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

Diabetes Mellitus, Type 2 Clinical Trial

— FREEDOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288452
• Other study ID #: IRB-300008387
• Secondary ID: 5P50MD017338-03
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Tapan Mehta, MSEE, PhD
• Phone: 205-975-9171
• Email: tapan[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Self-identified as Black/African American

2. ICD diagnosis of T2DM

3. =18 years of age

4. Ongoing insulin treatment

5. HbA1c =8% within 6 weeks of study screening

6. SDoH local area deprivation index (ADI) =5

7. has the ability to converse in and read English

8. must provide written informed consent prior to enrollment

Exclusion criteria:

1. Current enrollment in any diabetes-related interventional study

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

Inclusion Criteria

1. = 18 years of age

2. ICD diagnosis of T2DM

3. HbA1c = 8%

4. SDoH local area deprivation index (ADI) = 5

5. Confirmed HIV+ diagnosis

6. Prescribed HIV ART therapy as part of care

Exclusion 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.

Dietary Supplement:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UAB Hospital and UMMC Cardiology Clinics	Birmingham	Alabama

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Cooper Green Mercy Health Services, National Institute on Minority Health and Health Disparities (NIMHD), Pack Health, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FREEDOM Study: Change in HbA1c level between baseline and 12 month	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.	12 months
Primary	Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 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.	6 months