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Interventions on children’s and adolescents’ physical activity and sedentary behaviour: protocol for… Demetriou, Yolanda; Vondung, Catherina; Bucksch, Jens; Schlund, Annegret; Schulze, Carolin; Knapp, Guido; Coen, Stephanie E; Puil, Lorri; Phillips, Susan P; Reimers, Anne K Feb 26, 2019

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PROTOCOL Open AccessInterventions on children’s and adolescents’physical activity and sedentary behaviour:protocol for a systematic review from asex/gender perspectiveYolanda Demetriou1*† , Catherina Vondung2†, Jens Bucksch2, Annegret Schlund1, Carolin Schulze3, Guido Knapp4,Stephanie E. Coen5, Lorri Puil6, Susan P. Phillips7 and Anne K. Reimers3AbstractBackground: Low levels of physical activity (PA) and high levels of sedentary behaviour (SB) have been observed inyoung people. Both behaviours are detrimental for health with patterns tending to continue into adulthood. Thereis sustained value in establishing health habits in early years. Even though levels of SB and participation in PA differamong boys and girls, and the effectiveness of interventions to promote PA and/or prevent sedentary behavioursvaries by sex/gender to date, sex/gender in systematic reviews is not yet widely considered. Additionally, whiletools have been proposed, there is no consensus on the criteria to assess sex/gender in systematic reviews in thecontext of health promotion. The main objectives of this systematic review are to evaluate the effects ofinterventions on girls’ and boys’ PA and SB and to appraise the extent to which the studies have taken sex/genderinto account.Methods: Eleven electronic databases will be searched to identify all relevant (randomized) controlled trials. Twoindependent reviewers will screen studies, extract data and appraise the quality of studies. The main outcome ofthe studies will be a quantified measure of PA and/or SB. Risk of bias of individual studies will be assessed usingthe Cochrane Risk of Bias Tool for RCTs. Meta-analyses will be conducted when possible among studies withsufficient homogeneity. To evaluate sex/gender considerations in primary studies, we will use a sex/gender checklistthat builds on existing tools and was developed during a 2-day, iterative process among a multidisciplinary panelof 16 experts. The GRADE framework will be used to evaluate evidence across studies for each main efficacyoutcome.Discussion: To our knowledge, our systematic review will be the first to analyse how sex/gender is considered ininterventions promoting PA and/or reducing SB in children and adolescents in detail. The review will provideinformation on how sex/gender aspects have been considered in recent research and the extent to which sex/gender might impact study outcomes. Our findings will be of interest to stakeholders, health promoters,researchers and policy makers who wish to support more equal outcomes from interventions promoting PAand/or reducing SB.Trial registration: PROSPERO CRD42018109528.Keywords: PRISMA-P, Girls, Boys, Randomized controlled trial, Youth, Cochrane, Exercise* Correspondence: yolanda.demetriou@tum.de†Yolanda Demetriou and Catherina Vondung contributed equally to thiswork.1Department of Sport and Health Sciences, Technical University of Munich,Georg-Brauchle-Ring 62, 80992 Munich, GermanyFull list of author information is available at the end of the article© The Author(s). 2019 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.Demetriou et al. Systematic Reviews            (2019) 8:65 https://doi.org/10.1186/s13643-019-0963-2BackgroundGlobally, low levels of physical activity (PA) and a highdegree of sedentary behaviour (SB) have been observedin young people [1–4]. These low levels of PA and highlevels of SB are detrimental for health in this young agegroup [5, 6]. Additionally, patterns of PA and SB inchildhood and adolescence tend to continue into adult-hood during which there is strong evidence for healthbenefits of low SB and high PA [7, 8]. Therefore, it isvital to establish patterns of greater PA and less SB earlyin life.In recent research, lower PA levels are consistently re-ported for girls compared to boys [1, 9–11]. These dif-ferences are meaningful across all age groups and innearly all countries and regions. Interestingly, the differ-ence in PA is greatest for vigorous PA, less marked formoderate PA and does not exist for light PA [12].The picture for SB is different. Internationalself-report data from 2002 and 2010 showed that elec-tronic media use steadily increased across all countriessurveyed in