scholarly journals Protocol for the development of Core Outcome Sets for Early intervention trials to Prevent Obesity in CHildren (COS-EPOCH)

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048104
Author(s):  
Vicki Brown ◽  
Marj Moodie ◽  
Huong Ngoc Quynh Tran ◽  
Marufa Sultana ◽  
Kylie Elizabeth Hunter ◽  
...  

IntroductionChildhood overweight and obesity is prevalent in the first 5 years of life, and can result in significant health and economic consequences over the lifetime. The outcomes currently measured and reported in randomised controlled trials of early childhood obesity prevention interventions to reduce this burden of obesity are heterogeneous, and measured in a variety of ways. This variability limits the comparability of findings between studies, and contributes to research waste. This protocol presents the methodology for the development of two core outcome sets (COS) for obesity prevention interventions in children aged from 1 to 5 years from a singular development process: (1) a COS for interventions targeting physical activity and sedentary behaviour and (2) a COS for interventions targeting child feeding and dietary intake. Core outcomes related to physical activity and sedentary behaviour in children aged ≤1 year will also be identified to complement an existing COS for early feeding interventions, and provide a broader set of core outcomes in this age range. This will result in a suite of COS useful for measuring and reporting outcomes in early childhood obesity prevention studies, including multicomponent interventions.Methods and analysisDevelopment of the COS will follow international best practice guidelines. A scoping review of trial registries will identify commonly reported outcomes and associated measurement instruments. Key stakeholders involved in obesity prevention, including policy-makers/funders, parents, researchers, health practitioners and community and organisational stakeholders will participate in an e-Delphi study and consensus meeting regarding inclusion of outcomes in the COS. Finally, recommended outcome measure instruments will be identified through literature review and group consensus.Ethics and disseminationDeakin University Human Research Ethics Committee (HEAG-H 231_2020). The COS will be disseminated through peer-reviewed publications and engagement with key stakeholders.

Author(s):  
Mahalakshmi Ekambareshwar ◽  
Swathi Ekambareshwar ◽  
Seema Mihrshahi ◽  
Li Ming Wen ◽  
Louise A. Baur ◽  
...  

Abstract Background Increasingly, public health interventions are delivered via telephone and/or text messages. Recent systematic reviews of early childhood obesity prevention interventions have not adequately reported on the way interventions are delivered and the experiences/perceptions of stakeholders. We aimed to summarise the literature in early childhood obesity prevention interventions delivered via telephone or text messages for evidence of application of process evaluation primarily to evaluate stakeholders’ acceptability of interventions. Methods A systematic search of major electronic databases was carried out using the Population, Intervention, Comparison, Outcomes framework. Studies were included if interventions were delivered via telephone/text messages; aimed at changing caregivers’ behaviours to prevent early childhood obesity; with one or more outcomes related to early obesity risk factors such as breastfeeding, solid feeding, tummy time, sleep and settling, physical activity and screen time; published from inception to May 2020. All eligible studies were independently assessed by two reviewers using the Cochrane Collaboration tool for assessing risk of bias. Qualitative studies were assessed using the Consolidated Criteria for Reporting Qualitative Research and Standards for Reporting Qualitative Research tools. Results Twenty-four studies were eligible, and the overall risk of bias was low. Eight studies (33%) had evidence of process evaluation that examined participants’ perceptions of interventions. Participants appreciated the convenience of receiving interventions via telephone or text messages. 63% of all studies in this review showed improvement in one or more behaviours related to childhood obesity prevention. Participants were likely to modify behaviours if they received information from a credible source such as from health professionals. Conclusion There is limited reporting of stakeholders’ experiences in early obesity prevention studies delivered by telephone or text messages. Only one-third of studies examined participants’ acceptability and the potential for delivery of childhood obesity prevention interventions conveniently using this mode of delivery. Interventions delivered remotely via telephone or text messages have the potential to reach equal or a greater number of participants than those delivered via face-to-face methods. Future research should build in process evaluation alongside effectiveness measurements to provide important insight into intervention reach, acceptability and to inform scale up. Trial registration PROSPERO registration: CRD42019108658


2020 ◽  
Author(s):  
Brittany J Johnson ◽  
Kylie E Hunter ◽  
Rebecca K Golley ◽  
Paul Chadwick ◽  
Angie Barba ◽  
...  

