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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Remote Patient Monitoring (RPM); Behavioral: Diabetes Education Class; Dietary Supplement: Food Box Delivery; Behavioral: Digital Health Coaching

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05288452

5P50MD017338-03 (U.S. NIH Grant/Contract)

IRB-300008387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. has the ability to converse in and read English
7. 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 ≥ 7%
4. Confirmed HIV+ diagnosis
5. 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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304 participants in 8 patient groups

Arm 1

Experimental group

Description:

Digital coaching+ Food delivery+ RPM

Treatment:

Behavioral: Digital Health Coaching

Dietary Supplement: Food Box Delivery

Behavioral: Diabetes Education Class

Behavioral: Remote Patient Monitoring (RPM)

Arm 2

Active Comparator group

Description:

Digital coaching

Treatment:

Behavioral: Digital Health Coaching

Behavioral: Diabetes Education Class

Arm 3

Active Comparator group

Description:

Digital coaching+ Food delivery

Treatment:

Behavioral: Digital Health Coaching

Dietary Supplement: Food Box Delivery

Behavioral: Diabetes Education Class

Arm 4

Active Comparator group

Description:

Digital coaching+ RPM

Treatment:

Behavioral: Digital Health Coaching

Behavioral: Diabetes Education Class

Behavioral: Remote Patient Monitoring (RPM)

Arm 5

Active Comparator group

Description:

Food delivery+ RPM

Treatment:

Dietary Supplement: Food Box Delivery

Behavioral: Diabetes Education Class

Behavioral: Remote Patient Monitoring (RPM)

Arm 6

Active Comparator group

Description:

The participant's will not receive any Intervention

Treatment:

Behavioral: Diabetes Education Class

Arm 7

Active Comparator group

Description:

Food delivery

Treatment:

Dietary Supplement: Food Box Delivery

Behavioral: Diabetes Education Class

Arm 8

Active Comparator group

Description:

RPM

Treatment:

Behavioral: Diabetes Education Class

Behavioral: Remote Patient Monitoring (RPM)