NCT05288452

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Detailed Description: 1. FREEDOM Study (Type 2 Diabetes Mellitus): The FREEDOM study is a 12-month clinical trial enrolling 304 Black adults with Type 2 Diabetes Mellitus across three healthcare systems in Alabama and Mississippi. Participants are randomly assigned to one of eight combinations of three intervention components: * Digital Health Coaching: Participants receive one-on-one phone-based coaching for optimized diabetes management. * Food Box Delivery: Food boxes are delivered every two weeks to participants' homes, * Remote Patient Monitoring (RPM): Participants receive essential supplies, including glucometers, for remote blood glucose measurement. Data is monitored remotely for timely interventions. The study involves three in-person visits at baseline, month 6, and month 12, as well as two telephone study check-ins at month 3 and 9. Survey packets are administered at each time point. 2. FREEDOM-HIV Study (Type 2 Diabetes Mellitus and HIV Cohort): Additionally, a cohort within the study, known as the FREEDOM-HIV study, will enroll additional 80 adults who have both Type 2 Diabetes Mellitus and HIV. This cohort will be observed over a 6-month period and will also consist of the same three intervention components.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-03-21
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States