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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50MD017338-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Mississippi Medical Center | OTHER |
| Cooper Green Mercy Health Services | UNKNOWN |
| Pack Health | INDUSTRY |
| National Institute on Minority Health and Health Disparities (NIMHD) |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Digital coaching+ Food delivery+ RPM |
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| Arm 2 | Active Comparator | Digital coaching |
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| Arm 3 | Active Comparator | Digital coaching+ Food delivery |
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| Arm 4 | Active Comparator | Digital coaching+ RPM |
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| Arm 5 | Active Comparator | Food delivery+ RPM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion criteria:
Exclusion criteria:
HIV Cohort Criteria
Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital and UMMC Cardiology Clinics | Birmingham | Alabama | 35205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41354173 | Derived | 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. |
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| NIH |
We used the multiphase optimization strategy (MOST) as the ideal approach for the proposed study as, with the three proposed intervention components, identifying an optimal intervention through a single randomized controlled trial (RCT) with multiple arms or through multiple RCTs would be methodologically inefficient and resource-intensive. Given this, we rely on the eloquent and rigorous MOST-based optimization design, which leverages factorial experimentation to identify an optimal set of intervention component(s). In a factorial experiment, the goal is not to compare individual experimental conditions (in this case, eight conditions), but to use combinations of conditions to estimate the main and interaction effects of the intervention components. Thus, numerous intervention components can be evaluated simultaneously while utilizing the entire randomized sample.
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| Arm 6 | Active Comparator | The participant's will not receive any Intervention |
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| Arm 7 | Active Comparator | Food delivery |
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| Arm 8 | Active Comparator | RPM |
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| 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. |
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| 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. |
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| Diabetes Education Class | Behavioral | The diabetes education class will be administered by a certified diabetes educator. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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