Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Dietary Supplement: Food Box DeliveryBehavioral: Digital Health CoachingBehavioral: Diabetes Education ClassBehavioral: Remote Patient Monitoring (RPM)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 304
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm 8 Diabetes Education Class RPM Arm 7 Diabetes Education Class Food delivery Arm 7 Food Box Delivery Food delivery Arm 4 Diabetes Education Class Digital coaching+ RPM Arm 6 Diabetes Education Class The participant's will not receive any Intervention Arm 1 Digital Health Coaching Digital coaching+ Food delivery+ RPM Arm 1 Diabetes Education Class Digital coaching+ Food delivery+ RPM Arm 2 Digital Health Coaching Digital coaching Arm 2 Diabetes Education Class Digital coaching Arm 4 Remote Patient Monitoring (RPM) Digital coaching+ RPM Arm 5 Food Box Delivery Food delivery+ RPM Arm 5 Remote Patient Monitoring (RPM) Food delivery+ RPM Arm 1 Food Box Delivery Digital coaching+ Food delivery+ RPM Arm 3 Digital Health Coaching Digital coaching+ Food delivery Arm 3 Diabetes Education Class Digital coaching+ Food delivery Arm 4 Digital Health Coaching Digital coaching+ RPM Arm 5 Diabetes Education Class Food delivery+ RPM Arm 1 Remote Patient Monitoring (RPM) Digital coaching+ Food delivery+ RPM Arm 3 Food Box Delivery Digital coaching+ Food delivery Arm 8 Remote Patient Monitoring (RPM) RPM
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UAB Hospital and UMMC Cardiology Clinics
🇺🇸Birmingham, Alabama, United States