More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fruit and Vegetable Prescription Voucher.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Detailed description
Participants upon enrollment will be randomized into two groups, either to immediately receive nutrition incentive vouchers for 12 months (intervention group) or to receive nutrition incentive vouchers for 12 months after a 6-month delay (delayed-intervention group). To evaluate the implementation and outcomes of this program, we will collect fruit and vegetable prescription (FVRx) voucher data in addition to standardized laboratory studies, (hemoglobin A1c (HbA1c), total cholesterol, HDL cholesterol and liver function tests (LFTs)) and physiologic assessments (height, weight) at the child's follow-up appointments through the Diabetes Clinic. These markers will be evaluated at baseline, 6-, 12- and 18-months. Additionally, we will ask participants to complete online or phone surveys including the Dietary Screener Questionnaire (DSQ) for youth and parents and the 18-item US Household Food Security Survey Module every 6 months.
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]
- Change in Hemoglobin A1c [Time frame: Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months]
Secondary outcome measures (7)
- Change in BMI z-score [Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
- Change in Total cholesterol [Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
- Change in Liver function tests [Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
- Change in Blood pressure [Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
- Change in beta carotene [Time frame: Measured at baseline and 12 months]
- Change in fruit and vegetable intake [Time frame: Survey will be completed at baseline and 12 months.]
- Change in HDL cholesterol [Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rady Children's Hospital San Diego — San Diego
Identifiers
NCT: NCT05138432 · 1027421