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Research methods
Protocol
Protocol for the development of Core Outcome Sets for Early intervention trials to Prevent Obesity in CHildren (COS-EPOCH)
  1. Vicki Brown1,2,
  2. Marj Moodie1,2,
  3. Huong Ngoc Quynh Tran1,2,
  4. Marufa Sultana1,
  5. Kylie Elizabeth Hunter2,3,
  6. Rebecca Byrne2,4,
  7. Dorota Zarnowiecki2,5,
  8. Anna Lene Seidler2,3,
  9. Rebecca Golley2,5,
  10. Rachael Taylor2,6,
  11. Kylie D Hesketh2,7,
  12. Karen Matvienko-Sikar8
  1. 1Deakin Health Economics, Institute for Health Transformation, Global Obesity Centre (GLOBE), School of Health and Social Development, Deakin University, Geelong, Victoria, Australia
  2. 2Centre for Research Excellence in the Early Prevention of Obesity in Childhood, University of Sydney, Sydney, New South Wales, Australia
  3. 3NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
  4. 4School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland, Australia
  5. 5Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia
  6. 6Department of Medicine, University of Otago, Dunedin, New Zealand
  7. 7Institute for Physical Activity and Nutrition, Deakin University, Geelong, Victoria, Australia
  8. 8School of Public Health, University College Cork, Cork, Ireland
  1. Correspondence to Dr Vicki Brown; victoria.brown{at}deakin.edu.au

Abstract

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.

  • paediatrics
  • Community child health
  • Preventive medicine
  • public health
http://creativecommons.org/licenses/by-nc/4.0/

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/.

http://dx.doi.org/10.1136/bmjopen-2020-048104

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    Footnotes

    • 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.