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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Digital Health Coaching
* Dietary Supplement: Food Box Delivery
* Behavioral: Remote Patient Monitoring (RPM)
* Behavioral: Diabetes Education Class


Participation Criteria
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Eligibility Criteria
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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 SDoH local area deprivation index (ADI) ≥5 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 ≥ 8% SDoH local area deprivation index (ADI) ≥ 5 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Digital coaching+ Food delivery+ RPM | Behavioral: Digital Health Coaching<br>* 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.<br>Dietary Supplement: Food Box Delivery<br>* 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.<br>Behavioral: Remote Patient Monitoring (RPM)<br>* 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.<br>Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|
| Active Comparator: Arm 2<br>Digital coaching | Behavioral: Digital Health Coaching<br>* 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.<br>Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|
| Active Comparator: Arm 3<br>Digital coaching+ Food delivery | Behavioral: Digital Health Coaching<br>* 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.<br>Dietary Supplement: Food Box Delivery<br>* 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.<br>Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|
| Active Comparator: Arm 4<br>Digital coaching+ RPM | Behavioral: Digital Health Coaching<br>* 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.<br>Behavioral: Remote Patient Monitoring (RPM)<br>* 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.<br>Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|
| Active Comparator: Arm 5<br>Food delivery+ RPM | Dietary Supplement: Food Box Delivery<br>* 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.<br>Behavioral: Remote Patient Monitoring (RPM)<br>* 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.<br>Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|
| Active Comparator: Arm 6<br>The participant's will not receive any Intervention | Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|
| Active Comparator: Arm 7<br>Food delivery | Dietary Supplement: Food Box Delivery<br>* 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.<br>Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|
| Active Comparator: Arm 8<br>RPM | Behavioral: Remote Patient Monitoring (RPM)<br>* 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.<br>Behavioral: Diabetes Education Class<br>* The diabetes education class will be administered by a certified diabetes educator.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Diabetes Mellitus, Type 2