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

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ClinicalTrials.gov Identifier: NCT05288452
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : December 7, 2023
Sponsor:
Collaborators:
University of Mississippi Medical Center
Cooper Green Mercy Health Services
Pack Health
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Tapan Shirish Mehta, University of Alabama at Birmingham

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Digital Health Coaching Dietary Supplement: Food Box Delivery Behavioral: Remote Patient Monitoring (RPM) Behavioral: Diabetes Education Class Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
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.
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : July 1, 2026
Estimated Study Completion Date : December 1, 2027

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. SDoH local area deprivation index (ADI) ≥5
  7. has the ability to converse in and read English
  8. 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 ≥ 8%
  4. SDoH local area deprivation index (ADI) ≥ 5
  5. Confirmed HIV+ diagnosis
  6. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05288452


Contacts
Layout table for location contacts
Contact: Tapan Mehta, MSEE, PhD 205-975-9171 tapan@uab.edu
Contact: Aseel El Zein, MS, PhD, RDN aelzein@uab.edu

Locations
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United States, Alabama
UAB Hospital and UMMC Cardiology Clinics Recruiting
Birmingham, Alabama, United States, 35205
Contact: Destiny Taylor - for Alabama Inquiries, MPH    205-224-2567    destinytaylor@uabmc.edu   
Contact: Maddie Chaney - for Mississipi Inquiries, MS    601-815-8702    mchaney@ummc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
University of Mississippi Medical Center
Cooper Green Mercy Health Services
Pack Health
National Institute on Minority Health and Health Disparities (NIMHD)
Layout table for additonal information
Responsible Party: Tapan Shirish Mehta, Professor, Director of Research, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05288452    
Other Study ID Numbers: IRB-300008387
5P50MD017338-03 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2022    Key Record Dates
Last Update Posted: December 7, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tapan Shirish Mehta, University of Alabama at Birmingham:
Diabetes Mellitus, Type 2
HIV
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases