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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Digital Health Coaching; Dietary supplement: Food Box Delivery; Behavioral: Remote Patient Monitoring (RPM); Behavioral: Diabetes Education Class

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.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tapan Mehta, MSEE, PhD; Phone Number: 205-975-9171; Email: tapan@uab.edu
• Study Contact Backup: Name: Aseel El Zein, MS, PhD, RDN; Email: aelzein@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • UAB Hospital and UMMC Cardiology Clinics
      • Contact: Destiny Taylor - for Alabama Inquiries, MPH; Phone Number: 205-224-2567; Email: destinytaylor@uabmc.edu
      • Contact: Maddie Chaney - for Mississipi Inquiries, MS; Phone Number: 601-815-8702; Email: mchaney@ummc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Digital coaching+ Food delivery+ RPM	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.; Behavioral: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.
Active Comparator: Arm 2; Digital coaching	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.; Behavioral: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.
Active Comparator: Arm 3; Digital coaching+ Food delivery	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: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.
Active Comparator: Arm 4; Digital coaching+ RPM	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.; 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.; Behavioral: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.
Active Comparator: Arm 5; Food delivery+ RPM	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.; Behavioral: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.
Active Comparator: Arm 6; The participant's will not receive any Intervention	Behavioral: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.
Active Comparator: Arm 7; Food delivery	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: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.
Active Comparator: Arm 8; RPM	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.; Behavioral: Diabetes Education Class; The diabetes education class will be administered by a certified diabetes educator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); University of Mississippi Medical Center; Pack Health; Cooper Green Mercy Health Services

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Diabetes Mellitus, Type 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-300008387; 5P50MD017338-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No