 42% respectively [11, 12]. The remarkable success of these three studies firmly established diet and exercise modifications as the cornerstone of T2D prevention and championed T2D prevention research for years to come. Progressing beyond the valuable groundwork established by these trials, all three clinical trials engaged in extension studies to examine the long-term impact of the intervention. With between 13-20 years of follow-up data, the three clinical trials demonstrated that individuals who engaged in diet and exercise modifications sustained reduced diabetes risk in the long term [13-15]. The long-term effects of diet and exercise modifications have been further described in a recent systematic review and meta-analysis of randomized diabetes prevention trials. Results demonstrate that diet and exercise modifications have sustained effects compared to medication approaches where the effects tend to diminish soon after medication discontinuation [16]. In addition, modifying diet and exercise reduces risks for diabetes and related comorbidities such as cardiovascular disease and cancer, offering broad health benefits. These modifications have minimal negative side effects and are suitable options for individuals across various risk levels, making them a viable and preferable treatment option [17].The evidence is clear and strong: the most potent solution for individuals who wish to lower their risk for T2D is to target diet and exercise modifications. 1.3 Translating Landmark Trials into Real-World Solutions Results from these landmark clinical trials demonstrated that diet and exercise modifications are effective at helping individuals at risk for T2D reduce their risk. However, the substantial financial, human, and organizational resources needed to implement these clinical trials are not realistic for large scale, sustainable implementation. The clinical trials followed strict protocols, selective inclusion and exclusion criteria, and employed a large team of highly trained study staff. For example, the US Diabetes Prevention Program consisted of a 24-week 4 intervention delivered by a trained health care professional followed by monthly in-person and telephone meetings totaling 1063 hours per participant [18]. Each participant also received up to $100 per year to support adherence and maintenance of behaviour change (‘toolbox funds’). Toolbox funds could be used for eligible strategies such as joining a gym; purchasing nutritious foods, a cookbook or exercise equipment; or engaging in one-on-one sessions with an exercise trainer [4]. Overall, the estimated cost to deliver the US DPP for each participant in the diet and exercise group was $2269 USD over three years [18]. While this high cost is less than the cost for diabetes treatment, it is not realistic for healthcare systems and poses significant burdens for implementation, scalability, and sustainability in real-world settings. Using more cost-effective delivery of diet and exercise interventions are needed for widespread implementation [17]. There are numerous translations of DPPs to date that incorporate lower-cost strategies for real-world practice. Adaptations such as group-based formats, using lay community members to deliver DPP over more costly HCP staff, shorter program duration, less frequency of sessions, delivery in free community settings, and/or use of technology are all ways to reduce costs [3]. DPPs have been translated to hospital, work, community, and school settings and implemented across the world [3]. Systematic reviews have examined the effectiveness of these real-world DPP and while results vary substantially between trials, the cumulative evidence is that real-world DPPs are effective [19]. For example, one systematic review examined 22 diabetes prevention programs translated to routine practice or a community setting and found significant weight reductions of 2.1kg at 12 months follow-up [19]. Results demonstrate a typical ‘voltage drop’ phenomenon that exists when efficacy studies are translated to effectiveness conditions [20, 21]. A cumulative mean 2.1kg reduction from the systematic review represents approximately a third of the results reported from the US DPP clinical trial (average >6.0 kg weight loss at 12 months follow-up and average 5.6kg over the three years follow-up) [9, 19]. While this voltage drop seems severe, the effect produced under real-world conditions remains 5 clinically meaningful. As little as 1% reduction in weight can significantly reduce an individual’s risk for T2D [22]. Real-world translations of DPPs can have beneficial health outcomes for a large population of individuals at risk of T2D, and thus should be made widely available. 1.4 Examining the Efficacy-Effectiveness-Implementation Continuum Efficacy trials, such as the US Diabetes Prevention Program, aim to test an intervention under controlled conditions, allowing researchers to monitor various factors such as inclusion and exclusion criteria, adherence, study staff, and standardized protocols to determine causality [21, 23]. Efficacy studies have high internal validity, referring to the extent to which a study accurately measures what it claims to measure, in order to establish a causal conclusion between the intervention and the observed outcomes [21]. Efficacy studies are intensive and demanding on both staff and participants and results may not translate well to real-world settings [21]. In contrast, effectiveness studies, such as a translation of the US Diabetes Prevention Program to a new setting, aim to produce generalizable results by including a diverse sample of participants, using more accessible settings, and training individuals to implement the study within their everyday workflow/organization [21, 23]. Effectiveness studies have high external validity, referring to the extent to which results from a study apply to broader real-world settings [21]. Efficacy and real-world trials exist on a continuum [23]. The more tightly controlled a study is the more it will use efficacy components to isolate effects of an intervention, and may be referred to as a clinical trial. As controls loosen, and the study is implemented under more real-world conditions, the study will fall more on the effectiveness end of the continuum. Implementation studies exist at the far (effectiveness) end of this continuum with a primary focus on the adoption of an intervention by staff or volunteers within or outside care systems [24] [25]. Implementation studies place less emphasis on intervention outcomes, and more on process variables such as whether the intervention is accepted and implemented by providers and the system in which it is run. 6 Historically, studies followed a linear path, building evidence from an efficacy study to an effectiveness study to an implementation study. This step-wise, linear progression was notoriously long and consistently resulted in large time-lags from research discoveries to uptake in routine clinical practice [26]. Early implementation research was empirically driven and did not have strong theoretical underpinnings [27]. Lacking a solid theoretical foundation, understanding the reasons behind successful or failed implementation became challenging, hindering the ability to replicate such outcomes. Modern perspectives recognize that moving evidence-based interventions along the continuum to be adopted into real-world practice requires different variables, measurement levels, and theories [28]. The main challenge is heterogeneity; there are substantially more variables actively influencing the intervention in a real-world setting compared to a controlled trial. Hybrid designs (e.g., effectiveness-implementation trials) were introduced to improve the utility of research to address both external validity and clinical utility within a single trial [26]. Hybrid designs are one example of how implementation science has impacted the traditional research pipeline. Over the past 15 years, a substantial volume of scholarly work has emerged, driving the growth and theoretical advancements of implementation science. 1.5 Theoretical Tenets of Implementation Research For greater than a decade, implementation research has rapidly expanded with theoretical developments. A common definition of implementation science is the study of the methods used to promote systematic uptake of research findings into routine practice resulting in the improvement of the quality and effectiveness of health services and care [29]. Three broad categories of theoretical approaches have been proposed within implementation science: 1) process frameworks, 2) explanatory frameworks, and 3) evaluation frameworks [27]. Such frameworks will be described in detail below. 7 1.5.1 Overview of Three Theoretical Approaches within Implementation Science 1.5.1.1 Process Framework Process frameworks generally focus on describing the steps or stages that guide translating research into practice. While early research typically depicted a linear process, most process models today highlight the need for flexibility, contextual adaptation, facilitation and an iterative nature resulting in nonlinear relationships between stages [27]. Process models often describe key steps or stages and may not specify exactly how to go about each stage or what variables to examine within each stage. The knowledge-to-action (KTA) framework [30] is one example of an implementation process framework. This framework provides an overview of the stages to move knowledge into action and consists of two interrelated components: knowledge creation funnel and action cycle [30]. The knowledge creation phases consists of knowledge inquiry (e.g. primary studies), knowledge synthesis (e.g. systematic review and scoping reviews), and knowledge products and tools (e.g. clinical practice guidelines and decision aids) [30]. As knowledge moves through the funnel it becomes tailored and more specific for use. The action cycle consists of 7 phases: a) identify need and problem, b) tailoring knowledge to the local context, c) assessing facilitators and barriers to knowledge use, d) select, tailor and implement interventions, e) monitor knowledge use, f) evaluate outcomes and g) sustain knowledge use [30]. The KTA does not need to be implemented sequentially, rather the KTA allows for dynamic use of the framework as you move iteratively between stages, allowing flexibility in the process and adaptability to the unique scenario for each project. The KTA helps with overall conceptualization and guidance by demonstrating important stages to consider. Finally, the knowledge funnel can be used to create knowledge to support any of the phases within the action cycle. The KTA framework has been used in numerous implementation science studies to describe the process of implementation. 8 1.5.1.2 Explanatory Frameworks Explanatory frameworks aim to understand and/or offer explanations for the factors that influence implementation outcomes. Three different categories exist within this approach: 1) determinant frameworks, 2) classic theories, and 3) implementation theories. First, determinant frameworks describe constructs, sometimes classified within domains, that may facilitate or hinder implementation outcomes, aiming to understand and explain what influenced implementation outcomes. Many include constructs at multiple levels (individual user, adopter, organization, environment) that interact within and between levels [27]. An example of a determinant framework is the Consolidated Framework for Implementation Research (CFIR; described in greater detail below) [31]. Second, classic theories are those that were developed in fields outside implementation science but have relevant application to implementation. Implementation science may borrow theories developed in other fields such as theories related to training or fidelity to explain how these concepts, that are related to implementation, can be measured and studied within an implementation context. Finally, implementation theories are theories developed by implementation scientists and aim to explain implementation (e.g., organizational readiness). One of the most prominent determinant frameworks is the Consolidated Framework for Implementation Research (CFIR) [31]. The framework has a strong theoretical lineage developed from Greenhalgh’s synthesis [32] and 18 other theories[31]. It includes 39 constructs within 5 domains (inner setting, outer setting, intervention, individuals, and process). CFIR constructs are fully operationalized and individuals wishing to use the CFIR have access to a support website that describes and provides sample measurement tools for each construct. Finally, the CFIR is a multilevel framework that can be used to understand individual-, program- and organization-level data. In 2022, CFIR developers proposed an addendum to add implementation outcomes for use with the current implementation determinants within the CFIR 9 [33]. Proposed work also includes the addition of innovation determinants and innovation outcomes and the distinction between innovation variables and implementation variables [33]. This laudable task will be a strong addition to the field. 1.5.1.3 Evaluation Frameworks Evaluation frameworks aim to determine implementation success by examining implementation outcomes. Implementation outcomes differ from the traditional clinical outcomes of efficacy research (e.g., HbA1c, weight, satisfaction) or service delivery (e.g., safety, equity, efficiency) outcomes [28]. Implementation outcomes are a set of variables that occur because of implementation and the degree to which an intervention has successfully been integrated into practice [28]. Implementation outcomes are the proximal indicators of implementation and act as intermediary indicators of clinical outcomes or service delivery [28]. Compilations of implementation outcomes have been developed. One well-known taxonomy is by Proctor and colleagues (2011) that identified eight implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability) [28]. Overall, the three broad theoretical approaches within implementation research (process, explanatory and evaluation frameworks) may have some overlap, but each approach has a distinct strength. Understanding the strengths of each approach helps to select the most relevant theory, model, or framework to answer a specific research question. 1.5.2 Intricacies of Implementation Research In a resource- and time-constrained world, implementation outcomes are often overlooked as researchers, evaluators, and funders focus on clinical outcomes and assume implementation success [28]. Without appropriately investigating the plethora of contextual variables that interplay in real-world settings, research is at risk of a type III error [34, 35]. A type III error takes place when an intervention is mistakenly perceived as ineffective, but the 10 cause of the ineffectiveness lies in implementation failure (for instance, when facilitators didn't deliver the intervention to the client) rather than the intervention itself (where positive outcomes could have been expected if properly implemented) [27]. Therefore, studying implementation-specific variables is of utmost importance when moving research into the real-world. There is some incongruency in the literature on how to define implementation variables. For example, Proctor and colleagues (2011) identified eight implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability). In contrast, McKay and colleagues (2019) developed a minimum dataset of five implementation outcomes (adoption, dose [delivered dose] delivered, reach, fidelity [adherence], and sustainability [maintenance]) and 10 implementation determinants (context, acceptability, feasibility, compatibility [appropriateness], cost, culture, dose [satisfaction], complexity, and self-efficacy) [36]. There is overlap between the two lists of variables, but McKay’s minimum data set labels some of the variables listed in Proctor’s taxonomy as determinants instead of outcomes. Variability in terminology is common in the field of implementation science [28, 36, 37]. Implementation science is interdisciplinary which allows results to be published in a wide range of journals and topics areas, limiting the concentration of cross-referencing [28]. Specifically, the distinction between implementation determinants and outcomes is murky. By definition, an implementation determinant is a variable that influences implementation outcomes, and implementation outcomes are the end result of implementation efforts [36]. However, in some cases an implementation determinant, for example acceptability, may be regarded as an implementation outcome if the researcher is interested in how acceptability is influenced by other implementation determinants, for example cost, complexity, culture [36]. To further complicate matters, implementation determinants and outcomes act as determinants when researched in relation to clinical outcomes [36]. To heighten the confusion additional terms can be incorporated considering that implementation also encompasses 11 innovation outcomes and innovation determinants. Innovation variables are those which relate to the success or failure of the innovation being implemented (e.g., DPP) on innovation recipients, innovation deliverers, and key decision-makers [33]. Clearly, there are numerous complexities within the field related to levels of measurement and clarity of terminologies. 1.5.2.1 Levels of Analysis Implementation is complex. The terms described in the previous section alone signify the breadth and intricacies of this field. One reason for this is the multiple levels that need to be researched. First you have the innovation itself, the ‘thing’ that gets implemented (e.g., a DPP). Second, you have the clients who participate in the innovation. Third, you have the context in which the innovation is implemented within. The context may include staff who implement the innovation, staff to support the innovation, staff to manage and coordinate the innovation, and the general physical and social environment of the organization that the innovation is implemented within. Finally, you have a broader environment that the organization is situated within (e.g., geographical, political). Implementation research involves the interdependent interaction of these levels. When researching implementation variables, it is important to specify the level at which the variable is being measured [28, 36]. The CFIR represents these levels as the five different domains of the framework (inner setting, outer setting, process, intervention characteristics, and individual characteristics) [31]. The process domain within the CFIR does not represent a level but rather the strategies, actions and activities that take place during implementation. The process domain recognizes the dynamic nature of the process, evolving from initial planning to execution and reflection. The inclusion of the process domain strengthens the CFIR by highlighting this important component of implementation broadly. More specific guidance is needed to articulate the exact actions, strategies, and activities to conduct for successful implementation. 12 1.5.2.2 Implementation Strategies The implementation process, specifically the planning component, is consistently documented as key implementation determinants [38, 39]. Implementation strategies are the specific methods, actions, or techniques to get an innovation into practice [40]. Unfortunately, insufficient reporting is a common challenge as implementation studies consistently lack detailed information about how the intervention was implemented [41-43]. In 2015, The Expert Recommendations for Implementing Change (ERIC) study resulted in the compilation of 73 implementation strategies, ranging from passive strategies, such as distributing educational material, to active strategies, such as conducting ongoing training [44]. The goal of publishing a compilation was to improve conceptual clarity and detail a comprehensive list of implementation strategies to subsequently facilitate the identification, development, and testing of implementation strategies with established terminology [44]. In 2017, the Standards for Reporting Implementation Studies (StaRI) Statement was published to hold researchers accountable to sharing transparently and accurately the reporting of implementation studies [41]. Ongoing research in implementation strategies demonstrates that active strategies, sustaining strategies, and tailoring strategies to the individual context are all ways to enhance effective implementation [45]. While in many cases the use of multiple strategies may be more effective, there are scenarios where simple implementation strategies may be more effective than complex, multicomponent ones [45]. Implementation strategies continue to be a rich area of study, with more research needed and better reporting of implementation strategies (e.g., use of ERIC or STARI) in the literature. 1.6 Small Steps for Big Changes In Canada, there remains a paucity of available diabetes prevention programs, with no large-scale translational study to date. To reach and positively impact Canadians living at risk of 13 T2D, effective programs need to be implemented in diverse community settings and scaled-up across the country. Small Steps for Big Changes (SSBC) is an evidence-based diet and exercise behaviour change counselling program with demonstrated effectiveness. Small Steps for Big Changes has moved along the research pipeline from development to a hybrid implementation effectiveness trial. The program was initially designed based on a comprehensive review of evidence associated with physical activity behaviour change and informed by social cognitive theory [46]. The program was pilot tested in 32 adults with high risk of T2D and demonstrated increased physical activity and cardiorespiratory fitness at one-month post-program [47]. Subsequently, an efficacy trial was conducted using a randomized trial under ideal conditions where 99 adults with overweight/obesity participated [35]. Overall, individuals improved their cardiorespiratory fitness and had increased physical activity levels up to one-year post-intervention [48]. Building on this success, the program was adapted for delivery in the community, strengthened by incorporating motivational interviewing-informed counselling skills, dietary counselling, and implemented using research staff at one community site [49]. Preliminary 6-month follow-up data of 90 participants demonstrated significant reductions in weight and waist circumference, increased physical function and self-reported physical activity, and improved self-reported food frequency in the direction of desired study outcomes (e.g., increased vegetable intake, decreased refined carbohydrates and added sugar) [49]. Over the years, the program underwent continual quality improvement and adaptation based on participant feedback, recommendations from program staff, and up-to-date research evidence. In 2017, a collaborative process was initiated to translate the program for implementation by non-research staff within a community organization [50]. Throughout this yearlong process, knowledge translation events were executed to obtain a wide-range of 14 stakeholder1 insights including past and present participants, prospective coaches, community organization management staff and community stakeholders (e.g., from the local health authority, the university) [50]. Working with the community partner, collaborative decision-making was used to ensure the program, program materials, training, support and other logistics were appropriate [50]. The resulting program retains core components including the brief nature of the program, evidence-based behaviour change techniques, and uses tenets of social cognitive theory (e.g., strategies to bolster a client’s self-efficacy). The program consists of six motivational-interviewing informed sessions over three-four weeks. Each session begins with counselling (30-50 minutes) where coaches discuss a behavioural target (e.g., dietary changes, exercise modifications or self-regulatory support skills). The intention of each session is to support individuals to discover realistic ways to incorporate the program content into their daily life. With the support of the coach, the client creates and refines a personalized behavioural goal to attempt to achieve before the following session. After the counselling portion, the client engages in an individually supervised physical activity session, choosing the equipment and type of aerobic exercise. The choice is either moderate-intensity continuous training (MICT; e.g., walking at a consistent pace for 20 – 30 minutes) or high-intensity interval training (HIIT; e.g., alternating between higher intensity intervals of 30 – 60 seconds and active recovery, for 12 – 15 minutes). Early appointments are spaced close together to encourage application of key program concepts within everyday life and time for the coach to follow-up and facilitate accountability and motivation. As the program progresses, it encourages development of self-regulation skills as the appointments are spaced further apart to reduce coach dependance. The SSBC program was designed with scalability in mind. The brief program has a total of six strategically placed appointments over 3-4 weeks with 3 additional follow-ups over 1 year. 1 I acknowledge the colonial origins of the term "stakeholder" and its association with colonial systems. Although I now prefer using "interested parties," I chose to be consistent in my use of the word stakeholder throughout my dissertation as it was the term used in my published manuscript (Chapter 4). 15 The number of appointments is at a much lower frequency than many other diabetes prevention programs, for example the National Diabetes Prevention program in the United States consists of a minimum of 22 sessions over one year [51]. The SSBC diet and exercise content are based on readily available resources therefore lay community staff could deliver the program (e.g., Canada’s physical activity guidelines and reducing added sugar, refined carbohydrates and fruit intake and increasing vegetable intake). Finally, the training for prospective coaches does not require any previous counselling experience nor higher education. This capitalizes on the lay community members readily available in a delivery area at an affordable payrate who know the contextual facilitators and barriers of their community. Any interested coach must complete training to learn the diet and exercise content for T2Drisk reduction, motivational interviewing techniques, behaviour change techniques, and procedures to conduct the program sessions. Thus, many of the core components of SSBC strategically support its suitability for scale-up. 1.7 Dissertation Aims Moving evidence-based research into practice is complex. Implementation science undertakes the difficult job of unpacking the complexity and creating meaning to support future researchers. The relatively young field has progressed immensely over the past 15 years to develop a strong theoretical foundation. Nearly two decades ago, strong evidence emerged for the use of diet and exercise modifications to reduce an individual’s risk for developingT2D. Since then, numerous research projects developed, translated, or adapted various diabetes prevention programs within community settings with generally favourable results. Unfortunately, many of the programs were focused on replicating positive effectiveness outcomes and lacked reporting on key implementation science concepts and variables [52]. Thus, the overarching purpose of this dissertation was to use an implementation science lens to examine the translation of DPPs to the community. To achieve this, I conducted four studies. Three of my studies are situated within the context of the SSBC program. Prior research showed SSBC was 16 effective both in a laboratory setting and in a community setting when research staff facilitated the program. However, it remained unknown if community fitness facility staff could successfully implement the program. Thus, in Chapters 2-3 I comprehensively investigated the implementation outcome of fidelity using the National Institute for Health Behaviour Change Consortium’s 5 intervention fidelity components as a guide [60]. Chapter 2 evaluated the effectiveness of the in-person SSBC training for fitness facility staff using the 4-level Kirkpatrick training evaluation model [73]. Chapter 3 examined the delivery of, and engagement with, an evidence-based diet and exercise DPP when delivered by fitness facility staff within a community organization. Chapter 4 reported the implementation strategies used and identified implementation determinants through a qualitative examination of the implementation process as an evidence-based diabetes prevention program was implemented into two local community organization sites to inform future scale-up. After learning about implementation science within the real-world SSBC program, I was interested in learning about what works for other real-world DPPs and found the research hard to find. Thus, I conducted in-depth systematic search and review to thoroughly identify implementation strategies, outcomes, and determinants when DPPs were implemented in real-world settings. 1.8.5 Summary Greater emphasis on reporting implementation strategies and measuring implementation determinants and outcomes at various levels (e.g., program and implementation strategy levels) are needed to improve implementation science, specifically in diabetes prevention programs. This dissertation is comprised of three published works (Chapter 2-4) on the implementation of SSBC within a community organization and one work submitted for publication (Chapter 5) on extracting implementation details from diabetes prevention programs. A summary of the contribution of this dissertation to the field, limitations of this research, and areas for future research are discussed in chapter 6. 17 Chapter 2: Fitness Facility Staff Can Be Trained to Deliver A Motivational Interviewing-Informed Diabetes Prevention Program 2.1 Introduction The prevalence of diabetes continues to rise, with 1 in 3 Canadians affected [53]. Prediabetes acts as an early warning sign for type 2 diabetes (T2D), when individuals have blood glucose levels that are higher than normal, but not high enough to be diagnosed as T2D. This window of opportunity is important as individuals with prediabetes have up to 70% increased risk of developing T2D in the future [54]. Large clinical trials have demonstrated that diet and exercise modifications are effective at reducing T2D risk by up to 58% in individuals with prediabetes [9], with risk-reducing effects lasting long after intervention end [16]. Thus, a focus on reducing risks of developing T2D is critical to address this public health priority. There have been multiple translations of T2D prevention programs into real-world settings with demonstrated effectiveness [22, 55]. Many countries have developed large-scale translational studies (see [56] for an overview). Despite the effectiveness of diabetes prevention programs in community settings [57], there remains a paucity of available programs in Canada. To reach and positively impact Canadians living at risk of T2D, effective programs need to be implemented in community settings and scaled-up across the country. Several translational studies have been modelled on the United States Diabetes Prevention Program, adopting a group-based format. While group-based approaches demonstrate one method to reduce overall program costs [58], use of community members represents another. A recent systematic review indicated that overall, diabetes prevention programs are cost-effective in any setting, and the review contained no studies examining an individual format with community members [58]. A systematic review assessing real-world impact of global diabetes prevention interventions identified 63 studies, of which only three adopted an in-person, individual approach with a health care provider [22]. No studies adopted an in-person, individual approach led by a community member. More research on programs for 18 reducing T2D risk using an individualized approach with community members, such as fitness facility staff, are needed. Training is a core component of implementation with implications on program fidelity and subsequent effectiveness [59]. Understanding the effectiveness of a training program, especially for fitness facility staff without experience in counseling and diabetes prevention, is integral to development of scalable, cost-effective diabetes prevention programs. Assessing training is one of the five domains of the Behavioral Change Consortium’s best practice guidelines for assessing fidelity in health behavior change trials [60]. A training program must sufficiently teach the required knowledge and skills for attendees to be successful in implementing the program. Motivational interviewing (MI) has been used in numerous health-related programs to help individuals change various health-related behaviours, including in the management of diabetes and obesity [61, 62]. When evaluated, MI training has been shown to be effective among health care practitioners [63]. Evaluated training programs typically include a 1.5 to 3-day workshop with individual MI skill practice, role-play scenarios, and post-training support [63]. To our knowledge no study to date has examined MI training for fitness facility staff, and few researchers have examined MI training for non-health care practitioners. Of the limited research, one study examined teaching community health agents to lead a T2D self-management program using a MI-informed approach in Brazilian primary care centers [64]. The researchers examined MI fidelity with most community health agents performing at medium-to-high levels. However, MI fidelity was assessed using researcher-completed MI fidelity checklists, a less reliable method compared to audio or video recording sessions [60]. The current study builds on previous work by examining the effectiveness of training fitness facility staff (hereafter referred to as staff) to deliver a MI-informed program using independently coded audio recordings to examine MI fidelity. Recently, Phillips and Guarnaccia [65] recommended researchers who study MI could benefit from measuring self-determination theory [66] variables, such as basic psychological 19 needs. Self-determination theory has been identified as a valuable theory to understand the mechanisms behind MI [67]. There are three basic psychological needs: autonomy (i.e., client-centered approach, elicit client ideas), competence (i.e., confidence in the capacity to change), and relatedness (i.e., understand client perspective, non-authoritarian position) which overlap with core MI components [67]. The learning climate questionnaire [68, 69] is a self-determination theory measure used to examine whether clients felt their basic psychological needs were met through program participation. To our knowledge, this is the first study to assess the learning climate questionnaire as an indicator of client perceptions of staff MI skills. 2.1.1 Background and Rationale The Small Steps for Big Changes (SSBC) program uses an individual approach to deliver behavior change techniques coupled with MI techniques to bolster client’s self-regulatory skills in an autonomy supportive manner [70]. The program’s main behavior change techniques include goals and planning, feedback and monitoring, and repetition and substitution in relation to diet and exercise topics. The free program is housed in a community not-for-profit organization, the YMCA of Okanagan2, and consists of six sessions over 3-weeks (for full program overview see [70]). Prior to this current translation project, SSBC was running as a research project in a community site with research staff implementing the program. In the first two years, the program had 213 participants enrolled with a 95% completion rate [49]. Clients demonstrated improved self-reported physical activity and dietary behaviors, improved distance on a 6-minute walk test, and reduced weight and waist circumference [49]. To accelerate the benefit of this program reaching the 6 million at-risk Canadians [71], translation to the community is necessary. Translating the program to be run by a community organization presents an ideal opportunity to supplement gaps in primary healthcare and provide a cost-efficient program using 2 The YMCA waived their rights to anonymity 20 YMCA staff. Hosting the program in a community organization has numerous benefits including increasing reach to those underserved by the healthcare system and enabling clients to have ongoing access to facilities (including their staff) post-program. The YMCA of Okanagan was actively looking for a program to adopt and inquired whether SSBC could be implemented within their facility [50]. YMCA staff are well-suited to deliver such a program with their demonstrated interest in the health and fitness industry and expertise in physical activity [72]. Through their established community presence, dedication to supporting healthy communities and availability of assisted membership post-program, the YMCA is an ideal partner to increase reach, accessibility, and long-term support. As part of a national organization, there are opportunities for scale-up across Canada. However, it is unknown if YMCA staff can effectively learn the program’s counselling strategy (MI), diabetes prevention concepts and implement the program with fidelity. This current case study was needed to examine the effectiveness of training YMCA staff to implement a MI-informed diabetes prevention program. As noted, SSBC centers on the delivery of diabetes prevention topics using MI skills and specific behavior change techniques (e.g., goal setting) to support clients’ basic psychological needs and program success. The goal of the training was to teach staff core program components and skills necessary to be successful in facilitating the program to clients. The Kirkpatrick Evaluation Model [73] is a frequently used model to evaluate training programs. The model consists of four levels: (a) reaction, (b) learning, (c) behavior, and (d) results. The first level measures reactions to the training received. The second level measures the knowledge and skills learned. The third level measures whether the knowledge and skills acquired from the training are used in practice. The fourth level measures the effect from the use of the skills/information in practice. Despite the popularity of Kirkpatrick’s evaluation model, all four levels are rarely assessed—with levels one and two being most reported (e.g., [74]). Levels three and four are more challenging to measure as they require post-training follow-up to examine both the application of training skills in practice and the effect of those skills that were 21 used. The current study delivers a comprehensive training evaluation using all four levels of the model. The purpose of this case was to evaluate the effectiveness of the in-person SSBC training using the Kirkpatrick 4-level training evaluation model. In line with this model, four research questions guided the case: (a) How satisfied are staff with the training?, (b) To what extent do staff learn the material taught in the training?, (c) To what extent do staff enact what they learned in practice?, (d) To what extent are clients satisfied with their staff and feel their basic psychological needs are supported? 2.1.2 Case Description A 1-year collaborative planning process with the YMCA of Okanagan was undertaken to support uptake and sustainability of the program [50]. Two local YMCA sites were selected to implement the SSBC program and staff were invited to engage in the 1-year planning process. Following this planning process, interested staff volunteered to attend a 3-day (17-hour) training workshop that covered MI principles, program content, and standard operating procedures. Two master trainers from the SSBC team (TD and KC) facilitated the training. The training workshop was previously developed and tested by the SSBC study team and refined prior to the current case [75, 76]. The workshop included didactic teaching of intervention content (e.g., effect of physical activity on diabetes prevention), a variety of role-play activities to practice use of skills (e.g., MI skills), demonstration of skills (e.g., exercise protocol), videos of session content delivered using MI skills, and how-to videos for common program procedures (e.g., how to review client’s app-based diet and exercise tracking). All staff were given an implementation manual, including standard operating procedures, sample session scripts and checklists for the six sessions, and had ongoing access to the training videos through an online platform. All staff were shadowed by a research team member for their first client and given feedback after each session. Finally, 22 ongoing monthly meetings with staff from each site were led by the first author to provide study updates, support, and review successes, challenges, and lessons learned. Assessing the training is an important fidelity assessment to gain confidence that staff are adequately trained to implement a program with high fidelity. This is a crucial step for effective program implementation, especially prior to scaling-up an intervention. Results will support refining a standardised training program for a community behavior change program for individuals at risk of T2D and support future scale-up of the training to other YMCAs. 2.2 Methods 2.2.1 Participants 2.2.1.1 Staff and Clients All staff and clients provided written informed consent prior to participating. Staff who facilitated a minimum of three clients through the program were included in the present study (n = 8). Staff were, on average, 31.88 ± 9.05 years of age (range 24-51), predominantly self-identified as female (75%), and white (88%). There was a wide range in years of employment (50% had worked for 10+ years, 38% for 1-5 years, and 13% for less than one year) and education (75% had a university degree, 25% had obtained a college diploma) in staff. The eight staff facilitated clients (n = 32) through the program between August 2019 and March 2020. Clients were on average 59.56 ± 6.88 years of age (range 43-70), and predominantly self-identified as female (68%) and white (95%). 2.2.2 Data Collection Staff completed a pre-training, post-training, and implementation follow-up survey measuring various Kirkpatrick levels further described in the following sections. The pre- and post-training survey link were emailed to staff immediately before and after the 3-day workshop. The implementation follow-up survey link was emailed to staff after facilitating three participants 23 through the program (M = 5 months post-training). Clients were emailed a pre-program survey link after their baseline appointment and a post-program survey link after completion of the program. All surveys were hosted on Qualtrics. The following sections describe how each level was measured and with what measure (see table 1 for the measurement time-point table). 2.2.2.1 Level 1: Reaction A post-training satisfaction survey was used to assess staff reaction to the training. A 12-item training satisfaction measure with demonstrated reliability was used (α = 0.88; [77]) whereby staff were asked to rate their confidence on a 5-point scale (totally disagree-totally agree; “In your opinion, the planned objectives were met”). Overall scale means were used in the analyses and demonstrated strong internal consistency (α = .89). 2.2.2.2 Level 2: Learning To assess staff learning of program content and MI knowledge, two measures were assessed post-training and at implementation follow-up. First, staff knowledge of the program content and standard operating procedures were assessed using a 39-item measure developed for this study. The measure was developed by the first author and pilot tested among the study team for readability, relevance, and suitability, resulting in minor modifications to questions to increase question comprehension (e.g., “How much sugar is recommended for women daily?”). Second, staff MI knowledge was assessed using a modified MI knowledge test [78]. The original measure was modified from 23 to 17 items to reflect the MI content taught in the SSBC training. Responses to both knowledge measures were scored for each staff. A third measure was used to assess staff knowledge of MI skills. The helpful response questionnaire (HRQ) is a brief measure to assess MI skills [79] and was administered to staff at pre-training, post-training and at implementation follow-up. Staff were asked to document how they would respond to six hypothetical patient statements. Staff were presented with the pre-and post-HRQ in person at the training workshop. The implementation follow-up HRQ was 24 completed as part of the implementation follow-up online survey. An adapted scoring method was used for this study to reflect the level of MI taught and the skills in which staff were expected to be proficient. One point was given for a response with the presence of an MI communication skill (open-ended question, affirmation, and/or reflection) and zero points were given for a MI non-adherent response. A final score was calculated out of six. Two coders (TD and KC) scored all responses. Any disagreements were discussed by both coders. 2.2.2.3 Level 3: Behaviour To assess if staff used their program knowledge and skills in practice, an in-depth fidelity assessment was conducted and has been reported elsewhere (see [80]). The study assessed whether staff implemented the program as intended by examining staff self-reported fidelity to session specific checklists and two independent coders cross-checked a sub-sample of audio-recorded sessions to ensure accuracy of staff self-report. In addition, goal setting fidelity (a key program component that relates to the goal setting and action planning behavior change techniques) was also examined. In this current study, staff use of MI-specific skills and strategies were assessed using the MI Competency Assessment (MICA)[81]. The MICA has been used in past research to assess use of MI during a session and has demonstrated reliability and validity [82]. Two coders (KC and MM) listened to 20-minutes of one randomly selected program session for each client (n = 32). Coders rated the staff’s use of five MI intentions (supporting autonomy and activation, guiding, expressing empathy, partnering, and evoking) and two MI strategies (strategically responding to change talk and strategically responding to sustain talk) on a 5-point scale from 1 (inconsistent with MI) to 5 (proficient with MI) for each audio recording. Items could be given a half-point. The five MI intentions aim to capture the overall spirit of MI. The coders also counted the frequency of two MI micro-skills (open-ended questions and reflections) within each coded 25 session. A random 25% of sessions were double-coded. Based on the MICA double-coding standards [81], the coders discussed any disagreements and came to consensus. 2.2.2.4 Level 4: Training Outcomes To assess training outcomes, two client measures were examined post-program that reflected staff program delivery. The first measure was the 15-item learning climate questionnaire [68, 69], which examined whether clients felt their basic psychological needs were met through program participation. The learning climate questionnaire has been used in various learning settings, such as within university and physical education contexts [68, 83]. Three additional items were included to examine empathy, a key aspect of MI, including one item for each of the three elements of empathy: ability to understanding another’s thoughts, feelings, and condition (e.g., “I felt the trainer was sensitive to my thoughts”). Clients were asked post-program to respond on a 7-point Likert scale (1 = strongly disagree; 7 = strongly agree). The learning climate questionnaire sub-scales (autonomy, competence, relatedness) demonstrated good internal consistency (α = .74–.97) in addition to the empathy sub-scale (α =.91). Finally, clients were asked to rate their overall satisfaction with their YMCA staff who facilitated them through the program. For this study, 1-item from a 10-item measure developed for this study on program quality (program and structures) was reported. The item measured overall staff satisfaction: “Please rate your satisfaction with your trainer?”