Overweight and obesity in early childhood is a significant issue, with 41 million children aged from birth to five years now affected globally (1). Addressing childhood overweight and obesity has been identified as critically important (1), particularly given that children with overweight and obesity are five times more likely to be obese in adulthood compared to their healthy weight peers (2). Evidence suggests that efforts to alter obesity trajectories into adulthood should ideally commence before six years of age3, highlighting the need for effective and cost-effective childhood obesity prevention interventions in the early years of life.
There are a number of risk factors for early childhood overweight and obesity (with early childhood defined here as from birth to age five years). These risk factors include poor nutrition, insufficient physical activity or sleep and excess sedentary behaviours (1). Given this wide range of risk factors, there are currently a large number of outcomes reported from early childhood obesity prevention intervention studies. There are also a wide range of methods currently used for measuring relevant outcomes, leading to challenges of consistency and comparability of findings between studies. This variation in outcome reporting limits the quality and comparability of trial data and can lead to research waste (4).
Core outcome sets (COS) are agreed minimum sets of outcomes recommended for measurement in studies of specific conditions or areas of health or health care (5). COS aim to improve the consistency of measurement and reporting of outcomes from randomised controlled trials (RCTs), potentially leading to better informed resource allocation and decision-making through improved comparability and transparency of study findings. A COS has been developed to identify the minimum outcomes that should be measured and reported in trials of infant-feeding interventions to prevent childhood obesity (6,7), recommending 16 outcomes for inclusion in trials of feeding interventions involving infants aged =1 year of age. To date, a COS that could be more broadly applied to early childhood obesity prevention interventions spanning the wider range of risk factors, and for prevention interventions in children aged from birth to five years, has not been published.
This study therefore aims to develop a COS for RCTs of early childhood obesity prevention interventions in children aged from birth to five years.
Principal Investigator - Dr Vicki Brown, Deakin University, Geelong, Deakin Health Economics, Institute for Health Transformation, Global Obesity Centre (GLOBE), School of Health and Social Development, Victoria 3220, Australia
Kylie Hunter, The University of Sydney, Faculty of Medicine and Health
Prof Rebecca Golley, College of Nursing and Health Services, Flinders University, Adelaide SA
Prof Rachael Taylor, Department of Medicine, University of Otago, New Zealand
Prof Kylie Hesketh, Institute for Physical Activity and Nutrition, Deakin University, Melbourne Australia
Dr Rebecca Byrne, Faculty of Health, Queensland University of Technology, Brisbane Australia
Dr Dot Zarnowiecki, College of Nursing and Health Services, Flinders University, Adelaide SA
Prof Marj Moodie, Deakin University, Geelong, Deakin Health Economics, Institute for Health Transformation, Global Obesity Centre (GLOBE), School of Health and Social Development, Victoria 3220, Australia
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Literature review
Stakeholders, including (i) policy-makers/funders, (ii) parents, (iii) researchers, (iv) clinicians and health practitioners, and (v) community and organisational stakeholders to obesity prevention interventions, will be invited to participate.