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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | The control group will receive usual care (including diabetes educational materials) without the prescription benefit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eat Well | Other | A program offered by Reinvestment Partners giving clients gift/debit cards that allow the purchase of WIC approved fruits and vegetables. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Outpatient visits | Number of outpatient visits during the study period | up to 18 months pre program, during program, and up to 18 months post program |
| Hospitalizations | Number of patient hospitalizations during the study period |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42036037 | Derived | 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 Jun;156(6):101548. doi: 10.1016/j.tjnut.2026.101548. Epub 2026 Apr 25. | |
| 41697676 |
| Label | URL |
|---|---|
| Resource guide to be provided to all patients, regardless of selection in intervention or control group | View source |
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Access to all participant data and information will be restricted to authorized personnel. Internal monitoring of data may occur as required by Duke for investigator-initiated clinical research.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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) | A measure of body fat based on height and weight. | up to 18 months pre program, during program, and up to 18 months post program |
| Change in cholesterol | Measure of lipids | up to 18 months pre program, during program, and up to 18 months post program |
| Medication adherence (proportion of days covered) | 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 | up to 18 months pre program, during program, and up to 18 months post program |
| Change in number of diabetes and hypertension medications | Change in diabetes and hypertension medication numbers | up to 18 months pre program, during program, and up to 18 months post program |
| Change in blood pressure | Systolic and Diastolic blood pressure | up to 18 months pre program, during program, and up to 18 months post program |
| Change in HbA1C | A measure of average blood sugar levels over the past 3 months. | 18 months post program |
| Change in number of ED Visits | Number of ED visits throughout the study period | 18 months post program |
| 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. |
| 39111387 | 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. |
| Link provided to all patients to find diabetes self management education and support in their area | View source |