Eat Well Produce Benefit for Diabetes and Food Insecurity

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus; Food Insecurity
• Interventions: Other: Eat Well

• Registration Number: NCT05896644
• Lead Sponsor: Duke University

Brief Summary

The goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity. The main questions it aims to answer are:

* whether there is a difference in Haemoglobin (Hb) A1c measurements and emergency department (ED) utilization between the Eat Well and control groups up to 18 months post-program completion.

* whether there are differences in cardiometabolic health-related outcomes for Eat Well participants.

Participants in the program will receive gift/debit cards for fruits and vegetables and educational nutrition materials. Researchers will compare Eat Well participants with those only receiving educational materials to see if there are differences in cardiometabolic health outcomes.

Detailed Description

This pragmatic trial aims to assess the impact of Eat Well participation for diabetes patients at risk of food insecurity. Eligible patients will receive gift/debit cards for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-approved fruits and vegetables and be assigned to either receive the card for up to 12 months or not. Random assignment will occur using a 2 to 1 treatment to control allocation ratio. Both treatment and control groups will receive curated diabetes educational materials. The study will assess the impact of the intervention on clinical factors such as glycemic control, weight, BMI, lipids, medication adherence, medication number, blood pressure, and utilization up to 18 months pre, during, and post program enrollment using data from clinical visits. The primary analysis of interest will be differences in HbA1c measurements and ED visits between the Eat Well and control groups at 12 months of program participation, with further evaluation of differences at 12 months post-program completion.

Study Timeline

• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-09
• Study Start: 2023-06-20
• Primary Completion: 2024-07-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2177

Inclusion Criteria

• Be active in the Duke Diabetes Registry in the past 12 months AND

• have had at least one outpatient A1c measurement AND

• are at risk for food insecurity as defined by one of the following:

  1. answered often true or sometimes true on one or both of the food insecurity questions as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
  2. answered hard or very hard to the financial stress question as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
  3. has Medicaid as insurance payer OR
  4. lives in Area Deprivation Index (ADI) zip code of 7th decile or harder

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eat Well	Eat Well	The experimental group will participate in the Eat Well Produce Prescription program, receiving an $80 monthly benefit for eligible produce for 12 months and diabetes education materials through email, including curated nutrition and diet information from the Diabetes Resource Page, consistent with standard of care at Duke University Health System.

Primary Outcome Measures

Name	Time	Method
Change in HbA1C	18 months pre program, during program enrollment, up to 12 months	A measure of average blood sugar levels over the past 3 months.
Change in number of ED Visits	up to 18 months pre program, during program enrollment, up to 12 months	Number of ED visits throughout the study period

Secondary Outcome Measures

Name	Time	Method
Outpatient visits	up to 18 months pre program, during program, and up to 18 months post program	Number of outpatient visits during the study period
Hospitalizations	up to 18 months pre program, during program, and up to 18 months post program	Number of patient hospitalizations during the study period
Change in weight	up to 18 months pre program, during program, and up to 18 months post program enrollment
Change in body mass index (BMI)	up to 18 months pre program, during program, and up to 18 months post program	A measure of body fat based on height and weight.
Change in cholesterol	up to 18 months pre program, during program, and up to 18 months post program	Measure of lipids
Change in number of diabetes and hypertension medications	up to 18 months pre program, during program, and up to 18 months post program	Change in diabetes and hypertension medication numbers
Change in blood pressure	up to 18 months pre program, during program, and up to 18 months post program	Systolic and Diastolic blood pressure
Change in HbA1C	18 months post program	A measure of average blood sugar levels over the past 3 months.
Change in number of ED Visits	18 months post program	Number of ED visits throughout the study period
Medication adherence (proportion of days covered)	up to 18 months pre program, during program, and up to 18 months post program	Medication adherence will be measured by linking EHR data with Surescripts e-prescription network data. Surescripts facilitates medication refill information exchange between healthcare organizations and pharmacies. Adherence will be calculated using the proportion of days covered (PDC) approach

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States