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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 : April 26, 2024
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

Tracking Information
First Submitted Date  ICMJE February 17, 2022
First Posted Date  ICMJE March 21, 2022
Last Update Posted Date April 26, 2024
Actual Study Start Date  ICMJE January 1, 2023
Estimated Primary Completion Date June 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2023)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2022)		 Change in HbA1C level between baseline and 12 month [ Time Frame: 12 months ]
The inclusion criteria for a participant enrolling in the study is HbA1c ≥8%. 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. The measure of HbA1C at the end of 6 months (end of the intervention period) will be considered as the primary outcome, to assess the effectiveness of the intervention and HbA1C measured at the end of the 12-month period will be considered as the primary endpoint to measure if the participants have benefitted from the interventions and are able to maintain their HbA1C levels by sustaining the behavioral changes during the maintenance phase, without any guidance and support.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
Official Title  ICMJE Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Arm 1
    Digital coaching+ Food delivery+ RPM
    Interventions:
    • Behavioral: Digital Health Coaching
    • Dietary Supplement: Food Box Delivery
    • Behavioral: Remote Patient Monitoring (RPM)
    • Behavioral: Diabetes Education Class
  • Active Comparator: Arm 2
    Digital coaching
    Interventions:
    • Behavioral: Digital Health Coaching
    • Behavioral: Diabetes Education Class
  • Active Comparator: Arm 3
    Digital coaching+ Food delivery
    Interventions:
    • Behavioral: Digital Health Coaching
    • Dietary Supplement: Food Box Delivery
    • Behavioral: Diabetes Education Class
  • Active Comparator: Arm 4
    Digital coaching+ RPM
    Interventions:
    • Behavioral: Digital Health Coaching
    • Behavioral: Remote Patient Monitoring (RPM)
    • Behavioral: Diabetes Education Class
  • Active Comparator: Arm 5
    Food delivery+ RPM
    Interventions:
    • Dietary Supplement: Food Box Delivery
    • Behavioral: Remote Patient Monitoring (RPM)
    • Behavioral: Diabetes Education Class
  • Active Comparator: Arm 6
    The participant's will not receive any Intervention
    Intervention: Behavioral: Diabetes Education Class
  • Active Comparator: Arm 7
    Food delivery
    Interventions:
    • Dietary Supplement: Food Box Delivery
    • Behavioral: Diabetes Education Class
  • Active Comparator: Arm 8
    RPM
    Interventions:
    • Behavioral: Remote Patient Monitoring (RPM)
    • Behavioral: Diabetes Education Class
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2022)		 304
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2026
Estimated Primary Completion Date June 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tapan Mehta, MSEE, PhD 205-975-9171 tapan@uab.edu
Contact: Aseel El Zein, MS, PhD, RDN aelzein@uab.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05288452
Other Study ID Numbers  ICMJE IRB-300008387
5P50MD017338-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tapan Shirish Mehta, University of Alabama at Birmingham
Original Responsible Party Tapan Shirish Mehta, University of Alabama at Birmingham, Associate Professor, Director of Research
Current Study Sponsor  ICMJE University of Alabama at Birmingham
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Mississippi Medical Center
  • Cooper Green Mercy Health Services
  • Pack Health
  • National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP