Eat Well Produce Benefit for Diabetes and Food Insecurity

Study Overview
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Brief Summary
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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: 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
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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.

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

Conditions
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Diabetes Mellitus, Food Insecurity

Intervention / Treatment
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* Other: Eat Well


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eat Well<br>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<br>* A program offered by Reinvestment Partners giving clients gift/debit cards that allow the purchase of WIC approved fruits and vegetables.<br>|
| No Intervention: Control<br>The control group will receive usual care (including diabetes educational materials) without the prescription benefit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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, and up to 18 months post program | 
| Change in number of ED Visits | Number of ED visits throughout the study period | up to 18 months pre program, during program, and up to 18 months post program enrollment | 

Secondary Outcome Measures

| Outcome Measure | 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 enrollment | 
| Hospitalizations | Number of patient hospitalizations during the study period | up to 18 months pre program, during program, and up to 18 months post program enrollment | 
| 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 enrollment | 
| Change in cholesterol | Measure of lipids | up to 18 months pre program, during program, and up to 18 months post program enrollment | 
| 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 enrollment | 
| 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 enrollment | 
| Change in blood pressure | Systolic and Diastolic blood pressure | up to 18 months pre program, during program, and up to 18 months post program enrollment |