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ACTIVE NOT RECRUITING
NCT05288452
NA

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

304

Start Date

2023-01-01

Completion Date

2026-06-30

Last Updated

2025-05-30

Healthy Volunteers

No

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.

Locations (1)

UAB Hospital and UMMC Cardiology Clinics

Birmingham, Alabama, United States