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Protocol for the development of Core Outcome Sets for Early intervention trials to Prevent Obesity in CHildren
Vicki Brown1,2, Marj Moodie3,2, Huong Ngoc Quynh Tran3,2
1Deakin Health Economics, Institute for Health Transformation, Global Obesity Centre (GLOBE), School of Health and Social Development, Deakin University, Geelong, Victoria, Australia victoria.brown@deakin.edu.au.
Insights
This study develops standardized core outcome sets (COS) for early childhood obesity prevention interventions. Establishing consistent measurement improves research comparability and reduces waste in tackling childhood obesity.
Area of Science:
- Public Health
- Pediatrics
- Health Services Research
Background:
- Childhood overweight and obesity present significant lifelong health and economic burdens.
- Current randomized controlled trials for early obesity prevention interventions report heterogeneous outcomes, hindering comparability and increasing research waste.
- A need exists for standardized outcome measurement in early childhood obesity prevention.
Purpose of the Study:
- To develop two core outcome sets (COS) for interventions targeting physical activity, sedentary behavior, child feeding, and dietary intake in children aged 1-5 years.
- To identify core outcomes for physical activity and sedentary behavior in children aged ≤1 year to complement existing feeding intervention COS.
- To provide a comprehensive suite of COS for consistent measurement and reporting in early childhood obesity prevention studies.
Main Methods:
- Follow international best practice guidelines for Core Outcome Set (COS) development.
- Conduct a scoping review of trial registries to identify commonly reported outcomes and measurement instruments.
- Engage key stakeholders (policy-makers, parents, researchers, practitioners) through an e-Delphi study and consensus meeting.
- Identify recommended outcome measurement instruments via literature review and group consensus.
Main Results:
- The study protocol outlines a systematic approach to developing standardized Core Outcome Sets (COS).
- Stakeholder engagement through e-Delphi and consensus meetings will ensure relevance and applicability of the COS.
- The developed COS will facilitate consistent measurement and reporting across diverse early childhood obesity prevention interventions.
Conclusions:
- Standardized Core Outcome Sets (COS) are crucial for improving the quality and comparability of evidence in early childhood obesity prevention.
- The developed COS will reduce research waste and enhance the translation of effective interventions.
- This initiative will provide valuable tools for researchers, practitioners, and policymakers addressing childhood obesity.
Introduction:
Childhood 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 Analysis:
Development 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 Dissemination:
Deakin University Human Research Ethics Committee (HEAG-H 231_2020). The COS will be disseminated through peer-reviewed publications and engagement with key stakeholders.
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