Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
NCT ID: NCT05288452
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
304 participants
INTERVENTIONAL
2023-01-01
2026-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm 1
Digital coaching+ Food delivery+ RPM
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.
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.
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Arm 2
Digital coaching
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Arm 3
Digital coaching+ Food delivery
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.
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Arm 4
Digital coaching+ RPM
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.
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Arm 5
Food delivery+ RPM
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.
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Arm 6
The participant's will not receive any Intervention
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Arm 7
Food delivery
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Arm 8
RPM
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Interventions
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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.
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.
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.
Diabetes Education Class
The diabetes education class will be administered by a certified diabetes educator.
Eligibility Criteria
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Inclusion Criteria
2. ICD diagnosis of T2DM
3. ≥18 years of age
4. Ongoing insulin treatment
5. HbA1c ≥8% within 6 weeks of study screening
6. has the ability to converse in and read English
7. must provide written informed consent prior to enrollment
1. ≥ 18 years of age
2. ICD diagnosis of T2DM
3. HbA1c ≥ 7%
4. Confirmed HIV+ diagnosis
5. Prescribed HIV ART therapy as part of care
Exclusion Criteria
2. Cognitive impairment
3. End-stage kidney disease (CKD-5)
4. Pregnant or plans to become pregnant within 12 months
5. Currently enrolled in a structured lifestyle change program
6. Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
HIV Cohort Criteria
1. Current enrollment in any diabetes-related interventional study or structured lifestyle change program
2. Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
3. Cognitive impairment
4. End-stage kidney disease (CKD-5)
5. Pregnant or plans to become pregnant within 12 months
18 Years
ALL
No
Sponsors
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University of Mississippi Medical Center
OTHER
Cooper Green Mercy Health Services
UNKNOWN
Pack Health
INDUSTRY
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Tapan Shirish Mehta
Professor, Director of Research
Locations
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UAB Hospital and UMMC Cardiology Clinics
Birmingham, Alabama, United States
Countries
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Other Identifiers
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IRB-300008387
Identifier Type: -
Identifier Source: org_study_id
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