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

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 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six months of publication or 18 months of the conclusion of the funding period (November 2025) if the study remains unpublished.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.