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

Summary

Brief Summary:

The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.

Conditions

• Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Digital Health Coaching

The digital health coaching intervention program involves an evidence-based curriculum and one-on-one support to promote positive health behaviors and patient self-management of diabetes.

DIETARY_SUPPLEMENT

Food Box Delivery

The food box intervention component will consist of biweekly food boxes delivered directly to participants over the course of 6 months. The food boxes will contain shelf-stable groceries that adhere to ADA nutritional guidelines for individuals with T2DM.

BEHAVIORAL

Remote Patient Monitoring (RPM)

The RPM team will instruct the participants to monitor blood glucose levels 3 times daily. Glucose levels will be monitored 8 a.m. to 5 p.m.Monday to Friday. Data summaries will be reviewed bi-monthly with RNs and pharmacists. Participants will be provided with a glucometer, test strips, and mobile divide to record their blood glucose levels.

BEHAVIORAL

Diabetes Education Class

The diabetes education class will be administered by a certified diabetes educator.

Sponsors & Collaborators

• University of Mississippi Medical Center

  collaborator OTHER

• Cooper Green Mercy Health Services

  collaborator UNKNOWN

• Pack Health

  collaborator INDUSTRY

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• United States

Study Locations