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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05288452

Collaborator

University of Mississippi Medical Center (Other), Cooper Green Mercy Health Systems (Other), Pack Health (Industry)

304

Enrollment

Arms

51.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM) study is to develop an optimized, multilevel, and scalable intervention to improve type 2 diabetes mellitus (T2DM) control in low-income Black adults in the Deep South by targeting relevant social determinants of health (SDoH) including reduced healthcare access, poverty, transportation barriers, and food insecurity. The FREEDOM study will enroll 304 Black adults with T2DM and T2DM-related cardiovascular disease (CVD) and chronic kidney disease (CKD), as they disproportionately burden Black Americans, through three health systems in Alabama and Mississippi. This project will be comprised of three intervention components: 1) digital health coaching, 2) food box delivery, and 3) remote patient monitoring (RPM).

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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program	N/A

Study Design

Study Type:

Interventional

Anticipated 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.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)

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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 4 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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.
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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.
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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.
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 4 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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.
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 4 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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.
Active Comparator: Arm 6 The participant's will not receive any Intervention	Behavioral: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.
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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.
Active Comparator: Arm 8 RPM	Behavioral: Remote Patient Monitoring (RPM) The RPM team will instruct the participants to monitor blood glucose levels 4 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: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program DSMES program is certified by the American Diabetes Association (ADA) and provided by an ADA-certified diabetes educator. DSMES includes 4-6 hours of interactive group classes covering topics related to diabetes management.

Outcome Measures

Primary Outcome Measures

Change in HbA1C level between baseline and 12 month [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥18 years of age.
self-identified as the black race.
ICD (Implantable cardioverter-defibrillator) diagnosis of Type 2Diabetes Mellitus and either Cardiovascular disease (including coronary artery disease, stroke, or heart failure) or Chronic kidney disease referred by a primary care provider.
ongoing insulin treatment
HbA1c ≥8%
local area deprivation index (ADI) ≥9
has a PCP
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
severe untreated depression in the past 6 months
major cardiac events in the past 12 months
resting tachycardia
end-stage kidney disease
present or plans to become pregnant within 12 months
currently enrolled in s structured lifestyle change program or intervention.
All successfully screened participants must provide written informed consent prior to enrollment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alabama at Birmingham
University of Mississippi Medical Center
Cooper Green Mercy Health Systems
Pack Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tapan Shirish Mehta, Associate Professor, Director of Research, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05288452

Other Study ID Numbers:

IRB-300008387

First Posted:

Mar 21, 2022

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tapan Shirish Mehta, Associate Professor, Director of Research, University of Alabama at Birmingham

Type 2Diabetes Mellitus -related cardiovascular disease (CVD)

Type 2Diabetes Mellitus -related chronic kidney disease (CKD)

Diabetes Mellitus, Type 2

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 6, 2022