Eat Well Produce Benefit for Diabetes and Food Insecurity

NCT05896644 | Completed

• 1 other identifier: Pro00112649
• Study Type: interventional
• Target: 2,177
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Food Insecurity

Outcome Measures

Primary Outcomes (2)

• Change in HbA1C

  A measure of average blood sugar levels over the past 3 months.

  18 months pre program, during program enrollment, up to 12 months

• Change in number of ED Visits

  Number of ED visits throughout the study period

  up to 18 months pre program, during program enrollment, up to 12 months

Secondary Outcomes (10)

• Outpatient visits

  up to 18 months pre program, during program, and up to 18 months post program

• Hospitalizations

  up to 18 months pre program, during program, and up to 18 months post program

• 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

• Change in cholesterol

  up to 18 months pre program, during program, and up to 18 months post program

Study Arms (2)

Eat Well

EXPERIMENTAL

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.

Other: Eat Well

Control

NO INTERVENTION

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

Interventions

Eat Well OTHER

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

Eat Well

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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
• has Medicaid as insurance payer OR
• lives in Area Deprivation Index (ADI) zip code of 7th decile or harder

You may not qualify if:

• none

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27708, United States

Location

Related Publications (3)

• Rader A, Buckman C, Pignone M, German JC, Spratt SE, McPeek Hinz E, Brucker A, Hoeffler S, Kane RM, Drake C. Factors Associated with Produce Prescription Program Enrollment and Benefit Use Among Patients with Diabetes and At Risk for Food Insecurity. J Nutr. 2026 Apr 24:101548. doi: 10.1016/j.tjnut.2026.101548. Online ahead of print.

  PMID: 42036037 DERIVED

• Drake C, Buckman C, Brucker A, McPeek Hinz E, Pignone M, Shaikha H, Rader A, Granados I, Goldstein BA, Chamorro C, Hoeffler S, Wirth C, Spratt SE. Produce Prescription Subsidy for Patients With Diabetes: A Pragmatic Randomized Clinical Trial. JAMA Intern Med. 2026 Apr 1;186(4):416-424. doi: 10.1001/jamainternmed.2025.8008.

  PMID: 41697676 DERIVED

• 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.

  PMID: 39111387 DERIVED

Related Links

• Resource guide to be provided to all patients, regardless of selection in intervention or control group
• Link provided to all patients to find diabetes self management education and support in their area

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 9, 2023
• Study Start: June 20, 2023
• Primary Completion: July 16, 2024
• Study Completion: May 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)