Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Tapan Shirish Mehta
Professor, Director of Research
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
Time Frame: 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
Time Frame: 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.