. Staff satisfaction was chosen as a training outcome to represent whether clients felt their staff had delivered program components in a satisfactory manner. Clients were asked post-program to rate their confidence on a 7-point Likert scale from extremely dissatisfied to extremely satisfied. The entire 10-item program quality measure is available for reference in Supplementary File A. 2.2.3 Data Analysis A mean score was calculated for each measure and sub-scale. A paired-samples t-test was run to test for sustained effects on the program and MI knowledge measures, and the HRQ. 26 As recommended, multiple agreement statistics were calculated for the HRQ including percent agreement, Cohen’s kappa (K), and prevalence, and bias adjusted Kappa (PABAK) statistics [84, 85]. For MICA coding, the five MI intentions were averaged and added to the average of the two MI strategies to have one overall score to represent each staff’s use of the spirit of MI. Interclass Correlation Coefficients (ICC) were used to measure consistency in MICA coding across both coders [86]. All MICA-subscales and the question to reflection ratio are averaged for each staff and presented in Supplementary File B. All measures demonstrated normality with the Shapiro-Wilks test and no outliers identified based on Tabachnick and Fidell’s [87] criteria. 2.3 Results Overall, missing data for staff were low. One staff did not complete a post-training survey and one staff did not complete the implementation follow-up HRQ. Overall, post-program survey completion was moderate with 18 clients completing the learning climate questionnaire survey (56% response rate) and 17 clients completing the program quality survey (53% response rate). 2.3.1 Level 1: Reaction Table 2 presents the mean and standard deviation for staff satisfaction with the 3-day training. Overall, staff were satisfied with the training (M = 4.43, SD = 0.45). Staff agreed or totally agreed to 95% of all statements. Two statements had one staff responded neutrally to the items, “the topics were dealt with in enough detail and depth as the training allowed” and “the method of delivery was well-suited to the objectives and content”. Two staff disagreed to the item, “the length of the training was adequate for the objectives and content”. 2.3.2 Level 2: Learning Similar trends occurred for all three learning measures; all demonstrated high post-training scores that were retained at implementation follow-up. A paired samples t-test (t[6] = -0.13, p = 0.90) demonstrated staff’s program knowledge test scores did not significantly differ 27 between post-training (M =18.74, SD = 2.20) and implementation follow-up (M = 18.84, SD =1.40). Similarly, a paired-samples t-test (t[6] = -1.00, p = 0.36) demonstrated staff MI knowledge test scores did not significantly differ between post-training (M =13.17, SD = 1.33) and implementation follow-up (M = 14.00, SD =1.41). Finally, a paired-samples t-test (t[7] = -4.04, p = 0.01 demonstrated staff MI knowledge test scores significantly improved from pre- to post-training and there were no differences (t[6] = -0.18, p = 0.86) between post-training and implementation follow-up (see Table 3 for individual staff HRQ scores). Overall, coders had high agreement on all consensus markers for HRQ coding (84.78% agreement, K = 0.64; PABAK = 0.70). 2.3.3 Level 3: Behaviour On average staff delivered the program at a client-centred level (M = 6.34, SD = 0.83; Range: 3.75-7.80). Based on staff availability, staff facilitated between 3- 6 clients during the study timeframe. When assessed at the individual staff level, 5 staff operated above a client-centred level and 3 were below (see Table 3 for individual staff MICA scores). Overall, coders demonstrated excellent consistency with an ICC of 0.93. 2.3.4 Level 4: Training Outcomes Table 4 presents descriptive statistics for client responses to the learning climate questionnaire. Overall, clients perceived staff supported their basic psychological needs (M = 6.55, SD = 0.64). The mean for all the learning climate questionnaire sub-scales and the added empathy items obtained similar high results (A: 6.52, C: 6.47, R: 6.58, E: 6.67). Overall, clients reported high staff satisfaction scores (M = 6.88, SD = 0.33). 2.4 Discussion Training evaluations are an important component of assessing program fidelity and a vital implementation strategy during program translation and scale-up. Assessing training is a 28 necessary factor to understand if a program was delivered as planned to have confidence in program outcomes [60]. As a program is translated from research staff to community members, researchers must examine whether the training is effective in the new context. Thus, the present study examined the SSBC training for YMCA fitness facility staff and had positive results. This evaluation was guided by the Kirkpatrick Evaluation Model [73], a model commonly used in training evaluations. Study strengths include evaluating all four levels of Kirkpatrick’s model and using multiple perspectives. The training was effective for staff and demonstrated community members are a feasible resource to implement evidence-based counselling programs. Past diabetes prevention programs have used MI (e.g., [88, 89], including the original United States Diabetes Prevention Program [9]. However, MI training and subsequent fidelity have not been explicitly evaluated in these programs. Rather, training effectiveness was determined using client outcomes as a proxy. In doing so, it is impossible to determine if staff were using MI skills in practice. One related study that targeted diet, exercise, or smoking behaviors among individuals at risk for diabetes and/or cardiovascular disease did include an MI evaluation [90]. Practice nurses underwent 12 hours of MI training, received a treatment manual and on the job coaching halfway through the intervention. Overall, nurses’ skills in practice were low, despite their self-reported confidence. The researchers hypothesized the training was not long enough to improve counselling techniques and suggested the shift in practice (i.e., common for nurses to give advice, explain things to patients which is avoided when using MI) may require more time to implement. While the above examples took place in healthcare contexts, there remains a lack of research examining the use of MI in non-healthcare related fields. Prior research has demonstrated that the YMCA is a promising organization to disseminate a group-based diabetes prevention program achieving positive program outcomes [91]. The current study extends this notion by demonstrating YMCA staff can learn MI during a 3-day (17-hour) in-person training workshop and implement MI within their program sessions. When examining MI specific skills, staff HRQ increased from pre- to post-training and staff 29 maintained their skills at the implementation follow-up timepoint, which is in line with previous MI training evaluations [63]. Fitness facilities may be a promising community-based venue to deliver an MI-informed brief-counselling diabetes prevention program. Although the fidelity of MI skills has not been examined in diabetes prevention programs, it has been examined in other fields. For pragmatic reasons, staff did not complete a pre-training audio recording of a counselling session. Therefore, comparisons of staff MICA scores from pre- to post-training were not done, which has been done in past training evaluations [63]. Rather, the MICA tool was used to assess if staff reached the client-centered level of care, a less reported and valuable statistic. Overall, staff used MI skills in practice with an average MICA score of 6.3, indicating a client-centered level of care (≥6). When examining individual staff scores, some staff achieved higher MICA scores than others. Overall, five staff were operating above a client-centered level of care and three staff were operating close to, but below a client-centered level of care. These results are similar to a sample of community health agents from Brazil who underwent MI training. Overall, 13 community health agents were categorized as medium-or-high performance and 3 were categorized as low performance when MI fidelity was assessed using a researcher completed checklist of 10 MI techniques [64]. It is important to recognize that some staff may learn and apply MI more quickly than others. Thus, more research is needed on how to move individuals operating at a level below client-centered care to a level at or above client-centered care, or how to effectively screen for competency prior to training. Self-determination theory has been suggested as a potential conceptual framework for explaining how and why MI works [65, 67]. While the learning climate questionnaire was developed for assessing the basic psychological needs (autonomy, competence, relatedness), it has been argued that MI is a complementary approach that also aims to support closely related constructs [68, 69, 92], Therefore, in response to a recommendation in the literature [65], the learning climate questionnaire was used as a marker of MI use. To our knowledge, this is the 30 first study to use the learning climate questionnaire to assess basic psychological needs in an MI study. Results demonstrated that clients felt supported by their staff on all three basic psychological need sub-scales and on the added empathy measure. Although some staff may not have reached a client-centered level of care on their MICA coded sessions, the staff were able to foster a positive leaning environment throughout the program that was perceived as by clients empathetic and supporting clients’ autonomy, competence, and relatedness. Future research should consider similar analyses to assess MI use. 2.4.1 Limitations This research was affected by COVID-19 (YMCA and associated programming were forced to close due to the pandemic), is limited by a small sample size and results may lack generalizability. A pre-training knowledge test was not administered as all staff were naïve to working with individuals at risk for developing T2D and the program’s standard operating procedures prior to the workshop. Similarly, there was no pre-training audio recorded session to capture staff pre-training MICA scores. This decision was made for pragmatic reasons. In evaluation research, data collection methods (e.g., knowledge test) can act as part of the training to increase the likelihood that staff demonstrate a minimum level of knowledge gained [93]. In doing so, after the evaluation is over, the data collection tools used remain a component of the training, increasing feasibility (i.e., reduce staff burden) and supporting future scale-up. All staff were naïve to MI prior to the training except one who completed a university level MI course. No staff had previous counselling experience. The HRQ gauged pre-training MI levels and indicated all staff had low levels of MI skills prior to the training, except the one staff with prior MI knowledge. In the current training, all staff had a research team member shadow all sessions with their first client and provide feedback post-session. As a conservative measure, these clients were included in the MICA scoring. In general, MICA scores for the shadowed clients were consistent with future client scores. While not all staff reached a client-centered 31 level, clients’ perceived staff to support their basic psychological needs. The current study was pragmatic in nature and aimed to examine the training effectiveness. Therefore, all staff continued regardless of MI quality. On completion of the program, clients were sent a post-program survey through an email from the research team and had a moderate response rate (~50%). Future research should consider completing surveys during the final appointment or offer an incentive to increase response rates. 2.4.2 Lessons Learned Staff praised the shadowing experience for providing comfort during their first experience implementing the program and an opportunity to receive direct feedback on their program delivery. However, it was difficult to coordinate scheduling and is not feasible for scale-up. Similarly, finding time for all staff to attend a 3-day in-person training workshop was challenging due to conflicting staff work schedules. Translating the training into a self-paced digital training may better support scale-up and sustainability of the training for broad scale-out. Future research should examine novel ways to mimic the reverse shadow experience to adequately prepare staff, such as incorporating a mock session. Conducting a training evaluation was invaluable to learn how the training was received and implemented by YMCA staff, and how clients were affected by their staff’s execution of the program. The current study demonstrates that MI can be taught to fitness facility staff. Previous research has suggested MI was difficult to learn, with those struggling wishing to have more training [89]. Indeed, the one item that two staff disagreed with related to training length. Interestingly, current results indicate that staff who complete training at a client-centered level of care, generally maintain that level post-training. Markers for staff competency or booster training sessions should be explored to better achieve a client-centered level of care for all staff prior to graduating the training. 32 2.4.3 Conclusion Implementing a program as it was intended to be implemented gives confidence that program outcomes are a result of the program structure and delivery [60]. All staff attended a standardised training to learn how to implement the SSBC program effectively and reliably. Results demonstrate staff were satisfied with the training, developed the knowledge and skills to implement the program effectively, and applied the knowledge and skills in practice. In turn, clients felt their basic psychological needs were supported and were satisfied with their staff. While this study does not assess client outcomes, a successful training can positively affect clinical outcomes [28]. Although client outcomes from the current study have been affected by the COVID-19 pandemic and are ongoing, evidence of program effectiveness when implemented by research staff is high [49]. Current and prior results (i.e., [94]) indicate that staff implement the program with fidelity which provides confidence that similar outcomes may result. Overall, this study demonstrated that the SSBC training was effective for fitness facility staff and is suitable to use for program scale-up. Future research should consider community members as a feasible resource to implement community-based counselling programs. 33 Table 1: Overview of measurement timepoints Kirkpatrick level Measurement Timepoint Staff Pre-training Staff Post-training Staff Implementation follow-up Client Post-program 1 Training satisfaction  2 Program knowledge test   2 Motivational interviewing knowledge test   2 Helpful response questionnaire    3 Motivational Interviewing Competency Assessment * 3 Program fidelity * 4 Learning climate questionnaire  4 Satisfaction with staff  Note. * Staff behaviors were assessed for every client they facilitated post-training 34 Table 2: The mean and standard deviation for staff satisfaction with the 3-day training program. How would you rate the following items? Mean (SD) In my opinion the planned objectives of the training were met 4.29 (0.49) The topics were dealt with in enough detail and depth as the training allowed 4.29 (0.76) The length of the training was adequate for the objectives and content 3.86 (1.35) The method of delivery was well suited to the objectives and content 4.29 (0.76) The method of delivery used enabled us to take an active part in training 4.57 (0.54) The training enabled me to interact/share experiences with my colleagues/others in the group 4.71 (0.49) The training was realistic and practical 4.43 (0.54) The resources provided were useful 4.43 (0.54) The training context was well suited to the training process 4.43 (0.54) The training received is useful for my specific job 4.71 (0.49) The training received is useful for my professional development 4.71 (0.49) The training merits a good overall rating 4.43 (0.54) Scale ranged from 1 to 5 35 Table 3: Helpful response questionnaire (HRQ) and Motivational Interviewing Competency Assessment (MICA) scores per staff Staff ID Pre-training HRQ score (n = 8) Post-training HRQ score (n = 8) Implementation follow-up HRQ score (n = 7) MICA Score M (SD) (n = 32) 1 1 6 6 6.62 (0.42) 2 0 6 Missing 5.81 (0.56) 3 3 3 5 6.96 (0.55) 4 0 6 3 5.03 (1.11) 5 0 3 6 6.07 (0.15) 6 6 6 6 7.08 (0.39) 7 0 5 6 6.20 (0.74) 8 4 5 4 5.83 (0.88) Total M (SD) 1.75 (2.31) 5.00 (1.31) 5.14 (1.21) 6.34 (0.83) HRQ score is out of 6; MICA score is out of 10 with a score of ≥ 6 indicating a client-centered level of care. 36 Table 4: The mean and standard deviation for client responses to the learning climate questionnaire Sub-scale Statement Client A I felt that the trainer provided me with choices and options 6.50 (0.86) A I felt understood by the trainer 6.50 (0.71) A I was able to be open with the trainer during the sessions. 6.61 (0.61) A The trainer showed confidence in my abilities to do well. 6.50 (0.79) A The trainer encouraged me to ask questions. 6.56 (0.71) A The trainer tried to understand how I’d see things before suggesting new ways to do things. 6.39 (0.98) A The trainer listened to how I would like to do things. 6.61 (0.61) C The trainer helped me to improve. 6.67 (0.59) C The trainer made me feel like I was good at exercise. 6.17 (1.54) C I felt that the trainer wanted me to do well. 6.72 (0.58) C The trainer made me feel like I was able to do the activities in the program. 6.33 (1.46) R The trainer supported me. 6.67 (0.59) R The trainer had respect for me. 6.67 (0.59) R The trainer was interested in me. 6.28 (1.49) R I felt that the trainer was friendly towards me. 6.71 (0.59) E I felt the trainer was sensitive to my thoughts 6.71 (0.59) E I felt the trainer was sensitive to my feelings 6.67 (0.59) E I felt the trainer was sensitive to my current life situation 6.65 (0.86) Autonomy sub-scale 6.52 (0.71) Competence sub-scale 6.47 (0.87) Relatedness sub-scale 6.58 (0.68) Empathy items 6.67 (0.63) Scale ranged from 1-7; A, autonomy; C, competence; R, relatedness; E, empathy 37 Chapter 3: Fitness Facility Staff Demonstrate High Fidelity When Implementing an Evidence-Based Diabetes Prevention Program 3.1 Introduction Four hundred, sixty-three million adults are living with diabetes worldwide and 374 million people are at increased risk of developing type 2 diabetes (T2D) [95]. With T2D on the rise, prevention is a priority. Diet and exercise modifications remain the foundation of T2D prevention [96] with demonstrated efficacy [9]. Despite this strong evidence, costly interventions designed for clinical trials are not feasible to implement in real-world settings [21]. To better reach individuals living at risk, programs must be implemented into accessible and sustainable community settings. There have been multiple studies examining the translation of diabetes prevention programs in real world settings (e.g., [19, 97]) and community settings (e.g., [98]), the largest to date being the dissemination of the United States National Diabetes Prevention Program [51, 99], a translation program from the original United States Diabetes Prevention Program [9]. However, many of these studies focus predominantly on physiological outcomes (e.g., weight, HbA1c). Few studies to date engaged in implementation evaluations to understand conditions that led to effective implementation and understanding the quality in which diabetes prevention programs are implemented. From the limited work that exists, the implementation of the National Diabetes Prevention Program was examined, identifying promising features of program delivery, including recruitment, program adaptations, and techniques to engage participants [51]. However, this study did not provide in-depth information on how or why such features were implemented and lacked any assessments of the fidelity of implementation. Such information is essential for program improvement and understanding mechanisms leading to program outcomes. Conducting implementation evaluations can help close this gap. Such an evaluation examines the extent an intervention is delivered as intended per protocol and increases 38 confidence that intervention results are due to the intervention [60, 100]. Knowing exactly what was implemented, and how, is critical to understanding the internal and external validity of translating evidence-based interventions into practice [60]. The National Institute for Health Behavior Change Consortium identified five intervention fidelity components: (a) study design, (b) training providers, (c) delivery of treatment, (d) receipt of treatment, and (e) enactment of treatment [60]. Together, these five components provide a thorough understanding of how and why an intervention produces (or does not produce) intervention effects. First, the study design must adequately test the active ingredients. Second, staff must be satisfactorily trained to deliver the program to clients. Third, the program must be delivered as intended per protocol (delivery of treatment). Fourth, clients must understand the content provided in the program and/or perform intervention skills (receipt of treatment). Finally, clients must put the skills and information learned through the program into action in their daily life (enactment of skills; [60]). Assessing these five components is the best practice for improving the reliability and validity of complex health behavior intervention research to be translated into real-world settings [60]. Despite the value of implementation evaluations, they are rarely conducted [101]. Researchers typically only investigate treatment delivery [102-104]; intervention receipt and enactment are rarely assessed [101, 105]. Specifically, fidelity assessments are limited in the field of diabetes prevention. A systematic review on critical factors for implementing real-world diabetes prevention programs identified only one study from 38 that vaguely mentioned program components were delivered more frequently than omitted [97]. To our knowledge, there is only one similar study that assessed fidelity in a community-based, volunteer-led diabetes education program [103]. However, they did not specifically target those at risk for developing T2D and did not examine staff self-reported fidelity, client receipt or engagement. Comprehensive fidelity assessments that target multiple fidelity components are needed. Therefore, the current study addressed these gaps in the literature. As in prior research, intervention receipt and enactment are collectively referred to as intervention engagement [101]. 39 The purpose of this research was to examine the delivery of, and engagement with, an evidence-based diet and exercise diabetes prevention program when delivered by a community organization. Prior research has studied the efficacy of the program within a laboratory setting on health-related outcomes [48] and evaluated the program training [94]. The current study evaluates the three remaining fidelity components outlined by Bellg [60]. Two guiding questions were asked: (a) to what extent do trained staff implement the program as planned; (b) to what extent do clients engage in the program? Based on the nature of the research questions, no hypotheses were proposed. Understanding how interventions are delivered and engaged with can provide feedback on program implementation, give confidence to intervention results and support future scale-up. 3.2 Methods 3.2.1 Program Description After Small Steps for Big Changes demonstrated efficacy and effectiveness on health-related outcomes (e.g., improved cardiorespiratory fitness, moderate to vigorous physical activity, body fat percentage and waist circumference measured at 6- and 12-months post-program) in a laboratory setting [48], the program was translated into a community setting. To support uptake and sustainability, a one-year collaborative planning process with the community partner, a local not-for profit fitness facility with over 17 000 members, was undertaken. This 1-year knowledge translation process resulted in an implementation plan to translate the program into two local community sites, as a feasibility test for future scale-up [50]. Small Steps for Big Changes is a brief diabetes prevention program for individuals aged 18+ who are at risk for developing T2D based on HbA1c of 5.7-6.4% or completion of the American Diabetes Association risk questionnaire with a score of ≥5 [106]. The goal of the program is to help clients make lasting changes to their diet and exercise behavior to lower risk of developing T2D. Clients were recruited through a local physician referral system, social media posts, promotional 40 materials (e.g., pamphlets, posters), program website, word-of-mouth, and community events. The program consists of six, one-on-one in-person sessions with trained staff over a 3-week period (3 sessions in week 1, 2 sessions in week 2, 1 session in week 3). This structure allowed clients time to practice their self-management skills (e.g., self-regulation, routine physical activity) between sessions. Clients were encouraged to track their diet and exercise on a mobile tracking application (app) over the 3-week program period. Sessions ran between 70-90 min in duration (30-min exercise portion, 35-50-min counseling portion, 5-10-min logistics/paperwork portion for staff). 3.2.1.1 Staff Training Staff learned of the program during the one-year planning process and those interested voluntarily enrolled in the training. Any staff not available for the first training was offered to attend the second training, in addition to any new staff wanting to enroll at that later date. To sufficiently prepare for implementation, fitness facility volunteers (N =1) and staff (N = 12) attended a three-day training workshop. Attendees were given an implementation manual, including standard operating procedures, scripts, and checklists for each of the six sessions, and watched videos of research team members deliver session content. Finally, a research team member shadowed new staff with their first client and provided feedback after each session. As a pragmatic trial, all staff were retained regardless of quality. Monthly meetings were held with all trained staff and the research team. Meetings were used as an in-person community of practice to provide support, the opportunity for staff to learn from one another and to discuss program delivery, ongoing challenges, and lessons learned. 41 3.3.1 Data Collection 3.3.1.1 Staff and Clients All clients and staff provided written informed consent. One staff and one volunteer dropped out of the training for unrelated reasons. One staff completed the training but did not facilitate any clients through the program due to reduced hours. Thus, 10 staff completed the training and facilitated clients through the program. Staff were on average 32.60 ± 9.06 years of age (range 24-51), were predominantly women (90%), and self-identified as Caucasian (90%). Staff were employees of the community organization for <1 year (10%), 1-5 years (40%), and 10+ years (50%). Most staff had a University certificate, diploma or degree (60%), other non-university certificate or diploma (30%) or prefer not to answer (10%). Twenty-six clients enrolled between August 2019 and March 2020 and were matched to one of the ten staff. Clients were on average 59.46 ± 7.69 years of age (range 43-70), were predominantly women (62%), and self-identified as Caucasian (85%). 3.3.1.2 Staff Self-Reported Session Fidelity Staff completed six session-specific checklists that covered intervention components, divided into 4 categories: (a) logistics, (b) counseling, (c) exercise, (d) optional tools. The fidelity checklists were developed to reflect key elements from each session in the program and staff were instructed to complete them post-session. One (1) point was awarded if the item was completed and zero (0) points were awarded if the item was not completed. Items left blank were labelled “missing” and no points were awarded. This conservative approach for treating missing data has been used in one prior fidelity study [107]. Points were manually awarded if staff documented a valid reason for not completing an item (e.g., if a client was not able to exercise due to safety protocol, all exercise fidelity points were awarded). The session checklists contained between 19-28 compulsory items and 2-3 optional tools. Program tools (e.g., mobile tracking app, client notebook, sample nutrition labels) were designed to 42 complement the compulsory intervention material and offered to each client. To support client autonomy, the use of program tools were optional. Feedback on checklist readability and understanding was provided by staff during their first monthly meeting and minor editorial revisions were made to ensure accurate recording of session fidelity. Completed staff checklists were entered into Qualtrics and exported to SPSS. 3.3.1.3 Independent Coder Counseling Session Fidelity Check All sessions were audio-recorded. In line with similar fidelity assessments of audio recordings [108, 109], and to ensure feasibility of this research, two sessions (33.3% of client sessions) were selected to undergo independent coder fidelity checks, staff were unaware of session selection. Sessions three (physical activity focused) and four (diet focused) were chosen as these sessions are in the middle of the intervention (rapport has been built) and both focus on a specific intervention behavior. By selecting two sessions, as opposed to a random assortment, staff comparison is facilitated as selected sessions had specific information to exchange and accounts for staff delivery of two different behavioral topics. Selecting specific sessions to complete a fidelity check has been done in previous research [109]. Only the counseling portion of the appointment was audio-recorded; thus, only the counseling and optional tools section of the fidelity checklist were completed for the independent coder fidelity check. The independent coder also answered two questions after listening to the session: (a) Please rate the client’s engagement in the session and (b) Please rate the overall quality of session delivery. Both questions were rated on a scale from 0 (client did not engage in the session) to 5 (client engaged in all of the session with maximal interest; took active interest in discussion) and 0 (staff did not cover any of the session content as defined by the checklist) to 5 (staff delivered all of the session content as defined by the checklists, went over and above delivering the content in a clear and concise manner and supported client exploration of the topics). Completed independent coder fidelity checklists were entered into Qualtrics and 43 exported to SPSS. To ensure reliability and internal consistency, 20% of the audio-recorded sessions were tested for inter-rater agreement by a trained research assistant (first author). 3.3.1.4 Independent Coder Goal Fidelity Check Staff were trained to engage in brief action planning [110] with their client at the end of every session and document client goals on the session-specific checklists. Ideas for goals came from the client, with staff providing support to build an action plan. Clients could choose how many goals they wanted to set or decide not to set a goal. All goals were extracted from the session checklists and entered in a spreadsheet (n = 285). Each goal was assessed for (a) staff goal-setting fidelity, (b) client intervention receipt, and (c) client goal enactment independently by two coders (outlined below). All disagreements were discussed by two coders (first and second authors), and independent insight was consulted when needed (third and fourth authors). Successful brief action planning should result in clients creating SMART (specific, measurable, attainable, relevant, time-based) goals [110]. To assess staff goal-setting fidelity, all goals were assessed according to SMART criteria. A goal qualified as specific if it answered at least two of the following questions: what, why, where, with who, how. A goal was measurable if the success or lack of success could be quantitatively measured. A goal was attainable if the client indicated a confidence level of ≥7 (staff were trained to ask and document client confidence levels for goals). If a client had not reported a confidence level, they received a “no” as we did not want to assume if a goal was attainable for the client. A goal was relevant if it was applicable to the program topics (diet, tracking, behavioral regulation and/or exercise). A goal was time-based if the client noted a specific date or time to achieve their goal. Each letter in the SMART acronym was dichotomized into a yes and no coding system, with a score of yes receiving one (1) point and a score of no receiving zero (0) points. A fully SMART goal resulted in a score of 5, such as, “Walk in the local park Thursday afternoon for 30 minutes”. 44 To assess client engagement, client goals were examined for fit with intervention content (receipt) and if the client achieved their goal (enactment). Client intervention receipt used client goals as a proxy, with the assumption that a client only created a goal if they adequately understood the session content and applied the information to their diet and/or exercise behaviors. All documented goals were coded to determine if they reflect intervention content and were coded into the following themes: (a) exercise, (b) diet, (c) tracking, (d) behavioral regulation, and (d) not related. A goal involving completing a physical activity bout of any type fell under the "exercise" category. Goals in relation to nutrition were categorized under "diet". Goals that revolved around tracking diet or exercise in any form were coded under "tracking". Goals set to encourage the client to perform a behavior or learn more about a behavior were coded as "behavioral regulation". A goal was coded as "not related" if it did not fall under one of the four other respective categories (e.g. pick-up furniture on Saturday). Clients were encouraged to track their diet and exercise on a mobile tracking app, a program tool where staff and researchers were able to view client tracking through a research portal. Client goal enactment was retrospectively accessed through the research portal. Goals were scored as either (a) achieved, (b) partially achieved, (c) not achieved, (d) not able to assess, (e) not tracking, or (f) no goal. If the client’s tracking matched their goal fully then it qualified as “achieved”. A goal was “partially achieved” if a client’s tracking reflected working towards their goal but not completing it. “Not achieved” was coded if the client did not show any progress towards achieving the goal. If a client had <5 items tracked for 3 days in a row, the client received the code “not tracking”. A goal received the code “not able to assess” if the client’s goal was unable to be evaluated from the information available on the mobile tracking app (e.g., step-count goal). Finally, if staff did not record a goal on the session checklist, then the client received the code “no goal”. To ensure the goals documented on session checklists accurately reflect the verbal communication between client and staff, an independent coder assessed a random 20% of audio files and extracted clients’ goals from the audio-recorded 45 sessions. Extracted goals were then SMART scored and compared to staff-documented SMART scores. 3.4.1 Data Analysis Fidelity scores (overall fidelity, four individual checklist categories), were obtained as mean scores and converted into a percentage for each session. The independent coder fidelity checklist responses were compared to staff checklist responses and agreement statistics were calculated. Descriptive statistics were completed for client engagement and staff quality questions. Client’s goals were analyzed using content analysis to determine a SMART goal score, client receipt of intervention, and client goal enactment. Descriptive statistics were calculated for SMART goals and client goal enactment. Based on recommendations to present multiple agreement statistics [84, 85], Cohen’s kappa, prevalence, and bias adjusted Kappa (PABAK) and percent agreement statistics were calculated. Both Cohen’s kappa and PABAK consider chance agreement, with PABAK considering both positive (code is present) and negative agreement (code is not present) and Cohen’s kappa only considering positive agreement [84]. Percent agreement does not consider chance agreement [84]. 3.3 Results 3.3.1 Staff Self-Reported Fidelity All clients completed the program, resulting in 156 session checklists. Table 5 presents descriptive statistics for staff self-reported fidelity. Only 5% of checklist items were missing across all 6 sessions, with 39% of the missing data coming from one staff. Fidelity was high with compulsory items being delivered on average 85-93% of sessions. 3.3.2 Independent Coder Counselling Session Fidelity Check An independent coder listened to session three (n = 24) and session four (n = 25) audio files and completed a fidelity checklist. Two session three and one session four audio files were 46 missing. A second coder listened to a random 20% of audio files and had high agreement with the independent coder (Session 3: 94%; Session 4: 89%). Table 6 compares staff self-reported fidelity and independent coder fidelity. Overall, the staff and independent coder agreed in 90% of cases. The independent coder’s assessment of client engagement and staff quality was high. Client engagement averaged 4.08±0.78 (range: 3-5) and 4.00±0.73 (range: 3-5) and staff quality averaged 4.00±0.81 (range: 2-5) and 4.00±1.06 (range: 1-5) for session 3 and 4, respectively. 3.3.3 Independent Coder Goal Enactment Fidelity Check Of the 156 session checklists entered, 275 goals were extracted whereby clients made at least one goal in 94% of program sessions (M = 1.8/session); 10 checklists contained no goals. All documented goals were coded for meeting SMART criteria and descriptive statistics are presented in Table 7. Two independent coders had high percent agreement (94%). In general, staff-documented goals had high agreement with the independently coded audio-file documented goals (S 87%; M 91%; A 87%; R 100%; T 81%). Goals reflected program topics with 43% exercise (n = 123), 31% diet (n = 89), 14% tracking (n = 39), 8% behavioral-regulation (n = 22), and 0.4% not related (n = 1) with 90% agreement between coders (Cohen’s kappa = -0.05; PABAK = 0.80). Of the 275 goals created, 55% were not able to be assessed either (a) through the mobile tracking app (64%) or (b) the client not tracking on the mobile tracking app (36%). Thus, 45% of goals were assessed. Of those goals, 78% were achieved, 15% were partially achieved, and 7% were not achieved with an 87% agreement between coders. 3.4 Discussion Implementation evaluations are rarely conducted, and client engagement and delivery fidelity are often assumed [101]. Without understanding whether interventions are delivered as planned (by staff) and engaged with (by clients), it is difficult to fully understand whether an intervention is effective, and why or why not. This comprehensive evaluation assessed the 47 implementation of an evidence-based diabetes prevention program by trained staff within a non-profit community organization. To our knowledge, this is the first in-depth fidelity assessment in a community-based diabetes prevention program that assesses treatment fidelity in addition to client engagement and receipt. The evaluation examined three fidelity components (delivery, receipt, and enactment of treatment) as identified by Bellg [60] with the other two components (study design, training providers) assessed in prior research [48, 94]. The study includes multiple perspectives (client, researcher, staff) and multiple methods (fidelity checklists, audio recordings) to examine implementation delivery, receipt, and enactment. In addition, in-depth goal coding was completed to assess the degree clients set SMART goals, a key program component. Overall, the program was implemented with high fidelity when delivered by staff employed at a community organization and clients were highly engaged. Staff delivered the intervention as intended with high fidelity. Average staff self-reported fidelity was 90%, which is similar to other fidelity studies (100%, [102]; 65%, [109]). The high fidelity may be related to the use of the following recommended strategies, including 3-day training workshop, intervention manual with scripts, a senior trainer observing new staff with a client, audio recording of sessions, session checklists and monthly staff meetings [60]. Future research will test a modified version of these strategies in future scale-up sites (e.g., virtual training program, practice phone calls) to understand what combination of strategies, resources and level of support is needed to support successful implementation. The gold standard to assess treatment fidelity is to audio-record all sessions and evaluate sessions compared to a priori criteria [60, 104]. As in similar fidelity assessments, to maintain feasibility, a selection of audio-recoded sessions were coded [108, 109]. Independent coder scores for the counseling sessions (83%, 81%) were modestly lower when compared to the staff scores (91%, 89%) for session 3 and 4, respectively. In the case of disagreement (overall 11%), the majority were a staff reporting they completed an item (87%), but the coder did not. Although this discrepancy between staff and independent coder has been found in 48 previous research (45%, [102]; 42%, [109]), our results show less discrepancy. Higher independent fidelity scores have been previously reported (81%, [103]; 66%, [104]). Agreement may have been enhanced by using a simple fidelity checklist [111]. Comparing these fidelity studies, lower fidelity scores seem to occur with comprehensive fidelity assessments (e.g., evaluating specific behavior change techniques [BCTs] and/or intervention behaviors [102, 104, 109]) compared to less comprehensive fidelity assessments, such as coding broad intervention techniques (e.g., goal setting, providing information; [103]). Future research is encouraged to examine what level of fidelity evaluations provide the best feedback on program implementation, whilst minimizing burden. The current analysis reflects staff delivery of core intervention components and broad clusters of BCTs (e.g., goal setting, self-monitoring of behaviors) and does not analyze delivery of all the specific BCTs contained in Small Steps for Big Changes. Full BCT coding of the program was completed after this study and can inform a future, more comprehensive, fidelity assessment [70]. More comprehensive fidelity evaluations may increase burden on the researcher (developing and coding the intervention), training of intervention facilitators, ongoing assessment of fidelity and trained research staff to analyze data and provide feedback [102]. Conducting quality fidelity evaluations that balance researcher burden and providing useful program data is necessary. Client receipt and enactment are two understudied factors that impact intervention success [101]. For interventions to be successful, clients must interact with the program to learn and apply the targeted skills. Overall, 96% of client-created goals were related to program content, suggesting clients received the intervention as intended (gather program information and create relevant goals to put that information into action). Only 4% of program sessions resulted in no goal formed. Of the goals that could be assessed (45% of all goals), 93% were achieved or partially achieved suggesting that clients are not solely receiving program information, but actively making behavior changes. A fidelity study by Walton et al. [107] 49 assessed receipt and enactment through four participant self-reported responses with comparable results. Although examining program effectiveness is outside the scope of the current study, high levels of participant engagement have been shown to be associated with greater participant outcomes [109]. Brief action planning is a highly structured technique to facilitate goal setting, create a SMART goal, and foster client self-efficacy [110]. A well-defined goal can help individuals focus their intentions and evaluate their behavior to a success standard [112]. Overall, goals had a high SMART score, with attainable and timebound categories having the lowest scores. For the attainable category, only 50% of goals had a confidence rating. Asking for a confidence rating is important to gauge client self-efficacy [110] as low self-efficacy is associated with non-completion [113]. Just over 50% of goals were timebound. Within the Small Steps for Big Changes program, goals are often created to be executed between sessions. Staff may have omitted this detail when documenting goals thinking it was implied. Indeed, in the 20% audio-file check, time-bound had the lowest agreement (81%). Future staff training will reiterate the importance of SMART goal categories, specifically attainable and time-bound, to facilitate even stronger SMART goals. The operationalization and evaluation of this key program component led to useful practical feedback to improve implementation and should be considered in future implementation evaluations. High goal achievement (78%) may have been facilitated by the program through offering clients the opportunity to create their own goal(s), execute goal(s) within a short time-frame, reflect on the goal(s) at the following session, and modify goal(s) as needed [113]. High goal achievement has been found before. For example, an online health behavior change study examined self-reported weekly action plan completion over a 6-month study period and found 49% of action plans were completed, 40% partially completed and 11% not completed [113], similar to our current results. Despite the commonly reported “intention-behavior” gap [114], 50 current results indicate clients in Small Steps for Big Changes turned their intentions into actions. 3.4.1 Limitations and Future Directions Study limitations must be acknowledged. A dichotomous scale (yes/no) was used to evaluate fidelity checklist components and does not reflect the extent to which material and skills were delivered by staff. Future fidelity checklists could consider a broader scale (e.g., 5-point). Client goals were evaluated from staff-completed checklists and therefore may not accurately reflect all the details described orally between the staff and client. However, staff documented goals had high agreement to audio-file goals from a 20% random independent audio-file review. Client goal enactment could not be assessed for clients who were not tracking or chose to create goals that were not able to be assessed via the app (e.g. step goal). The method for analyzing client enactment was chosen for pragmatic reasons as it minimized client burden; tracking was an optional tool for clients to engage in and researchers had access to app data. The current method is limited in that the difference between a client not achieving a goal and not being able to assess a goal was not able to be examined. Although only 45% of goals were able to be assessed using this method, we feel that it reflects client behaviors and is a novel method to assess goals as opposed to client self-report on a questionnaire as used in previous studies [107]. Future research should continue to explore methods to examine low-resource techniques to study treatment enactment such as having coaches confirm client goal achievement on fidelity checklists. Fidelity checklists were developed to minimize burden for staff, whereby they were short and easy to complete and had a dual-purpose—an implementation tool (e.g., reminder of intervention content and skills) and a data collection tool [60]. Although fidelity checklists are low cost and easy to use, social desirability and recall bias may make them less reliable. The present analysis suggests the programs’ fidelity checklist are a good measure of treatment 51 fidelity when compared to the audio-recorded independent coder scores. The low rate of missing data on the fidelity checklists provide positive indications for checklist practicality and acceptability [101] and will be further investigated in qualitative work interviewing staff within the community organization. Qualitative work will help ensure feasibility and sustainability of the intervention and to investigate the high degree of missing data from one staff in this present study. 3.4.2 Conclusion Small Steps for Big Changes was implemented with high fidelity in two community sites, which increases the confidence that program results are from the intervention. Working with a community partner to develop and execute an implementation plan, may have led to higher fidelity. While evidence of effectiveness in a community setting is high [49], preliminary outcomes related to the current study demonstrate success, yet are ongoing. Implementation evaluations are useful to understand how programs are being implemented, received, and engaged with. Such valuable feedback can be used to understand the program, refine implementation strategies to support future program translations and scale-up efforts, and better reach and impact at risk individuals. 