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HealtheSteps™ Study Protocol: a pragmatic randomized controlled trial promoting active living and healthy… Gill, Dawn P; Blunt, Wendy; Bartol, Cassandra; Pulford, Roseanne W.; De Cruz, Ashleigh; Simmavong, P. K; Gavarkovs, Adam; Newhouse, Ian; Pearson, Erin; Ostenfeldt, Bayley; Law, Barbi; Karvinen, Kristina; Moffit, Pertice; Jones, Gareth; Watson, Cori; Zou, Guangyong; Petrella, Robert J Feb 7, 2017

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STUDY PROTOCOL Open AccessHealtheSteps™ Study Protocol: a pragmaticrandomized controlled trial promotingactive living and healthy lifestyles in at-riskCanadian adults delivered in primary careand community-based clinicsDawn P. Gill1,2,3, Wendy Blunt1,2, Cassandra Bartol1,2, Roseanne W. Pulford1,2, Ashleigh De Cruz1,2,P. Karen Simmavong1,2, Adam Gavarkovs1,2,4, Ian Newhouse5, Erin Pearson5, Bayley Ostenfeldt6, Barbi Law7,Kristina Karvinen7, Pertice Moffit8, Gareth Jones9, Cori Watson10, Guangyong Zou11,12 and Robert J. Petrella1,2,13*AbstractBackground: Physical inactivity is one of the leading causes of chronic disease in Canadian adults. With lessthan 50% of Canadian adults reaching the recommended amount of daily physical activity, there is anurgent need for effective programs targeting this risk factor. HealtheSteps™ is a healthy lifestyle prescriptionprogram, developed from an extensive research base to address risk factors for chronic disease such asphysical inactivity, sedentary behaviour and poor eating habits. HealtheSteps™ participants are provided within-person lifestyle coaching and access to eHealth technologies delivered in community-based primary careclinics and health care organizations.Method/Design: To determine the effectiveness of Healthesteps™, we will conduct a 6-month pragmaticrandomized controlled trial with integrated process and economic evaluations of HealtheSteps™ in 5 clinicsettings in Southwestern Ontario. 110 participants will be individually randomized (1:1; stratified by site) toeither the intervention (HealtheSteps™ program) or comparator (Wait-list control). There are 3 phases of theHealtheSteps™ program, lasting 6 months each. The active phase consists of bi-monthly in-person coachingwith access to a full suite of eHealth technology supports. During the maintenance phase I, the in-personcoaching will be removed, but participants will still have access to the full suite of eHealth technologysupports. In the final stage, maintenance phase II, access to the full suite of eHealth technology supportsis removed and participants only have access to publicly available resources and tools.(Continued on next page)* Correspondence: petrella@uwo.ca1Centre for Studies in Family Medicine, Department of Family Medicine,Western Centre for Public Health and Family Medicine, 2nd Floor, SchulichSchool of Medicine and Dentistry, Western University, 1465 Richmond St.,London, ON N6G 2M1, Canada2Lawson Health Research Institute, London, Ontario, CanadaFull list of author information is available at the end of the article© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Gill et al. BMC Public Health  (2017) 17:173 DOI 10.1186/s12889-017-4047-8(Continued from previous page)Discussion: This trial aims to determine the effectiveness of the program in increasing physical activity levelsand improving other health behaviours and indicators, the acceptability of the HealtheSteps™ program, andthe direct cost for each person participating in the program as well as the costs associated with deliveringthe program at the different community sites. These results will inform future optimization and scaling up ofthe program into additional community-based primary care sites.Trial registration: NCT02413385 (Clinicaltrials.gov). Date Registered: April 6, 2015.Keywords: Physical activity, Sedentary behaviour, Healthy eating, Primary care intervention, Chronic diseaseprevention and management, Health technology, Behaviour change, Lifestyle coachingBackgroundPhysical activity (PA) is one of the most modifiable riskfactors for preventing chronic disease, yet less than 50%of Canadian adults are considered physically active [1, 2]and only a third of adults meet the recommendation of10,000 steps per day [3]. The high level of physical in-activity combined with a poor diet amongst adults hasled to higher rates of chronic disease, such as obesity,type 2 diabetes, cardiovascular disease, hypertension,cancer, osteoporosis, depression, and premature death[1–6]. Furthermore, the cost of physical inactivity inCanada is estimated at $6.8 billion per year, representingapproximately 3.7% of all direct and indirect governmentspending [1, 7]. Fortunately, modest increases in levelsof PA can reduce this spending by $2.6 billion over thenext 25 years, making low-cost and effective healthylifestyle interventions that target physical activity animportant public health and economic priority in Canada[2, 7–9]. Living a physically active lifestyle providesnumerous health benefits, including protection fromchronic diseases and improved quality of life [1]. In fact,being physically active is associated with a greater than50% reduction in risk for premature death, and even smallimprovements in physical fitness can significantly reduceone’s risk for chronic disease [1].Research shows that many chronic diseases can beprevented by decreasing four main behavioural riskfactors: physical inactivity, poor nutrition, smokingand alcohol consumption [5, 10]. Public health orga-nizations have worked to develop many resources toaddress