the Health Behaviour in School-aged Chil-dren (HBSC) study [12]. In 2010, boys reported about6 h of sedentary screen time per day compared to about5 h for girls. Girls more often use computers for socialand academic purposes, whereas boys more frequentlyuse them for gaming [10]. Objectively measured overallSB by the International Children’s Accelerometry Data-base (ICAD) showed that girls and boys sit up to 70% oftheir waking time, with slightly more SB for girls, butthe difference between boys and girls consistently widensfrom childhood to adolescence [13].Despite growing research and interventions to pro-mote PA and decrease SB, sex/gender differences persist.This suggests that current interventions may not be suf-ficiently taking into account the evidence about sex/gen-der differences in PA and SB [10, 14]. A recentsystematic review of the effectiveness of after-schoolprogrammes to enhance moderate-to-vigorous physicalactivity (MVPA) reported that a small minority of stud-ies had conducted subgroup analyses in boys and girlswith some evidence of greater effect on MVPA in boys.However, this finding was based on only the few studiesthat had compared sex/gender-specific findings [15].Most systematic reviews of PA and SB interventions donot report on sex/gender. There is, therefore, a real needto evaluate this issue more rigorously.With the introduction and expansion of PRISMA-E(quity), the field of health promotion is moving in thedirection of becoming more sensitive to equity issues insystematic reviews and meta-analyses [16]. An equityframework also takes into account the fact that interven-tions can result in intervention-generated inequalitiesbetween different target groups (e.g. sex/gender groups),also referred to as the inverse law of evidence [17, 18].Two scoping reviews related to sex/gender inequalitiesin adult PA interventions found some heterogeneitiesbetween the effects of interventions in men and women[19, 20]. Nevertheless, sex/gender is not yet widely con-sidered in systematic reviews when appraising theexisting evidence, potentially leading to suboptimal in-terventions for diverse populations [21].Several theoretical approaches can be used toconceptualize gender and its relation to health [22–24].The Canadian Institutes of Health Research define gen-der as “the socially constructed roles, behaviours, ex-pressions and identities of girls, women, boys, men andgender diverse people” [25, 26]. Gender is consideredmultidimensional and dynamic and includes genderroles (behavioral norms), gender identities (how we seeourselves), gender relations (how we interact with eachother) and institutionalized gender [26]. Although gen-der has been traditionally conceptualized as binary (fem-inine/masculine), there is growing recognition of thediversity with which individuals understand, experienceand express gender on a fluid continuum [25]. Sex is amultidimensional biological construct that encompassesanatomy, physiology, genes and hormones [22]. Vari-ation also exists in the biological attributes that com-prise sex and how those attributes are expressed [25,26]. The Cochrane Sex/Gender Methods Group, a sub-group of the Campbell and Cochrane Equity MethodsGroup, emphasizes that sex-based biological factors andgendered social factors influence each other and inter-actively shape health behaviour, opportunities and out-comes. In recognition of this theoretical and empiricalentanglement, the group recommends using the termsex/gender [27, 28], terminology we have adopted in thisprotocol.The main objectives of this systematic review are toevaluate the effects of interventions on girls’ and boys’PA and SB, and to appraise the extent to which the stud-ies have taken sex/gender into account. To reach thisaim, all primary studies included in the review will beassessed based on the previously mentioned sex/genderchecklist developed by the authors of this manuscript incooperation with an international expert group (pleasecontact the corresponding author for the current versionof the checklist).MethodsThis systematic review protocol is registered in the PROS-PERO international prospective register of systematicreviews (registration number: CRD42018109528). We pre-pared the protocol using the Preferred Reporting Items forSystematic Reviews and Meta-Analysis Protocols (PRIS-MA-P) 2015 statement [29] (Additional file 1). The final re-view will be reported using the Preferred Reporting Itemsfor Systematic Reviews and Meta-Analysis (PRISMA)Demetriou et al. Systematic Reviews            (2019) 8:65 Page 2 of 7statement and its equity extension (PRISMA-E) as guidance[16]. Important protocol amendments will be documentedand published with the results of the review.Search strategyThe search strategy will be based on Cochrane standardsand designed in collaboration with a Cochrane informa-tion specialist [16, 30]. The Cochrane Central Register ofControlled Trials (CENTRAL) via Ovid; Ovid MED-LINE, Epub Ahead of Print, In-Process and otherNon-Indexed Citations, Daily, and Versions; OvidEmbase; Science Citation Index Expanded (SCI-EX-PANDED); Clarivate Web of Science; Conference Pro-ceedings Citation Index (CPCI-S); EBSCO PsycINFO,EBSCO Eric, EBSCO SPORTDiscus; and ProQuest Dis-sertations & Theses Global will be searched. The subjectstrategies for databases will be based on the MEDLINEsearch strategy (Appendix), which will combine MedicalSubject Heading (MeSH) terms and keywords related tophysical activity and sedentary behaviour. We will alsosearch ClinicalTrials.gov and the World HealthOrganization (WHO) International Clinical Trials Regis-try Platform (ICTRP) to identify ongoing or recentlycompleted studies.Reference lists of existing systematic reviews, identifiedby searching Epistemonikos, will be cross-checked to en-sure all studies are identified. Experts in the field willalso be contacted to identify potentially eligible studies.The included primary studies will be complemented byadditional information from, e.g. study protocols and/ ormaterials to identify all relevant aspects of the interven-tion components.Eligibility criteriaWe will include randomized controlled trials (parallelgroup or cluster-randomized) and controlled trials in thesystematic review. The main outcomes will be quantifiedPA and/or SB by any type of measure (e.g. self-reported,accelerometer data) in children and adolescents withinthe average age range of 3–19 years. Studies only target-ing children and adolescents with specific health issueswill be excluded. Additionally, we will exclude collegeand university students because this population grouprepresents the beginning of a new life stage. The aim ofthe intervention programmes must be promotion of in-formal and formal PA behaviours and/or the reductionof SB in children and adolescents. Additionally, all inter-vention studies must have reported sex/gender disaggre-gated PA and/or SB at baseline and/or follow-up, and/orexplained how they dealt with sex/gender during theoutcome analysis (e.g. sex/gender adjusted analysis),and/or reported that there were no differences in theoutcome when looking at sex/gender. The comparatorsshould either be an active control group for examplereceiving an intervention to promote children’s creativityor cognitive performance without components promot-ing PA or reducing SB or a control group with no inter-vention. In order to base the results of the systematicreview on current activities, only studies published afterthe year 2000 will be included. Due to resources andtime constraints, we will restrict eligibility to publishedpeer-reviewed studies in the English language.Study selectionTwo independent reviewers will screen all identifiedreferences for inclusion against eligibility criteria. Allrecords will be imported into Covidence, and dupli-cates will be removed automatically from the soft-ware. In the first step of screening, titles andabstracts will be screened to remove clearly irrele-vant records. In the second step, the full text of cita-tions that are considered of potential or uncertainrelevance by the two reviewers will be retrieved. Anydisagreements during the study selection process willbe resolved by a third independent reviewer or if ne-cessary by discussions of the three reviewers afterre-examination of the articles. If full texts are notavailable or additional data are needed to determineeligibility, authors will be contacted via e-mail. Amaximum of two contact attempts will be made.Additionally, after searches and study selection areconducted, we will contact experts in the field to de-termine further studies that meet the inclusioncriteria.Data extractionAll data extraction will be carried out by two inde-pendent reviewers and any discrepancies resolvedthrough discussion or adjudication by a third reviewerif consensus is not reached. To ensure consistency ofdata extraction across reviewers, we will pilot a dataextraction spreadsheet. For each study, specific detailswill be extracted. First, information about generalstudy characteristics, description of study sample anddropout rate, intervention content details and inter-vention approaches will be extracted. Second, we willextract intervention outcomes, measurement