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

> **NIH NIH P50** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2021 · $728,408

## Abstract

ABSTRACT
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.
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.

## Key facts

- **NIH application ID:** 10437096
- **Project number:** 1P50MD017338-01
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Tapan S Mehta
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $728,408
- **Award type:** 1
- **Project period:** 2021-09-24 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10437096

## Citation

> US National Institutes of Health, RePORTER application 10437096, Food Delivery, Remote Monitoring, and coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM) (1P50MD017338-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10437096. Licensed CC0.

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