these risk factors; however, previous researchhas noted that those who are the most physically in-active are not aware of these resources [11] or maybe unsure of how to use this information to make achange. While research interventions promoting PAand healthy eating in controlled settings have shownunequivocal results in reducing chronic disease riskunder certain conditions, effective methods for imple-menting this evidence into everyday primary carepractice requires further exploration [12–15]. This isparticularly true for rural and remote regions inCanada where increased rurality leads to an increasedrisk for chronic disease and also limited access tocost-effective, evidence-based, chronic disease preven-tion programs and tools [16, 17].The HealtheSteps™ program was developed in re-sponse to the literature demonstrating the effectivenessof primary care-based chronic disease prevention pro-grams [18], consultations with stakeholders and expertsacross Canada (including targeted discussions withknowledge users), and the need for such programs espe-cially in rural and remote areas [19]. The HealtheSteps™program was developed from an extensive research base[18, 20–27]; draws on evidence from diverse areas in-cluding PA, nutrition, behaviour change, and knowledgetranslation; and has been refined by our experienceimplementing the program in diverse community set-tings including Family Health Teams, CommunityHealth Centres, health clubs, and workplaces.The HealtheSteps™ program provides individualswith a specific plan of action to improve their PAlevels, healthy eating habits, and reduce their seden-tary behaviour. This is achieved through personalizedcoaching, grounded in the principles of MotivationalInterviewing [28] and Co-Active coaching [29], andsupported by innovative health services technologies,hands-on training, and widely available health promo-tion resources and tools. A distinct advantage ofHealtheSteps™ is the pragmatic nature of the programand ability to work within the existing workflow of anorganization. While certain elements of the programmust be conducted exactly as designed to follow theevidence-based protocols, other aspects are flexible.For example, the program may be conducted in-person insmall groups or one-on-one; it can be run in a variety ofprimary care based settings; and it can be integrated withother existing programs.MethodsStudy aims1. To conduct an outcome evaluation to determineeffectiveness of the HealtheSteps™ program inhelping at-risk individuals increase PA levels (i.e.,Gill et al. BMC Public Health  (2017) 17:173 Page 2 of 12average number of steps per day), improve eatinghabits, and improve other health behaviours andhealth indicators.2. To conduct a process evaluation to determineacceptability of the intervention, to informprogram improvement and optimization.3. To conduct an economic evaluation to determinethe direct cost associated with delivering theHealtheSteps™ program at different community sites,and the average cost per participant involved in theHealtheSteps™ program.Study designA 6-month, two-arm, pilot, pragmatic, randomizedcontrolled trial (RCT) with integrated process andeconomic evaluations will be conducted within fiveclinic/health care organization settings in both urbanand rural communities in Southwestern Ontario.Participants will be individually randomized (1:1,stratified by site [three sites in London, one site inForest, and one site in Tillsonburg, Ontario Canada])to either the intervention (HealtheSteps™) or the com-parator (Wait-list control). Participants in both groupswill complete measurement sessions at baseline and6 months; participants in the intervention group willcomplete additional measurements at 12 and 18 months.Participants in the comparator group will be giventhe opportunity to start the HealtheSteps™ programafter a 6-month delay. See Fig. 1 for study flowdiagram.Study recruitment will begin in May 2015 at the 5clinic sites, with the intervention starting in June2015. Western University Health Sciences ResearchEthics Board approved this study and all partici-pants will provide written informed consent. Thepragmatic RCT portion of this study was registeredon April 6, 2015 with ClinicalTrials.gov (identifier:NCT02413385).Recruitment of study sites & coach trainingThis trial was designed to recruit primary care sitesand/or health service organizations as they providegreater opportunities to recruit participants at risk ordiagnosed with a chronic disease. We will solicitinterest from primary care community sites for par-ticipation in the trial by contacting primary care leadsin target communities where they had not beenpreviously exposed to the HealtheSteps™ program.Sites will be recruited opportunistically through con-nections with the research team. A variety of stafffrom each site will be recruited for training to becoaches in the program. Meetings with sites willoccur with the central research team to ensure thecoaches are trained in the program protocol andunderstand the commitment required (space, coachingstaff, and timelines). HealtheSteps™ coaches will betrained by the central research team or via eLearningmodules available through the HealtheSteps™ website[30]. In order to keep the trial highly pragmatic,coaching sessions and measurement sessions willoccur at the sites.Sample sizeWe set a recruitment target of 110 participants. Bakerand colleagues [31] conducted a 12-week RCT of apedometer-based walking program plus PA consult-ation in 80 community-dwelling Scottish adults [mean(SD) age: 49.2 ± 8.8 years; 79% women] who were