Study protocol for clinical trial of the FIT Families multicomponent obesity intervention for African American adolescents and their caregivers: Next step from the ORBIT initiative.

ABSTRACT

INTRODUCTION: This study will test the effectiveness of FIT Families (FIT), a multicomponent family-based behavioural intervention, against a credible attention control condition, Home-Based Family Support (HBFS). This protocol paper describes the design of a randomised clinical trial testing the efficacy of the FIT intervention. The protocol will assess the efficacy of FIT to improve health status in African American adolescents with obesity (AAAO) and their primary caregivers on primary (percent body fat) and secondary (physical activity, metabolic control, weight loss) outcomes and its cost-effectiveness. METHODS: 180 youth/caregiver dyads are randomised into FIT or HBFS, stratified by age, gender and baseline per cent overweight. The proposed study follows a two condition (FIT, HBFS) by four assessment time points. Tests will be conducted to identify potential relationship of baseline demographic and clinical variables to our dependent variables and see whether they are balanced between groups. It is hypothesised that youth/caregiver dyads randomised to FIT will show significantly greater reductions in percent body fat over a 12-month follow-up period compared with AAAO receiving HBFS. Preliminary findings are expected by November 2023. ETHICS This protocol received IRB approval from the Medical University of South Carolina (Pro00106021; see 'MUSC IRB 106021 Main Approval.doxc' in online supplemental materials). DISSEMINATION Dissemination activities will include summary documents designed for distribution to the broader medical community/family audience and submission of manuscripts, based on study results, to relevant peer-reviewed scientific high-impact journals. TRIAL REGISTRATION NUMBER NCT04974554.