Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. has the ability to converse in and read English 7. 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 ≥ 7% 4. Confirmed HIV+ diagnosis 5. 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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention 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.
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

UAB Hospital and UMMC Cardiology Clinics
Birmingham, Alabama 35205
Contact:
Druss Hays - for Alabama Inquiries, BS
drusskhays@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Tapan Mehta, MSEE, PhD
205-975-9171
tapan@uab.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.