notmeeting current PA recommendations (20% with-drawal rate by 12 weeks). After 12 weeks, this studyreported a difference between intervention and con-trol groups in mean change of 3021 steps per day –favouring the intervention group. Using a pooledstandard deviation of 3498 steps per day results aCohen’s d effect size of 0.86. In order to be conserva-tive, we reduced the effect size to 0.65, a moderate tolarge effect size. Thus, with 38 participants per group,our study would have 80% power at a 0.05 two-sidedsignificance level to detect an effect size of 0.65 [32].We estimate a dropout rate of 30% over the 6-month period, which will increase our target to 110participants (55 participants per group). Since wehave 5 sites who expressed interest in taking part inthis study, we propose that each site will need toenroll 22 participants (i.e., 11 participants per groupper site).Participant recruitment & enrollmentParticipants will be recruited at the sites throughposter advertisements, word of mouth, health careprovider referrals, staff e-mails, and in-person recruit-ment booths. Those interested in participating will becontacted by the central research team and asked toattend an in-person screening session. At this sessionthey will be screened for eligibility and if deemedeligible will take part in baseline measurements.Randomization will occur after baseline assessments.All individuals who contact a study site will be askedto report where they heard about the program. Partic-ipants who are ineligible and those who choose notto enroll in the study after initial contact will betracked, along with reasons for ineligibility/not enrol-ling. Acceptability of randomization will be estimatedfrom the percentage of participants who adhered totheir allocation assignment (i.e., attend program ses-sions if allocated to the intervention group) and/or at-tend measurement sessions. Participation in the follow-upmeasurement sessions will be used to assess retentionGill et al. BMC Public Health  (2017) 17:173 Page 3 of 12throughout the trial. Attendance at program sessions willbe obtained from coach’s logs and will be used to assessadherence to the program.Inclusion criteriaIndividuals 18–85 years of age; one or more self-reported or measured risk factors for chronic diseaseincluding: body-mass index (BMI) greater than 25 kg/m2;less than 150 min of exercise per week; 3 or more hourssitting per day; consuming less than 8 fruit and vege-table servings per day; diagnosis of metabolic syn-drome or type 2 diabetes; and clearance to participate inPA via the Physical Activity Readiness-Questionnaire(PAR-Q) or a health care provider.Exclusion criteriaIndividuals who are unable to comprehend the letter ofinformation and consent documentation.Randomization and allocationFollowing the baseline measurement, participants ateach site will be individually allocated to either theintervention (HealtheSteps™ program) or comparator(Wait-list control). The randomization sequence (1:1,stratified by site) will be computer-generated andconducted by a member of the research team who willnot be involved in allocation. Following allocation, allparticipants (intervention and comparator groups) willreceive Eating Well with Canada’s Food Guide [33] andthe Canadian Physical Activity Guidelines for Adults [34].Fig. 1 HealtheSteps Flow DiagramGill et al. BMC Public Health  (2017) 17:173 Page 4 of 12Adverse eventsParticipants will be given information at baseline onreporting adverse events to the central research teamthroughout their participation in the study. Adverseevents are described as any injury or newly diagnosedhealth condition (i.e., high blood pressure, diabetes) thatoccurs while a participant is enrolled in the HealtheSteps™study, whether or not it is related to their participation inthe HealtheSteps™ program. At each coaching session, par-ticipants in both the intervention and comparator groupswill be asked about any adverse events they may have ex-perienced while they were enrolled in the HealtheSteps™study, and whether it was related to their participation inthe program. The adverse events will be reviewed by thelead study physician and if necessary, refer participants forappropriate event follow-up. The outcome of adverseevents will be followed until the end of the study.Intervention group: HealtheSteps™ ProgramThere are three phases to the intervention: an active phasethat encompasses the first six months, a maintenancephase I for the next six months, and finally a maintenancephase II, which is the last six months of the trial.Active phase (months 0–6)Participants assigned to the intervention group will startthe HealtheSteps™ program within three weeks of complet-ing their baseline measurement session. Participants willreceive a handbook that contains documents to help themtrack their progress throughout the program and will begiven a pedometer to use to track their PA. The researchteam chose to utilize pedometers to measure step counts asthey are inexpensive, easy to use, and easily interpreted bythe participant and research team [35]. In total, participantswill receive four bi-monthly in-person coaching sessions(occurring at months 0, 2, 4, and 6) with a HealtheSteps™coach who will be trained on how to create an action planwith the participant to help them work towards achievingtheir lifestyle prescriptions. Strategies for setting lifestyleprescriptions are based on S.M.A.R.T. goal setting princi-ples (specific, measurable, attainable, realistic, and timelyfor the participant), as goal setting has been found toproduce positive behaviour change in adults [36]. Thelifestyle prescriptions and supports are as follows:1) Exercise Prescription: The exercise prescriptionfocuses on making incremental changes in theamount of time the participant engages in moderateto vigorous activity or the amount of time theyexercise within their target heart rate zone, up tothe recommended 150 min/week. At each programsession, participants will complete a sub-maximalfitness test, the Step Test and Exercise Prescriptiontool (STEP™ Test) [37]. Based on their fitness scorefrom this test (i.e., predicted maximal oxygen uptake,VO2max), participants will receive an exercise prescrip-tion with a personalized target heart rate (65–85% ofestimated maximum heart rate) for exercise. Coacheswill then encourage participants to exercise at theirtraining heart rate and/or at a rating of 5–8 on the10-point modified Borg Rating of Perceived Exertionscale during aerobic activities [38]. The HealtheSteps™coach will collaborate with the participant to set aweekly target of exercise minutes that includesfrequency, duration, and type of exercise to facilitateachievement of their exercise prescription.2) Physical Activity Prescription: The PA prescriptionfocuses on making incremental changes to theparticipants’ daily step count to reach therecommended 10,000 steps per day. This requiressetting a baseline step count, which for coachingsession 1 will be the participants’ step count recordedduring the baseline measurement session. For sessions2 to 4, the prescription will be based on steps loggedin the participants’ handbook completed betweensessions. If the participant did not track their stepcounts between coaching sessions, the coach andparticipant will work together to develop a reasonabletarget step count to set a new PA prescription.3) Healthy Eating Prescription: Using Eating Well withCanada’s Food Guide, participants will work withtheir coach to determine their current daily intakefrom each food group, their water intake, andconsumption of a healthy balanced breakfast.The healthy eating goal is set through increasingor decreasing a serving in one of the food groups tobetter meet the recommendations (i.e., increasingone serving of vegetables and fruit or decreasing aserving of meats and alternatives), increasing waterintake and increasing the number of days theparticipant consumes a healthy balanced breakfast.4) Access to the HealtheSteps™ eHealth TechnologySuite: Tyze Personal Networks [39] and Sykes [40]phone coaching will provide participants withsupport in between coaching sessions and will beavailable during the maintenance phase I until the12 month assessments are complete. Tyze PersonalNetworks is a web-based platform that providesan exclusive network for connecting with centralresearch staff, coaches, and other participants throughprivate chat services and posting information on aCareWall (similar to a Facebook wall). Sykes providesphone coaching services to support participantsin-between coaching sessions and during maintenancephase I. Sykes CareCoaches® are trained in theHealtheSteps™ protocol and act similarly to theHealtheSteps™ coach, working with participants toaddress any challenges they may be experiencingGill et al. BMC Public Health  (2017) 17:173 Page 5 of 12and providing encouragement for them to meettheir goals.Participants will be encouraged to seek out publiclyavailable healthy living supports, such as theHealtheSteps™ website (http://healthesteps.ca/) forhealthy living resources and the HealtheSteps™ andeaTracker smartphone apps. The HealtheSteps™ app(available for free download on Apple and Androiddevices) has a built-in fitness test and heart ratemonitor. Additionally, through the help of a virtualcoach, the app provides personalized prescriptions,goals, and tracking options to help participantsmaintain their goals developed with their in-personcoach. The eaTracker allows participants to monitorfood and activity choices, analyze recipes, and createmeal plans. These publicly available supports areavailable to participants throughout the active andmaintenance phases as well as beyond the trial period.Between coaching sessions, participants will be ex-pected to self-direct their healthy living activities, usinghealthy living resources (Eating Well with Canada’s FoodGuide and Canadian Physical Activity Guidelines) andeHealth technology support options.Maintenance phase I (months 6–12)Participants will no longer have in-person coaching ses-sions, but will have access to the full suite of eHealthtechnology support tools.Maintenance phase II (months 12–18)Participants will no longer have access to the onlineTyze Personal Networks, and Sykes phone coaching ser-vices, but will still have access to the publicly availableresources, including the HealtheSteps™ and eaTrackerSmartphone apps, and the HealtheSteps™ website.Comparator group (wait-list control)This group will continue with usual activities without inter-vention from the study team for the first 6-month period.After the 6 month measurement sessions are completed,participants allocated to this group will be given the oppor-tunity to start the 6-month HealtheSteps™ program.Data collectionOutcome evaluationThe outcome measures will be taken at baseline and6 months in both groups, and then again at 12 and18 months in the intervention group only (see Table 1).Home visits will be conducted when participants are un-able to attend follow-up measurement sessions at thesites to increase participant retention throughout thelong-term follow-up. Data sources will include self-reported PA, participant