pointsand instruments as well as sample size calculationand confounders taken into account to analyse the ef-fectiveness of the intervention on PA and/or SB out-comes. Reviewers will not be blinded to authors orjournals when extracting the data. If information ismissing or clarification of data is required, authorswill be contacted via e-mail. A maximum of two con-tact attempts will be made. The process in which sex/gender will be appraised and transferred to dataextraction is described below (see “sex/genderchecklist”).Demetriou et al. Systematic Reviews            (2019) 8:65 Page 3 of 7Quality assessment and risk of biasFor the assessment of the risk of bias of the primarystudies, we will use the Cochrane Risk of Bias Tool forRCTs [30, 31] for both RCTs and controlled clinical tri-als. The tool is a domain-based evaluation, in which crit-ical assessments will be made separately for sequencegeneration (selection bias), allocation sequence conceal-ment (selection bias), blinding of participants andpersonnel (performance bias), blinding of outcome as-sessment (detection bias), incomplete outcome data (at-trition bias), selective outcome reporting (reporting bias)and other potential sources of bias. The judgment foreach entry will involve assessing the risk of bias as“low risk”, “high risk” or “unclear risk”, with the lastcategory indicating either lack of information or un-certainty about the potential for bias. Controlled clin-ical trials will be considered to be at high risk of biasfor domains related to randomization. Quality assess-ment will be done by two independent reviewers, anddiscrepancies resolved through discussion or adjudica-tion by a third reviewer if consensus cannot bereached.Sex/gender checklistTo assess the degree to which sex/gender was consid-ered in intervention studies that promote PA and/or re-duce SB in participants, we developed a comprehensivesex/gender checklist in a three-step procedure. First, theexisting literature [22, 32–35] and tools [36–40] that ap-praise sex/gender in research were collated, includingexisting guidance for systematic review authors [41, 42].Second, we summarized existing instruments andchecked them for applicability to our objectives. Third,the first draft of the sex/gender checklist was set up andfinalized in collaboration with international experts inthe field of sex/gender sciences and methodology (e.g.members of the Cochrane Sex/Gender Methods Group,a subgroup of the Campbell and Cochrane EquityMethods Group). The current version of the sex/genderchecklist consists of 16 items in the following categories:background and concepts, study design, interventionplanning and delivery, statistical accounting and presen-tation and interpretation of findings. These items arerated using three categories by item-specific definitionsand provide information on the extent to which the pri-mary study took sex/gender into account regarding therespective item.Statistical analysesMeta-analyses for interventions promoting PA and/orreducing SB will be undertaken if the studies are suffi-ciently similar clinically and methodologically, otherwisea semi-quantitative or narrative synthesis will be con-ducted. Possible estimated effect sizes for the controlledintervention studies may be, e.g. Cohen’s d for the stan-dardized mean difference of PA or SB before and afterthe intervention, separately reported for boys and girlsor interaction effects for boys and girls from regressionmodels. For all reported estimated effect sizes, a measureof precision like standard error or confidence intervalmust be available. The inclusion of cluster-randomized tri-als in the meta-analyses will be handled appropriately[43]. The random-effects meta-analysis model will be thefirst model considered for combining the estimated effectsizes. The assumption of a common effect size in all thestudies is too restrictive due to different designs of inter-vention studies or of the interventions used, or the fre-quency or duration of the intervention. If substantialheterogeneity between the studies is present, moderatorvariables will be examined in the context of meta-regres-sion. As there is the danger of overfitting inmeta-regression, at least ten relevant studies should beavailable for a meta-regression with one moderator vari-able. Meta-regression techniques will also be used to judgethe effect of high risk of bias.If the meta-analyses produce significant results, publi-cation bias will be examined. First, we will address thepossible effect of publication bias using a fail-safe num-ber, e.g. the number of non-published