Eat Well Produce Benefit for Diabetes and Food Insecurity

NCT ID: NCT05896644

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2026-01-31

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.

Conditions

Diabetes Mellitus; Food Insecurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Eat Well

Intervention Type: OTHER

A program offered by Reinvestment Partners giving clients gift/debit cards that allow the purchase of WIC approved fruits and vegetables.

Control

The control group will receive usual care (including diabetes educational materials) without the prescription benefit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Eat Well

A program offered by Reinvestment Partners giving clients gift/debit cards that allow the purchase of WIC approved fruits and vegetables.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

References

Drake C, Granados I, Rader A, Brucker A, Hoeffler S, Goldstein BA, Chamorro C, Johnson F, Hinz EM, Bedoya AD, German JC, Hauser J, Thacker C, Spratt SE. Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial. Contemp Clin Trials. 2024 Oct;145:107655. doi: 10.1016/j.cct.2024.107655. Epub 2024 Aug 5.

Reference Type: DERIVED

PMID: 39111387 (View on PubMed)

Related Links

http://diabetes.my.dukehealth.org

Resource guide to be provided to all patients, regardless of selection in intervention or control group

https://nf01.diabeteseducator.org/eweb/DynamicPage.aspx?Site=aade&WebCode=DEAPFindApprovedProgram

Link provided to all patients to find diabetes self management education and support in their area

Other Identifiers

Pro00112649

Identifier Type: -

Identifier Source: org_study_id