52 Table 5: Descriptive statistics for fidelity checklist data per session and sub-scale (N = 26). Session 1 M (range) Session 2 M (range) Session 3 M (range) Session 4 M (range) Session 5 M (range) Session 6 M (range) Logistics (%) 90 (45-100) 93 (40-100) 93 (44-100) 91 (0-100) 94 (50-100) 88 (12-100) Counselling (%) 88 (38-100) 88 (71-100) 90 (75-100) 87 (0-100) 82 (29-100) 76 (0-100) Exercise (%) 85 (0-100) 94 (25-100) 100 (100-100) 96 (0-100) 88 (0-100) 88 (0-100) Optional tools (%) 94 (50-100) 85 (33-100) 68 (0-100) 72 (0-100) 58 (0-100) 54 (0-100) Total score (%) 88 (33-100) 92 (57-100) 93 (71-100) 90 (0-100) 89 (32-100) 85 (7-96) Total score with optional tools (%) 89 (38-100) 91 (63-100) 90 (71-100) 98 (0-100) 86 (38-100) 83 (7-97) Missing* (%) 6 3 2 5 3 6 Note. If an item was left blank on the checklist, it was deemed missing and no point was awarded. As a conservative measure, missing data was not subtracted from the total count, therefore missing data is equivalent to selecting no. 53 Table 6: Agreement between staff and independent coder on delivery of intervention components Checklist Items Agreement Disagreement Staff = Yes Coder = Yes Staff = No Coder = No Staff = Yes Coder = No Staff = No Coder = Yes Session 3 I checked in or helped revise the client's goal(s) 24 (100%) 0 0 0 Information exchange: Physical sensations during exercise 22 (91.7%) 0 2 (8.3%) 0 Information exchange: Talk test 23 (95.8%) 1 (4.2%) 0 0 Information exchange: Physical sensations after exercise 23 (95.8%) 0 1 (4.2%) 0 I helped the client create goal(s) (depending on client readiness) 22 (91.7%) 0 1 (4.2%) 1 (4.2%) I wrapped up the session 16 (66.7%) 3 (12.5%) 5 (20.8%) 0 Total Counselling Checklist 130 (90.3%) 4 (2.8%) 9 (6.3%%) 1 (0.7%) I offered to look through: Mobile tracking app with the client 19 (79.2%) 4 (16.7%) 1 (4.2%) 0 I offered to look through: Client workbook with the client 9 (37.5%) 8 (33.3%) 6 (25.0%) 1 (4.2%) Total Optional Tools 28 (58.3%) 12 (25.0%) 7 (14.6%) 1 (2.1%) Total Session 3 158 (82.3%) 16 (8.3%) 16 (8.3%) 2 (1.0%) % Agreement 90.63 Kappa 0.59 PABAK 0.81 54 Session 4 I checked in or helped revise the client's goal(s) 25 (100%) 0 0 0 Information exchange: Carbohydrate choices 24 (96.0%) 0 1 (4.0%) 0 Information exchange: Above ground/below ground vegetables 23 (92.0%) 2 (8.0%) 0 0 Information exchange: Portion sizes: The plate model 21 (84.0%) 0 4 (16.0%) 0 I helped the client create goal(s) (depending on client readiness) 23 (92.0%) 0 2 (8.0%) 0 I wrapped up the session 16 (64.0%) 3 (12.0%) 6 (24.0%) 0 Total Counselling Checklist 132 (88.0%) 5 (3.3%) 13 (8.7%) 0 (0.0%) I offered to look through: Mobile tracking app with the client 15 (60.0%) 4 (16.0%) 2 (8.0%) 4 (16.0%) I offered to look through: Client workbook with the client 11 (44.0%) 10 (40.0%) 4 (16.0%) 0 I drew and/or looked at the plate model 21 (84.0%) 1 (4%.0) 3 (12.0%) 0 Total Optional Tools 47 (62.7%) 15 (20.0%) 9 (12.0%) 4 (5.3%) Total Session 4 179 (79.6%) 20 (8.9%) 22 (9.8%) 4 (1.8%) % Agreement 88.44 Kappa 0.54 PABAK 0.77 Overall Total 337 (80.8%) 36 (8.7%) 38 (9.1%) 6 (1.4%) 55 Table 7: SMART goal coding (n = 275) Specific Measurable Attainable Relevant Timebound Yes (M%) 86 82 50 99 54 No (M%) 15 18 51 1 46 Kappa 0.56 0.63 1.00 0.49 0.79 PABAK 0.80 0.80 1.00 0.97 0.79 % Agreement (%) 90 90 100 99 90 SMART score M ± SD (range) 3.70 ± 1.10 (1-5) 56 Chapter 4: Implementation of a Diabetes Prevention Program within Two Community Sites: A Qualitative Assessment 4.1 Background Worldwide, 837 million people are diagnosed with, or at risk for, type two diabetes (T2D), costing 10% of global health expenditure [95]. Individuals with T2D have increased risk for kidney disease, cardiovascular disease, eye disease and foot and lower limb complications [95]. With the economic and health burdens of T2D, increased attention is needed to prevent diabetes. Diet and exercise modification programs have demonstrated success in reducing future risk of developing T2D by up to 80% [9, 96] and indicated greater long-term effectiveness than pharmaceutical interventions (5.7–9.4 years) [16]. However, these efficacy studies have been executed under intensive, tightly controlled experimental conditions and are not suitable to implement and sustain in real life settings [21]. To reach the large number of at-risk individuals, programs must be implemented in community settings in a sustainable and scalable way. To date, there have been multiple translations of diabetes prevention programs (e.g., [19, 97, 98]) with demonstrated effectiveness (e.g., [22, 55]). Despite many countries developing large-scale translation efforts (e.g., the United States, India, Australia, see [56]), there has been a lack of reporting on the implementation process, strategies, and context. Further, there have been no large-scale translations within a Canadian context. Implementation, as defined by Greenhalgh, is the “active and planned efforts to mainstream an innovation within an organization” [32, p. 582]. There is a dearth of research in this area. A meta-narrative review of 495 sources on diffusion of innovations in healthcare identified the most serious research gap as limited research examining the processes of implementing and maintaining innovation in health service delivery and organizations in specific contexts [32]. Understanding the process and strategies used across studies can improve the field of implementation science by identifying effective strategies to improve future implementation efforts. 57 The largest translation study to date, the U.S. National Diabetes Prevention Program, conducted an evaluation aimed to report from an implementation perspective [99]. Successful scale-up was demonstrated, and promising site-level and program-level features were documented to boost engagement [115]. However, this study did not provide in-depth information on how or why such features were implemented, lacked description of the scale-up process, did not include provider-level perspectives, and did not describe specific implementation strategies. Such information is essential for understanding mechanisms leading to successful implementation. The Kerala Diabetes Prevention Program is a translational study that was culturally adapted to Kerala, India [116] and a thorough implementation evaluation has been conducted [117]. The evaluation of the cultural adaptation reported several contextual details including the impact of community stakeholders as a success factor and the use of a local resource person. In addition, the implementation evaluation reported several important implementation markers (e.g., feasibility, acceptability) from multiple perspectives. However, the study did not report specific implementation strategies. The present research builds on previous research by conducting a process evaluation of implementing a diabetes prevention program within a community organization by specifying the implementation process, strategies, and context. Greenhalgh identified context and confounders as a paradox at the center of implementation efforts that must be studied to understand what leads to success or lack of success of an implementation effort [32]. For example, within the National Diabetes Prevention Program, only 25% of sites received full Centre for Disease Control recognition within the study period (implemented the program for 12 months and achieved program outcomes per the Standards and Operating Procedures, necessary to continue to receive funding) [99]. To increase the likelihood of future success, in-depth evaluations on implementation processes can help identify contextual features from sites where there was successful, or unsuccessful, implementation. Building on the work of Greenhalgh, and 18 other theories, the Consolidated 58 Framework for Implementation Research (CFIR) was developed as a multilevel framework to systematically assess the implementation context to understand, “what works, where and why” [31, p. 2]. The CFIR framework established a list of factors likely to influence implementation through individual, program, and organizational levels resulting in 39 fully operationalized constructs organized into five domains (intervention, inner setting, outer setting, individuals, and process) [31]. The intervention domain includes eight constructs associated with characteristics of the intervention that may influence implementation (e.g., complexity). The inner setting domain includes 12 constructs associated with characteristics of the organization that is implementing the intervention (e.g., culture). The outer setting domain includes four constructs associated with characteristics of the broader environment in which the organization is situated (e.g., cosmopolitanism). The individual domain includes five constructs associated with characteristics of individuals involved with the implementation (e.g., self-efficacy). Finally, the process domain includes eight constructs associated with strategies used to implement the intervention within the organization (e.g., opinion leader). In the current study, CFIR was used to systematically identify relevant factors that contribute to the success (or lack of success) of implementation, at multiple levels of the implementation context. The CFIR has been adopted and used widely. In 2015, a systematic review identified 429 unique articles referencing the framework; however, the authors, including the author of the CFIR framework, stated only 6% of studies used CFIR in a meaningful manner [118]. Meaningful was defined as “to guide data collection, measurement, coding, analysis and/or reporting” [118, p. 2]. The review also provided recommendations to help researchers apply the CFIR. This current study applied two of the reviews’ recommendations through (1) justifying selection of CFIR constructs (see methods section) and (2) meaningfully using the CFIR across different phases of implementation. In this present study, meaningful use of the CFIR occurred by using a during-implementation evaluation to inform future program scale-up initiatives. To date, the CFIR has been used in a pre-implementation study for integrating community health 59 workers in primary care for diabetes prevention [119], in a protocol evaluating the implementation of a Veterans Affairs diabetes prevention program [120] and in community-based diabetes self-management education classes [121]. To our knowledge this research is the first to use the CFIR to examine a community-based diabetes prevention program. The present study utilized a qualitative approach to evaluate the process of implementing a diabetes prevention program within two sites of a local community organization. The purpose of this research was to examine the multilevel factors that facilitated or impeded implementation to inform future scale-up. Understanding the process of implementation, as well as the key contextual factors as the program enters a new organizational context, will help explain the success (or lack of success) of implementation and provide useful information to inform future scale-up. CFIR represents an ideal fit to help elucidate important process factors as it is a comprehensive, multi-level implementation determinant framework with strong theoretical heritage and fully operationalized constructs. This study contributes to the field a thorough implementation evaluation, allowing for future studies to understand the implementation process, strategies and factors impacting implementation. 4.2 Methods 4.2.1 Program Description and Study Setting Small Steps for Big Changes (SSBC) is an evidenced-based diabetes prevention program with demonstrated success on health-related outcomes (e.g., improved cardiorespiratory fitness, moderate to vigorous physical activity) [47, 48, 122-124]. The program uses a client-centered approach to support adults (age 18+) at risk of developing T2D make diet and exercise modifications. The 3-week program set in Kelowna, British Columbia, includes six one-on-one sessions of brief-counselling and supervised exercise. The program has been previously described (see [70] and supplementary file A for full program details). Working with 60 the community partner, a local not-for-profit community organization (YMCA of Okanagan3) housed within a broader national organization, a one-year planning process facilitated co-development of a plan to sustainably translate the program into local community sites, with a goal to scale-up in the future [50]. The planning process engaged multiple stakeholders in face-to-face meetings, including a planning task force (consisting of researchers and upper-level YMCA leadership), site managers, prospective staff from the YMCA to enroll in the project, program alumni, and an external facilitator who guided two planning meetings (see [50] for further details). Throughout this process, both partners emphasized the importance of program fidelity, sufficient training, ongoing support, and open communication. These key factors were then targeted through the development of implementation strategies. In response to multiple calls for consistent language in the implementation field [31, 44], the strategies have been identified and described using the comprehensive list and definitions by Powell and colleagues (see Table 8) [44]. In doing so, this study will contribute to building an implementation evidence-base to support future implementation studies. The implementation plan was then executed to examine if SSBC can be successfully implemented within, and delivered by, YMCA staff. This current study examined the multilevel factors that facilitated or impeded the implementation process. During the planning process, three local YMCA sites were considered. The first site had hosted SSBC since 2017, with research staff implementing the program. Despite exposure and prior knowledge of SSBC, staff were not involved in the program until the start of this current study. The second site was selected as the prospective staff were committed to the project and the organizational structure was similar to the first site. Due to differences in organizational structure and site readiness, the third site was selected to be a future scale-up site. This 3 The YMCA waived their rights to anonymity 61 decision helped keep the project manageable and provided a location to implement lessons learned. 4.2.2 Paradigmatic Position A pragmatic epistemology was used to guide the design of this research, which prioritizes using research findings to develop practical recommendations to answer the research question and tolerates multiple truths [125]. A qualitative descriptive methodology was used to guide interpretation of the qualitative data. This methodology compliments a pragmatic epistemology as qualitative description is useful when seeking practical answers through understanding a phenomenon from the perspective of those involved [126, 127]. 4.2.3 Participants and Data Collection Each site nominated one staff as site-lead. This study involved two sets of participants: (a) staff who delivered SSBC and (b) implementation support staff. YMCA staff at both the delivery and implementation support staff level were invited to participate in the one-year planning process. After hearing about the project, interested staff volunteered to enroll. Training occurred in two rounds and covered the counselling style, motivational interviewing (MI), and program delivery (see [80] for detailed description). Staff unable to attend the first training, in addition to any new staff wanting to enroll, were offered to attend the second training. Implementation support staff included the manager and site lead for each site, and the vice-president of health, fitness, and aquatics for the region. Ethical approval was obtained from the researchers’ institution and written informed consent was obtained from all participants. 4.2.3.1 Semi-structured Interviews All YMCA staff (n = 8) who received training and counselled a minimum of three clients through the program were invited, and agreed, to participate in a semi-structured interview between four- and six-months post training (M = 5 months). This procedure was chosen to 62 ensure staff had sufficient experience implementing the program, prior to an interview. Within the study period, the eight YMCA staff facilitated 32 clients through the program. The purpose of the interview was to understand the implementation strategies (e.g., training, support, program resources), provide feedback on the program, and understand the experiences participating from an individual level. An interview guide was developed from previous research [76] and piloted with two staff, resulting in minor modifications (e.g., question wording, question addition; see Table 9 for sample interview guide questions). Staff ranged from 24-51 years old (M = 31.8, SD = 9.0), had between >1 and 17 years of experience at the community organization (M = 7.8, SD = 5.9), identified as 78% women and 89% Caucasian. Interview options (in-person [n = 8], or telephone [n = 1]), were provided to prioritize participant convenience and reduce burden. Staff interviews lasted 50-68 min (M = 58 min). 4.2.3.2 Focus Group- An in-person semi-structured focus group was arranged six-months into the project with implementation support staff. Each site lead and one site manager were trained to deliver the program and had direct experience in program facilitation. The purpose of the focus group was to understand the implementation strategies (e.g., training, support, program resources) and experiences participating from an organizational level. The focus group also discussed challenges identified in the project and solutions to promote sustainability. A semi-structured interview guide was created, guided by identified implementation determinants in the literature, including questions on feasibility, acceptability, culture, complexity and sustainability [36]. Focus group participants ranged from 24 -51 years old (M = 38.4, SD = 11.1), had between >1 and 17 years of experience at the community organization (M = 10.0, SD = 6.1), 80% identified as women and 100% as Caucasian. The focus group lasted 118 min. 63 4.2.4 Data Analysis The interviews and focus group were conducted by the first author, audio-recorded and transcribed verbatim. A note-taker was present during the focus group and documented non-verbal cues and other observations that helped inform the analysis. Transcripts were read multiple times to promote familiarization with the data. A Template Approach [128] was used to thematically analyze transcripts and NVivo12 software [129] facilitated data organization. Data was coded using an inductive-deductive approach. After data familiarization, the first author independently coded all transcripts inductively and then met to discuss codes with the second and third authors. Inductive codes were discussed and revised (e.g., consolidated, adjusted name) as necessary to ensure accurate interpretation. To avoid overlooking data, first transcripts were coded inductively to ensure salient data was captured before deductively linking to CFIR constructs. The CFIR technical assistance website [130] provided resources to facilitate data analysis including definitions of each construct within each domain. Rather than selecting which CFIR domains to examine, each inductive code was compared to all the CFIR construct definitions. By doing so salient CFIR constructs from relevant CFIR domains emerged from the data and any unrepresented CFIR constructs were excluded. The first author created an initial template that aligned the inductive codes with deductive CFIR constructs. The template included a section of inductive codes linked to deductive CFIR constructs that identified suggested modifications for sustainability. This section of the analysis helped identify modifications to inform future scale-up efforts. The template was reviewed with the second and third authors. Throughout the process, codes were examined for fit and consolidated, or separated, to better align with CFIR constructs. Definitions of CFIR constructs were constantly compared to inductive codes to ensure appropriate interpretation during the linkage step. The initial template was reviewed and discussed in multiple rounds of coding with the second and third authors, with the first author returning to the transcripts to ensure appropriate 64 representation of the data. Discrepancies were discussed between all authors until consensus was reached. Relevant quotations were selected to accurately represent the CFIR construct and the participants’ lived experiences. 4.3 Results Several constructs from each CFIR domain were matched to inductive codes and all five CFIR domains were represented within the data: (a) process, (b) intervention characteristics, (c) outer setting, (d) inner setting, and (e) individual characteristics. The CFIR’s process domain was difficult to link to the current qualitative findings as the interview guide focused more on participants’ reflections on the implementation plan execution and less on the planning process. Where possible, evidence supporting the process construct was provided in addition to a short descriptive overview of the planning process up to this project. Results are discussed according to each CFIR domain (heading) and CFIR construct (italicized). Quotes to support each construct are presented in Table 10. 4.3.1 Process As noted, a one-year planning process with the community partner engaged relevant stakeholders in co-developing the implementation plan [50]. A champion from the community organization spearheaded the partnership and was a respected, credible YMCA employee with formal influence on YMCA leadership, sufficient engagement in the initiative and capacity to participate in the planning process. An opinion leader was invited to contribute to the planning process, a respected YMCA employee with formal influence as Vice-President of health, fitness, and aquatics. A product from the planning process was the creation of a formally appointed internal implementation leader (site lead), a role designed to facilitate communication between the research team and the site. A second product was the creation of a formally appointed internal implementation team, designed to have the champion, the opinion leader, and one front-line staff attend monthly implementation team meetings during the project. To appease 65 both partners interest in assessing fidelity, an evaluation was developed to examine whether the YMCA staff executed the program as intended (see [80]). Finally, reflecting and evaluating was targeted both through formal evaluation (e.g., data collection tools) and ongoing reflection at monthly meetings at both implementation team and community organization staff levels. One CFIR construct in the process domain was unrepresented: external change agents. 4.3.2 Intervention Characteristics Staff praised the design quality and packaging of the program, training, and associated documents (e.g., manual, checklists). Although, there was specific program content to be delivered, each staff could deliver the session content in the order, manner, and depth that made sense to each client. This adaptability, encouraged by the client-centered nature of the program, was described as a facilitator. Staff were able to contextualize each appointment to their client. Although no staff described the program as difficult to deliver, staff did mention perceived complexities. A few staff discussed appointments being emotionally taxing from the effort needed to use and apply MI techniques. Even three months into program implementation, staff continued to prepare for each session. This, coupled with having some sessions run over-time, caused additional stress, especially when staff had appointments either right before or right after a scheduled SSBC appointment. YMCA staff described the relative advantage of SSBC compared to other YMCA programs. Specifically, three different advantages emerged. First, participants described the MI training as an asset that should be used in other YMCA programs. MI emerged as a valuable skill transferable to other YMCA roles (e.g., group fitness, one-on-one training, conflict management). Second, YMCA staff described a SSBC appointment as different compared to how YMCA staff typically work with clients. SSBC allotted more time with a client while they exercised, which enabled staff to help clients learn about the equipment and physical sensations experienced in exercise. In addition, typical YMCA appointments did not include 66 counselling time, which enabled staff to connect with their client, and genuinely listen and support them. Many staff were surprised by the amount of emotional support given to clients, requiring a tissue box in the counselling office. In addition, the counselling component allowed staff to discuss topics beyond traditional YMCA programs focused on physical activity, such as providing program-specific dietary content. Third, the staff felt the program structure (brief three-week program, with home days) coupled with the behaviour change techniques (e.g., action planning), helped clients build self-management and self-regulatory skills to build a diet and exercise habit. Staff explained that meeting a client regularly for three-weeks is atypical for YMCA programming and enabled them to build close connections to clients. For many staff, they appreciated and enjoyed these differences between SSBC sessions and their other YMCA programming. While the SSBC provided many perceived advantages relative to other YMCA programming, the program also included some relative disadvantages. Due to the schedule of SSBC sessions, only full-time staff could reasonably take-on clients as part-time staff could not accommodate the schedule needed in the first week of the program. In addition, many staff could only take on one client per month, which limited client capacity. Finally, while many of the CFIR constructs in the intervention characteristics domain were present, four were not: intervention source, evidence strength and quality, trialability, and cost. 4.3.3 Outer Setting Staff discussed how SSBC helped with peer pressure by setting the YMCA apart from other fitness facilities. Providing SSBC further supported their niche as a community, health-focused fitness facility that provided accessible and effective programming to support the health of the community. In addition, the YMCA helps fill a gap in the local health authority, private, and public health through supporting a diabetes prevention program. The cosmopolitanism of the YMCA, through its partnership with a research group, supports this community, health-focused 67 vision by offering an evidenced-based program. Two CFIR constructs were not represented in the outer setting domain: patient needs and resources and external policy and incentives. 4.3.4 Inner Setting During the project, evidence emerged that networks and communication within both community sites supported staff with implementation. Staff utilized both formal communication during SSBC meetings and informal communication through a community of practice with other staff to discuss the program, troubleshoot, and practice skills. There were distinctions between structural characteristics within the two sites. One site was more established and larger compared to the other site (opened 2001 versus 2017, respectively). These differences impacted the social architecture, whereby the older site had a more “tight-knit” feel amongst staff compared to the newer site. The newer site also had more staff turnover compared to the older site. Overall, the community organization had a supportive implementation climate. Staff saw SSBC as compatible with the YMCA at three different levels: (a) organization, (b) staff, and (c) client levels. First, SSBC was a good fit in the YMCA with its focus on helping individuals become healthier, especially in relation to increasing physical activity levels. Second, staff were well-suited to deliver SSBC as they shared many values with the program, including being passionate about health and fitness and helping individuals improve their overall health. Third, the YMCA provides an ideal environment for the clients to continue to achieve their goals post-program. While the program may end after the final session, the YMCA environment remains available for clients to benefit from. Relatedly, the organization had a positive learning climate where all participants worked together, regardless of rank in the organization, to implement the program and support each other. The project was ready for implementation through its leadership engagement (site lead). The site leads supported implementation by helping with logistics (e.g., scheduling), supporting 68 coworkers (e.g., check in with staff) and liaising with the research team. The project had available resources such as a dedicated project coordinator to provide ongoing support and lead monthly meetings. In addition, staff had access to knowledge and information through provision of implementation support documents (e.g., program manual, checklists) and ongoing access to an online training platform with support videos. Finally, discussions in the focus group identified a shared belief amongst management that everyone at the YMCA should be a SSBC staff, providing insight into the presumed culture at the YMCA to support such a program. While many CFIR constructs were represented within the inner setting domain, four constructs were unrepresented: tension for change, relative priority, organizational incentives and rewards, and goals and feedback. 4.3.5 Individual Characteristics Staff’s knowledge and beliefs of the program grew during implementation. Staff discussed benefits of program tools, program structure, and counselling style (MI), and believed that the program positively impacted clients. Overtime, staff’s self-efficacy for implementing the program increased, particularly regarding use of MI. Evidence demonstrated individual identification with organization as staff displayed commitment to the success of the pilot project. Strong indications of commitment included staff completing preparation time (including preparing at home), reflecting on their skills, and practicing skills amongst each other. However, staff also mentioned being impacted by the program itself and described wanting to do well in their role to better help the clients. This code was placed within this domain (individual characteristic), as some staff demonstrated more commitment than others. However, the outer (cosmopolitanism of the research group with the YMCA of Okanagan), inner (learning climate and culture), intervention (relative advantage) and process (engagement in the planning process) likely contributed to staff’s strong commitment. 69 Staff identified other personal attributes from participating in SSBC, such as building transferable skills for personal and professional development. Common skills described were listening, communication, teamwork, and conflict management. It was evident during the focus group that managers felt through providing SSBC, they were providing additional learning opportunities for their staff to build their resumé. One construct in the individual characteristics domain was unrepresented: individual stage of change. 4.3.6 Modifications for Increased Sustainability Ideas emerged during the focus group on how to modify the program for increased sustainability. 4.3.6.1 Intervention Chracteristics To increase sustainability, the program has been restructured to reduce the time-burden on staff in the first week of the program, to a maximum of two appointments per client, per week. This modification eases staff perceived complexity by reducing the amount of time dedicated to SSBC per week. In addition, the restructuring reduces the identified relative disadvantage and allows part-time staff and volunteers to enroll in the training, resulting in an increased number of clients that the program can support each month. 4.3.6.2 Inner Setting To increase sustainability, SSBC team meetings have been incorporated into the larger YMCA site meetings to encourage all YMCA staff to become familiar with SSBC. This shift in the formal networks and communication within the organization aims to maintain all the benefits of the formal team meetings, but also encourages wider YMCA staff buy-in and eases scheduling as staff are already required to attend these meetings. This modification intends to further support the organizations’ culture identified in the focus group, to encourage more part-time and volunteers to sign-up for the training and make staff aware of the professional and personal development opportunities that SSBC provides to staff. The YMCA plans to continue to 70 ensure leadership engagement through having managers and nominated site leads actively support staff who take the SSBC training through periodic check-ins. Some staff may need additional support and/or training to feel confident in implementing the program, which was indicated by the reliance on the research teams’ project coordinator (available resources). To encourage sustainability, the research team is working on additional training to transfer leadership from a research project coordinator to a coordinator within the organization. Training will support the individual assume a similar role to the project coordinator from the research team (e.g., lead SSBC meetings, provide ongoing support, check-in on staff). 4.4 Discussion To reduce the growing burden of T2D, more diabetes prevention programs need to be made available to those at-risk. To meet the need, there has been a focus on translating effective and scalable diabetes prevention programs into sustainable community settings. While there have been numerous diabetes prevention programs translated to date, there is a lack of research documenting the process of such translation efforts, the contextual factors impacting implementation and identifying the implementation strategies used to promote program uptake. The research team partnered with a local not-for-profit community organization to offer Small Steps for Big Changes with a goal of scaling-up to the national level of the organization. A co-developed implementation plan was used to translate the evidence-based program to two local YMCA sites. With context at the heart of implementation, an implementation determinant framework was used to analyze the implementation process and elucidate key contextual factors. The CFIR was a useful tool to frame the results. Moving from inductive to deductive analysis helped identify salient themes from participant perspectives prior to deductively linking to CFIR domains. This process enabled deep interpretation of the data as linkages were made to the CFIR framework and prominent CFIR constructs were generated from the data rather than preselected. As the analysis progressed, findings demonstrated an interaction between all 71 levels of the CFIR contributing to successful implementation, similar to previous studies [59, 131]. The current study contributes to the field an in-depth during-implementation evaluation reflecting on the process of implementing a program using the CFIR framework to guide analysis and identify modifications to inform future scale-up efforts. Such a study also provides an overview of implementation strategies used according to definitions described from the Expert Recommendations for Implementing Change (ERIC) project [44]. The analysis included multiple, in-depth perspectives from those involved in the project (front-line staff, managers, site-leads, vice-president of health, fitness, aquatics). All five CFIR domains were identified, with relevant constructs supported within each domain. Overall, the implementation plan was successful, with positive views from all study participants. Results suggest the high level of engagement during the planning process with the community partner positively influenced the successful execution of the implementation plan. While a partnered approach takes time and effort, the process of building a partnership embeds commitment and critical thinking throughout, ensuring appropriate steps are taken and a quality product results [132, 133]. The current study supports literature that sufficient planning through early engagement, the inclusion of a wide range of stakeholders, and prioritizing planning for scale-up from the outset is essential for success [38, 39]. A successful implementation context likely formed through strong commitment to the partnership at the leadership level of the YMCA (opinion leader and champion) and engagement of prospective SSBC staff at the YMCA, both important factors for implementation planning [59, 134]. Involvement of prospective staff developing the implementation plan, an often-overlooked part of implementation, likely fostered buy-in and encouraged adoption [32]. Engagement with the community partner ensured implementation strategies (e.g., provision of a staff training manual, program documents, ongoing implementation support through monthly site-meetings) were deemed acceptable and sufficient to front-line staff prior to implementation. Overall, the highly engaged, multi-level planning approach supported multi-level buy-in. 72 The YMCA has been identified as a promising partner to disseminate diabetes prevention programs [135]. Synergies were evident at multiple levels. The program itself was well suited to the vision of the YMCA being a community-health focused fitness facility [132] and the YMCA staff were well suited to deliver the program as they already had knowledge, skills, and desire to help clients within the health and fitness industry [134]. This synergy may have led to highly engaged staff, a facilitating factor for successful implementation [31, 39]. Participation in the project provided staff with new professional and personal development skills. Specifically, MI emerged as a valuable skill and a key component in the program. Staff discussed many relative advantages of SSBC, largely due to MI coupled with other program components (e.g., counselling component, diet and exercise focus, and one-month program) that are not typically included in YMCA programming. Having relative advantage is another facilitator identified in prior implementation studies [136, 137]. Specifically, in a program for individuals with overweight and obesity, health care workers who perceived relative advantage of an intervention had higher motivation to implement it [138]. To further increase the advantages and support sustainability in the future, feedback from the current results on complexity and the relative disadvantage have been modified to support future scale-up. A new program structure will reduce staff burden during the first week of the program, allow greater flexibility in scheduling, and allow part-time and volunteer staff to feasibly fit appointments into their schedules. All participants commented on the level of support provided with the program. Support was provided through multiple communication channels, both formal (e.g., team meetings, implementation team meetings, one-on-one support through project coordinator, site lead, program manual, checklists) and informal (e.g., community of practice, research team visit to sites). Multi-directional communication channels have been identified as a facilitator in previous research [134]. Specifically, health care professionals that perceived more support from their colleagues, had greater motivation to implement an intervention [137]. Relatedly, differences between the two sites emerged in the inner setting, with one site discussing more informal 73 communication (e.g., seeking support from co-workers) compared to the other site. This difference may be attributed to the structural characteristics of the two sites with the “tight knit” site being in existence longer, more staff working at one time (enabling overlap and communication opportunities), a site lead at a higher organizational leadership level, and less staff turnover. These differences may have impacted the level of informal support provided at the younger site, as one staff at the younger site struggled with the intervention at the early stages, despite the amount of formal support. A timely change in site-lead, enabled the staff member to receive additional peer-support to gain confidence in implementing the intervention. In prior research, specifically in relation to a study using MI, providing resources and communication between colleagues has been shown to enhance facilitators’ ability and experience of delivering MI by having constant access to feedback and support [139]. These observations demonstrate the importance of selecting an appropriate site lead and the impact of the inner setting on social knowledge; both have been identified in research using the CFIR [140]. More research is needed to understand important factors to cultivate an inner setting conducive to adopting an intervention and executing the intervention with success. The current findings support the strategy of having a site lead; however, selection of an appropriate site lead and provision of training will likely enhance the strategies’ success. In a study investigating the effects of champions as an implementation strategy, results determined the success of the strategy was dependent on the chosen champion and adequate organizational support [141]. Four characteristics of a successful champion were identified: engagement, influence, credibility, and capacity [141]. Building off this study, coupled with the characteristics identified for a successful champion, future research is needed to operationalize the site lead implementation strategy. It is important to note the amount of researcher engagement within the current implementation effort. The first author acted as project coordinator and was engaged in the 74 planning of the pilot, development of implementation tools (e.g., training manual, training plan), oversaw the execution of implementation activities (e.g., attended and co-led staff training, liaised with site leads, led monthly site meetings, attended monthly implementation team meetings, provided ongoing support to front-line staff), developed close connections to participants in the project, and acted as a knowledge broker to pass information between the implementation team, research team and the front-line staff. Close connections, open communication, and provision of support were likely facilitated by the size of the organization and the ability to have face-to-face meetings—two factors that have been identified as facilitators to successful partnerships in community health promotion [126, 134]. Feedback from a 15-year scale-up project identified that a local project coordinator was fundamentally important to implementation success [142]. Within the Kerala Diabetes Prevention Program, researchers had close communication with peer leaders (e.g., provided ongoing support via telephone calls prior to and after each group session) and utilized a local resource person (a leader nominated from the local self-governing bodies) to facilitate implementation (e.g., organizes group sessions, advocate for the program and send reminders/follow-up with participants) [116]. The engagement of peer leaders and local resource persons were crucial to implementation [133]. In the current project, the project coordinator was the researcher (first author) who ensured implementation strategies were executed and feedback collected. As the project continues to be scaled-up, the role of the project coordinator will shift to the YMCA site lead role. Careful selection and support to the site lead will be of utmost importance for successful implementation. 4.4.1 Limitations and Future Directions The first author participated in all front-line staff meetings, implementation team meetings and was involved in the one-year planning process. This involvement enabled the researcher to observe and simultaneously support the implementation strategies throughout the 75 project. Although this dual role may introduce bias, it has been used in similar implementation studies for an in-depth perspective of the implementation process [39, 143]. All participants regularly interacted with/collaborated with the first author. While these professional relationships likely resulted from the collaborative partnership approach, it can also introduce social desirability bias. However, the close working relationship also enabled mutual respect enabling participants to provide honest feedback to the research team. The first staff to volunteer for the project may have been more motivated compared to staff trained in subsequent rounds. The study was interrupted by COVID-19 and not all staff had facilitated three clients through the program prior to facility shut down/interruption, which reduced the study’s sample size. The sample was primarily Caucasian women, which may limit generalizability to other studies or new sites with a more diverse staff. Finally, the study design itself (e.g., interviews and focus group) were effective strategies to reflect on the process of implementation. Useful feedback was obtained to modify the program for increased sustainability with the community organization. Future research should include qualitative evaluation during implementation to understand the process and learn from it, to be able to make improvements in the future. Two of four recommendations identified in a 2016 systematic review on the application of the framework [118] were applied in this study (meaningfully use the CFIR to inform future scale-up initiatives and to describe how CFIR constructs were selected). Future research should work to include the other recommendations: associating CFIR constructs with study outcomes and integrating the CFIR throughout the research process. While the CFIR was integrated throughout much of the research process, future work should consider aligning data collection materials (e.g., interview guides) with resources available on the CFIR technical assistance website [130]. In this present research, had the interview guide been developed to align with CFIR constructs, unrepresented CFIR constructs might have had representation. For example, all participants were aware that the intervention was developed externally (i.e., intervention source), had demonstrated effectiveness (i.e., evidence strength and quality) and was being 76 piloted (i.e., trialability). However, by not aligning the interview guide with CFIR constructs, salient themes emerged inductively rather than asking participants about all constructs that may or may not be deemed relevant by the participants spontaneously. While the research team was not able to accommodate all recommendations from the systematic review, results contribute to the CFIR’s research base by identifying relevant constructs within this project’s successful implementation effort. The implementation strategies used in the project support their use in future scale-up efforts, which are underway. The current study was not able to assess which specific implementation strategies were most effective, rather the results presented are a result of the package of strategies used. Future experimental research should be used to tease apart the effects of specific implementation strategies and/or future systematic reviews and meta-analysis can be used to identify promising implementation strategies. In the current project, co-developed implementation strategies were executed with researcher support. In the next phase of program scale-up, implementation strategies will be executed by community organization staff. This tiered approach has been successful in prior research [143], after building off an initial study with strong involvement of the researcher [39, 142, 143]. The two sites where the project was conducted are well-suited to take on such leadership responsibilities having closely collaborated and shaped the current form of the program and will be invited to share lessons learned with new scale-up sites. When setting up a new site, sufficient support and engagement with prospective staff is warranted. While engagement requires additional resources and time, it has favorable outcomes when compared to more hands-off approaches (e.g., provision of a manual) that may not be sufficient to support implementation [59, 142]. Future research is needed to optimally operationalize provision of support in a sustainable way. 77 4.4.2 Conclusions This study provides an in-depth analysis into the process of executing a co-developed implementation plan to have staff facilitate an evidence-based diabetes prevention program within a community organization. Overall, the implementation strategies used were acceptable and staff were satisfied with the implementation process. Project success was likely a result of the process in which they were developed, planned, executed, and reflected, which provides valuable feedback to prepare for the future scale-up of the project. This study demonstrates an effective partnered approach to the process of implementation and demonstrated important constructs from all five levels of the CFIR. 78 Table 8: Identification and description of implementation strategies used in SSBC Implementation strategies Description of strategy in SSBC Develop and implement tools for quality monitoring Developed session-specific fidelity checklists for staff to complete after every session. Data is collected, inputted, and evaluated for fidelity purposes by research team. Staff are instructed to audio record every session to be reviewed by study staff for motivational interviewing fidelity and program fidelity. Audit and feedback Staff audio-recorded every session and research staff reviewed randomly selected sessions to assess for motivational interviewing fidelity and program fidelity. To assess program fidelity, after each session staff completed session-specific checklists documenting what was delivered to their client. Provided feedback through evaluation reports. Centralize technical assistance A project coordinator dedicated to assisting the implementation efforts. All staff, site leads, and site managers had the contact information for the project coordinator. Organize clinician implementation team meetings Project coordinator planned and led mandatory 1-hour monthly site meetings with all program staff. 