studies that wouldreverse the significant meta-analysis result into anon-significant one. If this fail-safe number is reason-able, that is, not too large, the Copas selection modelmay be used for a sensitivity analysis along with theHenmi-Copas confidence interval approach [44].All meta-analysis models will be analysed in the freelyavailable statistical software R using various packages(e.g. meta, metafor, metasens, metaplus, CAMAN).The quality of evidence across studies will beassessed for each outcome as high, moderate, low orvery low using the GRADE framework [45]. With theGRADE approach, RCT evidence starts at the highestquality level but may be downgraded based on an as-sessment of the following domains: study limitations(risk of bias), imprecision, heterogeneity, indirectnessand suspicion of publication bias. Controlled clinicaltrials that are not randomized will be downgradedbased on risk of bias due to lack of randomizationand start at moderate quality of evidence. GRADE-pro|GDT software will be used to create a summaryof findings table and rate the quality of the evidenceusing the GRADE framework.DiscussionTo our knowledge our systematic review will be the firstto systematically assess how sex/gender is considered ininterventions promoting PA and/or reducing SB in chil-dren and adolescents. The review will provideDemetriou et al. Systematic Reviews            (2019) 8:65 Page 4 of 7information on how sex/gender has been considered orreported in recent research and to what extent thesemight have an impact on the study outcomes.We anticipate this systematic review will lead to severalpublications based on a socio-ecological perspective and ac-cording to the U.S. Guide to Community Preventive Ser-vices in order to provide a better understanding regardingthe influence of different types of intervention programmes[46]. Additionally, a briefing note on appraising interven-tions that consider sex/gender in promoting PA or reducingSB will be published. This briefing note will be jointly devel-oped with the Cochrane Sex/Gender Methods Group anddistributed to the Cochrane Collaboration via the Campbelland Cochrane Equity Methods Group.Our findings will be of interest to stakeholders andhealth promoters as well as researchers and policymakers who wish to foster gender equity in interven-tions promoting PA and/or reducing SB. Therefore, aworkshop will take place where we will convert our pri-mary scientifically oriented sex/gender checklist and theresults of this systematic review into practical docu-ments that aid others in appropriately integrating sex/gender considerations in interventions.The results of the review will help establish sex/gender guidelines on the development, implementa-tion and appraisal of PA promotion and SB reductioninterventions. The project will build both the field ofPA promotion and SB prevention and methodologyfor conducting systematic reviews using a sex/genderlens. The results will be disseminated to academicTable 1 Sample MEDLINE search strategyNumber Search terms1 Adolescent/ (1879830)2 exp Child/ (1783242)3 (adolesc$ or boy? or child$ or girl? or juvenile? or kid? orschool$ or school age$ or student? or teen$).ti,kf. (1090760)4 (adolesc$ or boy? or child$ or girl? or juvenile? or kid? orschool$ or school age$ or student? or teen$ or youth?).ab./freq = 2 (908853)5 or/1-4 (3245722)6 exp Motor Activity/ (259691)7 exp Exercise/ (168655)8 exp Exercise Therapy/ (43456)9 exp Recreation/ (187698)10 exp *Sports/ (113371)11 Physical Exertion/ (55439)12 exp Physical Fitness/ (26257)13 exp “Play and Playthings”/ (12587)14 (active or activities or activity or aerobic? or athletic? orbadminton or baseball or basketball or bicycl$ or bike? orbiking or boxing or cardio or cricket or cycling or dance orTable 1 Sample MEDLINE search strategy (Continued)Number Search termsdancing or exercis$ or fitness or football or gymnastic? orhandball or hockey or jogging or jiu jitsu or judo or jujitsuor karate or playground? or rugby or running or soccer orsport? or swim$ or tennis or training or volleyball or walk? orwalking or yoga).tw,kf. (4104009)15 physical$ activ$.tw,kf. (97509)16 Sedentary Lifestyle/ (6980)17 Television/ (12915)18 (gaming or television or tv or video game? or videogame?).tw,kf. (27953)19 or/6-18 (4250380)20 intervention?.ti. and 19 (26682)21 ((amount? or effect? or effectiveness or encourag$ or evaluat$or impact? or improve$ or improving or increase? or increasingor intervention? or modif$ or promot$) adj3 (activity level? orexercise or fitness or mobility or physical activit$ or step$)).ti,kf.