demographics, clinical measures,and the completion of health related information andquestionnaires (See Table 2).1) Average steps per day, measured using YamaxDigiwalker SW-200 pedometers and self-reported byparticipants using a 7-day paper log [41, 42] (at least3 days of logging required).2) Total physical activity (Metabolic Equivalent (MET)-minutes/week) measured using the InternationalPhysical Activity Questionnaire (IPAQ) Short Form[43]; and time spent in sedentary activity (minutesspent sitting on a typical week day) measured withthe IPAQ.3) Objectively-measured clinical characteristics: weight(using Tanita HD 351 Digital Weight Scale; kg and% of baseline weight), Body Mass Index (BMI,calculated from weight and height in kg/m2), waistcircumference (cm) [44], and resting systolic bloodpressure (BP) and diastolic BP (using BP Tru BPM-100; mmHg).4) Self-reported eating: healthful eating score,measured using Starting the Conversation (STC)questionnaire [45]; fatty food score, sugary foodscore, as well as fruit and vegetable consumption,measured using a modified version of the DietaryInstrument for Nutrition Education (DINE) [46]and following scoring outlined by Hunt andcolleagues [47].5) Self-rated health measured using the EuropeanQuality of Life – 5 Dimensions – 3 Levels (EQ-5D-3 L) visual analog scale (VAS) score [48, 49].Process evaluationData collection for the process evaluation will also becollected during baseline, 6, 12, and 18 month meas-urement sessions (see Table 3). Information abouthow participants heard about the program, demo-graphic information, interviews with coaches, partici-pants and program non-completers, questionnairescompleted by participants, and participant complianceand retention will inform the acceptability of theintervention.At screening and baseline, participants will be askedhow they heard about the study and demographic infor-mation will be taken.At 6 months, participants who completed theHealtheSteps™ program will be asked to complete anInterviewer-Guided Program Feedback Questionnaire; inorder to capture all relevant information about the pro-gram, participants will be guided through the feedbackforms by a trained interviewer, in-person or by phone.Participants will be asked about how useful they founddifferent program components, benefits they may haveexperienced through the program, helpful methods forGill et al. BMC Public Health  (2017) 17:173 Page 6 of 12keeping on track with their healthy lifestyle goals, bar-riers and challenges in maintaining their goals, and ex-perience using the eHealth technology suite.HealtheSteps™ coaches will have the opportunity toexpress their thoughts on delivering the HealtheSteps™program through an interview conducted by a trainedinterviewer in-person or through the phone. Inter-views will be kept anonymous with questions explor-ing their experience delivering the HealtheSteps™program to participants, preparedness for programdelivery, effectiveness of different program compo-nents and suggestions to improve the different pro-gram components. Prior to these interviews, coacheswill be asked to read through a letter of informationand sign a consent form allowing the interviewerto audio record the interview for more thoroughanalysis.Participants who are enrolled in the study but do notcomplete any coaching sessions or complete only onecoaching session, half of the coaching sessions or do notattend sessions 3 or 4, will be defined as non-completers. Program non-completers will be askedin-person or via phone, a series of questions about whythey joined the HealtheSteps™ program, barriers forparticipating in the program, and changes they may havemade during their enrollment in the program.All data sources at 6 months will be kept anonymousin order to encourage open and honest answers andprevent bias during the data analysis stage.At 12 months, participants will be asked to completea 12-month Program Questionnaire detailing what theyhave been able to maintain throughout maintenanceperiod I, and whether they used the eHealth technologysupport tools. Participants will also be asked toTable 1 Screening and measurement sessions scheduleMeasurement Screening Baseline 6-month 12-month (InterventionGroup only)18-month (InterventionGroup only)Screening & Eligibility MeasuresParticipant Self-Reports at Screening XPre-Randomization ID # XLetter of Information & Consent Form X XPAR-Q XHealth Care Provider Clearance Form XEligibility Form XGroup Allocation XaParticipant ID# XaBaseline Health InformationDemographics & Health Related Information XClinical MeasuresAge X XbHeight X Xb Xb Xb XbWeight X Xb X X XBody Mass Index X Xb X X XWaist Circumference X X X XBlood Pressure X X X XSelf-Reported Physical ActivityAverage Steps/day (Step Count Outcome Tracking Form) X X X XInternational Physical Activity Questionnaire X X X XSelf-Reported EatingModified DINE X X X XStarting the Conversation X X X XHealth-Related Quality of LifeEQ-5D-3 L X X X XaOccurs at Randomization & Allocation SessionbUse number recorded at Screening SessionGill et al. BMC Public Health  (2017) 17:173 Page 7 of 12Table 2 Data collection & measurement protocolOutcome Measure Equipment required ProtocolSelf-Reported Physical ActivityAverage steps/day Pedometer (Yamax Digiwalker SW-200 withsecurity strap)• Participants wear pedometers during wakinghours for a 7-day period (putting pedometeron upon waking and removing immediatelybefore sleeping), but not during showering/bathing• Participants are asked to wear the pedometer atthe waist, centered over their most dominant foot• Participants