79 Create a learning collaborative Project coordinator planned and led monthly team meetings with staff involved in the project. Project coordinator provided a skeleton framework of support, and encouraged staff to seek support from each other beyond site meetings. Capture and share local knowledge Local knowledge from implementation sites was shared through the project coordinator from site to site. In addition, this local knowledge was shared at the implementation team meetings. This sharing of information generated interest and led to the confirmation of the third site in the local area, as well as with the region and beyond. Build a coalition During the planning process an implementation team formed. This team consisted of three stakeholders from the YMCA and three stakeholders from the research team committed to the project. The team met monthly. Use advisory boards and workgroups Monthly implementation team meetings discussed implementation progress, solved challenges that arose, developed marketing and communication plans and continued to plan future scale-up strategies. A client advisory committee provided feedback on intervention content and tools (e.g., recruitment letter, client workbook) A stakeholder advisory committee provided feedback on program promotion, recruitment, and marketing. Tailor strategies Continuous feedback was collected from site leads, monthly meetings, and individual interviews with staff after 3 clients. Feedback was collected and used to tailor implementation strategies (e.g., training program, additions to training manual) Purposely re-examine the implementation Implementation strategies were reviewed at monthly site meetings and implementation team meetings, minor adjustments were made (e.g., adaptations to the training based on staff feedback). Conduct educational meetings Two local community events were held with multiple stakeholder groups attending (e.g., physicians, local health authority staff, university staff, community members, YMCA staff). Goals of these meetings were to provide updates to the 80 community on study progress, distribute results, share success stories, and inform the community on the overall initiative to support stakeholder involvement, recruitment and support. Conduct educational outreach visits Research staff met with local physicians to educate practitioners about the program, promote recruitment and review process for referring eligible patients. Develop a formal implementation blueprint An implementation plan was created to support the program including standard operating procedures, a document describing the short- and long-term goals, roles and responsibilities, timeline, outcomes, and strategies for the project. The document was reviewed iteratively by both partners. Develop academic partnerships In 2017, the research team partnered with the YMCA. In 2019, an official memorandum of understanding was signed to signify long-term commitment to the partnership. Develop educational materials Developed a staff manual with details on the communication style (motivational interviewing), the program content (prediabetes, diabetes, diet and exercise), and additional supplementary information to support implementation (e.g., frequently asked questions section). Developed educational videos on program content, how-to videos and videos of senior research staff facilitating the program to clients to supplement the in-person training. All staff have ongoing access to videos on an online training platform. Distribute educational materials Each staff was provided a hard-copy program manual in addition to access to an online training platform with additional educational, how-to, and senior research staff facilitating the program videos. 81 Identify and prepare champions Identified and trained one site lead per site to oversee and support staff, liaise with research team and support the program. Selected and trained a project coordinator to oversee sites and liaise with site leads and staff. Identify early adopters Training was conducted in three rounds. First-round staff were early adopters who conveyed their experiences to others at their organization and provided support to the subsequent round of staff. Make training dynamic In-person training was delivered with a variety of tasks such as PowerPoint slides, role-play, videos, discussion, and hands-on learning, practicing, and skill demonstration. In addition, ongoing access was provided to an online training platform with additional videos (shadowing, educational and how-to videos). Obtain and use patients/consumers and family feedback All clients in the program were offered to participate in an optional interview at the end of the program. In addition, all clients were provided with surveys that collect program outcomes and program feedback at multiple time-points. Promote adaptability Staff were taught to deliver core program content (diet, exercise content and exercise protocols) in a client-centered manner, providing flexibility on delivery. Key program content must be provided to each client but can be tailored to the client e.g., order of content delivery, specific details. In addition, clients get a choice of exercise protocols (high-intensity interval training or moderate-intensity continuous training) and exercise mode (walking, cycling, elliptical). Shadow other experts Videos were created with a senior research staff facilitating the program to a client. As part of the mandatory training, all staff viewed segments of the videos demonstrating delivery of core program content. Full length videos were also added, and staff were encouraged to watch the full-length videos of a counselling session to understand session flow. 82 As part of the mandatory training, all new staff had a senior research staff shadow them while they facilitated their first client through the program (expert shadows new staff). Stage implementation scale up During the planning process two local sites were selected for the first stage. Building on the success and lessons learned from the first sites, a third local site would launch. The project would continue to scale-up in a such a staged process, continually building on lessons learned. Note: This table was compiled using the implementation strategies and definitions as described from the Expert Recommendations for Implementing Change (ERIC) project [18] 83 Table 9: Sample interview guide questions Interview questions Staff interviews Tell me about your overall experience as a trainer for SSBC. How has the SSBC been running at your YMCA so far? In what way has the program implementation met your expectations and/or needs? What challenges have you experienced? How do you believe you have been impacted by being a SSBC trainer? What recommendations do you have for adapting the current program? What do you like about the SSBC? Focus Group Tell me about how the SSBC has been implemented at your site so far? Do you feel that your team has all the necessary support in place to run the program at the YMCA? How satisfied are you with the program at your site? What recommendations do you have for adapting the current program to better fit within the YMCA? What has been working well/not working well related to implementing the program? In what way have you noticed that the YMCA has been impacted by having the SSBC at your site? Now that we have been implementing the program for 6 months, what do you think could have been better from the beginning? 84 Table 10: Overview of CFIR constructs linked to inductive themes CFIR Constructs Themes Example Quotes Process Domain Plan Planning process I also think just even the collaboration between two organizations. I think the amount of effort and time that goes into a collaboration to make it work from outside, from a place where you guys [research staff] are comfortable leading it, into a community-based place that has tons of stuff going on all the time. (C7) Engage Involvement of stakeholders in the planning process I feel like it was very inclusive. We've been included in different [planning] meetings and included in the two-year celebration, and that inclusion just made it feel like we were a part of it, almost like we were a part of it from the beginning in just that inclusion. And that was really nice. (C4) Opinion leader YMCA leadership I have been a part of the team from the beginning and really helping [principal investigator] bring this program to communities. So was part of bringing SSBC to the downtown Y[MCA]. And I’m now here to support my team and to ensure that we can continue to grow this program into our YMCA and potentially in the future grow this program into other Y[MCA]’s across the country. (VP) Formally appointed internal implementation leader Site lead I am a SSBC coach as well as the site lead for [site 2]. (C6) Implementation team I have been on the implementation team since we started SSBC and then I also lead the SSBC program. (C7) Champion Partnership spearhead Since I started at the Y[MCA] in 2006, I worked under [champion]. She was my manager from the beginning. And her goal since then has been to help individuals and help them change their behavior and focus on the ready-to-be-fit population; so the group of people who are inactive, maybe at risk of a chronic disease. That has been her sole focus and has become my sole focus since I started here… I think this program just fits in perfectly with that strategy that the Y[MCA] has had since 2006. (C7) Execute Fidelity evaluation I've never really been a part of a research program during the research phase… So just learning how to be very diligent with paperwork and completing it. (C7) 85 Reflect Implementation processes We’ve come up with different strategies of how to overcome different situations [during the site meetings]. We’re able to have a [research] update … so everyone gets the same amount of knowledge and has time to ask questions and get answers and everything. (C1) Intervention Characteristics Relative advantage Motivational interviewing training an asset for YMCA staff I think this is exactly what we have been looking for since I started here. You know about [other YMCA program name] and same kind of thing, but we didn't learn about motivational interviewing at all and I really do think that the motivational interviewing, that is the key piece that we were kind of missing in all of our other programs. (C7) Program structure supports client habit formation The biggest [difference] is just how you exercise with them for the first bit. You help them with a guiding hand a bit more because you see them so often right away; it's easier to establish a relationship and actually have them commit to exercise a little bit easier. Compared to having one meeting telling them what they should do and then them just going off and doing it. (C9) Building connections to clients I love it SSBC. I think this is my favorite thing that I do here [at the organization], honestly. It's kind of a nice break in my day. I love what SSBC brings to people.” (C5). I really like getting to know the participant. It's very rare that we would spend…this much one-on-one time with the same client for three weeks in a row. You really get to know them and really learn about them. It's not just the surface stuff…you really build a good relationship with these participants. I'm pretty sure if they keep coming to the Y[MCA], I'll stay connected with them for a long time…. I really enjoy that aspect. (C7) Relative (dis)advantage Limited staff and client capacity of program Currently we only have full time staff doing it. (C6) I think scheduling-wise, how many clients would each staff be able to take on without feeling maybe burnout and still maintaining our other appointment types that we have as well. (C3) Adaptability Program can be tailored to the client for benefits All the topics are great. I like that you have the flexibility. If you needed to, you could do the exercise ahead of time and then do counseling after... I like that you have the flexibility in the meetings to discuss a different topic if that's what they want to talk about that day. The fact that it's very client-centered and not black and white, I really think that’s important. (C7) 86 Complexity Effortful work It's not even more work as it is just-- what way to put it? It's not like you're doing more, it's just a little bit more taxing to do. I feel like you're putting more of yourself into it which you only have so much each time. (C9) Design quality and packaging Professionally packaged from research team I'm always writing out checklists for people to make sure they check all the boxes, so it's just nice having it seem like a very professionally put together program. It just makes my life as a coach so much easier; I can just really focus on the participant and delivering the program and not worry about the logistical aspects of it. (C3) Outer Setting Cosmopolitanism Research partnership It's re-educating the population if you will, that we are kind of at the forefront of health and partnering with the university and into your health and the community that way. I think the word is getting out that people know that if they've got a health condition, this is a safe place to come. Preventing future health issues. Having a quality research-based program within the Y[MCA], it just helps us accomplish what we're trying to do. (C3) Peer Pressure Supports vision for a community, health-focused gym As part of the Y[MCA], we've sometimes maybe struggled with our identity and that people think we're just a rec[reation] center and that our staff maybe aren't trained or certified above just a fitness instructor that teaches one type of class. No, we have not only very certified and qualified staff but also training that is backed by research. (C3) Inner Setting Structural characteristics Staff turnover It has been going very well; in total, we have three and a half trainers. [laughter] [Staff name] is still technically a coach, but unfortunately, she’s moving away and then [another staff name], just due to scheduling, isn’t able to take participants all the time. (C1) Networks and communication Community of practice among staff Or if they have questions about SSBC-- or if we're having troubles with a participant, we give each other ideas. We talk about it a lot. (C5) Team meetings It's really nice to have that check-in. It feels like much more open communication. We get to hear what's 87 going on the [research team] end, you get to hear our experiences, and it gives us all the opportunity to come together if there’s something that, say, we need a solution to, collaborate on that and see what we can find. Then it gives us, as trainers, an opportunity to get together and have that discussion as well. Sometimes we're having a bunch of one-on-one conversations. We don't have the opportunity to speak a group at the same time, so it does give that opportunity. (C2) Culture Everyone should be a SSBC staff There should be no reason why somebody opts out [of this opportunity] from our group. (M1) The implementation totally fits in with the YMCA mission, vision—all that stuff—and our strategic direction that we've been heading for the last 15 years. (C7) Implementation climate Compatibility Program is a good fit within YMCA The value is with the training and what we're able to provide in terms of coaching the participants, so value to [clients] in terms of changing their health and then value to us YMCA because we're keeping these members around, and they're staying active longer, and we're able to help them get healthier. (C3) I like what it represents. I like what the goal is to do. The goal is to have participant-led health intervention, lifestyle change. It follows all the YMCA values, which I value in my day-to-day and what I try to bring to coaching, what I try to bring all my clients. (C8) YMCA staff well-suited to deliver program I almost don't factor in the exercise part because it's so second nature to me. So that works well, but it's supposed to work well, right? I would have no excuse for it not working well. (C2) I think it's one of the reasons why people work at the Y[MCA] is because we're all about building relationships and fostering this community. That’s probably the biggest thing for me – the relationships. (C7) YMCA helps to set-up clients for long-term success Membership is number one. Being able to tell [clients] after SSBC that I'm still going to be here, you can still come and see me, you can send me an email. You're coming to this gym… you can get hold of me. Having it here-- the access to the gym, with the pool, the AquaFit, stuff like that. Being able to bring their families in. I think our demographic here is pretty friendly... pretty accepting. Having it in the gym makes it not as nerve 88 wracking to go to a different gym. They can get comfortable here, working with someone, and then kind of go on their own. Knowing that we're still in the office and they'll know us if they have any questions. (C5) Learning climate Teamwork We're a good team and everyone feels comfortable talking to anybody if they have a situation. (C6) The team is great. I have known some of them previously and sometimes if I get there-- because I go in early to get myself prepped—so if I'm having a challenge, I might say “I don't know what to do about this” and I might say, “I'm thinking this or that” and they're like, “Yeah. That sounds right. Go try it. Let us know how it goes”. (C3) Readiness for implementation Leadership engagement YMCA managerial support I had that [check-in] talk with [staff name], but I know they can handle that content, it’s just helping them and pulling them of the cliff, right? I think it just comes down to us [managers] motivating them [staff], supporting them. (M1) Site lead role It's really helping find their [staff] schedules and getting them booked in, helping them juggle things around if all of a sudden, we get a client that wants this timeslot, it's like okay, we can shift things. The new coaches that came on, we've had a couple touch-ins. The older coaches, the first-round coaches, not so much anymore. (C6) Available resources Research team support Sometimes I'll have a question in my mind that I will want to ask one of you. Then all of a sudden, you're already here. It's easy to just ask, right? If I don't, I just email and usually within that day, I have a couple of questions answered. And if I have a follow-up to that, I'm pretty confident that it's going to be responded to that day as well. The support has been great. (C2) Access to knowledge and information Implementation support tools I use my binder, the checklist, and I think those tools help me guide the session really well with knowing that it's okay to go in other topic directions if that's the way your client wants to go. (C7) I feel like I have all the resources and supports, the checklist and all of that. I feel very prepared to know what needs to be covered and it takes me maybe 5 to 10 minutes to go into the room, get all the equipment out that I need, the checklists, maybe flip through the coach manual. (C3) 89 Individual Characteristics Knowledge and beliefs Belief that the program is impacting the clients I think it's been amazing. I love almost every single aspect about SSBC. I truly believe people are able to change after our meetings that we have with them. (C7) All three of my clients have admitted to me that they've taken something away from this program that has helped their life and has made them healthier. That’s a great feeling to have. This program has done so much for not only my three participants, but for multiple participants that have been coming back to the Y[MCA] and telling me how great this program is. (C1) Self-efficacy Self-efficacy increases with more experience The more, I think, different people you interact with, the more confident you are. Some people are more confident, some meet all their goals and are super successful. Then some people don't. It's just navigating those different situations; there are always new situations. But once you've had experience with several, it's easier to think of what could be helpful to say next. (C3) It just goes back to the more you do it, the more confident you get. (C9) Individual identification with organization Committed staff I look at it [program manual] before every session. I'm not going to go by my memory about what the session is supposed to be about. I read through the script and find that I just go over everything during that session with every client. (C6) Just like with any skill, it gets rusty, so that's why I really try to use it in all aspects of my personal and professional life when I first went through the training because I really was like, ‘I want to hone in on this’. (C3) 90 Other personal attributes Building transferable skills for personal and professional development I really like spending time in improving my communication skills because in my lifetime of doing that, the ability to communicate with someone better and avoid a crisis between a person or to understand them on a greater level and connect with them and feel connected, as well as understood, is really important. I feel like utilizing them in my personal or/and professional life outside of all of that is the best way to continue with them. It's not like I have to switch it on for a client and then switch it back off. It's always there to some degree.” (C4) The training I found very valuable. It's really made a difference with not just SSBC, but it's made a difference with other clients or other people that I'm working with too. The whole training experience and understanding motivational interviewing has been a very good experience. (C6) Learning opportunity participating in SSBC The benefit is definitely the training and motivational interviewing; you can use that across the board with all clients any time. It’s further education for our trainers. It’s very impactful the way we speak to people and makes such a difference helping [clients] change. That is a huge benefit. (VP1) 91 Chapter 5: Implementation of Diabetes Prevention Programs into Real-World Settings: A Systematic Search and Review 5.1 Background Diabetes is among the fastest growing global health condition in the world. Worldwide, over 537 million adults have diabetes, while 541 million adults are at risk for developing type 2 diabetes (T2D) [144]. The condition is costly with $966 billion in total direct costs of diabetes worldwide in 2021, with this cost expected to grow to $1.03 trillion by 2030 [144]. Without proper treatment and preventative measures, devastating complications await individuals with T2D, including cardiovascular disease, kidney damage, nerve damage, blindness, and amputation [1]. In addition, individuals with diabetes have poorer mental health and have increased risk of mortality [3, 145]. Diet and exercise are two modifiable T2D risk factors that have repeatedly been shown to have a potent effect on effectively reducing progression from prediabetes to T2D [9-11, 146], with long-lasting effects [16, 146]. Diabetes prevention programs, of which the majority target diet and exercise modifications, have been effectively translated into community settings and demonstrated cost-effectiveness [19, 58]. Despite the known benefits of diabetes prevention programs and the increasing prevalence of prediabetes, access to programs is not yet widely available for individuals who are at-risk of T2D. To slow the T2D epidemic, widespread implementation of diabetes prevention programs is needed. A challenge exists in knowing how to effectively move evidence-based initiatives to resource-constrained and diverse settings. The field of implementation science focuses on this challenge through studying the methods used to promote uptake of evidence into practice [29]. In the past decade there has been a dramatic increase in implementation science theory, methodology, and tools. One such development is a compilation of 73 discrete implementation strategies used to facilitate the movement of evidence-based initiatives into real-world settings [44]. Implementation strategies (hereafter referred to as strategies) are defined as the how-to guides to change organizational practice used in implementation efforts [40]. Detailed reporting 92 of strategies facilitates the use of a common language and increases clarity on what actions researchers or implementers have done to implement new initiatives (e.g., program, guidelines, product). There is a need for greater reporting of strategies to increase the replicability of implementation trials, enable comparisons between results, and to learn from and support the development of future implementation efforts. Unfortunately, reporting implementation strategies is rare [52]. Many researchers are not aware of implementation strategies, and strategies may not be strategically applied. Identifying and understanding how to optimally use implementation strategies will contribute to an evidence base for effectively implementing programs. Evidence-based programs must be matched with evidence-based implementation [147]. In a resource and time-constrained world, implementation often gets overlooked in favour of program effectiveness outcomes or participant feedback. A type III error may result when implementation is not examined: when a program is considered ineffective, however the program may have been effective had it been properly implemented [35]. Implementation variables are essential to explain program effectiveness, especially when implementation occurs within real-world settings. A real-world setting refers to an initiative being implemented without or with limited support from researchers, in an individual’s everyday environment. Research in the real-world aims to increase generalizability of results [21, 23] as the real-world introduces greater variability within and between settings when factors such as competing priorities, availability of human resources, staffing, funding, communication channels and data management all interact and challenge implementation efforts. Each of these factors can impact program effectiveness. Implementation trials in real-world settings should collect data from multiple perspectives at varying levels (e.g., delivery team, sites, organization) and extend beyond the program to capture context, process, and strategies [28, 33, 36]. To understand implementation within real-world settings, a broad lens that extends beyond collecting program-related data and includes system-wide data is needed. 93 To guide this broad research area, McKay and colleagues created a minimum dataset for implementation evaluations for physical activity and nutrition programs [36]. The dataset was created using a Delphi consensus methodology with an international group of implementation scientists [36]. The work identifies implementation determinants (factors that affect implementation) and outcomes (results from the implementation) and specifies these must be researched from both delivery of the intervention (participant level) and delivery of implementation strategies (organizational level) levels [36]. Distinguishing the same variable measured at two levels reveals a more detailed understanding of how an implementation project was executed. For example, McKay and colleagues advocated that fidelity, designated as an implementation outcome, must be researched at both the program delivery level (i.e., extent to which the intervention was delivered as planned by the delivery team) and the delivery of implementation strategies level (i.e., extent to which the implementation strategies are delivered as planned by the support team) [36]. Measuring variables at both levels is a valuable practice within implementation evaluations, yet the extent to which variables are reported at these levels is unknown. To our knowledge, no previous review has examined implementation strategies within diabetes prevention programs, nor examined to what extent measurement of implementation determinants and outcomes have been reported at these two levels. One prior review examined a narrow range of implementation outcomes and did not examine determinants nor distinguish between levels [97]. Another review examined implementation outcomes, cultural adaptations, and translational strategies but only explored programs in the United States (U.S.) that were based on the U.S. Diabetes Prevention Program [148]. The ERIC compilation was published the same year of both reviews, and therefore implementation strategies could not have been included in these reviews. There is a need to conduct a review to identify such gaps in the literature and to synthesize implementation strategies. By doing so, one can understand how programs are being implemented worldwide, identify gaps in the literature, and make 94 recommendations for future implementation research. In a rapidly developing field of implementation science, an updated review looking at the prevalence of implementation determinants and outcomes from different levels is needed. Reviewing the literature using standardized terminology will synthesize the most frequently used strategies, determinants, and outcomes to date, helping to understand what is working (or not) in real-world contexts and allowing for recommendations to inform future implementation studies. Overall, this review provides a holistic synthesis of how diabetes prevention programs have been implemented and evaluated. The aim of this exploratory review is to describe the state of the literature and provide recommendations for implementation research in diabetes prevention programs. This review has two co-primary research questions, ‘(1) What implementation strategies, as defined by ERIC compilation, have been used when implementing a diet and/or exercise diabetes prevention program into a real-world setting?’ and ‘(2) What implementation determinants and outcomes, as defined by McKay and colleagues, have been reported when implementing a diet and/or exercise diabetes prevention program into a real-world setting and at what level(s)?’. In addition, one secondary research question examined whether included articles referenced an implementation theory, model, or framework (hereafter referred to as implementation frameworks) and for what purpose: ‘What implementation frameworks have been used and why when implementing a diet and/or exercise diabetes prevention program into a real-world setting?’. 5.2 Methods A systematic search and review was conducted. This review type includes a comprehensive search strategy, may or may not include a quality assessment, and aims to analyze included articles to develop recommendations for practice [149]. To increase methodological rigour, the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were used and modified as necessary to fit this review type [150] (see 95 Additional file 1). This review protocol was registered on Open Science Frameworks (see https://osf.io/cbzja) [151]. 5.2.1 Search Strategy An advanced electronic search strategy was developed in collaboration with a research librarian and reviewed by a second research librarian [152]. The final search strategy was tailored to four electronic databases used for the search (Medline, Embase, Web of Science and Google Scholar) and run on Oct 19, 2021. Reference lists of relevant published reviews and all included papers were examined for additional relevant literature. For full search strategy details please refer to the protocol [151]. 5.2.1 Eligibility criteria Specific inclusion and exclusion criteria were applied based on the population, intervention, comparison, outcomes, and study type (PICOS; see protocol [151]). This review examined the implementation of diabetes prevention programs, as such the population of interest are the programs that are characterized by the inclusion of individuals at risk of T2D. Thus, published articles on diabetes prevention programs that identify individuals as at risk of developing T2D via one of the following methods were included: (1) by a blood test including either a HbA1c, fasting blood glucose, or oral glucose tolerance test indicating impaired fasting glucose or impaired glucose tolerance as defined by the study, (2) a standardised risk assessment test that identified them at increased risk for T2D (e.g., CANRISK, FINDRISK, AUSDRISK, Indian Diabetes Risk Score), or (3) a previous gestational diabetes diagnosis. The program must be facilitated by non-research staff (i.e., community staff conduct the sessions with the participants), in a real-world in-person setting. Delivery of in-person programs differ from programs that use technology (e.g., cost, scalability, human resources, uptake) and thus the review focused on a homogenous sample of in-person programs [153, 154]. ‘Real-world’ was defined as any setting that a client may visit in their day-to-day lives (e.g., community centre, fitness facility, church, hospital). All studies that detail a program which targets diet 96 and/or exercise modifications to reduce the risk for T2D in at-risk individuals 18+ years old regardless of date, design, or duration were included. If a program included additional targets (e.g., diet, exercise, mindfulness), these programs were included. Awareness raising or educational campaigns (e.g., workshops, webinars) were excluded. Exclusion criteria included programs for individuals with a T2D diagnosis, non-human subjects, research staff facilitating the program directly to participants, use of technology to deliver the program (e.g., telehealth, digital programs, mobile health programs) and in a laboratory, university, or experimental setting. Due to time and resource constraints, non-English languages articles were excluded. No exclusions were made based on year of publication. 5.2.2 Study Selection Identified articles were imported into Covidence [155] for data management. After removing duplicates, two reviewers independently screened all titles/abstracts, and full texts to identify potentially eligible studies. To reduce bias and errors, both reviewers met after reviewing 20 title/abstracts and 5 full text manuscripts to ensure accuracy during the screening process. At each stage (title/abstract, and full text review) discrepancies were discussed among the two reviewers until consensus was reached. Interrater reliability statistics (% agreement) were assessed at each stage (title/abstract [89%] and full text review [77%]). 5.2.3 Study Quality Assessment Consistent with the review type, a risk of bias assessment was not conducted [149]. 5.2.4 Data Extraction and Analysis Two reviewers independently extracted data from included studies. A customized data extraction tool was created and piloted on the first five publications to ensure accuracy and precision during the extraction process. Discrepancies were discussed among the two reviewers until consensus was reached. General study details (program name, country, study design, 97 target behaviour, program setting, number of sites, program type, program duration, number of sessions) were extracted. To answer the primary research questions, implementation strategies were extracted using names and definitions from the compilation of implementation strategies (ERIC) [44]. To strengthen coding reliability, a codebook was created to assist consistent application of definitions (Additional file 2). To further describe the sample of strategies, strategies were then grouped according to thematic clusters and visually grouped into four quadrants according to importance and feasibility ratings identified in previous work by the ERIC group [156]. An attempt was made to extract implementation determinants and outcomes according to definitions from the minimum implementation dataset [36]. Efforts were limited by the small number of studies that reported implementation or implementation strategy level factors and the difficulty applying definitions provided for the variables in Table 2 of McKay and colleagues [36]. Many definitions were specific, limiting the applicability of the tool. For example, it was difficult to confidently assign generic interview data (i.e., facilitators and barriers to implementation) to specific variables based on the definitions by McKay (e.g., feasibility, satisfaction, adaptability). Therefore, a broader level of data extraction was used. Using Table 2 from McKay and colleagues [36] as a guide, the number of studies that reported data at the implementation determinant or outcome levels were described. Next, each study was assessed for whether data were reported at the level of the program or implementation strategy. With this necessary change in specificity of data extraction, conclusions can be made based on the broader level of data extraction. To further describe details on reporting implementation variables, additional descriptive details were extracted including whether the following items were reported: site or staff descriptive data, interview or focus group data, program effectiveness data, implementation data and finally, the level of research. Level of research was determined by examining the perspective of the target data collection as the participant, facilitator, managerial, site, 98 organization, community, cost, or reflections on implementation. For example, if staff were interviewed, but all interview questions reflected staff perspectives on participant participation, participant level was selected. If interviews with staff reflected the opinions of staff on program implementation, then staff level was selected. Multiple levels could be selected for one publication. Finally, all theoretical frameworks were extracted using the five categories of theories, models and frameworks used in implementation science as a guide [27]. Each publication was extracted individually. Any program referenced within multiple publications were combined at the data analysis stage. Data was descriptively analyzed to understand the presence of frameworks, implementation strategies, implementation outcomes and implementation determinants. 5.3 Results The search identified 8152 records and 3576 duplicates were removed. A total of 4576 unique studies were screened for eligibility by title and abstract and 420 studies were screened for eligibility by full-text (see Figure 1 for full PRISMA flowchart and reasons for study exclusion). 5.3.1 Study (N = 166) Characteristics Ultimately, 166 studies were included. Included studies were descriptive (22%), cohort (17%), pilot/feasibility (13%), randomized trials (13%), evaluation (11%), design (8%), reflection (8%), or other (8%). 5.3.2 Program (n = 94) Characteristics The 166 included studies represented 94 programs (Table 1 for program characteristics). Overall, programs were conducted in the U.S. (52%), United Kingdom (11%), the Netherlands (6%), Australia (4%), Spain (4%), Canada (4%), Finland (2%), New Zealand (2%), Thailand (2%), and other countries (Austria, Brazil, China, Denmark, Germany, Greece, Israel, India, Poland, Saudi Arabia, Uganda, South Africa, Sweden, [ 1%]). Programs were set in 99 primary care (49%), community (e.g., church, fitness center, library; 34%), a combination (12%), or workplace settings (4%). A minority did not describe the setting (1%). Most programs targeted diet and physical activity (94%) with one program targeting only dietary behaviours (1%) and five programs targeting diet, physical activity, and an additional behaviour (e.g., alcohol, smoking, sleep, stress; 5%). Program duration was for a year (50%), less than a year (39%), more than a year (5%), or not described (5%). The number of sites varied from small single site pilot/feasibility studies to national implementation efforts. Most programs (56%) presented data from less than 10 sites, a minority of programs (3%) had greater than 100 sites. Programs were group-based (56%), a combination of group and individual (34%) or individual (9%), with 1% not describing the type of program. Most programs included healthcare professionals in some capacity (72%). 5.3.3 Implementation Strategies A total of 69 of 73 strategies were identified (M = 13.8 ± 9.1, range 0 – 41 per program). The most reported strategies were: conduct educational meetings, build a coalition, and promote adaptability (see Table 1 for overview of frequency data per strategy). Four strategies were not represented within the data at all: change liability laws, develop disincentives, make billing easier, and start a dissemination organization. The strategies were extracted from each individual study (N = 166), then consolidated according to program (n = 94). The highest number of strategies were identified in large implementation scale-up efforts (United Kingdom National Health Service Diabetes Prevention Program, United States National Diabetes Prevention Program, and the Kerala Diabetes Prevention Program in India; 41, 39, 34 strategies respectively). One study did not contain any identified strategies (see Appendix F for the list of extracted implementation strategies identified per program). Two studies documented ERIC strategies within the manuscript. In both of these studies, the final set of implementation 100 strategies extracted from this review differed from the list published within these two manuscripts. Authors of the ERIC compilation published strategy clusters and quadrants of importance and feasibility [156]. The most frequently represented thematic cluster was develop stakeholder interrelationships and train and educate stakeholders, while the least frequently represented clusters were: utilize financial strategies, change infrastructure, support clinicians, and provide interactive assistance (see Table 3). Similar results are observed when looking at the number of programs represented within each thematic cluster. Overall, there were more strategies within the high importance, high feasibility quadrant than the rest of the quadrants and all quadrants had good representation amongst the programs (See Table 4). 5.3.4 Implementation Determinants and Outcomes Most programs reported program effectiveness data (81%). Programs reported implementation data (39%) and attendance data (62%) in some capacity. Of the programs reporting implementation data, 20% reported implementation outcomes (4% at both the program and implementation strategy level, and 17% at program level) and 20% reported implementation determinants (20% at both the program and implementation strategy level, 2% at program level, and 1% at implementation strategy level). A minority of studies reported coach or site descriptive details (23%). Most programs reported data at the participant level (88%), with less focus on the facilitator level (32%), site level (18%), cost data (16%), managerial level (10%), organizational level (6%), and community level (1%) and a small number of programs reported a descriptive overview of reflections on the implementation effort (12%). Of the identified levels of data reporting (such as participant, site, facilitator etc.), programs reported one level (54%), two levels (19%), 3 levels (14%), four levels (7%), five levels (4%) and one program reported six levels (1%). 101 5.3.5 Theoretical Frameworks The majority of studies lacked an implementation theoretical framework, model or theory (75%). Theories, frameworks, or models were used to inform analysis (42%), design (40%) or data collection (5%). When classified according to the categories by Nilsen and colleagues [27], the majority were used for evaluation (48%; REAIM; Proctor; PIPE; Stekler and Linnan; evaluation theories; Preceed Proceed). Determinant theories, models or frameworks (CFIR, TDF, ERIC) were used 20% of the time, process (K2A; MRC, Intervention Mapping; McKleroy; Grol and Wensing) 18%, classic (NIH BCC; coalition building; social learning theory, CBPR) 8%, and implementation (COM-B; Dynamic Sustainability Framework; Health care intervention implementation theory) 8%. 5.4 Discussion This review explored the reporting of implementation variables and strategies in diabetes prevention programs conducted in real world settings. To optimally build the field of implementation science, greater understanding is needed on how evidence-based programs are implemented (i.e., identification of implementation strategies), how well the implementation proceeded (i.e., reporting of implementation outcomes) and under what context (i.e., reporting of implementation determinants). This comprehensive systematic search and review extended the work of previous reviews by reporting on diabetes prevention programs from countries around the world, including projects at varying stages of implementation/scale-up, and extracting data using standardized tools [36, 44]. Laying the foundation for future work, this review is the first of its kind to retrospectively identify implementation strategies in diabetes prevention programs implemented in the real world. Future directions are discussed throughout the discussion section. Overall, 69 of 73 strategies were identified within the publications with an average of 13.7 strategies identified per program. The average number of strategies falls below the range 102 identified from other projects reporting implementation strategies (range 16 – 59; [115, 157-159]). Retrospective coding may result in fewer implementation strategies compared to prospective coding because extraction is limited to the information provided within the manuscript and may not reflect all strategies present during the implementation [70]. A large range of strategies were documented. Small single-site studies focused on demonstrating effectiveness within a new setting often resulted in few strategies extracted. In comparison, larger implementation projects with multiple sites often resulted in more strategies extracted. Regardless of the size of an implementation project, reporting implementation variables and strategies is important. Well thought out pilot and feasibility studies designed with scale-up in mind are needed to adequately prepare for larger trials and sustainable community-based DPPs [160]. In general, the more manuscripts contained within a grouping, the more implementation strategies identified. Having numerous publications may have allowed for greater depth and breadth of the research, and enabled more space for detailed reporting, thus increasing the number of extracted strategies. Large implementation trials included a greater number of sites, potentially requiring more planning and purposeful strategies to support implementation and consistency across sites. Additionally, large trials had a greater focus on implementation, resulting in more detailed documentation of implementation variables and strategies. Early research suggests a potential correlation between the number of strategies used and the uptake/delivery of an evidence-based innovation [115]. However, scenarios exist where simple implementation strategies may be more effective than complex, multicomponent ones [45]. The type of strategy (e.g., active strategies, sustaining strategies, and tailoring strategies to the individual context) may be more important than the quantity [45]. Implementation strategies continue to be a rich area of study, with more research and more reporting of strategies needed to answer such questions. 