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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.
Conditions:
🦠 Diabetes Mellitus 🦠 Food Insecurity
🗓️ Study Start (Actual) 20 June 2023
🗓️ Primary Completion (Estimated) June 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 3000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 May 2023
  • First Submitted that Met QC Criteria 8 June 2023
  • First Posted 9 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 June 2023
  • Last Update Posted 26 June 2023
  • Last Verified June 2023
I'm interested ...!!