record the number of steps completedeach day on a paper-based tracking formTotal physical activity (MET-min/weeka) International Physical Activity Questionnaire(IPAQ) – Short Form [43]• Self-completed paper‐based questionnaire• Participants recall information on vigorous activities,moderate activities, walking, and sitting• Sedentary time is measured with a single question(minutes spent sitting on a typical week day)• The IPAQ provides guidelines for data processingand score creationTime spent in sedentary activity (min/day)Clinical MeasurementsWeight (kg and percentage of baselineweight)Digital Weight Scale (Tanita HD 351) • Light clothing, no shoes and empty pockets• Blinded assessor post-baseline in private areaBody mass index (kg/m2) Digital weight scale (Tanita HD‐351)Portable stadiometer (seca 213)• BMI calculated using the participant’s objectivelymeasured height and weight• Height measured without shoesWaist circumference (cm) Tape measure • Follows protocol outlined by the Heart andStroke Foundation of Canada [44]• Two measurements taken to record an average; ifmeasurements differ by more than 5 mm, a thirdmeasurement is taken and used in the averageSystolic Blood Pressure (mmHg) Digital BP monitor (BP Tru BPM-100) • Participants sit quietly for 5 min prior to thefirst measurement; 3 measurements will be taken,2 min apart. The first one is discarded, and theaverage of the last two is recorded.• Feet flat on the floor, arm free of clothing, cuff atthe level of heart and arm resting, same arm used(left arm preferred), no talkingDiastolic Blood Pressure (mmHg)Self-Reported EatingFatty Food Score Modified version of the Dietary Instrumentfor Nutrition Education (DINE) [46]• Self-completed paper-based questionnaire• Participants recall eating habits over the last 7 days• Methods published by FFIT will be followed tocalculate a fatty food score (possible range 8–68)and sugary food score (possible range 3–16),with higher scores indicative of higherconsumption• Fruit and vegetable consumption is measuredwith a single questionSugary Food ScoreFruit and vegetable consumptionTotal healthful eating score Starting the Conversation [45] • Self-completed paper-based questionnaire• Designed for dietary assessment and interventionin a clinical setting• Participants recall eating habits over the pastfew months (on average) on 8 different items• A total healthful eating score (possible range 0–16)is calculated, whereby a lower score indicates amore healthful dietHealth-Related Quality of LifeSelf-Rated Health [visual analog scale(VAS) score]European Quality of Life 5 DimensionsQuestionnaire- 3 Level Version (EQ‐5D- 3 L) [48]• Self-completed paper-based questionnaire• For purposes of this study, the VAS score willbe used to assess current state of health on ascale from 0 (worst imaginable state of health)to 100 (best imaginable state of health)aMETs (metabolic equivalents) are multiples of the resting metabolic rate; MET-minute =multiplying the MET score of an activity by the minutes performedGill et al. BMC Public Health  (2017) 17:173 Page 8 of 12participate in an interview exploring their experiencemaintaining their health behaviour changes 6 monthsafter the active phase. Questions will explore theiroverall experience with the program; their experiencemaintaining the changes in exercise, PA levels, andeating habits; the eHealth technology support tools; andimpact their participation in the program may have hadon friends and family.At 18 months, participants will be asked to completea final questionnaire about their experience maintaininghealthy lifestyle changes one year after completion of theactive phase. Questions will also focus on supportsystems they may have used to maintain their lifestylechanges as Tyze Personal Networks and Sykes PhoneCoaching supports ended at 12 months.Data analysesOutcome evaluation – statistical (quantitative) analysisThe primary outcome will be the difference between theintervention and comparator groups in mean steps perday at 6 months. For all secondary outcomes, we willalso examine differences between intervention andcomparator groups in mean change at 6 months. Theadditional follow-up data collected from HealtheSteps™group will allow us to evaluate: i) feasibility of retainingindividuals for an extra 6 and 12 months (to inform alarger study); and ii) within group change to 12 and18 months to determine the sustainability of any positivechanges (in health behaviours and health indicators)observed following the active phase.We will analyze data based on an intent-to-treatapproach; thus, we will include all participants with atleast valid baseline data according to the randomizationscheme. We will analyze data using linear or generalizedlinear mixed models for repeated measurements and wewill retain the baseline outcome as part of the outcomevector and constrain the group means as equal becauseof randomization [50]. This approach is equivalent toanalysis of covariance approach, but has the advantageof including subjects with missing data [51]. For allmodels, we will examine differences between groups at6 months and changes within groups from baseline to6 months (and to 12 months and 18 months for theintervention group). Terms included in models will in-clude time, treatment (group) × time, age and site. Timewill be modeled categorically with indicator variables(with baseline as the reference category). Residuals frommodels will be examined and subject to assumptionschecks.To address participant dropout, we will also comparebaseline characteristics of participants who