Randomised trial of Mentored ‘Planning to be Active+Family’ [MPBA+F] for Appalachian youth at risk for diabetes: virtual delivery protocol

Abstract

Introduction Obesity (OB) in children remains a national epidemic. This trial targets children suffering from overweight (OW) and OB living in rural Appalachia. Rural Appalachia is fraught with unhealthy behaviours, high rates of OB, pre-diabetes and type 2 diabetes among children. Diabetes prevalence in Appalachia is nearly double that of other regions. The prevalence of Appalachian children suffering from OB and extreme obesity (EO) increases the severity of diabetes.Methods and analysis We will conduct a stratified randomised-controlled trial to evaluate Mentored Planning to be Active+Family (MPBA+F) among seventh grade children with OW/OB/EO from rural Appalachian counties. Based on the Social Cognitive Theory, MPBA+F curriculum is a self-regulation approach to physical activity (PA) developed at The Ohio State University and successfully tested for feasibility in rural Appalachian middle schools. MPBA+F (a) incorporates active skill-building activities; (b) reinforces self-regulating activities; (c) engages in individual and group PA; (d) builds the link between PA, hydration and physical health and (e) actively supports weekly PA goals. Weekly skills are incorporated into reinforcement assignments verified at the beginning the following week. The primary outcome is the average daily minutes of moderate-vigorous PA. We will stratify by sex assigned at birth and conduct intent-to-treat analysis. We use descriptive statistics to summarise cohort and group (MPBA+F or comparison) baseline characteristics and examine variable distributions. Bivariate tests examine the balance of baseline characteristics by intervention groups. Mixed-effects linear modelling will be our more primary regression strategy. A potential problem is loss of curricular integrity. Our process assessment, structured mentor training and Instructor’s Guide reduce this concern. Another concern may be the lack of reliable broadband access. Participating counties exceed 75% broadband access. Those who lose internet access may have materials mailed to their home or accessed on the study website.Ethics and dissemination This study was reviewed and approved by the American Diabetes Association Grants Review Committee (Grant number 11-22-ICTSN-30), the host institution’s Social and Behavioral Human Subjects Review Committee (Protocol 2022B0149) and is registered on ClinicalTrials.gov (Protocol NCT05758441). All data that can be shared without compromising human subject protections will be shared to an approved open data repository within six months of publication or 18 months of the conclusion of the funding period (November 2025) if the study remains unpublished. Dissemination to families and stakeholders is by project newsletters. Public presentation of findings will be shared at the Annual Appalachian Translational Research Network and local health department meetings.Trial registration number NCT05758441.