Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
Running, not enrolling · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
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 facts
- Study ID
- NCT05288452
- Run by
- University of Alabama at Birmingham
- People needed
- 304
- Starts
- 2023-01-05
- Expected to finish
- 2026-07-18
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Self-identified as Black/African American
- ICD diagnosis of T2DM
- ≥18 years of age
- Ongoing insulin treatment
- HbA1c ≥8% within 6 weeks of study screening
- has the ability to converse in and read English
- must provide written informed consent prior to enrollment
You may not qualify if…
- Current enrollment in any diabetes-related interventional study
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
- Currently enrolled in a structured lifestyle change program
- Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
- HIV Cohort Criteria
- Inclusion Criteria
- ≥ 18 years of age
- ICD diagnosis of T2DM
- HbA1c ≥ 7%
- Confirmed HIV+ diagnosis
- Prescribed HIV ART therapy as part of care
- Exclusion Criteria
- Current enrollment in any diabetes-related interventional study or structured lifestyle change program
- Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
Where it is running
- UAB Hospital and UMMC Cardiology Clinics — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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