NCT05138432 · University of California, San Diego
More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
What this study is about
Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic.
View original scientific description
Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).
Interventions
BEHAVIORAL
Fruit and Vegetable Prescription Voucher
Each participant will immediately (intervention group) or after a 6-month waiting period (delayed-intervention group) receive seven $15 vouchers (value $105 per month) for 12 months. Up to 4 vouchers ($60 total) can be redeemed at any one transaction for purchase of fresh fruits and vegetables, dried beans and legumes at participating Northgate Gonzalez markets. Both groups will continue to receive diabetes and nutrition education as is standard in their practice.
Primary outcome measures
Change in Household food security
Time frame: Survey will be completed at baseline and 12 months
18-item US Household Food Security Survey Module
Change in Hemoglobin A1c
Time frame: Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months
Point of care A1c
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \< 18 years old
- Diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c greater than or equal to 6.5
- Receiving care at the Rady Children's Hospital Diabetes Clinic
Exclusion criteria
- Another immediate family member living in the same household who is already recruited into the study
Where
- San Diego, California
Collaborators
United States Department of Agriculture (USDA), Rady Children's Hospital, San Diego
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations