Abstract
Background Heterogeneity in the outcomes collected and reported in trials of interventions to prevent obesity in the first five years of life highlights the need for a core outcome set to streamline intervention evaluation and synthesis of effects. This study aimed to develop a core outcome set for use in early childhood obesity prevention intervention studies in children from birth to five years of age (COS-EPOCH). Methods The development of the core outcome set followed published guidelines and consisted of three stages: (1) systematic scoping review of outcomes collected and reported in early childhood obesity prevention trials; (2) e-Delphi study with stakeholders to prioritise outcomes; (3) meeting with stakeholders to reach consensus on outcomes. Stakeholders included parents/caregivers of children aged <= five years, policy-makers/funders, researchers, health professionals, and community and organisational stakeholders interested in obesity prevention interventions. Results Twenty-two outcomes from nine outcome domains (anthropometry, dietary intake, sedentary behaviour, physical activity, sleep, outcomes in parents/caregivers, environmental, emotional/cognitive functioning, economics) were included in the core outcome set: infant tummy time; child diet quality, dietary intake, fruit and vegetable intake, non-core food intake, non-core beverage intake, meal patterns, weight-based anthropometry, screentime, time spent sedentary, physical activity, sleep duration, wellbeing; parent/caregiver physical activity, sleep and nutrition parenting practices; food environment, sedentary behaviour or physical activity home environment, family meal environment, early childhood education and care environment, household food security; economic evaluation. Conclusions The systematic stakeholder-informed study identified the minimum outcomes recommended for collection and reporting in early childhood obesity prevention trials. Future work will investigate the recommended instruments to measure each of these outcomes. The core outcome set will standardise guidance on the measurement and reporting of outcomes from early childhood obesity prevention interventions, to better facilitate evidence comparison and synthesis, and maximise the value of data collected across studies.