ABSTRACTIntroductionLittle is known about how early (e.g., commencing antenatally or in the first 12 months after birth) obesity prevention interventions seek to change behaviour and which components are or are not effective. This study aims to 1) characterise early obesity prevention interventions in terms of target behaviours, delivery features, and behaviour change techniques (BCTs), 2) explore similarities and differences in BCTs used to target behaviours, and 3) explore effectiveness of intervention components in preventing childhood obesity.Methods and analysisAnnual comprehensive systematic searches will be performed in Epub Ahead of Print/MEDLINE, Embase, Cochrane (CENTRAL), CINAHL, PsycINFO, as well as clinical trial registries. Eligible randomised controlled trials of behavioural interventions to prevent childhood obesity commencing antenatally or in the first year after birth will be invited to join the TOPCHILD Collaboration. Standard ontologies will be used to code target behaviours, delivery features and BCTs in both published and unpublished intervention materials provided by trialists. Narrative syntheses will be performed to summarise intervention components and compare applied BCTs by types of target behaviours. Exploratory analyses will be undertaken to assess effectiveness of intervention components.Ethics and disseminationThe study has been approved by The University of Sydney Human Research Ethics Committee (project no. 2020/273) and Flinders University Social and Behavioural Research Ethics Committee (project no. HREC CIA2133-1). The study’s findings will be disseminated through peer-reviewed publications, conference presentations, and targeted communication with key stakeholders.DiscussionOur study will provide an in depth understanding of behavioural components and delivery features used in obesity prevention interventions starting antenatally or in the first 12 months after birth. Understanding common intervention approaches in a systematic way will provide much needed insight to advance the design of early obesity prevention interventions and provide the opportunity to undertake future quantitative predictive modelling.RegistrationPROSPERO registration no. CRD42020177408STRENGTHS AND LIMITATIONS OF THIS STUDYThis study provides an understanding of behaviours targeted, behaviour change techniques and delivery features used in early childhood obesity prevention trials identified in a systematic review as being eligible for inclusion in the Transforming Obesity Prevention in CHILDren (TOPCHILD) Collaboration.Extends previous methods by coding behaviour change techniques in published and unpublished intervention materials and performing cross validation with trialists through the TOPCHILD Collaboration.Using standardised coding taxonomies will allow for comparisons across studies, and we will pilot test new ontologies from the Human Behaviour Change Project.Explores the complex area of targeting parent and caregivers’ behaviours to impact child outcomes across four key obesity prevention behavioural domains (relating to infant feeding practices, food provision and parent feeding practices, movement practices, sleep health practices).This study will provide preliminary results regarding the examination of intervention components’ effectiveness based on exploratory analysis. Yet, the internationally unique database this project creates will further our understanding of effective intervention components in future research.To date we already have 38 out of 65 eligible trials agreeing to share data, since not all trials may provide unpublished material we may perform sensitivity analyses comparing trials that have shared data to trials that have not shared materials.


2020 ◽  
Vol 15 (11) ◽  
Author(s):  
Anna Lene Seidler ◽  
Kylie E. Hunter ◽  
Brittany J. Johnson ◽  
Mahalakshmi Ekambareshwar ◽  
Sarah Taki ◽  
...  

2015 ◽  
Vol 169 (6) ◽  
pp. 543 ◽  
Author(s):  
Li Ming Wen ◽  
Louise A. Baur ◽  
Judy M. Simpson ◽  
Huilan Xu ◽  
Alison J. Hayes ◽  
...  

2020 ◽  
Author(s):  
Kylie E Hunter ◽  
Brittany J Johnson ◽  
Lisa Askie ◽  
Rebecca K Golley ◽  
Louise A Baur ◽  
...  

ABSTRACTIntroductionBehavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials worldwide. Combining the individual participant data (IPD) from these trials will enhance statistical power to determine overall effectiveness and enable examination of intervention-covariate interactions. We present a protocol for a systematic review with IPD meta-analysis to evaluate the effectiveness of obesity prevention interventions commencing antenatally or in the first year after birth, and to explore whether there are differential effects among key subgroups.Methods and analysisSystematic searches of Medline, Embase, CENTRAL, CINAHL, PsycInfo, and trial registries for all ongoing and completed randomised controlled trials evaluating behavioural interventions for the prevention of early childhood obesity have been completed up to March 2020 and will be updated annually to include additional trials. Eligible trialists will be asked to share their IPD; if unavailable, aggregate data will be used where possible. An IPD meta-analysis and a nested prospective meta-analysis (PMA) will be performed using methodologies recommended by the Cochrane Collaboration. The primary outcome will be body mass index (BMI) z-score at age 24 +/- 6 months using World Health Organisation Growth Standards, and effect differences will be explored among pre-specified individual and trial-level subgroups. Secondary outcomes include other child weight-related measures, infant feeding, dietary intake, physical activity, sedentary behaviours, sleep, parenting measures and adverse events.Ethics and disseminationApproved by The University of Sydney Human Research Ethics Committee (2020/273) and Flinders University Social and Behavioural Research Ethics Committee (project no. HREC CIA2133-1). Results will be relevant to clinicians, child health services, researchers, policy-makers and families, and will be disseminated via publications, presentations, and media releases.RegistrationProspectively registered on PROSPERO: CRD42020177408STRENGTHS AND LIMITATIONS OF THIS STUDYThis will be the largest individual participant data (IPD) meta-analysis evaluating behavioural interventions for the prevention of early childhood obesity to date, and will provide the most reliable and precise estimates of early intervention effects to inform future decision-making.IPD meta-analysis methodology will enable unprecedented exploration of important individual and trial-level characteristics that may be associated with childhood obesity or that may be effect modifiers.The proposed innovative methodologies are feasible and have been successfully piloted by members of our group.It may not be possible to obtain IPD from all eligible trials; in this instance, aggregate data will be used where available, and sensitivity analyses will be conducted to assess inclusion bias.Outcome measures may be collected and reported differently across included trials, potentially increasing imprecision; however, we will harmonise available data where possible, and encourage those planning or conducting ongoing trials to collect common core outcomes following prospective meta-analysis methodology.


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