103 The most common strategies reported were conduct educational meetings (n = 64), build a coalition (n = 63), and promote adaptability (n = 54). In a previous review conducted in the area of implementing community-based chronic disease prevention programs, educational meetings was the most commonly reported strategy [161]. However, an older version of the compilation was used and results may not be comparable to the current review. Our results differ compared to a paper that specified implementation strategies within seven large implementation interventions [157]. Thirty-three strategies were identified yet both build a coalition and promote adaptability were not represented [157]. The most common strategies in that aforementioned review were: develop educational materials, distribute educational materials, implementation facilitation, assess for readiness and identify barriers and facilitators, develop an implementation blueprint, and audit and provide feedback [157]. Perry and colleagues [157] suggested organizing strategies into four functional groups: (1) build health information technology to support data-informed quality improvement (QI), (2) build QI capacity and improve outcomes, (3) enhance clinician and practice member knowledge, and (4) build community connections and patient involvement [157]. We agree that these four functional groups are a useful way to organize implementation strategies. Implementation is complex and refining the organization of implementation strategies can help implementation scientists choose relevant implementation strategies as determined by the context and aim for representation of all four functional group. When looking at the thematic clusters of strategies, as defined by ERIC [156], engaging consumers was the most represented cluster, followed by use of evaluative and iterative strategies, adapt and tailor to the context, and train and educate stakeholders (see Table 3 for overview of cluster representation). Engaging consumers complements the current review’s finding that most research is done at the participant (i.e., consumer) level and implementation strategies seem to target the participant as well. This is further supported by less focus on support staff level strategies, especially beyond just educational strategies. Strategy clusters 104 that tend to support staff facilitating the implementation (e.g., provide interactive assistance and support clinicians) had limited representation. These clusters are important to build capacity as education and training (more frequent strategies) may not be sufficient. Research from the behaviour change field supports this, as often education is insufficient to change behaviour and additional behaviour change techniques to support individuals are needed [162, 163]. The least represented clusters include utilize financial strategies and change infrastructure. These two clusters are mainly focused on the outer setting which may be more difficult to change. Indeed, almost all the strategies in these two clusters are found in quadrant I, representing low feasibility and low importance [156]. More research is needed to understand the relationship between specific strategies and/or clusters of strategies and the success of innovation uptake. Reporting implementation strategies in diabetes prevention programs is rare. Only two of the 93 programs included reported implementation strategies using definitions provided by ERIC. This low reporting of implementation strategies is consistent with other fields [157]. Upon reviewing example codes provided by one of the publications, we noted discrepancies on the interpretation of implementation strategies definitions. This highlights ambiguity in the comprehension of implementation strategy definitions. Despite research demonstrating that implementation strategies are conceptually distinct [156] when used in practice, accurately selecting the correct strategies may be difficult. Similar to coding behaviour change techniques, additional supports such as standardized training, mobile phone application, and a technical assistance website may be needed to support researchers in accurately selecting strategies to ensure consistency in reporting [164]. Ambiguity in the coding of implementation strategies can undermine future efforts to collate research. Before we understand what strategies are important, we must first understand what strategies have been used in the past by accurately and consistently reporting them [158]. This review makes the first steps in identifying strategies used within diabetes prevention programs, based on consensus-based retrospective coding. 105 There were many challenges with extracting implementation strategies. Some strategies are inherently linked to other strategies [40]. For example, the provision of technical assistance, can be coded as either provide local technical assistance or centralize technical assistance depending on where the technical assistance is coming from. In addition, the action of providing technical assistance may include a range of other implementation strategies such as provide clinical supervision, provide ongoing consultation, facilitation, visit other sites, develop a learning collaborative, conduct educational meetings, develop education materials, and distribute educational materials [165]. In other instances, an implementation strategy directly implies multiple actions. For example, the strategy audit and feedback requires three discrete steps: data collection, review of data (audit), and provision of feedback. The data needed for an audit may have been collected as part of the quality monitoring tools and systems (i.e., develop and implement quality monitoring tools and develop and implement quality monitoring systems). Situations could arise where audit occurs without feedback, which limits the codability of this strategy. Finally, the provision of feedback can occur in a variety of ways from passive strategies such as a report to active strategies, individual one-on-one feedback meetings. Until strategies are disentangled from one another, coding will continue to be difficult. Indeed, the authors of ERIC recommend to always describe the discrete strategies within a larger strategy [40]. Clearly, detailed reporting is needed to understand exactly what was done, and implementation strategies should represent irreducible actions. We encountered challenges with the definitions provided by ERIC. Many strategies had a clinical focus and may benefit from general definitions. For example, organize clinician implementation team meetings specifies a specific profession; however, individuals other than clinicians may implement initiatives (e.g., nurses, fitness staff). Using general terms and removing specific professions from definitions would improve applicability to broader fields. Other definitions were very specific such as start a dissemination organization. While many programs discussed the importance of dissemination there were no instances that a specific 106 organization was created and thus, we did not code this strategy once throughout this comprehensive review. Within academia, dissemination is a normal aspect of the research process. We recommend a change in the strategy name to better reflect the common practice of disseminating results or innovations. We also suggest adding new strategies to the compilation. We partially agree with the suggestions by Bunger and colleagues [158] to add obtain worker feedback about implementation plan and plan for outcome evaluation. Obtain worker feedback about implementation plan could already be coded under conduct local consensus discussions; however, we felt that a strategy on obtain staff feedback on implementation would be a helpful addition (note we changed ‘worker’ to ‘staff’). Plan for outcome evaluation may already be encompassed in develop a formal implementation blueprint. The definition for develop a formal implementation blueprint could be enhanced by revising the wording ‘appropriate performance/progress measures’ to specifically highlight both outcome evaluation and implementation evaluation. Three additional strategies are suggested: organizational leadership from each site meet to discuss implementation, training for the support team, and obtain feedback from support team. Support staff and leadership staff have important support roles within implementation efforts [72] and feedback, training and meetings should be occurring beyond just the individuals facilitating the program. Based on our work, we disagree with two of the strategy suggestions by Perry and colleagues [157]: engage community resources and create online learning communities, as we feel these strategies are already encompassed through the current list of strategies. Specifically, engage community resources could be coded under develop resource sharing agreements, while create online learning communities could be coded under create a learning collaborative. We agree with their addition of assess and redesign workflow because building on existing workflows often benefits implementation, but requires changing to accommodate, encourage, or incentivize the new innovation. Assessing and building on existing workflows and tailoring to the intervention was mentioned as a positive 107 implementation strategy within the included programs [166-168]. Clearly, there is room for improvement in the definitions’ wording within the tool to promote consistency and comprehension of existing strategies and the suggested addition of other strategies. Suggestions to improve the reporting of implementation strategies reinforce the need for authors to provide details on the actor, action, action target, temporality, dose, implementation outcome affected, justification [40]. We agree this suggestion will help other researchers understand more clearly what was done. In addition, greater uptake and enforcement of reporting guidelines are needed. In 2017, the Standards for Reporting Implementation Studies (StaRI) statement and checklist was published specifically requesting strategies be reported [41]. Despite the current review including articles published after the release of STARI, there were only two publications that reported strategies. Results confirm that most programs focus on effectiveness data with a smaller focus on implementation variables. Despite facilitators and support staff having an integral role in the success of a program, only 23% of programs reported descriptive data on staff or the site. Similarly, only a minority of programs reported data from viewpoints other than participants. In the real-world and specifically implementation, broader vision of research participants must be considered [33]. Multiple layers of staff (facilitators, managers, administrative staff, leadership) support implementation and they all act within a broader environment (site, organization, community). Instead of extracting individual implementation variables, data were extracted at the outcome and determinant level, and each study was assessed whether data were reported at the program or implementation strategy level using Table 2 from McKay and colleagues’ [36] minimum dataset as a guide. Overall, there is a lack of reporting implementation data. When implementation outcomes are reported, they are most often at the program level, with little to no attention to the implementation strategy level. For implementation determinants, both program and implementation strategy levels are represented. This may be because implementation determinant data was often collected by qualitative interview or focus group data, allowing for 108 flexibility and breath of questions. A significant gap exists in researching implementation data, especially a broad and holistic view of implementation. While we were not able to extract the individual variables included within Table 2 of McKay and colleagues’ minimum dataset [36], the majority of programs fall short of meeting this list. Greater focus on implementation variables is needed. Only 25% of studies included an implementation theoretical framework. Framework classifications generally follow the same trend as variables reported. For example, most studies reporting reach, were informed by the RE-AIM framework (evaluation classification) just as there were only a small number of determinant frameworks reported and an equally small number of studies reporting implementation determinants. Greater focus on implementation my result in greater use of implementation frameworks. Continued advocacy for implementation research is needed. 5.4.1 Strengths,Limitations and Future Directions Extracting implementation strategies was limited to retrospective coding of published study details and is limited to the amount of detail reported in the original articles. Retrospective coding may underreport strategies when compared to the benefits of tacit knowledge held by authors when prospectively reporting strategies [70]. It is difficult to disentangle strategies implemented for research purposes (e.g., free program, evaluation or reporting strategy) that may or may not remain within a fully real-world initiative. The research team encountered difficulties applying definitions to extract strategies. To establish coding reliability, a codebook was created to assist consistent application of definitions, all manuscripts were coding by two researchers and numerous conversations and meetings were held to establish consensus. A possibility exists that our interpretation of a strategy is incorrect. Interested authors may review our codebook (Additional file 2) to understand our interpretation of ERIC definitions. We did not extract individual implementation outcomes and determinants due to the lack of meaningful data 109 coupled with the narrow definitions provided by McKay et al., 2019. Overall, the conclusion remains the same, there are significant gaps in reporting implementation level determinants and outcomes. The data collected from this systematic search and review has noted limitations (i.e., retrospective coding of published manuscripts), yet the large dataset contains interesting data to inform future directions. An identified trend of having more strategies extracted from larger implementation projects compared to smaller projects is worth exploring. There may be strategies that become more important as a project increases in size. In addition, a potential temporal relationship may exist within strategy use. Some strategies may be more important in the planning phase of implementation compared to active implementation and sustainability of the project. In multi-site projects, understanding the fidelity of implementation strategy enactment could uncover reasons for differences in implementation success between sites. Finally, programs that included manuscripts with a lesson learned or reflection section contained valuable insights for future implementation research to learn from. Completing a descriptive analysis of these sections could highlight potent implementation strategies worth including in future research and/or experimental research. 5.4.2. Conclusions Strong evidence supports diabetes prevention programs as a potent method to combat the rising prevalence of T2D. Yet research on how to best implement these programs is lacking. Implementation can have a large impact on program effectiveness and must be examined. To our knowledge this was the first systematic search and review that specifically aimed to extract implementation strategies, outcomes and determinants from previously reported diabetes prevention programs implemented in a real-world setting. Extracting implementation strategies was difficult due to a lack of detailed reporting in studies on how programs were implemented and difficulty applying the ERIC definitions. Most diabetes prevention programs implemented 110 within a real-world setting have focused on reporting participant level program effectiveness data with a lack of implementation level outcomes and determinants. Without implementation level data it is difficult to understand whether programs have been implemented effectively and how and why the implementation was or was not effective. Greater focus on implementation is needed to build the evidence base for evidence-based implementation. 111 Identification References from citation searching (n = 4) Studies screened (n = 4576) Studies assessed for eligibility (n = 420) Duplicates removed (n = 3576) Studies excluded (n = 4156) Studies excluded (n = 254) Published abstract (n = 83) Wrong population (n = 52) Wrong setting (n = 51) Wrong program (n = 33) Wrong publication type (n = 22) Non-English study (n = 12) Could not access (n = 1) Included Studies included in review (n = 166) Screening Studies from databases/registers Figure 1: PRISMA flow diagram 112 Table 11: Program characteristics Group ID Program Name Citations Country Target behaviour Program setting # of sites Program type Program duration # of sessions 141 Project Reaching Immigrants through Community Empowerment (RICE) [169, 170] United States Other: Diet, PA, stress and family access to healthcare Community 1 Combination of group and individual Less than a year 16 195 National Health Service Diabetes Prevention Program [171] United Kingdom Diet and physical activity Primary care 9 Group Less than a year 13 287 Diabetes Prevention in Chinese Women at Risk for Diabetes [172] China Diet and physical activity Primary care 3 Group A year 23 113 467 Small Steps for Big Changes [50, 94] Canada Diet and physical activity Community 2 Individual Less than a year 6 523 South Asian Health and Prevention Education Study pilot study [173] United States Diet and physical activity Not described 2 Group A year 16 535 Group Lifestyle Balance in women VA [174] United States Diet and physical activity Primary care 4 Group A year 22 604 PVS-PREDIAPS [175-177] Spain Diet and physical activity Primary care 9 Not described Not described not described 672 De Por Vida [178] United States Diet and physical activity Primary care 1 Group More than a year 32 114 696 Help Educate to Eliminate Diabetes [179] United States Diet and physical activity Community not described Group Less than a year 8 705 National Diabetes Prevention Program [51, 99, 180-182] United States Diet and physical activity Primary care + Community 435 Group A year 22 821 National Diabetes Prevention Program [183] United States Diet and physical activity Primary care 8 Group A year 22 1137 Thai Diabetes Prevention Program [184] Thailand Diet and physical activity Primary care 68 Group More than a year 17 1147 Prediabetes Intervention Package [185-187] New Zealand Diet Primary care + Community 4 Combination of group and individual Less than a year 10 115 1160 Diabetes Prevention Program in Large Healthcare Systems Evaluation of a Lifestyle Intervention Adopted for Clinical Practice for Diabetes Prevention [188, 189] United States Diet and physical activity Primary care 20 Group A year 22 1589 Diabetes Prevention Program for Chinese American Food [190] United States Diet and physical activity Workplace 1 Individual Less than a year 12 116 Service Employees 1616 A Person-Centered Approach to Self-Management and Reciprocal Learning for the Prevention and Management of Type 2 Diabetes [191] Other: Uganda, South Africa, Sweden Uganda: Diet and physical activity and alcohol, smoking, self-care and medication; South Africa: Diet and physical activity and alcohol, smoking, self-care and medication, sexuality and Primary care Not described Combination of group and individual A year 13 117 stress management; Sweden: Diet and physical activity 1659 Power Up for Health [192-194] United States Diet and physical activity Community 8 Group A year 16 1682 Group Lifestyle Balance Program in a Military Setting [195] United States Diet and physical activity Primary care 1 Combination of group and individual Less than a year 4 1942 National Health Service Diabetes Prevention Program [196-206] United Kingdom Diet and physical activity Primary care + Community 41 Group Less than a year 13 118 1959 Diabetes Prevention -Transferring Findings from European Research to Society [167] Spain Diet and physical activity Primary care 103 Combination of group and individual More than a year 16 2129 Diabetes Prevention Program - Group Lifestyle Balance [207] United States Diet and physical activity Community 3 Group A year 22 2152 Kerala Diabetes Prevention Program [208-213] India Other: Diet, physical activity, smoking, alcohol, sleep Community 30 Group A year 15 2308 Promotora Effectiveness [214] United States Other: Diet, physical Primary care 1 Group A year 24 119 Versus Metformin Trial activity, and medication intake 2319 Sydney Diabetes Prevention Program [215] Australia Diet and physical activity Primary care 1 Combination of group and individual A year 7 2399 Weight watchers [216] United Kingdom Diet and physical activity Community Not described Group Less than a year 48 2550 Intermountain Healthcare Diabetes Prevention Program [217-219] United States Diet and physical activity Workplace 63 Combination of group and individual Less than a year 12 2553 National Diabetes Prevention Programs in Los Angeles [220-223] United States Diet and physical activity Primary care + Community 4 Group A year 24 120 2556 Veterans Affairs Diabetes Prevention Program vs. MOVE! [224-226] United States Diet and physical activity Primary care 3 Group A year 19 (MOVE) 22 (VADPP) 2665 Primary Care Diabetes Prevention Program [227] Canada Diet and physical activity Primary care 6 Group A year Not described 2804 Sydney Diabetes Prevention Program [228] Australia Diet and physical activity Primary care 83 Combination of group and individual A year 8 2840 Diabetes Prevention Program for Diabetes Risk Reduction in Chinese [229] United States Diet and physical activity Community 1 Combination of group and individual A year 18 121 Immigrants in New York City 2946 SLIM iMplementation Experience Region Noord- en Oost-Gelderland [166, 230-232] The Netherlands Diet and physical activity Primary care 49 Combination of group and individual Less than a year 10 2952 YMCA Diabetes Prevention Program [233] United States Diet and physical activity Community 2 Group A year 25 2956 National Diabetes Prevention Program within a Health Disparities Population [234] United States Diet and physical activity Community 3 Group A year 16 122 3106 Weight Watchers vs. Your Game Plan to Prevent Type 2 Diabetes [235] United States Diet and physical activity Community Not described Group A year Unlimited 3195 GLICEMIA [236] Germany Diet and physical activity Primary care 42 Combination of group and individual A year 8 3222 Intervention Program in a Large Israeli Healthcare Organization with an Emphasize on Mediterranean Diet (MedDiet) [237] Israel Diet and physical activity Primary care Not described Combination of group and individual Less than a year 10 group meetings or 8 individual meetings over 6-months 123 and Physical Activity 3435 Road Map Towards Diabetes Prevention [238] The Netherlands Diet and physical activity Primary care 26 Individual A year 5 53471 Reaching Out and Preventing Increases in Diabetes [239, 240] United States Diet and physical activity Primary care + Community 15 Group A year 25 3477 Promotora-Led Diabetes Prevention Program (PL-DPP) in Latinas [241] United States Diet and physical activity Community 2 Group A year 24 3483 Healthy Living Program (HLP) and a Diabetes Prevention Program (DPP) [168] United States Diet and physical activity Primary care + Community 4 Combination of group and individual Less than a year 24 124 3577 New Life, New You [242] United Kingdom Diet and physical activity Community 1 Group Less than a year 8 3691 Group Lifestyle Balance Program Delivered by Diabetes Educators [243, 244] United States Diet and physical activity Primary care 3 Group A year 21 3868 Church-based Diabetes Prevention Program [245] United States Diet and physical activity Community 1 Combination of group and individual Less than a year 12 3897 New York State YMCA Diabetes Prevention Program [246, 247] United States Diet and physical activity Primary care + Community 14 Group A year 22 125 3920 Reaching Immigrants through Community Empowerment [248] United States Diet and physical activity Community Not described Combination of group and individual Less than a year 16 3939 Special Diabetes Program for Indians Diabetes Prevention Program [249, 250] United States Diet and physical activity Primary care 36 Combination of group and individual Less than a year 16 3974 New Life, New You [251] United Kingdom Diet and physical activity Community Not described Group Less than a year 20 4008 DHIAAN [252-254] The Netherlands Diet and physical activity Primary care Not described Combination of group and individual A year 32 126 4056 YMCA Diabetes Prevention Program [255] United States Diet and physical activity Community 46 Group A year 24 4091 Lifestyle intervention programs in the Brazilian public health system [256] Brazil Diet and physical activity Primary care 1 Combination of group and individual Less than a year 13 4235 ‘An Ounce of Prevention’ Healthy Lifestyle and Diabetes Program [257] Canada Diet and physical activity Primary care 1 Combination of group and individual Less than a year 17 4239 NHS Bolton (face-to-face) [258] United Kingdom Diet and physical activity Primary care 15 Individual Less than a year Not described 127 4311 Power to Prevent (P2P): A Family Lifestyle Approach to Diabetes Prevention [259] United States Diet and physical activity Community 3 Group Less than a year 12 4343 Melbourne Diabetes Prevention Study [260-262] Australia Diet and physical activity Primary care Not described Combination of group and individual Less than a year 6 4381 Health is Wealth [263] United States Diet and physical activity Community 1 Group Less than a year 8 4445 Lawrence Latino Diabetes Prevention Project [264] United States Diet and physical activity Primary care 1 Combination of group and individual A year 16 128 4711 Diabetes in Europe- Prevention Using Lifestyle, Physical Activity and Nutritional Intervention Project [265] Austria Diet and physical activity Primary care Not described Group A year 5 4793 Montana Department of Public Health and Human Services - Diabetes Self-Management Education [266-271] United States Diet and physical activity Primary care + Community 39 Combination of group and individual Not described N/A 4823 Making the Connection - [272] United States Diet and physical activity Community Not described Group A year 22 129 Healthy Living Program 4856 DPP in Thailand [273] Thailand Diet and physical activity Primary care + Community Not described Group Less than a year Not described 5011 DPP in African American Churches [274] United States Diet and physical activity Community 5 Group A year 6 and 16 (two arms) 5058 Reflections on Progress of DPP in Australia. Life! Taking Action on Diabetes [275, 276] Australia Diet and physical activity Primary care Not described Group Less than a year 6 5060 Diabetes in Europe Prevention using Lifestyle, Physical Activity and [277, 278] Poland Diet and physical activity Primary care 9 Group Less than a year 17 130 Nutritional Intervention 5113 Live Well, Be Well Study [279-281] United States Diet and physical activity Community 4 Combination of group and individual A year 19 5121 Diabetes in Europe Prevention using Lifestyle, Physical Activity and Nutritional Intervention [282] Greece Diet and physical activity Primary care + Workplace 12 Group A year 6 5148 Diabetes Prevention Program in YMCAs [283] United States Diet and physical activity Community Not described Group A year N/A 131 5176 Church-Based Diabetes Prevention Programs [284] United States Diet and physical activity Community Not described Group Not described Not described 5428 Diet-Exercise-Activity-Lifestyle Program [285] United States Diet and physical activity Primary care 1 Combination of group and individual A year 5 5432 Active Prevention in High Risk Individuals of Diabetes Type 2 in and around Eindhoven [286-289] The Netherlands Diet and physical activity Primary care 14 Combination of group and individual More than a year 17 5448 Beweegkuur [138, 290] The Netherlands Diet and physical activity Primary care 18 Individual A year unknown and individually tailored 132 5467 Healthy-Living Partnerships to Prevent Diabetes [291-293] United States Diet and physical activity Community 1 Combination of group and individual A year 28-45 5514 Living on the Edge of Diabetes [294] United States Diet and physical activity Community 1 Combination of group and individual A year 4 5559 Translating the Diabetes Prevention Program [295] United States Diet and physical activity Primary care 6 Group Less than a year 12 5702 National Type 2 Diabetes Prevention Programme in Finland [296-299] Finland Diet and physical activity Primary care 400 Combination of group and individual Less than a year 5 5865 Diabetes Prevention Program in a [300] United States Diet and physical activity Community 1 Group A year 6 133 Rural Africa-American Church 6008 Worksite Diabetes Prevention Program [301, 302] United States Diet and physical activity Workplace 1 Combination of group and individual A year 22 6214 Lifestyle Intervention Program for Maori [303] New Zealand Diet and physical activity Community 1 Combination of group and individual Less than a year 4 6712 National Diabetes Prevention Programme - Hawaii [304] United States Other: diet, physical activity, and stress management Primary care 7 Group A year 22 6831 Prevention of Diabetes in Euskadi [305, 306] Spain Diet and physical activity Primary care 14 Group A year 4 134 6986 Diabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA (DEPLOY) [135, 307, 308] United States Diet and physical activity Community 1 Group A year 22 7075 Tawazon [309] Saudi Arabia Diet and physical activity Primary care 4 Group Less than a year 22 7132 South Gloucestershire Diabetes Prevention (Pilot) Programme [310] United Kingdom Diet and physical activity Primary care 2 Group Less than a year 6 7166 Life in BALANCE [311] United States Diet and physical activity Community 1 Group Less than a year 16 135 7264 Good Ageing in Lahti Region [312, 313] Finland Diet and physical activity Primary care 16 Group Less than a year 6 7286 Norfolk Diabetes Prevention Study [314-316] United Kingdom Diet and physical activity Primary care 8 Group More than a year 21 7291 STAR Family Health Team (FHT) Prediabetes Lifestyle Intervention Program [317] Canada Diet and physical activity Primary care 1 Group Less than a year 8 7345 Living Well Taking Control [103] United Kingdom Diet and physical activity Community 4 Combination of group and individual A year 10 136 7376 Health Under Construction [318] The Netherlands Diet and physical activity Workplace 25 Individual Not described 7 7442 Diabetes Prevention Program Using Primary Care Nurses [89, 319] United States Diet and physical activity Primary care 5 Individual Less than a year 11 7877 DPP within General Practice in Denmark [320] Denmark Diet and physical activity Primary care 8 Individual A year 6 7955 Diabetes in Europe Prevention using Lifestyle, Physical Activity and Nutritional [321] Spain Diet and physical activity Primary care 16 Combination of group and individual Less than a year 4 137 7982 DPP in Norfolk [322] United Kingdom Diet and physical activity Primary care + Community Not described Group Not described 4 4041 YMCA Diabetes Prevention Program [323] United States Diet and physical activity Community N/A Group A year 22 138 Table 12: Frequency of implementation strategies represented within programs Implementation Strategy Frequency represented Build a coalition 64 Conduct educational meetings 63 Promote adaptability 54 Prepare patients/consumers to be active participants 46 Increase demand 43 Use mass media 40 Obtain and use patients/consumers and family feedback 39 Develop and organize quality monitoring systems 35 Conduct local consensus discussions 34 Develop academic partnerships 34 Intervene with patients/consumers to enhance uptake and adherence 34 Inform local opinion leaders 29 Use advisory boards and workgroups 29 Develop and implement tools for quality monitoring 28 Stage implementation scale-up 28 Promote network weaving 27 Distribute educational materials 26 Purposefully reexamine the implementation 26 Develop educational materials 25 Make training dynamic 25 Conduct local needs assessment 23 Develop resource sharing agreements 23 Use data warehousing techniques 23 Provide ongoing consultation 22 Conduct educational outreach visits 20 139 Alter patient/ consumer fees 19 Conduct ongoing training 19 Change physical structure and equipment 18 Facilitation 17 Access new funding 16 Change record systems 16 Create new clinical teams 16 Identify and prepare champions 16 Revise professional roles 16 Create a learning collaborative 14 Fund and contract for the clinical innovation 14 Provide clinical supervision 14 Work with educational institutions 14 Audit and provide feedback 13 Change service sites 13 Create or change credentialing and/or licensure standards 13 Organize clinician implementation team meetings 13 Tailor strategies 13 Assess for readiness and identify barriers and facilitators 12 Use train-the-trainer strategies 12 Centralize technical assistance 11 Develop a formal implementation blueprint 11 Obtain formal commitments 11 Recruit, designate, and train for leadership 11 Involve patients/ consumers and family members 10 Involve executive boards 8 Visit other sites 7 Alter incentive/ allowance structures 6 140 Conduct cyclical small tests of change 6 Place innovation on fee for service lists/formularies 6 Provide local technical assistance 6 Change accreditation or membership requirements 5 Develop an implementation glossary 5 Use data experts 5 Facilitate relay of clinical data to providers 4 Shadow other experts 4 Use other payment schemes 4 Model and simulate change 3 Remind clinicians 3 Capture and share local knowledge 2 Identify early adopters 2 Mandate change 2 Use an implementation advisor 2 Use capitated payments 2 Change liability laws 0 Develop disincentives 0 Make billing easier 0 Start a dissemination organization 0 141 Table 13: Overview of thematic clusters represented within this review Cluster name Frequency the thematic cluster represented Total # of programs represented within cluster # of strategies within cluster Range of strategies represented within cluster Develop Stakeholder Interrelationships 295 81 17 0-11 Train and Educate Stakeholders 254 76 11 0-8 Use evaluative and iterative strategies 227 68 10 0-10 Engage Consumers 169 73 5 0-5 Adapt and Tailor to the Context 93 74 4 0-3 Utilize Financial Strategies 67 41 9 0-6 Change infrastructure 66 60 8 0-4 Support Clinicians 60 48 5 0-3 Provide Interactive Assistance 49 47 4 0-4 142 Table 14: Overview of importance and feasibility quadrants represented within this review Zone name Frequency the zone represented Total # of programs represented within zone # of strategies represented within zone Range of strategies represented within zone High Importance and High Feasibility 634 86 28 0-20 Low Importance and Low Feasibility 300 84 24 0-11 Low Importance and High Feasibility 189 80 12 0-6 High Importance and Low Feasibility 157 75 9 0-7 143 Chapter 6: General Discussion The overarching purpose of this dissertation was to use an implementation science lens to examine the implementation of diabetes prevention programs in the community. In Chapter 2, the training for coaches was examined. Training is one of five categories of a treatment fidelity framework [60] and fidelity is a common implementation outcome [28]. Findings revealed that fitness facility staff can be trained to deliver a motivational-interviewing informed diabetes prevention program and are a feasible resource to run evidence-based counselling programs for a fraction of the cost of healthcare professionals. In Chapter 3, three additional categories of treatment fidelity were assessed, including treatment delivery, receipt, and enactment. The program was found to be delivered as intended. Clients received and enacted core components of the program, reinforcing the community organizations as feasible and cost-effective venues to deliver evidence-based programs. In Chapter 4, the implementation process and determinants were examined. Strong and early engagement with the community partner facilitated staff buy-in and program acceptability. Many implementation determinants were revealed highlighting the congruency between program and context in which it was implemented. Finally, in Chapter 5 a systematic search and review of diabetes prevention programs in the real world revealed there is inadequate reporting of implementation outcomes, determinants, and strategies within the field to date. More support is needed to report implementation strategies accurately and precisely. Additional research is also needed to understand the relationship between strategy use and intervention uptake. The theoretical, methodological, and practical contributions of this dissertation are discussed in this final chapter, followed by an overview of the strengths, limitations, and future directions. 144 6.1 Theoretical Contributions 6.1.1 Advanced Research on Treatment Fidelity Despite the importance of treatment fidelity, it is often overlooked or poorly researched [60]. Treatment fidelity is an assessment to ensure a research study reliably and validly tests a clinical intervention [60] When treatment fidelity is high, the observed results can be confidently attributed to the intervention itself. Treatment fidelity can be impacted by numerous implementation determinants and is generally viewed as an implementation outcome. Fidelity is classified as a determinant when explaining intervention outcomes. In 2015, a systematic review of 38 real-world diabetes prevention programs identified that only seven programs included quality assurance measures to monitor implementation. Only one study from the 38 included reported data on the extent to which program components were delivered and did so by briefly (and vaguely) describing components as ‘more frequently added than omitted’ [312]. Clearly, there is a lack of published research in this area. Results from Chapters 2 and 3 contributed to the literature by detailing a comprehensive fidelity assessment, moving beyond the narrow study of treatment fidelity that is often limited to assessing only treatment delivery [102-104, 324], to actively assessing of 4 of the 5 categories identified in the NIH behaviour change consortium [60]. The only area that was not assessed in SSBC as part of this dissertation was study design. At the time, previous work had examined the study design and theoretical underpinning of the SSBC program [46, 48]. The single-group pragmatic trial further diminished the need to examine the dimension of study design in this dissertation as recommended items to examine are not relevant, such as ensuring both treatment groups receive the same amount of contact time[60]). Extensive work on the NHS Diabetes Prevention Programme in the UK recently examined fidelity and added a large-scale and thorough fidelity evaluation to the literature [196-198, 325-327]. A series of studies has been published following the NIH treatment fidelity 145 framework examining the overall NHS-DPP design [325], the four provider plans [197], the provider training [198], intervention delivery [196], and participant receipt [327]. Only the participant enactment category was missing from this body of work [326]. This comprehensive work is a laudable addition to the fidelity literature, specifically for its thorough examination of such a large-scale program. This UK-based research concluded that the NHS-DPP delivered most of the behaviour change content, yet there was a drift in fidelity to intervention content at multiple points [326]. The authors noted the lack of a clear theoretical underpinning for the program from the outset may have led to fidelity issues [326]. Without a strong theoretical underpinning, the training did not target all the planned BCTs and program plans did not specify all the planned BCTs according to the study design [326]. In comparison, the SSBC DPP has a strong theoretical underpinning, and BCTs and motivational interviewing techniques have been coded [70]. As SSBC scales-up across British Columbia and across the country, implementation and treatment fidelity will be monitored over time and within and between sites. 6.1.1.1 Training Evaluation Chapter 2 detailed a fidelity assessment of the SSBC in-person training. Training is a common implementation strategy [161, 328]. Despite its prevalence, evaluations on training within interventions are scarce. The aim of chapter 2 was to conduct an in-depth training evaluation to assess category 2 (provider training) of the NIH Behaviour Change Consortium's five categories of treatment fidelity. Study strengths include the triangulation of multiple sources (e.g., coach, staff, researchers) and multiple methods (e.g., knowledge tests, audio recordings, MICA coding, self-reported survey data) to make strong conclusions. Overall, this study acts as a comprehensive guide for future researchers and implementers for how to conduct a detailed training evaluation encompassing all four levels of the Kirkpatrick evaluation model [73]. Typically, outcomes have not been assessed beyond immediate post-training within training evaluations. To ensure that the knowledge and skills taught during the training are applied in practice, resulting in desirable outcomes, the Kirkpatrick training model specifically 146 describes two levels beyond immediate post-training [73]. Planning and execution of data collection in the post-training follow-up period is required to measure the application of knowledge and skills in practice. The extra resources (e.g., time, financial, and planning) often preclude the final two levels of the Kirkpatrick training model from being evaluated [74]. The inclusion of post-training data in this dissertation provides evidence that the training had a long-term impact on behaviours in practice. The study in Chapter 2 examined all four levels of the Kirkpatrick training model, demonstrating that the SSBC training program was effective at changing coaches’ skills and knowledge to implement the SSBC program. Similarities exist between the Kirkpatrick training model and the NIH behaviour change consortium. Both the evaluation model and treatment fidelity framework highlight the need to ensure that information is received and enacted to determine outcomes. Treatment receipt from the Behaviour Change Consortium is typically applied to access what is learned (by clients) [60]. When applied to a training evaluation context, it aligns with the Kirkpatrick level of learning. The learning level aims to understand whether the knowledge and skills taught within the training is learned by the coaches [73]. Treatment enactment from the Behaviour Change Consortium is typically applied to assess whether the knowledge and skills taught are used (by clients) [60]. In the context of a training evaluation, this aligns with the Kirkpatrick level of behaviour. The behaviour level aims to understand whether the knowledge and skills taught within the training is used in practice by coaches post-training [73]. When the Behaviour Change Consortium levels are assessed with positive results, it can increase confidence that the outcomes are a result of the intervention. Similarly, positive results from the outcomes level from the Kirkpatrick evaluation model increases confidence that outcomes are a result of the training. Overall, the parallels between these two distinct frameworks provide credibility to the comprehensive evaluation design used in my dissertation. Two frameworks, developed in different fields, conversing on the measurement of similar processes from different viewpoints (training versus program implementation) in a comprehensive multi-level manner strengthens the rationale for 147 their inclusion. Both frameworks are useful, comprehensive, and should be considered when evaluating behavioural interventions. 6.1.1.2 Treatment Delivery, Receipt, and Enactment Chapter 2 demonstrated that SSBC trainers are taught as intended, and the knowledge and skills were received, and enacted in practice by coaches. Building from this study, Chapter 3 further investigated treatment delivery by coaches and the subsequent receipt and enactment by clients. This chapter used multiple perspectives (e.g., client, researchers, staff) and multiple methods (e.g., fidelity checklists and audio recordings) to examine treatment fidelity, intervention receipt, and intervention enactment. The unique assessment of participant receipt and enactment provides an exemplar for future researchers to use. The work confirmed core theoretical components of SSBC are received by clients and the knowledge and skills they derive from SSBC are subsequently used in their lives. This thorough assessment of treatment fidelity through examining treatment receipt and enactment speaks to the effectiveness of SSBC. Although fidelity is not well-researched in general, among all of its aspects, the delivery of treatment has received the most attention [324]. Chapter 3 examined session-specific checklists that SSBC coaches completed to assess the extent of program delivery. In our assessment of checklist validity, we found a high level of agreement between the checklist information reported by coaches and the checklists completed by researchers who listened to recorded sessions. These checklists were designed to be easy to use, quick to complete, and helpful to coaches. In an implementation trial, data collection measures should be selected for practical reasons as opposed to gold standard measures [329]. Practical considerations include measures that are pragmatic, feasible, user-friendly, low-cost, and have little interference with the program (and associated clients) [329]. Selection of measurement tools that remain a program component after the research project is concluded enhances sustainability of the program and reduces the impact of measurement reactivity [330]. For this reason, a more in-148 depth fidelity assessment on specific BCTs was not pursued for two reasons: (a) the research question could be answered without such an in-depth investigation and (b) SSBC had not yet been BCT coded[70]. A more focused BCT fidelity assessment could be designed in the future that would contribute to health behaviour change in T2D. Such an investigation would require additional human resources, training, and finances. The delivery of program components does not guarantee an effect. Program components may require active engagement and effort from the participant in order to have an effect [331]. This understudied aspect of fidelity is important and cannot be assumed. In 2020, Hankonen called for more focus on receipt and specifically enactment of BCTs [331]. While Chapter 3 examined receipt and enactment, we did not intentionally specify individual BCTs as Hankonen called for. Rather, the decision was made to examine receipt and delivery of a core SSBC program component that encompassed numerous BCTs (such as BCTs: 1.1 goal setting [behaviour], 1.4 [action planning], 2.3 [self-monitoring of behaviour], 2.6 [biofeedback]). This decision was made for several reasons. At the time, SSBC had not been BCT-coded; BCT receipt and enactment would have required more resources (time, training, financial) to research, and useful results were available from using a broader and more encompassing receipt and enactment measure. Chapter 3 examined SMART goals as a proxy indicator of program receipt and execution of goals as an indicator of enactment. By intensively assessing the delivery of a core SSBC program component (goal setting) by coaches through audit and checklists, and the resultant behaviour from their clients, results from Chapter 3 demonstrated that the knowledge and skills delivered by SSBC coaches were understood by clients and, in turn, enacted as expected. The act of tracking data, regardless of whether the goal was achieved, highlights enactment of behavioural skills taught within the program. Similarly, tracking an exercise session is evidence of applying a BCT in practice as the individual enacts BCT 8.1 Behavioural practice/rehearsal. While Chapter 3 did not operationalize receipt and enactment at the level of individual BCTs, the data collected implies receipt and enactment of 149 certain BCTs and may be sufficient to base conclusions on. Regardless of the specificity of the receipt and enactment measure, the tools and operationalizations are unique and an addition to the field of implementation science. Motivational interviewing and the person-centred approach of SSBC may have facilitated treatment receipt and enactment. Results from the study in Chapter 2 suggest that program content was delivered in a client-centered manner and clients felt supported. We know from listening to audio-recorded sessions that coaches collaborated with clients to support goal creation, but ideas came from the participant themselves to create the goal. Person-centered approaches, such as MI, may be more effective as they require active participation rather than interventions assuming a passive client where minimal participation is required (e.g., a goal is imposed on the participant) [331]. It is important to mention, albeit not explicitly stated in Chapter 3, that the SSBC protocol and training for coaches taught coaches to ask clients to summarize their learnings and main takeaways from the session. This program component is a fidelity check of participant receipt. If the participant is not able to correctly recall and summarize what they learned in the session, the coach will immediately know that the information was not delivered adequately. Coaches are instructed to review the session content that a client misses during their summary. Fidelity data from Chapter 3 indicated that this question was well-delivered; however, the checklist did not provide a space for the coach to document whether the participant successfully summarized the information. This question is a simple fidelity check that can be added to the session checklist in future SSBC (or other intervention) implementation evaluations that assess fidelity. From tacit knowledge garnered from listening to audio-recordings and mentoring numerous coaches throughout the program, clients almost always correctly summarized session content. The high indication of treatment receipt by clients aligns with the findings of Chapter 3. The observations from Studies 2 and 3 provide evidence that SSBC was designed with receipt and enactment checks embedded into the programming, which may have ultimately led to high receipt and enactment of SSBC content. 