dropped outversus participants who were included in the analysis.Interpretation of study results will primarily be based onestimation and associated 95% confidence intervals [50].Confidence intervals for differences excluding zero ortwo-sided p-values less than 0.05 will be reported asstatistically significant. Analyses will be performed usingSAS version 9.4 (SAS Statistical Analysis Software).Process evaluation – qualitative analysisQualitative data sources will include the Interviewer-Guided Participant Feedback Questionnaires and coachinterviews collected at the 6 month assessments and theparticipant interviews collected at the 12 month assess-ments. Due to the high volume of participant interviewsat 12 months, a representative sample (maximumvariation based on participant baseline demographics andclinical measures) of interviews from each site will beselected for transcription and analysis; these data sourceswill be analyzed separately by members of the researchteam whom will not be involved in direct programdelivery. An inductive content analysis will be performed.The research team will read through all of the transcriptsand identify common themes and exemplar quotes thatTable 3 Data sources to address process measuresProcess measures Data sourcesProgram Reach Participant Screening andBaseline Demographics12-Month Participant ProgramQuestionnaire12-Month Participant InterviewReasons Participants Stayed With/OptedOut of the ProgramInterviewer-Guided ParticipantFeedback QuestionnairesProgram Compliance RecordsNon-Completer TelephoneInterviews12-Month Participant ProgramQuestionnaire12-Month Participant InterviewExtent to which Coaches DeliveredHealtheSteps as DesignedCoach InterviewsParticipants’ Experience Taking Part inHealtheStepsInterviewer-Guided ParticipantFeedback Questionnaires12-Month Participant ProgramQuestionnaire12-Month Participant Interview18-Month Participant ProgramQuestionnaireCoaches’ Experience of DeliveringHealtheStepsCoach InterviewsParticipants’ Experience MaintainingLifestyle Changes12-Month Participant ProgramQuestionnaire12-Month Participant Interview18-Month Participant ProgramQuestionnaireGill et al. BMC Public Health  (2017) 17:173 Page 9 of 12represent this theme; following a group discussion, a finallist of overarching themes will be created. The findingsfrom the Interviewer-Guided Participant FeedbackQuestionnaires, and coach and participant interviews willbe triangulated to produce a detailed description of theparticipants’ experience with the HealtheSteps™ program,the coaches’ experience delivering the program, and theparticipants’ experience maintaining their changes. This willinform future optimization of the HealtheSteps™ program.Economic evaluationThe economic evaluation will be conducted by the Centrefor exceLlence in Economic Analysis Research (CLEAR)Team. The primary analysis will consist of calculating thetotal cost of the HealtheSteps™ program. Total costs will becalculated by summing all item costs, regardless of site,study group, payer perspective, component, and timeperiod. Total cost will then be broken down for each studygroup and site. Secondary analysis involves calculating theaverage cost per person of the HealtheSteps™ program. Theaverage cost per person will be calculated by dividing thetotal cost of the HealtheSteps™ program by the number ofparticipants at each site. Given that participants differ bysite, per person cost will be presented by site and by studygroup (intervention vs. comparator). Accordingly, total costof the program will be broken down for each study groupand site, and subsequently by component, payer perspec-tive, and time period. The same process will be used tocalculate the average cost of the HealtheSteps™ programper participant. The final analysis stage will estimate thetotal and average per person cost to implement theHealtheSteps™ program at a new site. Total costs will becalculated by summing all item costs that contributed tothe implementation of the HealtheSteps™ program at a newsite. The average cost per person will be calculated bydividing the total cost of the HealtheSteps™ program by thenumber of assumed participants and coaches (a participantto coach ratio of 15:1) at this hypothetical site. Boththe total and average per person cost will also becategorized by component costs (i.e., personnel, suppliesand miscellaneous, and supports and technology).DiscussionLiving a physically active lifestyle along with consuminga healthier diet and reducing tobacco intake can prevent80% of chronic diseases, such as heart disease, stroke,and type 2 diabetes, and 40% of cancer cases [10]. Themajority of Canadian adults continue to spend a signifi-cant amount of their waking hours being physicallyinactive and only 39.5% indicate that they consume 5 ormore fruits and vegetables per day [3, 52]. The generalpopulation is not aware of the PA and exercise guide-lines [53], and how to use Eating Healthy with Canada’sFood Guide to make healthy eating choices [54].Therefore, interventions that promote healthy lifestylesneed to include educational resources and guidance toensure people are aware of these guidelines and how touse this knowledge to reduce their risk for chronic disease.HealtheSteps™ is a lifestyle program developed from anextensive research base and designed to provide partici-pants with action specific goals and strategies to increasetheir PA and exercise levels, and encourage healthy eatinghabits, within the confines of their primary health carespace. HealtheSteps™ engages participants through mul-tiple avenues, including