Food delivery, Remote monitoring, and coaching-Enhanced EDucation for Optimized diabetes Management (FREEDOM)
- Principal Investigator (MPI): Tapan Mehta, PhD University of Alabama at Birmingham
- Principal Investigator (MPI): Michael Hall, MD, University of Mississippi Medical Center
Deep South states, including Alabama (AL) and Mississippi (MS), have the highest rates of type 2 diabetes mellitus (T2DM) and some of the worst outcomes due to T2DM-related cardiovascular disease (CVD) and chronic kidney disease (CKD). T2DM and related cardiorenal diseases disproportionately burden Black Americans.
Over half of the racial health disparities related to T2DM can be attributed to social determinants of health (SDoH), including reduced healthcare access, poverty, transportation barriers, and food insecurity. There is a need for effective and sustainable intervention packages that address T2DM-related outcomes and improve health equity.
The overall goal of the Food delivery, Remote monitoring, and coaching-Enhanced EDucation for Optimized diabetes Management (FREEDOM) study (Project 3) is to develop an optimized, multilevel, and scalable intervention to improve T2DM control in low-income Black adults with T2DM and cardiorenal complications in the Deep South by targeting relevant SDoH.
The FREEDOM study will enroll 304 Black adults with sub-optimal SDoH through three health systems in AL and MS. A randomized factorial optimization design using a multi-phase optimization strategy (MOST) will evaluate three intervention components: 1) digital health coaching, 2) food box delivery, and 3) remote patient monitoring (RPM). Thus, this project will evaluate multilevel interventions that address changes at the individual (patient), interpersonal (patient-care team communication), organizational (healthcare system–delivered RPM), and community (food box delivery) levels to improve T2DM management among socially vulnerable Black adults with cardiorenal comorbidities (CVD or CKD).
- Aim 1 will identify the combination(s) of the three intervention components that reduce HbA1c (primary outcome) at 12 months.
- Aim 2 includes within-trial cost-utility analyses of intervention components.
- Aim 3 will identify contextual factors that impact implementation of these different interventions using a Consolidated Framework for Implementation (CFIR) approach, and the implementation outcomes will be assessed via the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
This study will leverage multi-healthcare system and healthcare system–industry partnerships to develop optimized, sustainable intervention strategies to improve T2DM outcomes in socially vulnerable Black adults living in the Deep South.