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

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT05288452
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-21
• Study Start: 2023-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months	6 months	The primary outcome of the study is to track change in the HbA1c between baseline and 6 months (endpoint of the study). The HbA1C will be tested at baseline and 6 months.
FREEDOM Study: Change in HbA1c level between baseline and 12 month	12 months	The primary outcome of the study is to track change in the HbA1c between baseline and 12 months (endpoint of the study). The HbA1C will be tested at baseline, 6 and 12 months.

Trial Locations

Locations (1)

UAB Hospital and UMMC Cardiology Clinics; 🇺🇸 Birmingham, Alabama, United States