using technology and phonesupports to provide participants with the tools needed tomake and maintain a healthy lifestyle. In this study we aimto determine the effectiveness of the HealtheSteps™ pro-gram in helping at-risk individuals increase PA and exer-cise levels, and improve eating habits. This study also aimsto determine the acceptability of the program to informfuture optimization. Lastly, this study aims to determinethe direct cost per participant involved in the program,and the cost to the community or site running theprogram. If the results are promising, our next step will beto further scale-up the program into rural and remotecommunities focusing on delivery in primary care, work-place wellness, and community-based facilities.AbbreviationsBMI: Body Mass Index; BP: Blood pressure; DINE: Dietary Instrument forNutrition Education; EQ-5D-3 L: European Quality of Life – 5 Dimensions – 3Level; IPAQ: International Physical Activity Questionnaire; MET: MetabolicEquivalent; PA: Physical activity; PAR-Q: Physical Activity ReadinessQuestionnaire; pRCT: Pragmatic Randomized Controlled Trial; STC: Startingthe Conversation; STEP: Step Test and Exercise Prescription; VAS: Visualanalog scale.AcknowledgementsWe would like to thank those involved in coaching and measurementsessions: Beth Munro, Rebecca Brown, Abby Malott, Ashley Aker, Andy Alway,Leah Willemse Julie Potts, Kandis Tieman, Rebecca Everaert, Narlon CassioBoa Sorte Silva, Elizabeth Fryer, Thomas Petrella, John Petrella, BrendanRiggin, Erin Shellington, Michael Gregory, Claire Riley, Emma McCrady, SamTitheridge, Stephanie Muise, Katie Mairs, Amanda Deosaran, John Bocti, andAndrea Petrella. We would also like to thank Crystal Sharp for assisting withearly development of this manuscript.We would like to thank our research partners including Sykes AssistanceCorporation, St. Elizabeth Health Care, Dietitians of Canada, and funders:Dairy Farmers of Canada, Sanofi-Aventis, and the Public Health Agency ofCanada’s support of the program as a part of their Canadian Diabetes StrategyCommunity-based Program.FundingFunding was provided by the Public Health Agency of Canada (CanadianDiabetes Strategy).Availability of data and materialsNot applicable.Authors’ contributionsDG contributed to study design, study concept, and was a major contributorin writing the manuscript. WB contributed to acquisition of data and was amajor contributor in writing the manuscript. CB contributed to study design,acquisition of data and helped to draft the manuscript. RWP contributed tostudy design, acquisition of data, and helped to draft the manuscript. ADCcontributed to acquisition of data and critical revision of the manuscript.KS contributed to acquisition of data and critical revision of the manuscript.Gill et al. BMC Public Health  (2017) 17:173 Page 10 of 12AG contributed to study conception, acquisition of data, and critical revision ofthe manuscript. IN contributed to critical revision of the manuscript. EPcontributed to critical revision of the manuscript. BO contributed to criticalrevision of the manuscript. BL contributed to critical revision of the manuscript.KK contributed to critical revision of the manuscript. PM contributed to criticalrevision of the manuscript. GJ contributed to critical revision of the manuscript.CW contributed to critical revision of the manuscript. GZ contributed to studydesign and critical revision of the manuscript. RP contributed to studyconception, study design and was a major contributor in writing themanuscript. All authors read and approved the final manuscript.Competing interestsThe authors declare that they have no competing interests.Consent for publicationNot applicable.Ethics approval and consent to participateWestern University Health Sciences Research Ethics Board approved thisstudy and all participants provided written informed consent.Author details1Centre for Studies in Family Medicine, Department of Family Medicine,Western Centre for Public Health and Family Medicine, 2nd Floor, SchulichSchool of Medicine and Dentistry, Western University, 1465 Richmond St.,London, ON N6G 2M1, Canada. 2Lawson Health Research Institute, London,Ontario, Canada. 3School of Health Studies, Faculty of Health Sciences,Western University, London, Ontario, Canada. 4School of Public Health,Brown University, Providence, Road Island, USA. 5School of Kinesiology,Lakehead University, Thunder Bay, Ontario, Canada. 6Centre for Educationand Research on Aging and Health, Lakehead University, Thunder Bay,Ontario, Canada. 7School of Physical and Health Education, NipissingUniversity, North Bay Ontario, Canada. 8Aurora Research Institute, AuroraCollege, Yellowknife, Northwest Territories, Canada. 9School of Health andExercise Sciences, University of British Columbia, Kelowna, British Columbia,Canada. 10Northwest Local Health Integration Network, Chronic Disease,Health and Design Development, Thunder Bay, Ontario, Canada.11Department of Epidemiology and Biostatistics, Schulich School of Medicineand Dentistry, Western University, London, Ontario, Canada. 12Robarts ClinicalTrials, Robarts Research Institute, Western University, London, Ontario,Canada. 13School of Kinesiology, Faculty of Health Sciences, WesternUniversity, London, Ontario, Canada.Received: 16 December 2016 Accepted: 17 January 2017References1. 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Can J Diet Pract Res.2015;76(3):146–9.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:Gill et al. BMC Public Health  (2017) 17:173 Page 12 of 12


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