(24388)22 ((amount? or effect? or effectiveness or encourag$ or evaluat$or impact? or improve$ or improving or increase? or increasingor modif$ or promot$) adj4 (activity level? or exercise or fitnessor mobility or physical activit$ or step$)).ab. (131764)23 ((avoid$ or curb$ or decreas$ or discourag$ or effect? oreffectiveness or eliminat$ or evaluat$ or impact? or modif$ orprevent$ or reduc$) adj3 (computer$ or inactiv$ or screen-based or screen time or sedentary or sitting or television or tvor video game?)).ti,kf. (4977)24 ((avoid$ or curb$ or decreas$ or discourag$ or effect? oreffectiveness or eliminat$ or evaluat$ or impact? or modif$ orprevent$ or reduc$) adj4 (computer$ or inactiv$ or screen-based or screen time or sedentary or sitting or television or tvor video game?)).ab. (31431)25 or/20-24 (196821)26 5 and 25 (30682)27 randomized controlled trial.pt. (466685)28 controlled clinical trial.pt. (92572)29 randomi?ed.ab. (501162)30 placebo.ab. (190972)31 clinical trials as topic/ (184490)32 randomly.ab. (295330)33 trial.ti. (186030)34 (allocation or allocated).ab. (91828)35 assigned.ab. (212727)36 (controlled adj2 (study or trial)).ab. (130228)37 control group?.ab. (399548)38 ((singl$ or doubl$) adj blind$).ab. (141426)39 or/27-38 (1625780)40 animals/ not (humans/ and animals/) (4453468)41 39 not 40 (1431749)42 26 and 41 (8753)43 limit 42 to yr = “2000 - 2018” (7727)Demetriou et al. Systematic Reviews            (2019) 8:65 Page 5 of 7and non-academic audiences through peer-reviewedpublications, conferences and formal presentationsand in formal meetings.Additional fileAdditional file 1: Preferred Reporting Items for Systematic Review andMeta-Analysis Protocols (PRISMA-P) 2015 checklist: recommended itemsto include in a systematic review protocol. (DOC 84 kb)AbbreviationsMVPA: Moderate-to-vigorous physical activity; PA: Physical activity;PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analysis;PRISMA-E: Preferred reporting items for systematic review and meta-analysisEquity; PRISMA-P: Preferred reporting items for systematic review and meta-analysis protocols; SB: Sedentary behaviour; WHO: World Health OrganizationAcknowledgementsWe thank Douglas M. Salzwedel, MLIS, Cochrane Hypertension, University ofBritish Columbia for finalising the search strategy and conducting the searchfor the systematic review.FundingThis systematic review comprises the project “Effects of interventions onchildren’s and adolescents’ physical activity and sedentary behaviour: agender-sensitive systematic review (genEffects)”, funded by the FederalMinistry of Education and Research of Germany (BMBF) in the action “Health– A lifelong” (Gesund – Ein Leben lang). The funder has no involvement inprotocol development, review conduct, data analysis and interpretation, anddissemination of the final report. This work was supported by the GermanResearch Foundation (DFG) and the Technical University of Munich withinthe funding programme Open Access Publishing.Availability of data and materialsNot applicable.Authors’ contributionsCV and YD drafted the manuscript. YD, JB, AKR and LP designed thesystematic review protocol, worked on designing the sex/gender checklistand provided comments and edits to the manuscript. CV, AS and CS workedon designing the sex/gender checklist. GK worked on designing the sex/gender checklist and provided the statistical analysis part of the reviewprotocol. SEC and SPP worked on designing the sex/gender checklist andcritically reviewed a further version of this manuscript. All authors approvedthe final manuscript.Ethics approval and consent to participateNot applicable.Consent for publicationNot applicable.Competing interestsThe authors declare that they have no competing interests.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims in publishedmaps and institutional affiliations.Author details1Department of Sport and Health Sciences, Technical University of Munich,Georg-Brauchle-Ring 62, 80992 Munich, Germany. 2Department of Naturaland Human Sciences, Heidelberg University of Education, Heidelberg,Germany. 3Institute of Human Movement Science and Health, ChemnitzUniversity of Technology, Chemnitz, Germany. 4Department of Statistics,Technical University Dortmund, Dortmund, Germany. 5Department ofGeography, Western University, London, Canada. 6Department ofAnesthesiology, Pharmacology & Therapeutics, Faculty of Medicine,University of British Columbia, Vancouver, Canada. 7School of Medicine,Queen’s University, Kingston, Canada.Received: 22 October 2018 Accepted: 23 January 2019References1. 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