Eat Well Produce Benefit for Diabetes and Food Insecurity

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896644
• Other study ID #: Pro00112649
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: Connor Drake, PhD
• Phone: +1 919 724 2129
• Email: connor.drake[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Food Insecurity

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Change in weight		up to 18 months pre program, during program, and up to 18 months post program enrollment
Secondary	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
Secondary	Change in cholesterol	Measure of lipids	up to 18 months pre program, during program, and up to 18 months post program enrollment
Secondary	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
Secondary	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
Secondary	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

External Links

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