Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
FREEDOM
2 other identifiers
interventional
304
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jan 2023
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 30, 2025
May 1, 2025
3.5 years
February 17, 2022
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (8)
Arm 1
EXPERIMENTALDigital coaching+ Food delivery+ RPM
Arm 2
ACTIVE COMPARATORDigital coaching
Arm 3
ACTIVE COMPARATORDigital coaching+ Food delivery
Arm 4
ACTIVE COMPARATORDigital coaching+ RPM
Arm 5
ACTIVE COMPARATORFood delivery+ RPM
Arm 6
ACTIVE COMPARATORThe participant's will not receive any Intervention
Arm 7
ACTIVE COMPARATORFood delivery
Arm 8
ACTIVE COMPARATORRPM
Interventions
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.
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.
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.
The diabetes education class will be administered by a certified diabetes educator.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- ≥ 18 years of age
- ICD diagnosis of T2DM
- HbA1c ≥ 7%
- Confirmed HIV+ diagnosis
- Prescribed HIV ART therapy as part of care
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- University of Mississippi Medical Centercollaborator
- Cooper Green Mercy Health Servicescollaborator
- Pack Healthcollaborator
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
Study Sites (1)
UAB Hospital and UMMC Cardiology Clinics
Birmingham, Alabama, 35205, United States
Related Publications (1)
El Zein A, Garla V, Hall ME, Nawshin T, Hays D, John T, Delaney E, Wallace E, Hearld L, Cherrington AL, Mehta T. Rationale and design of the FREEDOM study: A hybrid type 1 optimization-implementation trial to improve type 2 diabetes management in primary care. Contemp Clin Trials. 2026 Feb;161:108173. doi: 10.1016/j.cct.2025.108173. Epub 2025 Dec 5.
PMID: 41354173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of Research
Study Record Dates
First Submitted
February 17, 2022
First Posted
March 21, 2022
Study Start
January 1, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share