Effectiveness and co-benefits of a telephone-based intervention in reducing obesity risk of children aged 2-4 years: findings from a pragmatic randomised controlled trial during the COVID-19 pandemic in Australia.

BACKGROUND:Evidence of effective early childhood obesity prevention is scarce and mainly derived from face-to-face interventions. However, the COVID-19 pandemic drastically reduced face-to-face health programmes globally. This study assessed effectiveness of a telephone-based intervention in reducing obesity risk of young children. METHODS:We adapted a study protocol (developed before the pandemic) and conducted a pragmatic randomised controlled trial of 662 women with children aged 2 years (mean age 24·06 months [SD 0·69]) during March, 2019, and October, 2021, extending the original planned intervention of 12 months to 24 months. The adapted intervention comprised five telephone-based support sessions plus text messages over a 24-month period (at child ages 24-26 months, 28-30 months, 32-34 months, 36-38 months, and 42-44 months). The intervention group (n=331) received staged telephone plus SMS support regarding healthy eating, physical activity, and information about COVID-19. The control group (n=331) received four staged mail-outs on information not related to the obesity prevention intervention, such as toilet training, language development, and sibling relationships, as a retention strategy. The intervention effects on BMI (primary outcome) and eating habits (secondary outcome), and perceived co-benefits, were evaluated using surveys and qualitative telephone interviews at 12 months and 24 months after baseline (age 2 years). The trial is registered with the Australian Clinical Trial Registry, ACTRN12618001571268. FINDINGS:Of 662 mothers, 537 (81%) completed the follow-up assessments at 3 years, and 491 (74%) completed the follow-up assessment at 4 years. Multiple imputation analysis showed no significant difference in mean BMI between the groups. Among low-income families (ie, annual household income More