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NCT07529184Completed

Evaluation of the Impact of a Food is Medicine Program on Diabetes-related Health Outcomes for People With Type 2 Diabetes in a Low Income Community-based Setting Compared to Usual Care

A Two-Arm Randomized Controlled Trial to Evaluate the Impact of a Food Is Medicine Program on Diabetes-Related Health Outcomes in People With Type 2 Diabetes in a Low Income Community-Based Setting Compared to Usual Care

Source: ClinicalTrials.gov · Last updated 14 Apr 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn if a food is medicine intervention (Healthy Food Rx) improves diabetes-related outcomes in adults diagnosed with type 2 diabetes in a low-income, community-based setting more than usual care. The main questions the study aims to answer are: * Does Healthy Food Rx program participation lead to improved A1C values (a measure of glycemic control over approximately the past three months) over a 6-month period compared to usual care in a highly food insecure population? * Does the Healthy Food Rx program lead to improved diabetes-related behaviors over a 6-month period compared to usual care in a highly food insecure population? Researchers will compare the Healthy Food Rx program to usual care to see if diabetes-related outcomes, including A1C, fruit and vegetable consumption, food security, physical activity, diabetes self-management behaviors and general physical and mental health status, improved more in those receiving Healthy Food Rx. Healthy Food Rx is a program that provides home-delivered, family-sized, recipe-based healthy food boxes with an approximate value of $40 every other week for 6 months to people with Type 2 diabetes living in Stockton, CA. Produce is sourced from local Central Valley growers, and the boxes also include pantry staples like chicken, fish, egg, beans and healthy snacks, such as nuts, yogurt, and cheese. Nutrition education opportunities are also provided to participants. Participants will: * Complete surveys at two time points in either English or Spanish. The surveys last around 10 minutes and will be conducted by trained Health Educators. * Provide HIPAA consent to allow researchers to obtain A1C values and demographic information from their medical record. * Retest A1C around the conclusion of the study. Intervention participants will receive Healthy Food Rx immediately following enrollment and the control group will receive Healthy Food Rx at the end of the study.

Status (registry)
Completed
Study type
Interventional
Enrollment
405 (actual)
First submitted
8 Apr 2026
Start date
Jan 2024
Primary completion date
Jan 2025
Lead sponsor
Public Health Institute Center for Wellness and Nutrition
NCT number
NCT07529184

What you commit to

  • Study type: Interventional
  • Participants enrolled: 405
  • From Jan 2024 to the primary completion date, Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous program participant

Other

  • no home address to receive the food boxes
  • unable to receive text messages

Who the study is looking for

  • Adult (over age 18)
  • Diagnosed with Type 2 diabetes
  • Residing in Stockton, CA
  • Recent (within previous 3 months) A1C above 7%
  • Patient of study site clinic

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Community Medical Centers
Coordinator of this site? Confirm its status
StocktonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.