Michael E. Hall, M.D.

Associate Professor, Chair, Department of Medicine, The University of Mississippi Medical Center

Food Delivery, Remote Monitoring, and coaching-Enhanced EDucation for Optimized Diabetes Management (FREEDOM)

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 suboptimal SDoH through three health systems in AL and MS. A randomized factorial optimization design using a multiphase 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. The FREEDOM 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.

Disease focus: Medically complex patients (i.e., those with DM on insulin and with existing cardiorenal disease);
Study population: Socially vulnerable Black adults within three health systems; one in Jackson, Mississipi (MS), one in Birmingham, Alabama (AL), and a safety net health system in Birmingham, Alabama (AL)
Study design: MOST trial testing three intervention components;
Intervention description:
1) Digital health coaching
2) Remote patient monitoring
3) Grocery delivery
Levels of action:
1) Individual-level (health behaviors, food insecurity, transportation barriers),
2) Interpersonal (Household environment) and
3) Community/system level (access to health care services, food environment)
Non-academic partner: Pack Health (AL) with a digital platform for chronic disease management

FREEDOM Research Project Status (NCT05288452): Recruiting participants. For more information, visit clinicaltrials.gov.