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

Part of paid clinical trials in Stockton, California.

Sponsor
Public Health Institute Center for Wellness and Nutrition
Study ID
NCT07529184
Status
Completed

Conditions

  • Diabetes (DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Food is medicine — DIETARY_SUPPLEMENT
    Healthy Food Rx provides family-sized, recipe-based healthy food boxes with an approximate value of $40 every other week for 6 months. The boxes are home-delivered and complementary nutrition education opportunities are provided to participants. Produce is sourced from local Central Valley growers, and the boxes include pantry staples like chicken, fish, egg, beans and healthy snacks, such as nuts, yogurt, and cheese.

Study Details

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.

Key Dates

Start date
Jan 16, 2024
Status verified
Apr 2026
Primary completion
Jan 21, 2025
Completion
Jan 21, 2025

Study Design

Enrollment
405 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention group
    This group will receive Healthy Food Rx after enrollment.
  • No Intervention: Control group
    This group will not receive Healthy Food Rx during the study, however they will receive Healthy Food Rx after the study conclusion.

Primary Outcome Measure

Hemoglobin A1C [ Time Frame: They will be measured at 2 points in time. Baseline value is valid up to 3 months before enrollment Follow-up, A1C measures are valid from 60 days before to 90 days after the last food box delivery. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Community Medical CentersStocktonCalifornia95210-

Find similar trials in Stockton, CA

By research site
Community Medical Centers· Stockton, CA

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