Eat Well Produce Benefit for Diabetes and Food Insecurity

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Food Insecurity
• Intervention / Treatment: Other: Eat Well

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Connor Drake, PhD; Phone Number: +1 919 724 2129; Email: connor.drake@duke.edu
• Study Contact Backup: Name: Susan Spratt, MD; Phone Number: +1 919 668 5360; Email: susan.spratt@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Recruiting
      • Duke University Health System
      • Contact: Connor Drake, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Pro00112649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No