150 6.1.1.3 Favourable Conditions to Support Fidelity The assessment of implementation determinants and identification of implementation strategies from Chapter 4 provided reasonable explanation to support high fidelity from chapters 2 and 3. First, Chapter 4 revealed a strong fit between the context and the intervention. A strong fit is essential for integration of an intervention within an organization and associated sustainability [332]. Organizational assets (e.g., culture, structure, available resources) from the YMCA likely led to an increased fit and ultimately supported results identified in Chapters 2 and 3. Results from Chapter 4 highlighted factors that influence implementation effectiveness and can be applied across various settings, populations, and contexts, facilitating broader implementation of effective programs. Second, the successful fidelity outcomes documented in Chapters 2 and 3 may be attributed to the extensive utilization of implementation strategies detailed in Chapter 4. These strategies were specifically designed to enhance training, provide coach support, and establish a supportive implementation context. Eleven implementation strategies were used specific to training and supporting SSBC coaches and include: conduct educational meetings, conduct ongoing training, make training dynamic, develop educational materials, distribute educational materials, shadow other experts (videos), use train-the-trainer strategies, provide ongoing consultation, remind clinicians (i.e., checklist), create a learning collaborative (i.e., staff meetings), organize clinician implementation team meetings (i.e., staff meetings) [72]. While it is not possible to determine which implementation strategies were most influential at eliciting the strong fidelity outcomes observed, the package of strategies used within the pilot implementation of SSBC can be used to inform future implementation efforts. Often, the use of multiple strategies [45], and active training strategies [333], increases effectiveness and may have cumulatively led to high SSBC coach fidelity. The implementation strategies reported in Chapter 4 had high representation of implementation strategies to support SSBC coaches (see 11 implementation strategies identified above). This finding differed compared to results from 151 Chapter 5’s systematic search and review that interactive assistance and support clinician strategies were not often reported. 6.1.2 Used A Common Determinant Framework to Contextualize Results The CFIR was a valuable framework to guide this work for its comprehensive range of determinants. To our knowledge, Chapter 4 was the first study to use the CFIR to examine a community-based diabetes prevention program. All levels of the CFIR were identified with most of the identified constructs supporting positive implementation and a select few indicating room for improvement. Targeted efforts were made to address identified barriers (i.e., staff burden) to enhance adoption and build interest among staff to become trained for SSBC. Coaches provided insights on factors that were important to them and that they felt made SSBC an effective program. Such information can be used to enhance program effectiveness and optimize program delivery and dissemination. Results from Chapter 4 also highlighted the implementation strategies and resources that were helpful from the coach perspective. To enhance successful adoption and likelihood of sustainability, favourable strategies were strengthened (e.g., facilitation) and others modified to reduce identified barriers (e.g., promote adaptability). Similarly, resources that were of little use could be discontinued or modified (e.g., program workbook) and resources of high value optimized (e.g., coach training). The process domain of CFIR was a strong implementation determinant that should not be overlooked. The process of planning SSBC implementation has been documented [50] and Chapter 4 outlined benefits of this process in relation to the CFIR constructs [72]. Future research should consider meaningfully using the CFIR framework across different implementation phases from planning, to measurement, analysis and reporting. 6.1.3 Identified Implementation Strategies within the SSBC Project Despite calls for thorough reporting of implementation strategies, researchers rarely make this information available. Chapter 5 revealed 2 of 94 programs explicitly reported 152 implementation strategies [334]. The level of reporting in published implementation research ranges yet is often insufficient to understand what exactly was done to implement the intervention [334]. To further move the implementation science field forward, researchers must commit to documenting implementation strategies. Once these strategies are specified, they can be synthesized and analyzed to highlight common strategies used in effective projects. Synthesized strategies can also be compared across studies to build an evidence base on what, how, when, and why implementation strategies work to improve implementation [335]. Altogether, building an evidence-base to support implementation development. Chapter 4 identified the implementation strategies used within SSBC when it was implemented within two local community sites. Within Chapter 5, I retrospectively extracted implementation strategies from published research with a goal of synthesizing what has been done in the past. Results from this review highlighted the dearth of reported implementation strategies. The extraction process uncovered challenges with using the ERIC tool, identified patterns within the extracted strategies, and proposed future directions. The study in Chapter 4 had not been published when the systematic search and review search was completed, and thus the implementation strategies used within SSBC were not synthesized as part of the review. In Chapter 4, 23 implementation strategies were identified [72]. This number of strategies is higher than the mean identified in Chapter 5 (M = 14 strategies) and lower than the number of strategies used in large implementation initiatives (range = 34-41) [334], which was expected. As mentioned above, the effectiveness of each implementation strategy remains unknown. Nevertheless, the combination of strategies employed in the SSBC pilot study can offer valuable insights for guiding future implementation projects because of the favourable results demonstrated to date. SSBC used many of the common implementation strategies identified in Chapter 5. However, SSBC differed from the results in Chapter 5 by using more implementation strategies in the strategy cluster ‘provide interactive assistance and support clinicians’ which had limited representation in results from the 153 review [72, 334]. The inclusion of more implementation strategies targeting staff in SSBC implementing the innovation may have led to the high-fidelity results reported. Staff implementing an innovation are often left out from data collection and from targeted and supportive strategies [334]. In contrast to Chapter 5’s systematic search and review results, Chapters 2-4 provided an in-depth examination of coach and management perspectives. This was a novel approach in implementation literature. The positive fidelity results give confidence that the implementation strategies specifically supporting staff were effective and should be considered for use in future implementation projects. Future research must prioritize collecting implementation data from this rich resource. 6.2 Methodological Contributions 6.2.1 Used a Self-Determination Theory Measure to Investigate Motivational Interviewing Motivational interviewing (MI) is a core component of SSBC used to deliver program content to clients. MI has repeatedly been shown to be efficacious at eliciting health behaviour change and favourably affect client outcomes [61, 62], the underlying mechanisms through which MI evokes change remain elusive [65]. MI was developed from clinical experience, is a counselling method for behaviour change, and is largely perceived as atheoretical [336]. Self-determination theory (SDT) has been proposed as a psychological theory useful for understanding MI’s efficacy [336]. Much of MI can be conceptualized and informed by SDT [336]. In SDT, there are three basic psychological needs (autonomy, competence, and relatedness) essential for psychological well-being and motivation [66]. Autonomy refers to an individual’s ability to have a sense of choice and control [66]. Within MI, techniques are used to bolster a client’s autonomy such as exploring options, prioritizing choice, letting the client make decisions, and brainstorming how they want to change or set goals. Coaches emphasize motivation for change comes from within clients and are taught to roll with resistance instead of 154 coercing the client into accepting their views [336, 337]. Competence refers to an individual’s ability to have confidence in one’s skills and ability [66]. Within MI, techniques are used to bolster a client’s competence, including establishing clear expectations around behaviour change, guiding the development of realistic and achievable goals, providing encouragement by emphasizing the client’s strengths and capabilities, and offering support and positive feedback when the client successfully adheres to their plan or makes progress toward their goals [336, 337]. Finally, relatedness refers to an individual’s sense of belonging, feeling of acceptance, and development of meaningful relationships [66]. Within MI, techniques are used to bolster a client’s relatedness such as expressing empathy, avoiding judgement or blame, genuine interest in understanding the individual’s experience/perspective, and exploring client’s concerns [336]. According to SDT, individuals must have all three basic needs fulfilled to achieve self-motivation and experience a sense of well-being [66]. From the preceding discussion, there are many MI techniques that directly aim to bolster the three basic psychological needs outlined in SDT. Parallels between MI and SDT are strong and integration of MI and SDT has been suggested [67, 92, 336] and MI researchers may benefit from measuring SDT variables [65]. The study in Chapter 2 used an SDT measure, the learning climate questionnaire [68, 69], to explore whether SSBC coaches supported clients’ basic psychological needs within the SSBC program. This study was the first to use the Learning Climate Questionnaire as a proxy measure for MI receipt. Results indicated high basic psychological needs satisfaction and indicates apparent good fit in using the Learning Climate Questionnaire to understand client receipt of MI. Future research should consider use of the Learning Climate Questionnaire within an MI context and validate the tool within this context. 6.2.2 Applied Novel Methodology to Access Client Receipt and Engagement Research on client receipt and engagement are scarce [101, 105] and measuring enactment can present challenges (e.g., social desirability bias) [331]. Previous research has 155 presented superficial assessments of receipt and enactment. In one study, client receipt was measured using a two-item self-report measure (‘information was clear and easy to understand’/‘understanding how to put plans into practice’) and client enactment was measured by a two item self-reported measure (‘recorded activities on calendar’/‘practiced and used information and skills learnt’) and a score was calculated [107]. In a second study, client enactment was measured at 1-year follow-up with clients reporting which BCT’s (eight relating to increasing physical activity, eight relating to eating a lower-fat diet) they had used over the past 11 months [338]. Both measures were limited by self-report biases, such as social desirability bias, hind-sight bias, and use of dichotomous scales [107, 338]. In comparison, Chapter 3 used a study-specific tool to assess receipt and enactment. Treatment receipt was operationalized as the clients’ ability to come up with a goal in line with study information actively demonstrating the information was learned instead of self-reporting that information was learned, overcoming client social desirability and recall biases. While the study used self-reported data to operationalize treatment enactment data, the data may be less biased than self-reported surveys as clients were tracking their diet and exercise within an application and not explicitly told their data would be used to assess whether they achieved their goals. The enactment data was scored on a 6-point scale (with no neutral option), overcoming limitations inherent in a dichotomous scale. The methods used in Chapter 3 also have limitations. Client enactment could not be assessed for individuals who created a goal that could not be assessed by the app, such as a step count goal, because the app did not count steps and daily step counts could not be entered into the app. Client enactment could also not be assessed for individuals who chose to manually track their behaviours using paper and pen methods (although this was a rare occurrence) or who chose not to track, resulting in 45% of goals not being assessed. This method did not permit us to distinguish between a client not achieving a goal and not being able to assess a goal. Despite these acknowledged limitations, the chosen method to assess client enactment 156 reflects real-time client behavioural data and is a novel methodological contribution to the field of implementation science. Overall, this method overcomes many challenges identified in previous measures and presents a useful option to assess client receipt and enactment. Future research is encouraged to consider how to make use of available resources to creatively address research questions, as was done in this case. 6.3 Practical Implications 6.3.1 Demonstrating Community Organization Are Feasible Resources to Supply Evidence Based Counselling Programs Diabetes was declared an epidemic in 1994 by the head of the Centers for Disease Control and Prevention (CDC) [339]. Such a declaration highlights the rapidly increasing prevalence of the disease and calls for public health approaches to control the epidemic [340]. Nearly three decades have passed since this declaration, yet the prevalence of this condition has only increased over time [341]. Current public health approaches are lacking; multi-pronged approaches must be used to address the escalating prevalence of diabetes. Diabetes prevention programs are potent approaches to help reduce the risk of developing T2D [9]. Both healthcare clinics and community organizations can implement DPPs. Chapter 2-4 demonstrate that community organizations, and the staff working within these organization, are feasible resources to offer evidence-based DPPs. The YMCA represented a community organization with great fit for implementation of a DPP; the community organization staff were able to be trained in an evidence-based counselling method, successfully applied the skills in practice, and delivered the program with fidelity [72, 76, 80]. Utilizing community staff as opposed to healthcare professionals has cost-saving implications and may increase accessibility by offering health programming outside of clinical settings to reach heterogenous populations [3]. 157 6.3.2 Informed the Small Steps for Big Changes Scale-Up Project In Canada, there remains a paucity of available diabetes prevention programs, with no large-scale translational study to date. To reach and positively impact Canadians living at risk of T2D, effective programs need to be implemented in diverse community settings and scaled-up across the country. Small Steps for Big Changes is an evidence-based diet and exercise behaviour change counselling program with demonstrated effectiveness (e.g., decreased weight, increased physical activity) in a laboratory and a community setting [47, 49, 122]. Results from Chapters 2-4 have directly informed SSBC scale-up by providing useful feedback to guide quality improvement (e.g., revised program workbook, SSBC coach certification), tailoring the training (e.g., transitioning to a digital self-directed training program), and a template of how to plan and execute SSBC at community sites (e.g., identified implementation strategies, meeting structure). Further, results demonstrated benefits for the local YMCAs, including facilitating new memberships, continuing education credits for employees, and solidifying their vision of being a community health-focused fitness facility [72, 342]. My doctoral work, in conjunction with all projects associated with delivering SSBC in YMCAs in Jung’s lab, provided preliminary evidence to support further expansion of SSBC both nationally and internationally. This important research is needed as no diabetes prevention programs have been translated and implemented across Canada. 6.3.2.1 Tailoring SSBC For Sustainable Scale-up Small Steps for Big Changes has been iteratively evaluated and refined. Results from the study in Chapter 2 demonstrated the training was effective, yet not sustainable nor feasible for scale-up [94]. In-person training was difficult to arrange within one site and used a lot of human resources, time, and money. Results from Chapters 3 and 4 identified features of the training that coaches liked and areas for improvement [72, 80]. Subsequent research has been conducted to develop an online training and resource platform for SSBC coaches [343]. The SSBC training was upgraded to an interactive virtual platform to increase feasibility of training 158 coaches while maintaining core components of the in-person training (e.g., knowledge checks, mock session) and supporting a high-quality training through a virtual certification process. The training was also modified to include cultural safety and delivery of inclusive care. Finally, results from Chapter 2 suggest coaches that achieve a client-centred level of MICA scoring maintain that level over time. Therefore, to achieve successful certification, prospective coaches must achieve a client-centred level of MICA to become a SSBC coach. This process supports program fidelity and enhances quality control as the program scales-up. Results from Chapters 2 and 3 are from high resource fidelity assessments (e.g., audio recorded sessions, all coaches included, independent researcher fidelity check). Results support lower resource fidelity assessments in the future such as solely using a fidelity checklist as a good indicator of fidelity without the need to assess audio recordings of sessions or by using random sampling or random audits of audio recordings to confirm coach fidelity. Additionally, the learning climate questionnaire could be used as a low-resource method to check coach use of MI skills in practice. Overall, the new training procedures are more cost-effective, require less time for trainers and coaches, and facilitate organization across large geographical areas. Reflecting on sustainability and tailoring the implementation strategy for sustainable scale-up is a worthwhile endeavour. 6.3.2.3 Implementation Strategies Developed for Scale-Up Evidence-based interventions must be complemented by evidence-based implementation. Results from Chapter 4 detailed the implementation strategies used when translating SSBC to two new sites and provide evidence of successful implementation [72]. Building from this preliminary evidence-base for successful implementation of SSBC, the implementation strategies used provide a template of strategies to replicate when setting-up future SSBC scale-up sites. When initiating future sites, the program and implementation strategies must be adapted and/or tailored to each site. This suggestion is supported by the commonly used implementation strategy identified from Chapter 5 (promote adaptability) [334]. 159 Overall, future SSBC scale-ups benefit from this preliminary research to use as a starting point to tailor implementation strategies. Future research should purposefully plan and examine the implementation strategies used within pilot, feasibility, and/or preliminary research to inform larger implementation studies. 6.3.2.3 Generalizability Biases Generalizability biases refer to the limitations in applying research findings from a specific pilot/feasibility project or context to a broader population or different settings [20]. These biases can affect the external validity or generalizability of research results. A recent systematic review of behavioural interventions in childhood obesity detailed nine risks of generalizability biases that, if present, may limit the reproducibility of results in a larger study [20]. These risks include delivery agent bias, duration bias, implementation support bias, outcome bias, measurement bias, directional conclusion bias, target audience bias, intervention intensity bias, and setting bias. The authors call for pilot studies to avoid generalizability biases by purposefully including features in a pilot that are scalable to larger trials [20].Proactively designing pilot studies to be more reflective of the larger study may diminish the common voltage drop that occurs between results from pilot and larger studies [20]. While many generalizability biases were intentionally addressed in my dissertation work, some generalizability biases remain and are explored in the following paragraphs. The involvement of the research team in the SSBC pilot could introduce implementation support biases [20]. It may be important to re-pilot the program to address this generalizability bias present in Chapters 2-4. In a larger scale-up project the site-lead at each SSBC site would take on most of the implementation support and work in a different relationship with the research team. As such, site leads may require additional training and support to succeed in their pivotal role. The site-lead role may be worthwhile to evaluate to understand the impact of the site-lead on implementation and program outcomes. For example, comparing site lead data between sites to elucidate what factors of the site-lead are important and/or specifically what the 160 site-lead does. Data could include feedback from coaches to understand site-lead factors and/or a site report of implementation strategies enacted at each site and their frequency to understand what each site-lead actually does. Small Steps for Big Changes is at risk for three additional risk of generalizability biases in the future: intervention duration, intervention intensity, and measurement bias. During the pilot, SSBC was tested as a three-week program involving 6 sessions, with a one-year follow-up consisting of 3 sessions. The community partner recommended stretching the length of the program such that the number of sessions is delivered over 4 weeks to reduce staff burden and accommodate client and staff feedback [342, 344]. The proposed change would increase the program to 4-weeks (intervention duration bias), while the number of sessions remains the same. Additional follow-up sessions may also be added based on partner feedback (intervention intensity bias). Finally, as the program expands, there may be different measures included or excluded from the project as part of the evaluation of this project. While the main outcome measures will remain the same, the inclusion of additional measurements or the reduction in measurements may have an impact of clients and/or coaches (measurement bias). For example, engaging in the research process such as completing an interview can have an impact on outcomes as the interview prompts reflection leading to development or empowerment and may encourage greater fidelity or effort to the program [93]. Additionally, the inclusion of sub-studies may impact outcomes for the clients involved in the sub-study who received additional measures (e.g., stress test), time with coaches (e.g., additional appointments for sub-study), or client interviews. While SSBC is not at risk of five of the nine risk of generalizability biases, the four risk of generalizability biases mentioned will require future decisions about whether to scale-up or re-pilot the program while addressing these biases [20]. Future work in SSBC includes program implementation at numerous sites, providing unprecedented opportunity to pilot these risk of generalizability biases before wide-scale implementation. 161 6.4 Strengths and Limitations The comprehensive work contained in this dissertation exhibits noteworthy strengths. Each study used rigorous and systematically planned methods. Chapters 2-4 build upon each other collectively gathering pragmatic data to support a future scale-up project for SSBC. Chapter 5 systematically searched the literature to gather implementation data on published implementation diabetes prevention projects. The aim of the review from the dissertation perspective was twofold: first, to contextualize the findings from Chapters 2-4 and the overall SSBC project within the existing literature; and second, to augment the pragmatic data collected from chapters 2-4 with broader lessons learned and insights from the field on implementation variables and strategies used. Altogether, the work contained within this dissertation can inform the development of an implementation plan and evaluation as the SSBC program scales-up provincially and nationally. Each study included theoretical underpinning from a variety of theories, models, and/or frameworks. Use of theoretical underpinning helps frame study questions, clarify constructs, encourage a common language, depict relationships, and contextualize results [345]. Each study was underpinned by one or more theoretical framework specifically chosen and justified in relation to the study aim. To answer the research question from each study, a variety of methodologies were used. The quantitative data from Chapters 2 and 3 are supported and explained by qualitative insights in Chapter 3. Chapter 5 then conducted a broader knowledge synthesis to contextualize results from Chapters 2-4. Within each study diverse and rigorous methods were used contributing unique methods to add to the field. Another strength of this dissertation is the in-depth pilot implementation study of SSBC. Although pilot studies have small sample sizes that limit their generalizability, this worthwhile work will be used to inform a larger study. The pilot project was designed to minimize generalizability risks by reflecting how a larger study might be implemented [20]. However, an implementation support bias was present as a student researcher and research team in the 162 SSBC pilot conducted all team meetings and provided ongoing support to coaches [20]. The results presented within this dissertation, coupled with other projects outside my dissertation, revealed that the SSBC program is ready and suited for scale-up in a larger project. The results from Chapter 4 specifically highlighted the context, highly motivated staff, and the implementation planning process benefited program implementation. Feedback from Chapter 4 calls for changes to the program which may introduce additional generalizability biases in the future. A limitation of the results from Chapters 2-4 is the homogenous sample of clients and staff with the majority identifying as female and white. Future research must examine SSBC implemented in diverse settings, with a focus on studying diversity variables of staff and clients. In addition, future work must have researchers at an arms-length to better understand the suitability of SSBC for scale-up and test the implementation strategies in practice. An additional limitation was that the dissertation was impacted by the COVID-19 pandemic which interrupted data collection and limited the sample size and data collection in Chapters 2 and 3. The research interruption of COVID-19 also impeded collection of outcome data. Many of the clients seen by the coaches included in my dissertation studies were lost to follow-up due to COVID-19 and research interruption. As such, the fidelity, training, or implementation determinant data collected within my dissertation are not able to be linked to client outcomes. While intervention outcome data was not directly a part of my thesis, this missing data limits the ability to examine relationships between the process variables collected and their downstream outcomes on clients. Finally, while we provided a brief example of how implementation strategies were operationalized within SSBC, specific details on the implementation strategies called for in the literature (actor, action, action target, temporality, dose, implementation outcome affected, justification) were not possible [40]. Future research could specify additional details of implementation strategies used in the SSBC scale-up research project. While the dissertation covers an in-depth assessment of fidelity, it does not examine other implementation outcomes that are worthwhile to investigate such as reach, adoption, dose 163 delivered, and sustainability. Prior research has investigated program reach when SSBC was implemented by research staff [49]. Future research must continue to examine these implementation concepts within the SSBC scale-up project and other diabetes prevention programs. 6.5 Future Research The work contained within this dissertation sparks numerous future directions. Throughout my dissertation I learned the complexities of implementation science—that successful implementation in the real world takes so much more than having a successful evidence-based program. The planning, resources, physical structures, organizational constraints, and multiple layers of human resources such as the clients, coaches, support team, management, and research team, all come together. Simplifying implementation into demonstrating solely program effectiveness is but one piece of a large puzzle. Fortunately, the maturing field of implementation science reflects the growing appreciation for these complexities and intricacies. For example, the minimum recommended dataset of implementation outcomes and determinants [36] highlighted that the implementation strategy/support system requires researching in addition to the program itself. Another example is the proposed addendum to the CFIR to update the framework since its inception in 2009 by broadening the framework to include outcomes. The CFIR addendum highlighted the need to distinguish between implementation and innovation outcomes and implementation and innovation determinants [33]. Innovation refers to the ‘thing’ (e.g., program) being implemented, while implementation is how the ‘thing’ is implemented [33]. More specifically, the CFIR addendum highlighted that the innovation has three components: the recipients, deliverers, and key decision-makers [33]. Both examples emphasize the broad, multi-layered aspects of implementation to extend beyond the program itself and encompass the context the program is implemented within. My dissertation solely focused on implementation, identified implementation strategies used, and extended to 164 include perspectives of the support system (deliverers and key decision-makers) an often forgotten group [33]. Within my dissertation, all the implementation strategies were under control of the research team. As these tasks are passed to the site-lead and community organization, greater focus will be needed to assess the feasibility, fidelity and other outcomes and determinants from the perspective of the delivery of the implementation strategy. For example, my dissertation examined the implementation outcome, fidelity, from the intervention perspective but did not examine to what extent the implementation strategy was implemented as planned. This under-researched aspect of implementation must receive enhanced attention in the future. The planning process was an important implementation determinant and cannot be overlooked. While planning takes time and resources, the benefits are worthwhile. Rushing the planning process or having inadequate resources dedicated to this aspect may lead to ineffective implementation and thus ineffective programming, wasting precious time and resources in the process [261]. Most programs fail to systematically plan for implementation, with implementation plans rarely being designed from the beginning [346]. Implementation strategies should be discussed at the planning stage. There is a need to critically think about the intentional inclusion or exclusion of strategies to address contextual determinants as opposed to choosing strategies based on heuristics (i.e., ‘how we have always done it’), or ISLAGIATT (‘it seemed like a good idea at the time’) principles [347]. Implementation mapping is one tool to plan for implementation [346]. The CFIR is another tool that can be used to inform implementation planning and recently researchers have linked ERIC implementation strategies to CFIR constructs [348]. Strategies must be continually tailored over time to respond to the dynamic nature of implementation and the ERIC-CFIR tool can be used mid-implementation to address barriers that arise during implementation. There are many future directions for the development, refinement, and use of implementation strategies in practice. Chapter 5 reveals a dearth of reported implementation 165 strategies within diabetes prevention research [334]. There is limited data on the extraction of implementation strategies for meaningful comparisons of our findings in diabetes prevention research to other fields. Nonetheless, it is widely acknowledged that reporting of implementation studies remains inadequate across the implementation science field [41]. Chapter 5 relied on researchers coding the strategies as has been done in similar retrospective studies [157, 161]. Within this chapter, I recommended additional strategies to be added, definitions broadened to encompass non-clinical staff, and review of certain strategies to be broken into discrete strategies and/or further differentiated. While some studies have referenced clustering implementation strategies [157, 335, 348], there is no one clear, agreed-upon clustering strategy. Similar to the BCT taxonomy organized into 16 hierarchical categories [349], clustering of implementation strategies may facilitate ease of use of the tool. A list of 73 unorganized strategies can seem daunting to navigate, creating confusion about which strategies to use [349]. Future work should attempt to organize implementation strategies into agreed-upon hierarchical clusters. In addition, to strengthen validity and reliability, future directions should develop associated coding tools, and may benefit from the types of supports developed to facilitate coding of BCTs, including BCT training (http://www.bct-taxonomy.com) and a related smartphone app (https://apps.apple.com/us/app/bct-taxonomy/id871193535). Moreover, the STARI reporting guidelines help by prompting implementation scientists to report implementation strategies, measurement and reporting of both implementation objectives and intervention objectives, and description of the context in which the intervention was delivered [41]. While the benefits of the STARI guidelines are notable, the benefits are only impactful if used and adopted in practice by researchers and journals. Over time, better reporting of implementation research will enable more comprehensive and meaningful data syntheses and can inform future experimental research. As the evidence for implementation strategies grow, experimental studies can complement real-world research by examining individual strategies to determine effectiveness in controlled environments. Isolating implementation strategy effects 166 can lead to understanding individual strategy impacts. There may be value in developing a hierarchical list to assist researchers with selecting potent strategies for their projects. Using both types of research can broaden the understanding of implementation strategies. The large dataset collected from Chapter 5 can be used to inform future research through either secondary analysis of the dataset or to inform future study designs. A trend emerged that more strategies were extracted from large implementation projects, and it is unknown whether the implementation strategies used in large implementation projects differ from those used in small implementation projects. Future research or secondary analysis can investigate this trend to understand whether there are specific implementation strategies important to consider as a project scales-up. In addition, a temporal relationship may exist with implementation strategy use. The intensity or use of various implementation strategies may change based on the program stage (i.e., planning, active implementation, and sustainability) and could inform future real-world trials. Further, in multi-site projects, understanding the fidelity of implementation strategy enactment could uncover reasons for differences or similarities in implementation success between sites. Finally, manuscripts that included a lesson learned or reflection section contained valuable insights for future implementation research to learn from. Future researchers should consider incorporating such a section within implementation manuscripts. Completing a descriptive analysis of the manuscripts with lessons learned or reflection data could highlight potent implementation strategies worth including in future research and/or investigating in experimental research. The research presented in my dissertation opened numerous future directions within future SSBC scale-up projects but can also be extended to benefit research community-based health projects more broadly. The implementation support bias present in my research may have influenced the fidelity of delivery of implementation strategies as almost all the implementation strategies were under the control of, and executed by, the research team. Future research within SSBC will need to assess the feasibility, acceptability, usefulness and the fidelity of 167 delivery or implementation strategies if executed and controlled by community partner staff. While not all strategies will be under control of community partner staff (e.g., training, provision of resources), community partner staff play a large role in implementation support, fidelity, and motivating staff to comply with the program protocols. Comparing the implementation strategies identified in Chapter 4 (SSBC) to the results from Chapter 5 (review) indicated that SSBC used more strategies that targeted coach support which may explain why there was such high fidelity. Therefore, continued support for SSBC coaches is needed to support effectiveness. In addition, as discussed above, continuous quality improvement is a strength of SSBC to date. As SSBC scales-up implementation strategies that support quality improvement (e.g., audit and feedback, develop quality monitoring systems) are important to maintain. Future research can help determine to what extent continued support is feasible, sustainable, and beneficial to effective implementation research. Future research should also examine how implementation strategies are tailored to each site and the resultant impact of such tailoring. A core value within the SSBC program to date has been the continuous quality improvement initiatives. SSBC has been iteratively developed and implemented, gathering quality improvement data from each step of the research process along the way. Maintaining this commitment to continuous quality improvement is necessary with and between all future SSBC sites. Similarly, another core value of SSBC is to foster a partnered approach, valuing multiple perspectives, evidenced through the thorough planning process that led to positive results. Each future SSBC site should be individually onboarded to tailor and adapt the intervention and implementation strategies to the context, while incorporating the core components of SSBC. Several countries, excluding Canada, have developed large-scale translational studies of DPPs [56]. However, research on the implementation of these scale-up projects is lacking, with large-scale projects failing to examine individual-site or between-site differences to understand the impact of context on implementation [99, 117]. Differences in implementation success across sites are common as site context and confounders remain an understudied 168 paradox at the centre of implementation efforts [32]. Reporting individual site data may reveal differences between sites to reveal where implementation was more, or less, successful [350]. From an equity lens, it is vital to disaggregate multi-site data and understand how community-, organization-, provider-, and client-level factors contribute to implementation outcomes when organizations deliver the same program in different contexts [350, 351]. For example, in the US DPP, only 25% of sites received full Centre for Disease Control recognition within the 4-year study period [99]. Full Centre for Disease Control recognition is only granted to sites that have implemented the program for 12 months and achieved outcomes described in the standards (e.g., ≥ 5% weight loss for active clients [those attending ≥ 4 sessions]) [352]. Equity-based contextual factors (e.g., sites with majority ethnic/racial groups) may be potential confounders [353] as evidence demonstrates racial/ethnic groups achieve lower weight loss [51]. Sites with majority ethnic/racial groups may have more difficulty achieving standards, despite these sites reaching high-risk populations. The research presented in Chapters 2-4 lacks diversity and represents a fairly homogenous group of clients and staff. As SSBC scales up to multiple sites, future research must examine equity-based contextual factors such as diversity of client and staff. The importance of evaluating numerous implementation outcomes (e.g., reach) and comparing within and between sites is extremely important. Quality implementation studies with a focus on context (including an equity lens) are needed to compare within and between site implementation outcomes and influencing determinants [351]. Implementation and effectiveness are interconnected. Future research must examine a wide range of implementation outcomes and determinants within and between sites. 6.6 Conclusion With the rising prevalence of prediabetes, there is an increasing need for the successful implementation of diabetes prevention programs. 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Diabetes Care, 40(11), e161–e162. https://doi.org/10.2337/dc17-1242 205 Appendices Appendix A: Supplementary File for Chapter 2: Client satisfaction with program quality (program and structures) Client Your overall experience 6.67 (0.49) Your trainer 6.88 (0.33) The nutritional content 6.17 (0.86) The exercise content 6.28 (0.96) Having the program in a YMCA facility 6.61 (0.61) The program workbook 6.00 (1.00) The Health Watch 360 app 6.17 (0.99) Receiving a target heart rate zone 6.28 (1.18) The length of sessions 6.44 (0.98) The program length 5.83 (1.62) Note. Scale ranged from 1-7 206 Appendix B: Supplementary File for Chapter 2: Average Motivational Interviewing Competency Assessment (MICA) scores by sub-scale per staff Staff ID Ratio of R:Q Sustain talk Change talk Autonomy Guiding Empathy Partnership Evoking Total MICA Score 1 (n = 6) 0.50 (0.22) 3.08 (0.20) 3.21 (0.33) 3.46 (0.33) 3.63 (0.38) 3.38 (0.21) 3.63 (0.31) 3.29 (0.25) 6.62 (0.42) 2 (n = 3) 0.37 (0.06) 3.00 (0.00) 2.75 (0.43) 3.08 (0.38) 2.50 (0.87) 3.00 (0.00) 3.08 (0.38) 3.00 (0.43) 5.81 (0.56) 3 (n = 6) 1.32 (1.24) 3.17 (0.41) 3.38 (0.44) 3.54 (0.33) 3.17 (0.75) 3.46 (0.33) 3.63 (0.38) 3.42 (0.41) 6.96 (0.55) 4 (n = 3) 0.27 (0.17) 2.50 (0.50) 2.67 (0.58) 2.50 (0.50) 2.42 (0.63) 2.58 (0.72) 2.58 (0.72) 2.17 (0.58) 5.03 (1.11) 5 (n = 3) 0.64 (0.15) 3.00 (0.00) 3.00 (0.00) 3.17 (0.29) 3.08 (0.14) 3.00 (0.00) 3.08 (0.38) 3.17 (0.29) 6.07 (0.15) 6 (n = 4) 0.94 (0.65) 3.13 (0.25) 3.44 (0.43) 3.63 (0.25) 4.00 (0.00) 3.75 (0.29) 3.81 (0.24) 3.81 (0.24) 7.08 (0.39) 7 (n = 4) 0.34 (0.41) 3.00 (0.00) 3.13 (0.25) 3.19 (0.63) 3.31 (0.63) 3.06 (0.66) 3.06 (0.66) 3.06 (0.66) 6.20 (0.74) 8 (n = 3) 0.85 (0.67) 3.00 (0.00) 2.83 (0.58) 3.17 (0.76) 2.83 (0.29) 2.92 (0.52) 2.83 (0.58) 2.83 (1.04) 5.83 (0.88) Total M (SD) (n = 32) 0.70 (0.70) 3.02 (0.30) 3.11 (0.44) 3.28 (0.50) 3.20 (0.69) 3.21 (0.49) 3.30 (0.57) 3.16 (0.61) 6.34 (0.83) 207 Note. R:Q = reflection to question ratio; All sub-scales are out of 5 with a score of ≥ 6 indicating a client-centered level of care; Total MICA score is out of 10 with a score of ≥ 6 indicating a client-centered level of care. 208 Appendix C: Supplementary File for Chapter 4: TIDieR Checklist The TIDieR (Template for Intervention Description and Replication) Checklist Information to include when describing an intervention and the location of the information Item number Item BRIEF NAME 1. Provide the name or a phrase that describes the intervention. Small Steps for Big Changes Diabetes Prevention Program WHY 2. Describe any rationale, theory, or goal of the elements essential to the intervention. Small Steps for Big Changes (SSBC) was developed using social cognitive theory and aims to foster long-term dietary and physical activity adherence through use of motivational interviewing (MI)-informed behavioural counselling sessions, supervised exercise sessions, and the application of evidence-based behaviour change techniques (BCTs). WHAT 3. Materials: Describe any physical or informational materials used in the intervention, including those provided to The SSBC takes the form of a conversation about physical activity and dietary behaviour change at a local fitness facility. Clients are provided with a free one-month gym membership. Clients are asked to download a mobile phone application to 209 participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed (e.g., online appendix, URL). self-monitor their diet and exercise. Additionally, clients are provided with a program workbook with brief informational resources related to program content, and space to take notes on the content discussed and their goals. The overarching purpose of this study was to describe the BCTs and MI techniques (MITs). These techniques are reported in the results section of the article. 4. Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities. The SSBC consists of 6 individual behavioural counselling and supervised exercise sessions over the span of ~3 weeks. Generally, the first session is directed at a program overview and exploration of client’s goals and motivation. The remaining sessions target exercise or dietary changes shown to decrease risk of developing type 2 diabetes (T2D; e.g., reducing sugar intake, increasing fruit and vegetable consumption, etc.). All sessions allow for diet and exercise goal setting and action planning if the client is ready to do so. Following the counselling sessions clients engage in either moderate-intensity continuous training or high-intensity interval training. In the first two sessions clients try out both types of exercise, in all remaining sessions they are provided with the 210 choice of exercise type. Every session, clients are provided the choice between aerobic exercise equipment (e.g., treadmill, elliptical, stationary bicycle). Exercise sessions increase in length from 20 – 30 minutes for moderate exercise and 12 – 15 minutes for interval exercise. SSBC counselling and supervised exercise sessions include the delivery of BCTs and MITs. Clients are encouraged to join our on-going community-engaged program initiatives which include a weekly participant-led walking group, monthly meeting held at the fitness facility, Facebook group and a quarterly program newsletter. Anyone is invited to attend these community-engaged program initiatives, even if they were not a part of SSBC. WHO PROVIDED 5. For each category of intervention provider (e.g., psychologist, nursing assistant), describe their expertise, background and any specific training given. All sessions are one-on-one, take place at the fitness facility, and are conducted by a coach who has taken part in a 3-day training covering MI and program delivery. Coaches are fitness facility staff members. HOW 211 6. Describe the modes of delivery (e.g., face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group. SSBC sessions are one-on-one and are delivered face-to-face. WHERE 7. Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features. SSBC counselling sessions are delivered in a private counselling room within the two fitness facility sites and the exercise sessions are delivered in the YMCA gymnasium using aerobic equipment (e.g., treadmill, elliptical, stationary bicycle) located within Kelowna, British Columbia. WHEN and HOW MUCH 8. Describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, and their duration, intensity or dose. SSBC counselling sessions typically last between 30 and 50 minutes, exercise sessions last between 12 and 30 minutes. Clients participate in 6 sessions over the course of ~3 weeks with a 1-month follow-up to check in on program progress. Sessions are scheduled to support self-management post-program and therefore clients engage in 3 sessions in the first week, two sessions in the second week and one final session in the third week of the 212 program. Home-days are scheduled between each in-person session to enhance self-regulatory skills. TAILORING 9. If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and how. SSBC counselling sessions are tailored to the client’s readiness to change, interests, motivations, goals, schedule, etc. In addition, each participant is provided with a tailored heart rate range for moderate and high intensity activity. The target heart rate range is based on their baseline resting heart rate and provides a target for clients to achieve during the exercise sessions. MODIFICATIONS 10.ǂ If the intervention was modified during the course of the study, describe the changes (what, why, when, and how). A modification to the program structure was introduced. The modification changes the session arrangement and length of the program to four weeks: two sessions in the first week, two session in the second week, and one session in week three and 4 four. HOW WELL 11. Planned: If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to Intervention adherence is monitored through program checklists completed post-session by program coaches. The checklists represent key program topics, protocols and components to be delivered. In addition, each session is audio-recorded for MI-fidelity. Currently, monthly 213 maintain or improve fidelity, describe them. meetings occur with program staff to discuss questions, and program updates, where program fidelity might be discussed. 12.ǂ Actual: If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned. Fidelity was assessed, see [22] for results. Overall fidelity was high. ** Authors - use N/A if an item is not applicable for the intervention being described. Reviewers – use ‘?’ if information about the element is not reported/not sufficiently reported. † If the information is not provided in the primary paper, give details of where this information is available. This may include locations such as a published protocol or other published papers (provide citation details) or a website (provide the URL). ǂ If completing the TIDieR checklist for a protocol, these items are not relevant to the protocol and cannot be described until the study is complete. * We strongly recommend using this checklist in conjunction with the TIDieR guide (see BMJ 2014;348:g1687) which contains an explanation and elaboration for each item. * The focus of TIDieR is on reporting details of the intervention elements (and where relevant, comparison elements) of a study. Other elements and methodological features of studies are covered by other reporting statements and checklists and have not been duplicated as part of the TIDieR checklist. When a randomised trial is being reported, the TIDieR checklist should be used in conjunction with the CONSORT statement (see www.consort-statement.org) as an extension of Item 5 of the CONSORT 2010 Statement. When a clinical trial protocol is being reported, the TIDieR checklist should be used in conjunction with the SPIRIT statement as an extension of Item 11 of the SPIRIT 2013 Statement (see www.spirit-214 statement.org). For alternate study designs, TIDieR can be used in conjunction with the appropriate checklist for that study design (see www.equator-network.org). 215 Appendix D: Additional File for Chapter 5: PRISMA Checklist Section and Topic Item # Checklist item Location where item is reported TITLE Title 1 Identify the report as a systematic review. 1 (title identifies the study as a systematic search and review) ABSTRACT Abstract 2 See the PRISMA 2020 for Abstracts checklist. 2 INTRODUCTION Rationale 3 Describe the rationale for the review in the context of existing knowledge. 5-9 Objectives 4 Provide an explicit statement of the objective(s) or question(s) the review addresses. 8-9 METHODS Eligibility criteria 5 Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses. 9-10 Information sources 6 Specify all databases, registers, websites, organisations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted. 9 Search strategy 7 Present the full search strategies for all databases, registers and websites, including any filters and limits used. 9 Selection process 8 Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process. 10-11 Data collection process 9 Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process. 11-12 Data items 10a List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in each study were sought (e.g. for all measures, time points, analyses), and if not, the methods used to decide which results to collect. 11-12 10b List and define all other variables for which data were sought (e.g. participant and intervention characteristics, funding sources). Describe any assumptions made about any missing or unclear information. 11-12 Study risk of bias assessment 11 Specify the methods used to assess risk of bias in the included studies, including details of the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process. N/A Effect measures 12 Specify for each outcome the effect measure(s) (e.g. risk ratio, mean difference) used in the synthesis or N/A 216 Section and Topic Item # Checklist item Location where item is reported presentation of results. Synthesis methods 13a Describe the processes used to decide which studies were eligible for each synthesis (e.g. tabulating the study intervention characteristics and comparing against the planned groups for each synthesis (item #5)). N/A 13b Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions. N/A 13c Describe any methods used to tabulate or visually display results of individual studies and syntheses. N/A 13d Describe any methods used to synthesize results and provide a rationale for the choice(s). If meta-analysis was performed, describe the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used. 11-12 13e Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta-regression). N/A 13f Describe any sensitivity analyses conducted to assess robustness of the synthesized results. N/A Reporting bias assessment 14 Describe any methods used to assess risk of bias due to missing results in a synthesis (arising from reporting biases). N/A Certainty assessment 15 Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome. N/A RESULTS Study selection 16a Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram. 13 and Figure ! (PRISMA flow diagram) 16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded. N/A Study characteristics 17 Cite each included study and present its characteristics. Additional file 5 Risk of bias in studies 18 Present assessments of risk of bias for each included study. N/A Results of individual studies 19 For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots. Narrative analysis of all studies and programs (groups of studies reporting on the same program) Results of syntheses 20a For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies. N/A 20b Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If N/A 217 Section and Topic Item # Checklist item Location where item is reported comparing groups, describe the direction of the effect. 20c Present results of all investigations of possible causes of heterogeneity among study results. N/A 20d Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results. N/A Reporting biases 21 Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed. N/A Certainty of evidence 22 Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed. N/A DISCUSSION Discussion 23a Provide a general interpretation of the results in the context of other evidence. 17 - 24 23b Discuss any limitations of the evidence included in the review. 24-25 23c Discuss any limitations of the review processes used. 25 23d Discuss implications of the results for practice, policy, and future research. 17-24 OTHER INFORMATION Registration and protocol 24a Provide registration information for the review, including register name and registration number, or state that the review was not registered. 3 24b Indicate where the review protocol can be accessed, or state that a protocol was not prepared. 3 24c Describe and explain any amendments to information provided at registration or in the protocol. 11-12 Support 25 Describe sources of financial or non-financial support for the review, and the role of the funders or sponsors in the review. 27 Competing interests 26 Declare any competing interests of review authors. 27 Availability of data, code and other materials 27 Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review. 27 From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71 For more information, visit: http://www.prisma-statement.org/ 218 Appendix E: Additional File for Chapter 5: Codebook for Implementation Strategies Codebook and Examples Note: Purple text are additions made by Tineke to contextualize ERIC definition to the review. Blue hyperlinks are links to other implementation strategies. Developed from Powell, 2015 [44] 219 Strategy ERIC Definition (Powell, 2015) Ancillary data (Powell, 2015) Contextualized details for review Coding decisions/rules Example(s) 1. Promote adaptability Identify the ways a clinical innovation (DPP) can be tailored to meet local needs and clarify which elements of the innovation (program) must be maintained to preserve fidelity Preserving fidelity to the innovation can be an uncertain process if the core elements of the innovation are not empirically defined. tailoring at the program level. changes made to the program. e.g., translating participant materials, modifying the number of sessions, change session topics Do not code if the program was developed that way. There needs to be evidence of a change. Code only if changes are at the program level. If changes are at the implementation strategy level, consider tailor strategies Modify program content for specific ethnic groups 220 2. Tailor strategies Tailor the implementation strategies (strategy level) to address barriers and leverage facilitators that were identified through earlier data collection The tailoring process tends to be idiosyncratic and driven by multiple factors. It is important to identify the core components of the intervention and implementation strategies that are required to maintain fidelity and effectiveness, and to distinguish those components amenable to modification/adaptation. Flottorp et al. [14] and Langley et al. [15] provide guidance regarding many of the multiple factors to consider. Wensing et al. [16, 17] provide an example of a structured approach to tailoring strategies. Tailoring at the organization/ strategy (e.g., training, provider meetings, provision of support, supervision, educational materials for staff etc.) level. Alter strategies or the process based on barriers identified formally through research, examining data collected from site/program and/or tacit knowledge. After reviewing data, results in a change/addition to an implementation strategy. If changes are at the program level, consider promote adaptability. Data driven adaptations. e.g., If there are issues with data entry or referrals review change record systems. If the strategy is directly tailored from collected data, consider coding any of the following data sources: obtain and use patients/consumers and family feedback; obtain and use worker feedback; plan for outcome evaluation; develop and implement tools for quality monitoring; conduct local needs assessment. After reviewing data from front-line staff, decision to implement ongoing training with a booster session every month. 221 3. Use data experts Involve, hire, and/or consult experts to inform management on the use of data generated by implementation efforts Consider engaging data experts early in the implementation planning process. Can be internal or external data personnel. If this individual helps with developing/ integrating or managing the input and sharing data from multiple sources across multiple sites code: use data warehousing techniques. If this individual also provides expertise on modifications to the record system, code change record systems. Hire a health information technologist to manage data collection, cleaning, organization, database creation and processes. 222 4. Use data warehousing techniques Integrate clinical records across facilities and organizations to facilitate implementation across systems Records that include variables that can serve as outcome measures are particularly useful. When outcomes of interest are not available, it may be useful to examine proxy measures. Merging of multiple databases, data protection and security, creating a new database to hold multi-site data. Making it easier to share and record data across multiple organizations/ sites. Participant registry, dashboard. If the program hired someone specific to integrate/develop/ manage the database, code: Use data experts If modifications are made to the record system, code change record systems. If modifications are made specifically to facilitate quality monitoring or outcome evaluation, code: develop and organize quality monitoring systems or plan for outcome evaluation Set-up a system that all data collected at each DPP site is entered into a central database. 223 5. Change accreditation or membership requirements Strive to alter accreditation standards so that they require or encourage use of the clinical innovation. Work to alter membership organization requirements so that those who want to affiliate with the organization are encouraged or required to use the clinical innovation None Accreditation is an assessment against standards to demonstrate competence to carry out the program. To officially recognize, accept or approve sites. For site/organizational level and not provider level. If at provider level, see: Create or change credentialing and/or licensure standards NDPP uses the DPRP to standardize the DPP across the US, and ensures each new site meets DPP standards. 6. Change liability laws Participate in liability reform efforts that make clinicians more willing to deliver the clinical innovation Liability reform can also make clinicians less willing to deliver alternatives to the clinical innovation. Make changes to laws/contracts for providers 224 7. Change physical structure and equipment Evaluate current configurations and adapt, as needed, the physical structure and/or equipment (e.g., changing the layout of a room, adding equipment) to best accommodate the targeted innovation None Purchase new equipment, expand clinic space. Includes the use of new mhealth technology. If opening a new site review code: Change service sites Providing new equipment, renting space to accommodate program. 8. Change record systems Change records systems to allow better assessment of implementation or clinical outcomes These changes may include modifying the format of progress notes and treatment plans to reflect the innovation (evidence-based practice) being implemented. Formal modifications to the way data are recorded. Create standardized data collection forms. If multiple settings or data moving outside of the setting, consider data warehousing techniques. If specific to quality monitoring, see also Develop and organize quality monitoring systems If developed a system to link across sites, consider use data warehousing techniques. If a data expert was hired to help change record systems, consider use data expert Participants complete questionnaires on iPads. If this is the case, also consider Change physical structure and equipment 225 9. Change service sites Change the location of clinical service sites to increase access Changing service sites can include collocating different services to better implement complex clinical innovations that require multiple disciplines or services, telemedicine, or bringing the services to the client in their home, the community, or other clinically relevant settings, such as busy public spaces for a client with PTSD. Open a new site or relocate for better access, e.g., moving diabetes prevention away from the hospital and into the community. Code if program is implemented in a new setting. If the program is at the same site, but the site had to order new equipment or reorganize, code: Change physical structure and equipment Implementing a DPP at a workplace, church to better reach clients. 226 10. Create or change credentialing and/or licensure standards Create an organization that certifies clinicians in the innovation or encourage an existing organization to do so. Change governmental professional certification or licensure requirements to include delivering the innovation. Work to alter continuing education requirements to shape professional practice toward the innovation none Have a specific organization that provides standardized training for all providers. Or Have the government formally create new certifications for a new job type (e.g., “lifestyle coach”) Add as a continuing education credit for professionals to maintain designation. If at the organizational level (an organization wants to provide the program), see: Change accreditation or membership requirements All staff go through standardized training and receive a certificate upon successful completion. 227 11. Mandate change Have leadership declare the priority of the innovation and their determination to have it implemented It is important to ensure that the individuals mandating the change have the power to do so, as implementers often lack such authority. Working with organizational leadership to develop buy-in and lobby for a change mandate is often needed. It can also be important to inform other stakeholders (e.g., auditors, groups that review services for billing) about the mandate to ensure they are on the same page. Top-down approach. Leaders at an organization demand the front-line workers to implement the program. Evidence of a rule, signed agreement, or other form of directive that comes from the top and forces the implementation. 228 12. Start a dissemination organization Identify or start a separate organization that is responsible for disseminating the clinical innovation. It could be a for-profit or non-profit organization This strategy can address concerns (e.g., conflict of interest) for situations in which it is desirable to have fidelity monitors that are independent from the care setting. The dissemination organization could be a for-profit or nonprofit organization. The organization could be ‘licensed’ by a university, if the innovation was born within an academic setting. It is important for dissemination organizations to be aware of organizations' approaches to implementing other interventions in order to build upon existing practices. Dissemination is “to spread” the innovation Code if the organization or sub-committee sole purpose is dissemination. 229 13. Build a coalition Recruit and cultivate relationships with partners in the implementation effort Partnerships can develop around cost-sharing, shared resources, shared training, and the division of responsibilities among partners. This work may proceed naturally from local consensus discussions. Coalition members commonly have defined roles in the implementation effort. Examine areas that manuscripts mention partnerships to help with funding, sharing resources, training, recruitment, IT help, outreach, dissemination. The coalition could be an already formed team. Examine these codes to see if they should also be coded: develop academic partnerships, local consensus discussions, develop resource sharing agreements If members of the coalition sign a contract or MOU, code obtain formal commitments 230 14. Capture and share local knowledge Capture local knowledge from implementation sites on how implementers and clinicians made something work in their setting and then share it with other sites This strategy is often coordinated with centralized technical assistance and learning collaboratives. There are multiple techniques for capturing local knowledge, which could be presented in multiple formats. For example, short YouTube videos could be created that document testimonials from clinicians who have successfully used a given innovation. Another example would be maintaining a running list of a team's response to specific implementation barriers that could be shared readily through a platform like GoogleDocs or Microsoft SharePoint. Additional techniques can be found at www.liberatingstructures.com. Capture lessons learned and share it with other sites. Program implementation must have started. Need more than one site to code this strategy. If only one site, consider create a learning collaborative If there are formal trips to visit sites, code visit other sites. If lessons are learned within a formal group of providers/organizations that meet regularly, review create a learning collaborative If a program is being developed and local opinion are sought consider conduct local consensus discussion If a centralized individual or organization facilitates the sharing of information, code centralized technical assistance. Highlight a certain site in a knowledge product (e.g., newsletter/blog/website/spotlight during a monthly meeting) that gets distributed to all sites. The knowledge product reviews site specific lessons learned and how the site overcame barriers. The knowledge product is used to share this information with a goal to help other sites. 231 15. Conduct local consensus discussions Include local providers and other stakeholders in discussions that address whether the chosen problem is important (diabetes prevention) and whether the clinical innovation to address it is appropriate (Diabetes Prevention Program) Identify stakeholders relevant to each project. Further, with each project, there will be a need to identify whether the goal of the consensus discussion is to characterize consensus or build consensus. Utilizing community based participatory research (CBPR) principles may be relevant to many innovations. Notably, the chosen problem needs to be a high enough priority, compared to other problems, that attention and resources will be dedicated to addressing the problem. Initiatives that seek out opinions on relevant local stakeholders (providers, local health authorities, diabetes organizations, participants). Focus of discussions need to be on the rationale for the DPP. Can include prospective participants. These conversations often occur before implementation, during the planning phase. Meetings, community presentations, focus groups. If formal data is collected on the need for the program, facilitators and barriers or other, review conduct local need assessment 232 16. Develop academic partnerships Partner with a university or academic unit for the purposes of shared training and bringing research skills to an implementation project HIPAA, and other legal limitations are common to encounter with academic partnerships. Formal relationships (e.g., contracts, MOUs) will be required in some instances. Not all academics have a full understanding of practice level stakeholder needs and this should be considered while developing this partnership. In settings where ‘research’ is not a commonly supported practice, evaluation or developmental evaluation may be more useful ways of characterize the activity [18]. Use of an academic (university) team to help with planning, designing, evaluation, consultation, training, dissemination etc. Disseminate the program results through academic outputs (conference presentations, manuscripts, community presentations) 233 17. Develop an implementation glossary Develop and distribute a list of terms describing the innovation, implementation, and stakeholders in the organizational change When compiling a glossary, reflect as to whether the terms being introduced are essential. Define key terms, roles, team members, program processes and distribute to the implementation effort. High level overview either in a meeting, written document, manual, or PowerPoint presentation. 234 18. Identify and prepare champions Identify and prepare individuals who dedicate themselves to supporting, marketing, and driving through an implementation, overcoming indifference or resistance that the intervention may provoke in an organization This strategy includes preparing individuals for their role as champions. Champions are primarily internal to the organization. Additional issues raised include the need for guidance regarding: a) Methods and considerations related to the selection and identification of champions. Social network theory and methods may be useful in this regard. b) Training and or providing champions support materials. c) Addressing incentives or disincentives to the champion role. d) Whether there are needs for champions at different levels of an organization Internal or external to the organization. Could be administrative leaders, providers, manager, outreach. Help spread the word for the need for the innovation or the effectiveness of the innovation or just get the team excited and on board. Article must describe someone as a champion, that an individual has gone over an above their role to support the implementation, or retrospectively attributed success thanks to “X” individual. A champion is more of a specific role are champions often know they are champions. Compare to inform local opinion leader. *Note: Opinion leaders may be considered more of an objective third party with relevant expertise. Less of an actual “role” but rather just influential individuals you want “on your side” 235 (e.g., clinic, region, national). Champions are often distinguished from opinion leaders. Opinion leaders may be considered more of an objective third party with relevant expertise. 236 19. Identify early adopters Identify early adopters at the local site to learn from their experiences with the practice innovation Early adopters are a good pool for identifying implementation champions. Recruit early adopters to attend stakeholder meetings to present their experiences. Investigating the adoption chasm between early adopters and the early majority has been found to be useful. Different engagement techniques for these two groups are typically needed. For further discussion see Moore [19]. Specifically seek out providers/admin from pilot/early sites to learn from them. Code this strategy if manuscript collects experiential data with the purpose of learning from early adopters at provider or organizational level – do not code from participants perspective (i.e., early participant adopters). Do not code identify and prepare champion unless the early adopter is acting as a champion for later sites or involved in stakeholder meetings to drive the implementation. Focus group with pilot project providers to understand facilitators and barriers to help start-up a new site. 237 20. Inform local opinion leaders Inform providers identified by colleagues as opinion leaders or “educationally influential” about the clinical innovation in the hopes that they will influence colleagues to adopt it The opinions of individuals who refer people to services, or who initiate the connection to services also function in a key opinion role. Keeping opinion leaders informed from pre-implementation through maintenance of the clinical innovation is important. Ensuring that opinion leaders do not serve as implementation obstacles if they are not actively promoting the innovation is also important. Individual must be outside of the study team. Therefore, an opinion leader cannot also be a champion, supervisor, or facilitator. Can code for networking purposes to spread the word to promote the program. Compare to identify and prepare champions. *Opinion leaders may be considered more of an objective third party with relevant expertise. Less of an actual “role” but rather just influential individuals you want “on your side”. Champions have more of a role. Inform individual at a local health authority who regularly meets with physicians and/or is respected among physicians and ask them to promote the program to their peers. Involve the pastor of a church to help with the implementation and recruitment from the pulpit. 238 21. Involve executive boards Involve existing governing structures (e.g., boards of directors, medical staff boards of governance) in the implementation effort, including the review of data on implementation processes Other types of leadership with ‘top-down’ powers may be involved for settings that do not have a governing board. Examples include administrative leadership, clinical leadership, policy makers, and insurance providers or other payment systems. Governing structures are any organizations that can impact the program. 22. Model and simulate change Model or simulate the change that will be implemented prior to implementation Computer simulations, walkthrough simulation exercises, or modeling the potential overall impact of stakeholder's behavior change may be used. System dynamics modeling is one example of a specific method that may be used [20]. This approach is often more relevant for complex multi-component innovations. These efforts could involve computer simulations, walk-through simulation exercises, or modeling the overall impact of the program. 239 23. Obtain formal commitments Obtain written commitments from key partners that state what they will do to implement the innovation Formal commitments should clarify roles, responsibilities, and detail tangible and non-tangible benefits (e.g., community partnerships). Ensure that key roles are supported within the organization (e.g., workload release credit for providing and receiving supervision in a new clinical practice). Formal commitments in no way diminish the importance of informal commitments to a change effort. Evidence that a contract, memorandum of understanding (MOU) or other document(s) have been signed. Not at client level (For example, do not code if participants sign a behavioural contract for the program. See also: build a coalition, develop resource sharing agreements 240 24. Organize clinician implementation team meetings Develop and support teams of clinicians {the people implementing the program – front line workers) who are implementing the innovation and give them protected time to reflect on the implementation effort, share lessons learned, and support one another’s learning None Formal meetings among providers (front-line), admin or anyone implementing the program. Not high-level Could also be webinars across sites. Must be formal meetings (protected time) If protected time is not given or lessons learned are shared within or between sites code create a learning collaboration 241 25. Promote network weaving Identify and build on existing high-quality working relationships and networks within and outside the organization, organizational units, teams, etc. to promote information sharing, collaborative problem-solving, and a shared vision/goal related to implementing the innovation Individuals functioning as network weavers usually have external links outside of the community to bring in information and ideas. An example would be nurses and doctors who staff hospitals and skilled nursing facilities, and the patients who rotate among these facilities. Networks are somewhat more organic than collaboratives and are often enduring and durable. See: http://www.networkweaver.com/ Purposely connect, develop, and seek out partnerships, relationships etc. that contribute to the implementation. Informal or formal networking. If specifically recruiting partners in a more formal role, consider build a coalition Can code if networking to optimize the implementation. Conduct community engagement events to connect with the broader community “network” to promote the program, build buy-in, gain new insights to improve program, recruitment, infrastructure. 242 26. Recruit, designate, and train for leadership Recruit, designate, and train leaders for the change effort Change efforts require certain types of leaders, and organizations may need to recruit accordingly, rather than assuming that their current personnel can implement the change. Designated change leaders can include an executive sponsor and a day-to-day manager of the effort. Change leaders should consider how to establish effective supervisory lines for clinical practice innovations that are enacted by clinicians when the change leader does not have similar clinical responsibilities. This can be someone already at the organization (specify their role as implementation facilitator/manager) or someone new (hired an implementation sponsor, manager). The individual must know they have a leadership role. Site lead hired to lead trained program staff at each site, host monthly meetings. 243 27. Use advisory boards and workgroups Create and engage a formal group of multiple kinds of stakeholders to provide input and advice on implementation efforts and to elicit recommendations for improvements Consider how group composition (or heterogeneity) impacts stakeholder participation and take active steps to reduce response bias. For example, inclusion of supervisors and supervisees in these groups can be problematic and it may be a desirable strategy to ensure that these situations are avoided due to the power difference in the relationship. Supervisees, for example, may feel pressure to report positively to put a good face on for the supervisors, and supervisors may feel pressure to deny having any problems with implementation to save face. It can be useful to distinguish between internal stakeholders and representatives (in a participatory approach to maintain Seek advice from a formal group of key stakeholders. Must be purposeful to collect feedback and advice on implementation. Can be a one-time meeting or ongoing, before implementation or during implementation. Must be a formal group that meets. Participant advisory board, stakeholder advisory board 244 buy-in and relevance) versus external experts and advisors. Similarly, depending on the input or oversight need, the workgroup composition may include multiple-level or multi-disciplinary stakeholders. 245 28. Use an implementation advisor Seek guidance from experts in implementation This could include consultation with outside experts such as university-affiliated faculty members, or hiring quality improvement experts or implementation professionals. This might include outside experts – professors, quality improvement experts, implementation professionals. Advice is at the broad implementation level, organizational level. Typically, high level program developers, researchers who need advice on broad implementation questions. If advice is given at the level of the providers needing help to implement sessions/the program, consider Provide ongoing consultation 246 29. Visit other sites Visit sites where a similar implementation effort has been considered successful Clarifying the goals of the site visit prior to making the visit is particularly useful. Comparing and contrasting the features of one’s own site with the comparison site in preparation for the visit may better inform the visit objectives. Clarifying goals, in part includes developing a plan for using the information upon returning to your setting. Identify adaptations made in implementing the innovation and any perceived impact on the effectiveness of the innovation/practice change. It is important to document facilitators and lessons learned. Much can be learned from visiting sites that have a strong track record for successfully implementing a wide Site visits. Visit a site to learn from it (positive or negative lessons), about implementation. If completing a site visit to audit sites, consider coding Audit and provide feedback If sharing lessons learned is completed consider coding capture and share local knowledge 247 variety of other innovations/practice changes. Consulting with sites where implementation has stalled or failed can also provide useful information. Sites also benefit from sharing implementation planning and execution notes virtually (i.e., information exchange is not limited to physical visits). 248 30. Increase demand Attempt to influence the market for the clinical innovation to increase competition intensity and to increase the maturity of the market for the clinical innovation One way of increasing demand is to educate patients about the clinical innovation so that they demand it from their providers Purposely attempt to increase the demand for the DPP – raise awareness among patients, providers, health authorities, government to want/ask to provide the program. Code this strategy if using community recruitment events to increase demand. If using mass media to increase demand, code use mass media. 31. Intervene with patients/consumers to enhance uptake and adherence Develop strategies with patients to encourage and problem solve around adherence This includes patient/consumer reminders and financial incentives to attend appointments. Feedback regarding patient/consumers' understanding and use of the treatment is also important to collect. Providing incentives is an example of an intervention to encourage adherence, this includes recruitment incentives. You can also code this strategy if participants provide feedback on how to improve adherence and uptake (e.g., have after work hour classes, send reminder emails before appointments) If including participants for general feedback code: Obtain and use patients/consumers and family feedback If including participants to make decisions or get their opinion in the implementation planning, consider: Involve patients/consumers and family members If incentive is at the provider level, consider Alter incentive/allowance structures Hold interviews, collect survey data and/or focus groups with participants for (prospective or retrospective) feedback on the uptake (enrolment) and adherence (attendance) 249 32. Involve patients/consumers and family members Engage or include participants/consumers and families in the implementation effort Feedback from stakeholders can be obtained at any stage of the implementation process depending on the needs and goals of project. Involving stakeholders in the pre-implementation phase for many innovations is advantageous. Training in the innovation, and relevant advocacy, may also be included in stakeholder involvement. Informal caregivers such as neighbors, friends, and other key sources of support may also be prudent to include. Clients need to be included in the implementation effort e.g., development, planning, evaluation. This can be at any phase; development, training, recruitment, dissemination. Code for events used to involve, engage or consult participant stakeholders on the implementation effort [involve in decision-making]. This strategy is different than obtaining feedback. If specifically including pathways for participants to provide (continuous) feedback during or post-program (participants), code Obtain and use patients/consumers and family feedback instead. This can be at the program level. NOTE: if specifically obtaining feedback on uptake (enrolment) or adherence (attendance) code Intervene with patients/consumers to enhance uptake and adherence If specifically obtaining feedback (from interviews, surveys, etc.) from participants after program participation, code Obtain and use patients/consumers and family feedback Involve participants in the planning phase, evaluation or meetings about the implementation to understand how to meet their needs. 250 33. Prepare patients/consumers to be active participants Prepare patients/consumers to be active in their care, to ask questions, and specifically to inquire about care guidelines, the evidence behind clinical decisions, or about available evidence-supported treatments Preparing consumers to inquire about specific practices can involve asking questions, and educating patients/consumers about the existence of treatments supported by evidence, as well as explicitly inviting them into the process of treatment decision-making. Educational outreach to the community or to program participants that specifically aims to empower them to take control over their prediabetes and their care decisions. If there are educational outreach events in the community to target participants to get to know the program. Most often this is a sort of “primer” before the program starts. Does not need to be part of the program. Can code this strategy for participant level outreach events e.g., community recruitment events that target educating the community about prediabetes or a specific program. Can be part of the program, but then it must be a clear focus of the session/consultation/program, such as a pre-program intake session. 251 34. Use mass media Use media to reach large numbers of people to spread the word about the clinical innovation Mass media may include television, newspapers, magazines, radio, electronic social media, listservs, mass email campaigns, mass mailings, and robocalls as methods for spreading information. Targets of these media campaigns may be clinicians, potential consumers of the innovation, or their associates. Other commonly used terms include marketing or social marketing. newsletters, social media, public service announcements, magazines, commercials, podcasts… to spread information about the program. Code if media used for recruitment, dissemination, awareness or any aspect of implementation. If specific target of mass media is to increase the number of sites delivering program/recruit new sites, OR to prompt participants to talk to their provider about the program consider increase demand. 252 35. Centralize technical assistance Develop and use a centralized system to deliver technical assistance focused on implementation issues This could be the designation of a lead technical assistance organization (could also be responsible for training). The lead technical assistance entity can develop other mechanisms (e.g., call-in lines or websites) in order to share information on how to best implement the clinical innovation. Could be its’ own organization or part of the implementation initiative. Can be a person or a team. Can also be in the form of support websites, call-centers to share information on how best to implement the program. Especially to multiple sites. Compile all information and project assistance in one place. In a multi-site program, all sites have access to this one central person/group/call center/website. In a single-site program first examine provide local technical assistance to see if that code fits. 36. Facilitation A process of interactive problem solving and support that occurs in a context of a recognized need for improvement and a supportive interpersonal relationship Facilitation can be internal or external to a system. This interactive support process can include a combination of any implementation strategies, and typically bundles multiple strategies as needed. Coaching, education and/or feedback general support from facilitator. This strategy is at the organizational level, NOT at client level. E.g., facilitation of the providers, admin, staff and NOT facilitation of the clients. If providing assistance, specifically organizational level assistance, at the local level or multi-site level, consider code provide local technical assistance or centralize technical assistance If goal is to facilitate/coach/support providers in a supervisory role, consider code provide clinical supervision 253 37. Provide clinical supervision Provide clinicians with ongoing supervision focusing on the innovation. Provide training for clinical supervisors who will supervise clinicians who provide the innovation Clearly defining the role of supervision and providing ongoing resources to ensure that it occurs can be important. Supervisor training often needs to include specific training in how to supervise the innovation. See Nadeem et al. [13] for a discussion of the distinction between consultation and supervision. Supervisor can be tasked with overseeing providers’ performance, provide support, guidance, manage relationship between providers and larger organization, provide study updates to providers Support is mostly for provider-level, but could also be for support staff (e.g., administrative staff) If someone is providing support/advice/coaching specific to certain skills, consider coding Provide ongoing consultation If there is a specific training for supervisors or other leaders in the implementation effort, review code: Recruit, designate, and train for leadership Site lead is responsible for overseeing trained staff. Trained staff understand they can go to the site lead for support. 254 38. Provide local technical assistance Develop and use a system to deliver technical assistance focused on implementation issues using local personnel Local technical assistants can be connected with a broader or centralized network of technical assistants. Technical assistance for both the clinical innovation and the implementation processes may be important. For example, the VA aims to have mental health Evidence-Based Psychotherapy coordinators, Military Sexual Trauma coordinators, and OEF/OIF/OND coordinators in each facility who can provide technical assistance to other local clinicians for relevant initiatives. Can be a person or a team local to the implementation site to share information on how to best implement the program. Local support using personnel. If multi-site, code this strategy if someone local is designated for support. If support systems are put in place that do not include personnel (e.g., website or online training program) consider centralize technical assistance. If support is centralized, consider code centralize technical assistance. If the goal is to just provide supervision of providers, code provide clinical supervision The supervisor cannot also be the person who provides technical assistance. The person who provides technical assistance would be who the site lead/ supervisor contacts with questions. 