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Completed

NCT Number: NCT05896644

Eat Well Produce Benefit for Diabetes and Food Insecurity

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

  • none

Treatment and study plan

Eat Well

Other

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

Primary outcomes

  1. Change in HbA1C

    Time frame: 18 months pre program, during program enrollment, up to 12 months

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

  2. Change in number of ED Visits

    Time frame: up to 18 months pre program, during program enrollment, up to 12 months

    Number of ED visits throughout the study period

Secondary outcomes

  1. Outpatient visits

    Time frame: up to 18 months pre program, during program, and up to 18 months post program

    Number of outpatient visits during the study period

  2. Hospitalizations

    Time frame: up to 18 months pre program, during program, and up to 18 months post program

    Number of patient hospitalizations during the study period

  3. Change in weight

    Time frame: up to 18 months pre program, during program, and up to 18 months post program enrollment

  4. Change in body mass index (BMI)

    Time frame: 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.

  5. Change in cholesterol

    Time frame: up to 18 months pre program, during program, and up to 18 months post program

    Measure of lipids

  6. Medication adherence (proportion of days covered)

    Time frame: 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

  7. Change in number of diabetes and hypertension medications

    Time frame: up to 18 months pre program, during program, and up to 18 months post program

    Change in diabetes and hypertension medication numbers

  8. Change in blood pressure

    Time frame: up to 18 months pre program, during program, and up to 18 months post program

    Systolic and Diastolic blood pressure

  9. Change in HbA1C

    Time frame: 18 months post program

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

  10. Change in number of ED Visits

    Time frame: 18 months post program

    Number of ED visits throughout the study period

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

An Evaluation of Eat Well, a Produce Benefit, for Patients With Diabetes and At-risk for Food Insecurity

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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