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.
- Community child health
- Preventive medicine
- public health
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Twitter @Vicki_BBB, @LeneSeidler
Contributors VB conceived the study, with significant input from all authors. VB, MS, MT, KEH, RB, DZ, ALS and KM-S will be involved in data acquisition, analysis and interpretation of data and will provide technical and administrative support. RG, RT, KDH, KM-S and MM will be involved in data analysis and interpretation, and will provide expert oversight of all aspects of the project. VB drafted the manuscript. All authors critically revised the manuscript and provided expert analysis. All authors have read and approved the manuscript.
Funding VB is supported by an Alfred Deakin Postdoctoral Research Fellowship. VB, MT, KEH, RB, DZ and ALS are researchers with the Centre for Research Excellence in the Early Prevention of Obesity in Childhood (CRE EPOCH, APPID1101675). KM-S receives support from a Health Research Board Applying Research into Policy and Practice Award (HRB-ARPP-A-2018-011).
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.