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Active, Not Recruiting

NCT Number: NCT05288452

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Hospital and UMMC Cardiology Clinics

Birmingham, Alabama, 35205, United States

About this study

Detailed Description:

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Digital Health Coaching

Behavioral

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

Dietary Supplement

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)

Behavioral

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

Behavioral

The diabetes education class will be administered by a certified diabetes educator.

Primary outcomes

  1. FREEDOM Study: Change in HbA1c level between baseline and 12 month

    Time frame: 12 months

    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.

  2. Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Cooper Green Mercy Health Services
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Pack Health
  • University of Mississippi Medical Center

Registry information

Acronym: FREEDOM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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