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

Summary

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.

Conditions

• Diabetes (DM)

Interventions

DIETARY_SUPPLEMENT

Food is medicine

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.

Sponsors & Collaborators

• Abbott Fund

  collaborator UNKNOWN

• Community Medical Centers

  collaborator UNKNOWN

• Emergency Food Bank of Stockton

  collaborator UNKNOWN

• Public Health Institute Center for Wellness and Nutrition

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-16

Primary Completion

2025-01-21

Completion

2025-01-21

Countries

• United States

Study Locations