255 39. Create new clinical teams Change who serves on the clinical team, adding different disciplines and different skills to make it more likely that the clinical innovation is delivered (or is more successfully delivered) none Adding a new role to the team. For example, hire a dietician to provide nutrition lessons for the diabetes prevention program or a kinesiologist for exercise sessions. Code if a NEW grouping of health professionals or a new type of health professional is a result of the program implementation. Perhaps typically just the physician completes diabetes consultations but now there is also a physiotherapist, dietician, psychologist, administrator, health promotor, volunteer etc. This would be a “new” team. 40. Develop resource sharing agreements Develop partnerships with organizations that have resources needed to implement the innovation For example, this could involve data sharing agreements, agreements to share necessary equipment (e.g., telemedicine equipment), or sharing the cost of bringing in experts who provide training and consultation. Resource sharing agreements could involve formal memorandums of understanding (MOUs), or be much more informal in nature. Resources are broad, for example, laboratories, new program sites (space for exercise, cooking demonstrations, meeting rooms). Partner with a lab to help recruitment. Do not code if resources are readily available to general population e.g., using published educational documents, routine lab work. Partner with a local laboratory to flag individuals with a HbA1c within the prediabetes range. 256 41. Facilitate relay of clinical data to providers Provide as close to real-time data as possible about key measures of process/outcomes using integrated modes/channels of communication in a way that promotes use of the targeted innovation For recommendations regarding how to introduce innovation or change of any kind into existing work flows, please see May [30]. Provide outcome data (weight loss, activity level) or process data (referral numbers, attendance) to providers. Must have a documented process to relay the information. Feedback goes directly to those directly facilitating the program. If the data that is relayed is specific to quality monitoring, consider coding Develop and implement tools for quality monitoring and Develop and organize quality monitoring systems 42. Remind clinicians Develop reminder systems designed to help clinicians to recall information and/or prompt them to use the clinical innovation Reminders could be patient or encounter-specific, provided verbally, on paper, or electronically. Computer-aided decision support, and drug dosages are included in this strategy. Reminders may be delivered at various time points (prior to service, during service, or following service delivery). Reminder could be on paper, verbal or on computer. Reminder could be used for providers during a session or other reminders e.g., recruitment processes. Does not have to be clinician specific but reminder to anyone on program team, to help them remember the innovation. Checklists for use during a session can include written reminders for providers. 257 43. Revise professional roles Shift and revise roles among professionals who provide care, and redesign job characteristics Revising professional roles includes the expansion of roles to cover provision of the clinical innovation and the elimination of service barriers to care, including personnel policies. This may mean expanding current roles to cover the program or adding new assignments (completing paperwork, data entry, collection, recruitment etc.) to current roles. Code if a departure from the normal staff duties. If fitness facility staff can now also counsel on diet. Ask admin staff at fitness facility to enter data into computer. 258 44. Conduct educational meetings Hold meetings targeted toward different stakeholder groups (e.g., providers, administrators, other organizational stakeholders, and community, patient/consumer, and family stakeholders) to teach them about the clinical innovation The content of the education may include information regarding what to expect as implementation moves forward. It is useful to ensure that meeting attendees are relatively homogeneous so that the education can be targeted toward the stakeholder group’s needs. For example, some educational meetings may inform the stakeholder group about the clinical innovation in a way intended to increase demand, while others may preview the clinical innovation for providers and administrators. It is often useful to have recordings or other materials from the educational meetings available to those who cannot attend the meetings (e.g., those covering patient care at the This can be formal events (e.g., community presentation) to teach the community about the initiative, or to gain support/ buy-in within an organization (e.g., start-up meeting). Targeted training for different members of the team. Code for introductory or first encounter educational events. For ongoing training or educational events see: Conduct ongoing training If the educational meeting is an “outreach” opportunity specifically at the practice setting, and at provider level, do not code and consider conduct educational outreach visits instead. If at participant level, consider Prepare patients/consumers to be active participants If the outreach/education is specific to raise awareness about the program and empower participants to make Have a member of the research team conduct a start-up meeting to raise awareness and teach providers about the innovation. 259 time of the meeting, new hires subsequent to the meeting). decisions about their care, 260 45. Conduct educational outreach visits Have a trained person meet with providers in their practice settings to educate providers about the clinical innovation with the intent of changing the provider’s practice Visits to the site may be in-person or virtually via the Internet. Some initiatives may require regular educational outreach as part of maintaining the innovation/practice change. Academic detailing is another commonly used term, although academic detailing typically involves many additional discrete implementation strategies (e.g., conduct ongoing training, modeling, developing and distributing educational materials; [21, 22]). “Academic detailing”, site recruitment opportunities, physician referral recruitment meetings. A form of dissemination of the program. Must be a specific meeting with an intent to change behaviour (individual – physician or organizational – site) to adopt the program. If the education is general to raise awareness about the program, consider conduct educational meetings instead. Do not code if outreach events are for participant recruitment. If the outreach/education is specific to raise awareness about the program and empower participants to make decisions about their care, consider Prepare patients/consumers to be active participants Lunch and learn for physicians to get them aware of the program and with the intent of receiving referrals from them to the DPP. OR lunch and learn with potential new sites to advocate that they want to implement the program. 261 46. Conduct ongoing training Plan for and conduct training in the clinical innovation in an ongoing way This can include follow-up training, advanced training, booster training, purposefully spaced training, training to competence, integration of off the- job and on-the-job training, structured supervision, the introduction of concepts in a specific sequence to ensure mastery, and trainings based on the level of clinician knowledge. Ongoing training efforts need to reach across shifts and accommodate staff turnover, as well as rotating staff (e.g., residents). Trainings can be in-person, on the web, or technology-assisted (e.g., simulation lab training), and may focus on individuals or involve groups. When planning for ongoing training, it is important to describe the training components, Formal follow-up training (booster, advanced training, purposefully spaced – part two of the training 2 months later, train to competence… etc.) Code formal trainings only. Do not code ongoing informal, or one-on-one support. If the description of the training describes multiple modes (e.g., role-play, discussion, online portal, didactic etc.) also code make training dynamic. This can be training for the provider level or implementation process level (e.g., admin, recruitment) If help/ ”training” is more “as needed” or providers are told to seek advice from specific “experts” for help with skills, consider provide ongoing consultation If more informal ongoing feedback comes from an individual from a Coaches completed an initial training and then met again in 6 months for a booster training. 262 including the timing and frequency of trainings. Issues related to the dynamics of training can be found in the strategy, make training dynamic. supervisory level. Consider provide clinical supervision 263 47. Create a learning collaborative Facilitate the formation of groups of providers or provider organizations and foster a collaborative learning environment to improve implementation of the clinical innovation There are several approaches to this in the literature including peer consultation networks, online communities of practice, quality circles, and learning collaboratives. Groups may meet in person or interact using a wide variety of media. The inclusion of a quality manager within the collaborative may be useful. Positive deviance approaches use “discovery and action dialogue” among peers to promote collaborative learning [23–25]. Resources specific to learning collaboratives include: The Health Resources and Services Administration (HRSA) [26] The Institute for Healthcare May be called peer consultation networks, community of practice (COP), quality circles. This is at the level of those at the front-line (directly interacting with participants) To code, must be a formal groups with a focus on collaborative learning If the groups are specific to those implementing the program, consider also coding: Organize clinician implementation team meetings Hold a monthly meeting for front-line staff to discuss successes, barriers, challenging scenarios and lessons learned. 264 Improvement (IHI) [27, 28] Key terms for searching literature specific to collaborative learning include: learning community, learning network, and community of practice. 265 48. Develop educational materials Develop and format manuals, toolkits, and other supporting materials in ways that make it easier for stakeholders (anyone supporting the program – physician, pharmacist, church leaders) to learn about the innovation and for clinicians (providers) to learn how to deliver the clinical innovation (DPP) Create eye-catching, easy-to-use educational documents. Distill complex information into easier-to-learn components. Consider teaching skills modularly. Use different forms of media, and target messages for different audiences. Educational materials should reflect principles of adult learning theory. Assessment of current, available technology infrastructure to accommodate educational media (e.g., firewalls, old hardware, old software) is merited. Consider how the educational materials will be used over time. For example, will the educational materials’ primary use be to train new or rotating staff; or to refresh staff knowledge; or to be This strategy is not for materials for clients (e.g., program workbook, program flyer). This strategy is at the organizational level. Can be materials for providers (manual, scripts, PowerPoint slides) or for other stakeholders (e.g., physician/ pharmacist/ church leadership buy-in). Help educate recruiters. Can also include materials on processes (e.g., overview of workflow, standard operating procedures). Do not code if materials are developed for participants. Any material that was developed to aid with supporting the community organization to learn about the program or about diabetes (e.g., training manual). This can also include materials online. Do not code for developing program level documents e.g., program workbook for participants. If materials are distributed, also code: Distribute educational materials training manual, online training, letter to physicians describing the program. 266 incorporated into existing supervision, competency, and performance review structures. Educational materials may be refined through the use of formative evaluation feedback. Relevant suggestions are provided via the REP framework, under its ‘packaging’ domain [7]. Further support related to developing educational materials can be found on the Training Within Industry Service website [29]. 267 49. Distribute educational materials Distribute educational materials (including guidelines, manuals, and toolkits) in person, by mail, and/or electronically none For organizational level. Do not code if distributing materials to client (e.g., program workbook) Do not code if educational materials are distributed to clients. Only code for formally developed materials. If materials were developed for the implementation also code: Develop educational materials Each provider received a training manual. 268 50. Make training dynamic Vary the information delivery methods to cater to different learning styles and work contexts, and shape the training in the innovation to be interactive Making training dynamic includes efforts to divide material into small time intervals, the use of small group breakouts, audience response systems, and other measures, such as having learners try new skills between training sessions. Interactive components of training can be very dynamic with participants actively contributing to the training content, engaging in problem solving, and identifying solutions that can be tested. Use of break-out groups, role-play, quizzes, power-point, mock sessions. Not just lecture-style education. There must be evidence of more than one delivery method during a training. Training is at the level of the provider (who implements the DPP program). Do not code at participant level. If a formal training, code: Conduct educational meetings. If an ongoing training, code: conduct ongoing training 269 51. Provide ongoing consultation Provide ongoing consultation with one or more experts in the strategies used to support implementing the innovation Ongoing consultations could include in-person or distance consultation and feedback on taped clinical encounters. Consultations are tailored to the clinician’s actual practice, thus, differentiating a consultation from ongoing trainings. Feedback may be from a consultant external to the organization, which distinguishes consultation from clinical supervision. Some practice changes can involve a recertification process, thus, involving consultation ensures adequate fidelity. Consultation may also be necessary for non-clinical staff such as administrators and those responsible for billing, constructing feedback systems, or other staff with duties Consultation at the level of implementation, or at the level of providers. Should be on an add-needed basis or one-on-one instead of a group and from an expert. If consultation occurs at regular interval and is for all providers, consider conduct ongoing training. If consultation to support the individuals facilitating program sessions and comes from someone within the organization, consider code: provide clinical supervision If advice is needed at the high level broad overview of the entire implementation project in general, consider Use an implementation advisor If a frontline staff is struggling with motivational interviewing, they can consult with an expert of motivational interviewing for additional support. 270 that impact the implementation process. 271 52. Shadow other experts Provide ways for key individuals to directly observe experienced people engage with or use the targeted practice change/innovation While shadowing traditionally has involved in-person observation, creative use of technology may provide additional opportunities for individuals to observe and learn from those experienced in the innovation. Must describe shadowing in the article Code if this is part of training or onboarding protocols. New coaches shadow experienced coaches prior to having their first participant. 53. Use train-the-trainer strategies Train designated clinicians or organizations to train others in the clinical innovation Restrictions regarding who can serve as a trainer are idiosyncratic to the innovation or practice change, for example, some innovations may require that supervisors have specific levels of education, training, or experience, and such restrictions should be explored in the planning phase. Train-the-trainer strategies may also apply to those responsible for administrative procedures, and who are part of implementing the innovation. If training was led by a previously trained individual, or article mentioned that trained individuals can then train new providers to deliver the organization. If an organization conducts the training, consider code: work with educational institutions New coaches are trained by coaches with over 1-year of experience. 272 54. Work with educational institutions Encourage educational institutions to train clinicians in the innovation This strategy fits well with innovations requiring clinical training and other skills where training expertise is more likely to be housed in educational institutions. Not just for training but also for supporting or disseminating implementation If a program is partnered with an academic institution consider: develop academic partnerships 273 55. Assess for readiness and identify barriers and facilitators Assess various aspects of an organization to determine its degree of readiness to implement, barriers that may impede implementation, and strengths that can be used in the implementation effort Readiness assessments may focus on agency finances, staffing levels, and other material or logistical resources needed, or available, to support the implementation effort. Further this assessment may also focus on leadership support, the organizational priority for change, and the presence of successful experience with quality improvement techniques and change management. Additional aspects for assessment may include other services provided, as well as community support, stakeholder attitudes, and beliefs and perceptions of evidence for the innovation or change. Rationale for current practices, organizational climate and culture, Assessment may focus on finances, other services provided, community support, clinician attitudes and beliefs, organizational climate and culture, structure, and decision-making styles. OR use of specific site readiness assessments. Focused on context, front-line workers, and other personnel; barriers to implementation, Includes formal (e.g. baseline focus groups) and informal methods for gathering this information. Site start up meeting to discuss barriers, discuss strategies. Discuss necessary changes to infrastructure to accommodate the program. 274 structure, decision-making styles, and the perceived needs of frontline stakeholders to implement the change or innovation (consider adaptation needs and limits) are also important aspects to consider in this assessment. Readiness assessments can be used to vet, eliminate, or prioritize implementation sites. More so, the assessment can help make internal decisions about whether to go ahead with an implementation initiative. Some barriers can be difficult to observe prior to implementation. Specific measures have been created to assess readiness for change, which may be useful (e.g., [1–3]). 275 56. Audit and provide feedback Collect and summarize clinical performance data (process variables, outcome variables, observation) over a specified time period and give it to clinicians and administrators to monitor, evaluate, and modify provider behavior The information may be obtained from a variety of sources, including medical records, computerized databases, observation, or feedback from patients. Performance evaluations may also be considered as audit and feedback data if the evaluation included specific information on clinical performance. Feedback summaries may include recommendations. Feedback may be displayed publicly, and often involves comparisons to peers or to local, state, national, or international norms. Feedback may be designed to guide a clinician in improving fidelity. It should also be noted that audit and feedback data can be helpful in promoting the Feedback can be in the form of presentations, report, consultation. Code this strategy if manuscript mentioned “performance evaluation” Do not code if there is an audit and no feedback to clinicians/administrators. Collecting data and presenting in a manuscript is not sufficient for audit and feedback. 276 continuation of intended behavior. Performance data may include process variables, outcomes, or fidelity measures. Feedback can include mandatory performance measures, which are related to benchmarks from the literature or normative data within an organization or industry. 277 57. Conduct cyclical small tests of change Implement changes in a cyclical fashion using small tests of change before taking changes system-wide. Tests of change benefit from systematic measurement, and results of the tests of change are studied for insights on how to do better. This process continues serially over time, and refinement is added with each cycle Two common small tests of change cycling strategies are “Plan-Do-Study-Act” from Deming’s quality management work [4], and six sigma’s Define- Measure- Analyze-Improve-Control sequence [5]. “Plan-Study-Do-Act” is an example of change cycling strategies in the literature. Same with Define-Measure-Analyze-Improve-Control Sequence. Pilot a change at one site before implementing it at all sites. 278 58. Conduct local needs assessment Collect and analyze data related to the need for the innovation This assessment could be focused on: • Outcomes of usual care • Process of care • Description of usual care and its distance from evidence-based care (e.g., gaps in care) • Opinions from stakeholders (including patients) on (a) barriers and facilitators to the desired outcome (e.g., recovery from mental illness), (b) the need for any innovation (i.e., tension for change), (c) the need for a specific innovation, or (d) the special considerations for delivering the innovation in the local context. Common needs assessment methods include surveys, Could be focused on collecting data (survey, focus group, interviews, document/data analysis) from various stakeholders, participants, etc. for: 1) Data they want collected as part of implementation or program evaluation 2) Date demonstrating high levels of diabetes and/or prediabetes in an area 3) Need for a diabetes prevention program in a certain community 4) Physicians/participants/health authority describing the need for a DPP 5) Barriers and facilitators to reducing diabetes risk 6) special considerations for delivering the Often before implementation begins. Consider coding these strategies if the needs assessment leads to modifications to the program (promote adaptability) or the implementation strategies (tailor strategies) 279 focus groups, key informant interviews, direct observation, and data mining of administrative records utilized to identify target populations, as well as identify baseline care process and outcome clinical care data. If the change involves multiple sites or facilities, then it is necessary to examine practice variation across facilities, and outline strategies for the needs assessment to support a standardized approach across sites. Collecting data from a random sample of stakeholders may be necessary to reduce response bias and decrease chances that the level of need is not over or under-estimated. DPP in the local context (site specific needs) 280 59. Develop a formal implementation blueprint Develop a formal implementation blueprint that includes all goals and strategies. The blueprint should include the following: 1) aim/purpose of the implementation; 2) scope of the change (e.g., what organizational units are affected); 3) timeframe and milestones; and 4) appropriate performance/progress measures. Use and update this plan to guide the implementation effort over time The implementation blueprint or manual may be informed by one or more theories or conceptual frameworks and/or data from pre-implementation needs assessments. This blueprint can also provide a useful historical record of the implementation process, as well as provide a mechanism to track changes over time. The implementation blueprint is often useful to ensure feedback is received from prospective frontline users of the blueprint prior to implementation. Consider coordinating this strategy with the development of a fidelity monitoring tool. Issues to consider separately, especially for research purposes: Plan can include staffing, funding, monitoring. Use of theory or multiple theory. Update the plan overtime. To code this strategy, there must be written evidence that there were products from the planning discussions e.g., Gantt charts, written planning document, blueprint, protocol. 281 • Number and type of implementation strategies • Organizational levels involved—this can vary by type of intervention. It may be possible to do some interventions at the lowest level. Others may require top management. • Pre-implementation assessments would be separate step Other examples of how to create an implementation blueprint include the CDC's Replicating Effective Programs [6, 7]. Examples of projects using a blueprint include: • HI-TIDES [8] • Depression in a substance abusing population [9] 282 Mental health services in federally qualified health centers [10] 283 60. Develop and implement tools for quality monitoring Develop, test, and introduce into quality-monitoring systems the right input—the appropriate language, documents, protocols, algorithms, standards, and measures (of processes, patient/consumer outcomes, and implementation outcomes) that are often specific to the innovation being implemented These tools should be flexible enough to reflect fidelity, even after adaptations to the setting or client. Performance sites can benefit when these tools are available locally, particularly to help clinicians develop a sense of ownership for the change process. Quality monitoring tools can be coordinated with other strategies to encourage or reward performance that is in alignment with the clinical innovation. See Krein et al. [11] for an example of this process. This strategy focuses on data collection tools. Quality monitoring can be related to implementation outcomes (fidelity, adherence) or program outcomes (adherence, recruitment reports). Code if data collection tools specific to quality monitoring. If an article described they did “quality monitoring” without describing WHAT they monitored or HOW, do not code this strategy, instead code develop and organize quality monitoring systems Implement fidelity checklists that frontline staff must complete during the session. 284 61. Develop and organize quality monitoring systems Develop and organize systems and procedures that monitor clinical processes and/or outcomes for the purpose of quality assurance and improvement This includes developing systems for monitoring through peer reviews, collecting data from patients and consumers, clinicians, and supervisors, and using administrative and electronic record data. This category of strategies also includes the design of disease-specific clinical registries, where clinical information and tools (graphical representations, real-time report cards, comparisons with benchmarks, etc.) are available to care team members. These systems may inform audit and feedback strategies. Some intensive fidelity monitoring activities (e.g., psychotherapy recordings) are more practical at random, but not infrequent, intervals. This includes developing systems for monitoring could be at the administrative level, electronic data (database), or disease-specific clinical registries. The monitoring should be continuous. This strategy focuses on the infrastructure or system to collect the data. Development and/or modifications to systems. These systems may inform audit and feedback strategies and may use specific tools for quality monitoring. Code accordingly. If an article described they did “quality monitoring” without describing WHAT they monitored or how, code this strategy but do not code develop and implement tools for quality monitoring. All sessions are audio recorded for fidelity purposes. Every three month a supervisor watches a coach implement the program for fidelity purposes (continuous data collection system) 285 62. Obtain and use patients/consumers and family feedback Develop strategies to increase patient/consumer and family feedback on the implementation effort This can continue throughout the implementation effort. Strategies could include complaint forms, or methods, which funnel feedback to change managers or advisory boards. Consider whether anonymous feedback formats are appropriate. Specific methods to collect participant feedback – survey, complaint form, interviews, focus groups Do not code this strategy for feedback BEFORE program implementation Client feedback Strategy is at client level. If collecting feedback specifically on retention/adherence, consider coding: intervene with patients/consumers to enhance uptake and adherence If obtaining feedback prior to implementation or during design process, consider coding conduct local needs assessment if feedback is at the program level. If feedback is about understanding if there is a need for a program or understanding if diabetes is important to participants, consider Conduct local consensus discussions Client interviews to understand participant feedback on the program. 286 63. Purposely reexamine the implementation Monitor progress and adjust clinical practices and implementation strategies to continuously improve the quality of care It is beneficial to use a concrete schedule for monitoring rather than ‘as needed.’ Time-sensitive benchmarks for determining when adjustments are needed have also been found to be useful. Formal discussions on implementation successes and challenges to make changes to the process/plan as needed. Similar to quality monitoring or audit and feedback strategies, however, broader, may not be data-driven (compared to quality monitoring which requires collection and review of data) – a change may result after a formal or informal discussion. Modifications can be implemented anywhere. Often in the form of meetings. Higher level progress and practice level that might not be caught by quality monitoring. 287 64. Stage implementation scale up Phase implementation efforts by starting with small pilots or demonstration projects and gradually move to a system wide rollout This involves an iterative process that often results in adaptations. Strategies for integrating pilot feedback into the scale-up or spread process should be established in advanced. Depending on the innovation, piloting may also involve phasing in elements or components of the practice change. Many innovations involve more than one service (e.g., inpatient and outpatient; primary care and specialty care), and the scaling-up or spread process may have different needs to address the interactions among services (e.g. needs related to ensure continuity of care while connecting services). For more details see the Institute for Need evidence in the manuscript that the program was/is being built on smaller pilot projects to larger projects. Code this if prior research included a pilot or feasibility study (or in general this program is building from prior research) Only code if a larger study built off of a smaller study. If you are reading a pilot study, do not code this strategy because we don't know if a larger study was informed by it. NHS program started with 4 demonstrator locations. 288 Healthcare Improvement’s white paper, which describes a framework for spread [12]. 289 65. Access new funding Access new or existing money to facilitate the implementation Accessing new funding sources could involve new uses of existing money, accessing block grants, shifting funding from one program to another, cost-sharing, passing new taxes, raising private funds, or applying for grants. These monies may be used to fund the delivery of a clinical innovation, or to support other time limited actions needed for initial implementation, such as to purchase material or logistical support, training, and consultations. This could involve new uses of existing money; applying or winning new grants; shifting funding from one program to another; cost sharing; passing new taxes; or raising private funds; Code this for mention of where funding came from for the project. 290 66. Alter incentive/allowance structures Work to incentivize the adoption and implementation of the clinical innovation (DPP) **Work to incentivize providers or an organization to adopt and implement the DPP Incentives may be based on the performance of individual clinicians or larger performance units at the organizational level. The incentive could be in the form of an increased rate of pay to cover the incremental costs associated with implementing the clinical innovation. The incentive could be through loan reduction or forgiveness to clinicians to learn an innovation. This category of financial strategies also includes the elimination of any perverse incentives that become a barrier to receiving appropriate care. An incentive suggests the payment is tied to performing a clinical action or improving outcomes. An allowance suggests that the clinician or Not at participant level. Incentive at staff level. At organizational level. Do not code if incentives are at the participant level or recruitment level. Rather review: Intervene with patients/consumers to enhance uptake and adherence Incentives are generally financial incentives. Incentives or benefits that result from a mutually beneficial partnership are not be sufficient for this code. Review Develop resource sharing agreements 291 organization is not required to perform the clinical action or meet the performance standard. 292 67. Alterpatient/consumer feesCreate fee structures where patients/consumers pay less for preferred treatments (the clinical innovation - DPP) and more for less-preferred treatments none This strategy makes the program easier for clients to participate (strategy is at client level) Client level. Code if the program is free or a reduced fee. Free program 68. DevelopdisincentivesProvide financial disincentives for failure to implement or use the clinical innovations In addition to direct financial disincentives, this strategy could include tying promotion decisions to the use of certain innovations. Penalize providers financially for failure to implement or use the clinical innovation. Organizational level. If a site onboards to participate in delivering the program but never has a single participant and so the organization fines them. 293 69. Fund and contract for the clinical innovation Governments and other payers of services issue requests for proposals to deliver the innovation, use contracting processes to motivate providers to deliver the clinical innovation, and develop new funding formulas that make it more likely that providers will deliver the innovation none If an organization puts out requests for other organizations to enrol in the DPP and start a new site. Request comes from organization. If the implementation team/organization advocates to and is successful in getting the government or insurance providers to provide coverage for the innovation (DPP) so that the program is available at a reduced rate for participants. Scale-up level within an organization OR specific money from governments or insurance providers to support the innovation. Code this strategy if a program is covered under insurance policies (participants can make claims to their insurance provider for participation). The United States National Diabetes Prevention program has insurance coverage 294 70. Make billing easier Make it easier to bill for the clinical innovation Making billing easier might involve requiring less documentation, ‘block’ funding for delivering the innovation, and creating new billing codes for the innovation. Developing progress note templates to facilitate documentation of the clinical innovation can also decrease the burden for obtaining payment. Less documentation, set of money for the overall implementation (block funding) or new billing codes for the program Billing at organizational level. 71. Place innovation on fee for service lists/formularies Work to place the clinical innovation on lists of actions for which providers can be reimbursed (e.g., a drug is placed on a formulary, a procedure is now reimbursable) none If diabetes prevention program is placed on a list that providers get reimbursed for. At organizational level. 295 72. UsecapitatedpaymentsPay providers or care systems a set amount per patient/consumer for delivering clinical care This is an implementation strategy to the degree that it frees the clinician to provide services that they may have been disincentivized to provide under a fee-for-service structure. This may be helpful to motivate clinicians to use certain clinical innovations. These changes often come about as part of policy changes that alter fee structures, alter coverage, or add items to reimbursement formularies. This is an implementation strategy to the degree that it frees the clinician to provide services that they may have been disincented to provide under a fee-for-service structure. This may be helpful to motivate clinicians to use certain clinical innovations. Payments scheme at organizational level. Payment scheme to motivate clinician to use the program. 296 73. Use other payment schemes Introduce payment approaches (in a catch-all category) Payment scheme approaches may involve prepayment and prospective payment for service, provider salaried service, the alignment of payment rates with the attainment of patient/consumer outcomes, and the removal or alteration of billing limits, such as numbers of encounters that are reimbursable. Payment may also be based on measures of treatment fidelity. Payment schemes are implementation strategies to the degree that they free the clinician’s time to provide the clinical innovation. Other strategies motivate clinicians to provide better service. Pre-payment and prospective payment for service, provider salaried service, the alignment of payment rates with the attainment of patient/consumer outcomes, and the removal or alteration of billing limits (such as numbers of encounters that are reimbursable). These are implementation strategies to the degree that they free the clinician to provide the clinical innovation. Others motivate the clinician to provide better service Payments scheme at organizational level. Code if unsure about payment scheme but manuscript mentions there is one. GrpIDIS_1IS_2IS_3IS_4IS_5IS_6IS_7IS_8IS_9IS_10IS_11IS_12IS_13IS_14IS_15IS_16IS_17IS_18IS_19IS_20IS_21IS_22IS_23141 Yes Yes Yes Yes Yes Yes195 Yes287 Yes Yes467 Yes Yes Yes Yes Yes Yes Yes Yes Yes523 Yes535 Yes Yes Yes604 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes672 Yes Yes Yes Yes Yes Yes Yes696 Yes Yes Yes Yes705 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes821 Yes Yes Yes Yes Yes1137 Yes1147 Yes Yes Yes Yes Yes Yes1160 Yes Yes Yes Yes1589 Yes Yes1616 Yes Yes Yes Yes Yes Yes1659 Yes Yes Yes Yes Yes Yes16821942 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes1959 Yes Yes Yes Yes Yes Yes Yes Yes2129 Yes Yes Yes2152 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes2308 Yes Yes Yes2319 Yes2399 Yes Yes Yes2550 Yes Yes Yes Yes Yes Yes2553 Yes Yes Yes Yes Yes Yes2556 Yes Yes Yes Yes Yes Yes Yes2665 Yes Yes2804 Yes2840 Yes Yes Yes297Appendix F: Additional File 3 from Chapter 5: Implementation Strategies per ProgramGrpIDIS_1IS_2IS_3IS_4IS_5IS_6IS_7IS_8IS_9IS_10IS_11IS_12IS_13IS_14IS_15IS_16IS_17IS_18IS_19IS_20IS_21IS_22IS_232946 Yes Yes Yes Yes Yes2952 Yes2956 Yes Yes Yes Yes Yes Yes Yes Yes Yes3106 Yes Yes3195 Yes3222 Yes Yes3435 Yes Yes Yes3471 Yes Yes Yes Yes Yes Yes Yes34773483 Yes Yes Yes Yes3577 Yes Yes Yes3691 Yes Yes Yes Yes3868 Yes Yes Yes3897 Yes Yes Yes Yes Yes Yes Yes3920 Yes Yes Yes3939 Yes Yes Yes Yes3974 Yes Yes Yes4008 Yes Yes Yes Yes Yes4041 Yes Yes4056 Yes Yes Yes Yes Yes Yes40914235 Yes Yes Yes Yes4239 Yes Yes4311 Yes Yes Yes Yes4343 Yes Yes Yes Yes Yes Yes Yes4381 Yes Yes Yes Yes4445 Yes Yes Yes Yes Yes Yes Yes4711 Yes4793 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes4823 Yes Yes Yes Yes Yes4856 Yes Yes Yes298GrpIDIS_1IS_2IS_3IS_4IS_5IS_6IS_7IS_8IS_9IS_10IS_11IS_12IS_13IS_14IS_15IS_16IS_17IS_18IS_19IS_20IS_21IS_22IS_235011 Yes Yes Yes Yes Yes5058 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes5060 Yes Yes Yes Yes Yes5113 Yes Yes Yes Yes Yes Yes Yes5121 Yes5148 Yes Yes Yes Yes Yes Yes Yes5176 Yes Yes Yes Yes5428 Yes Yes Yes Yes5432 Yes Yes Yes Yes5448 Yes Yes Yes Yes Yes Yes Yes Yes5467 Yes Yes Yes Yes Yes Yes Yes Yes5514 Yes Yes Yes5559 Yes Yes Yes Yes5702 Yes Yes Yes Yes5865 Yes Yes Yes Yes6008 Yes Yes6214 Yes Yes Yes Yes Yes Yes6712 Yes Yes Yes Yes Yes Yes6831 Yes Yes Yes6986 Yes Yes70757132 Yes Yes Yes7166 Yes Yes7264 Yes Yes Yes Yes Yes Yes Yes Yes7286 Yes Yes Yes Yes Yes Yes Yes Yes72917345 Yes Yes Yes7376 Yes Yes7442 Yes Yes Yes Yes7877 Yes Yes Yes Yes7955 Yes Yes Yes7982 Yes Yes Yes299GrpIDIS_24IS_25IS_26IS_27IS_28IS_29IS_30IS_31IS_32IS_33IS_34IS_35IS_36IS_37IS_38IS_39IS_40IS_41IS_42IS_43IS_44141 Yes Yes Yes Yes Yes195 Yes Yes287 Yes467 Yes Yes Yes Yes Yes Yes Yes Yes Yes523 Yes535604 Yes Yes Yes Yes Yes Yes672 Yes Yes Yes Yes Yes Yes Yes Yes Yes696 Yes Yes705 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes821 Yes Yes Yes1137 Yes Yes1147 Yes Yes Yes Yes Yes Yes Yes1160 Yes Yes Yes Yes Yes1589 Yes Yes1616 Yes Yes1659 Yes Yes Yes Yes Yes Yes Yes Yes Yes16821942 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes1959 Yes Yes Yes Yes2129 Yes Yes Yes2152 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes2308 Yes Yes Yes Yes23192399 Yes Yes Yes Yes2550 Yes Yes Yes Yes Yes Yes2553 Yes Yes Yes Yes Yes Yes Yes2556 Yes Yes Yes Yes Yes Yes Yes266528042840 Yes Yes Yes300GrpIDIS_24IS_25IS_26IS_27IS_28IS_29IS_30IS_31IS_32IS_33IS_34IS_35IS_36IS_37IS_38IS_39IS_40IS_41IS_42IS_43IS_442946 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes2952 Yes Yes2956 Yes Yes Yes Yes Yes Yes3106319532223435 Yes3471 Yes Yes Yes Yes Yes Yes Yes3477 Yes Yes Yes Yes Yes Yes Yes3483 Yes Yes Yes Yes3577 Yes Yes Yes3691 Yes3868 Yes Yes Yes3897 Yes Yes Yes Yes Yes Yes Yes Yes Yes3920 Yes Yes3939 Yes Yes Yes Yes Yes3974 Yes Yes Yes4008 Yes Yes Yes Yes Yes Yes4041 Yes Yes Yes4056 Yes Yes Yes409142354239 Yes Yes Yes4311 Yes Yes Yes Yes Yes Yes4343 Yes Yes Yes Yes Yes Yes Yes4381 Yes Yes Yes Yes4445 Yes Yes Yes Yes Yes Yes Yes Yes4711 Yes Yes4793 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes4823 Yes Yes4856301GrpIDIS_24IS_25IS_26IS_27IS_28IS_29IS_30IS_31IS_32IS_33IS_34IS_35IS_36IS_37IS_38IS_39IS_40IS_41IS_42IS_43IS_445011 Yes Yes5058 Yes Yes Yes Yes Yes Yes Yes Yes Yes5060 Yes Yes5113 Yes Yes Yes Yes Yes5121 Yes5148 Yes Yes Yes Yes Yes Yes Yes5176 Yes Yes Yes Yes Yes Yes Yes5428 Yes Yes5432 Yes Yes Yes Yes Yes Yes Yes5448 Yes Yes Yes Yes Yes5467 Yes Yes Yes Yes Yes Yes Yes Yes Yes5514 Yes Yes Yes5559 Yes Yes5702 Yes Yes Yes Yes Yes Yes5865 Yes Yes Yes Yes6008 Yes Yes Yes6214 Yes Yes Yes Yes Yes Yes6712 Yes Yes Yes Yes6831 Yes Yes Yes Yes6986 Yes Yes Yes Yes Yes Yes707571327166 Yes Yes Yes Yes7264 Yes Yes Yes Yes Yes Yes Yes Yes7286 Yes Yes Yes Yes Yes Yes72917345 Yes Yes Yes7376 Yes7442 Yes Yes Yes Yes Yes7877 Yes Yes79557982 Yes Yes302GrpIDIS_45IS_46IS_47IS_48IS_49IS_50IS_51IS_52IS_53IS_54IS_55IS_56IS_57IS_58IS_59IS_60IS_61IS_62IS_63IS_64IS_65141 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes195287 Yes467 Yes Yes Yes Yes Yes Yes Yes523 Yes Yes Yes535 Yes Yes Yes Yes Yes604 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes672 Yes Yes Yes Yes Yes Yes Yes696 Yes Yes Yes705 Yes Yes Yes Yes Yes Yes Yes Yes Yes821 Yes Yes Yes Yes Yes Yes11371147 Yes Yes Yes Yes Yes Yes Yes1160 Yes Yes Yes Yes1589 Yes1616 Yes Yes Yes1659 Yes Yes Yes Yes Yes Yes Yes Yes Yes16821942 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes1959 Yes Yes Yes Yes Yes2129 Yes Yes2152 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes2308 Yes Yes Yes2319 Yes Yes2399 Yes Yes2550 Yes Yes Yes2553 Yes2556 Yes Yes Yes Yes Yes Yes Yes Yes2665 Yes28042840 Yes Yes Yes303GrpIDIS_45IS_46IS_47IS_48IS_49IS_50IS_51IS_52IS_53IS_54IS_55IS_56IS_57IS_58IS_59IS_60IS_61IS_62IS_63IS_64IS_652946 Yes Yes Yes Yes Yes Yes Yes2952 Yes Yes2956 Yes Yes Yes Yes Yes3106 Yes319532223435 Yes Yes3471 Yes Yes Yes Yes Yes3477 Yes Yes Yes Yes Yes3483 Yes Yes Yes Yes Yes3577 Yes Yes Yes Yes Yes3691 Yes Yes3868 Yes3897 Yes Yes Yes Yes Yes Yes Yes Yes3920 Yes Yes Yes Yes3939 Yes Yes Yes3974 Yes Yes Yes4008 Yes Yes Yes Yes Yes Yes4041 Yes Yes4056 Yes Yes Yes40914235 Yes Yes Yes4239 Yes Yes4311 Yes Yes Yes Yes Yes Yes4343 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes4381 Yes Yes Yes Yes4445 Yes Yes Yes Yes Yes Yes Yes Yes4711 Yes4793 Yes Yes Yes Yes Yes Yes4823 Yes Yes Yes Yes Yes4856 Yes Yes304GrpIDIS_45IS_46IS_47IS_48IS_49IS_50IS_51IS_52IS_53IS_54IS_55IS_56IS_57IS_58IS_59IS_60IS_61IS_62IS_63IS_64IS_655011 Yes Yes Yes Yes Yes Yes5058 Yes Yes Yes Yes Yes Yes5060 Yes Yes Yes Yes5113 Yes Yes Yes Yes Yes Yes Yes5121 Yes5148 Yes Yes Yes5176 Yes Yes Yes Yes Yes Yes5428 Yes5432 Yes Yes Yes Yes Yes5448 Yes Yes Yes Yes5467 Yes Yes Yes Yes Yes Yes Yes Yes5514 Yes Yes5559 Yes Yes Yes5702 Yes Yes Yes Yes5865 Yes Yes6008 Yes6214 Yes Yes6712 Yes Yes Yes Yes Yes6831 Yes Yes Yes Yes Yes6986 Yes Yes Yes Yes Yes Yes Yes7075 Yes Yes7132 Yes Yes Yes Yes7166 Yes Yes Yes Yes7264 Yes Yes Yes7286 Yes Yes Yes Yes Yes Yes7291 Yes7345 Yes7376 Yes Yes Yes Yes Yes7442 Yes Yes Yes Yes Yes7877 Yes Yes Yes7955 Yes7982 Yes305GrpIDIS_66IS_67IS_68IS_69IS_70IS_71IS_72IS_73 straclus 1clus 2clus 3clus 4clus 5clus 6clus 7clus 8clus 9zone 1zone 2zone 3zone 4141 Yes Yes 23 5 1 2 8 3 3 1 0 10 5 2 6195 3 0 0 0 1 2 0 0 2 1287 4 1 2 1 0 2 2 0467 Yes 26 6 7 7 2 3 1 14 5 6 1523 Yes 6 1 1 1 3 0 3 2 1535 Yes 9 1 1 2 1 1 0 1 2 4 0 3 2604 Yes 29 10 2 3 5 5 3 1 19 3 4 3672 Yes Yes 25 2 2 2 5 4 3 4 2 1 11 3 8 3696 9 1 1 4 1 1 0 1 5 2 2 0705 Yes Yes Yes Yes Yes 39 6 2 3 8 8 4 5 3 18 6 9 6821 Yes 15 2 0 1 2 1 2 4 2 1 5 2 4 41137 3 0 0 1 2 2 11147 Yes Yes 22 4 1 1 5 7 1 2 1 11 4 5 21160 Yes Yes Yes 16 4 1 3 4 1 3 7 5 2 21589 5 1 0 1 3 0 0 4 1 01616 Yes 12 4 0 1 3 4 0 9 3 0 01659 Yes Yes 26 6 1 1 5 7 2 4 16 3 4 31682 Yes 1 1 0 11942 Yes Yes Yes Yes Yes 41 8 3 11 5 2 5 6 1 19 5 10 71959 Yes 18 5 2 2 2 6 0 1 13 2 3 02129 Yes Yes 10 1 0 0 1 4 1 3 0 3 3 3 12152 Yes 34 8 3 1 7 8 2 3 1 1 20 3 6 52308 Yes 11 1 2 1 2 3 0 2 6 2 1 22319 3 1 1 1 2 12399 9 2 0 1 4 1 1 4 2 2 12550 Yes Yes 17 5 2 3 1 1 2 2 1 9 2 4 22553 Yes Yes 16 3 1 6 1 0 3 1 1 6 3 5 22556 Yes Yes 24 6 1 2 6 5 2 1 1 13 6 3 22665 Yes 4 0 1 1 2 0 1 32804 1 0 0 1 12840 9 4 1 4 0 8 1306#of GrpIDIS_66IS_67IS_68IS_69IS_70IS_71IS_72IS_73clus 1clus 2clus 3clus 4clus 5clus 6clus 7clus 8clus 9zone 1zone 2zone 3zone 42946 22 6 1 2 7 3 3 15 4 1 22952 Yes 6 1 0 1 1 3 2 3 12956 Yes Yes Yes Yes 24 5 1 1 7 8 0 2 13 6 4 13106 3 1 1 1 1 1 13195 1 1 13222 Yes 3 1 1 0 1 1 23435 6 1 1 2 0 2 0 2 2 1 13471 Yes Yes Yes 22 2 3 2 3 5 1 3 1 2 8 4 6 43477 12 3 1 1 3 4 8 1 33483 Yes 14 2 3 0 5 2 1 1 0 4 4 2 43577 11 1 0 1 6 1 2 0 6 2 2 13691 Yes 8 1 3 2 1 1 2 3 33868 Yes 8 1 3 3 1 3 1 2 23897 Yes Yes Yes Yes 28 5 4 2 4 6 2 1 3 1 12 4 8 43920 9 3 0 3 1 2 0 5 2 1 13939 12 1 1 5 2 2 1 4 1 4 33974 Yes Yes 11 2 1 3 2 3 0 6 1 3 14008 17 5 1 2 4 4 1 11 2 1 34041 7 1 5 1 0 3 1 2 14056 Yes Yes Yes Yes 16 1 1 1 3 4 2 1 3 5 2 7 24091 0 0 0 0 04235 Yes 8 3 2 2 1 0 0 6 2 04239 Yes 8 2 3 2 1 0 4 1 34311 Yes Yes 18 3 0 2 7 2 0 3 1 10 3 4 14343 Yes 25 3 1 2 6 3 3 4 2 1 10 2 7 64381 Yes4445 Yes Yes Yes Yes 27 1 2 2 9 7 2 3 1 12 4 7 44711 Yes 5 0 0 1 4 0 3 24793 Yes Yes 30 4 2 1 8 4 3 3 3 2 10 5 10 54823 Yes4856 Yes307stra#of GrpIDIS_66IS_67IS_68IS_69IS_70IS_71IS_72IS_73clus 1clus 2clus 3clus 4clus 5clus 6clus 7clus 8clus 9zone 1zone 2zone 3zone 45011 13 4 0 1 3 2 0 2 1 7 2 2 25058 Yes Yes Yes 29 5 2 6 6 1 3 3 3 13 4 9 35060 Yes 12 1 2 4 4 1 5 2 3 25113 Yes 20 1 6 5 1 4 2 1 7 4 7 25121 Yes 4 1 3 1 2 15148 Yes 18 4 2 2 8 2 11 4 3 05176 Yes 18 3 1 1 7 0 2 4 0 10 1 5 25428 Yes 8 1 1 1 1 1 3 2 5 15432 16 5 1 2 4 2 2 11 1 1 35448 17 4 1 5 3 2 1 1 12 2 35467 Yes Yes Yes Yes 29 3 2 3 4 6 3 4 1 3 13 2 11 35514 Yes Yes 10 0 2 3 1 1 2 1 0 3 1 4 25559 Yes 10 1 1 1 4 1 2 4 1 4 15702 Yes 15 1 1 4 3 4 2 7 2 3 35865 10 1 1 3 1 1 3 0 0 5 2 1 26008 Yes 7 1 4 1 1 5 26214 14 4 0 0 4 1 2 1 2 9 3 26712 Yes 16 1 0 2 1 2 2 3 1 4 3 3 8 26831 Yes Yes 14 2 3 1 4 3 1 6 2 4 26986 Yes 16 4 1 3 3 4 1 9 2 3 27075 2 1 1 0 0 0 0 2 0 0 07132 Yes 8 1 0 3 1 0 2 1 0 3 1 2 27166 Yes 11 1 0 1 3 4 2 4 1 4 27264 Yes 20 5 1 1 6 5 1 1 14 2 3 17286 Yes 21 5 1 4 4 3 3 1 11 3 6 17291 1 1 0 0 0 1 0 07345 7 3 1 2 0 1 5 1 17376 Yes 9 5 0 2 1 0 1 7 1 1 07442 Yes 15 4 2 2 6 1 12 1 27877 Yes 10 2 0 1 6 1 0 0 0 6 3 1 07955 4 0 1 1 1 1 1 1 27982 Yes 7 0 2 1 1 2 1 1 1 5 0308stra#of
Thesis/Dissertation
eng
Health and Exercise Sciences
Vancouver : University of British Columbia Library
Attribution-NonCommercial-NoDerivatives 4.0 International
Graduate
Jung, Mary E.
Bean, Corliss
Examining the implementation of diabetes prevention programs in the community
Text