More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus

University of California San Diego

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Fruit and Vegetable Prescription Voucher

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05138432

1027421

Details and patient eligibility

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. 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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Intervention Group

Other group

Description:

Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment.

Treatment:

Behavioral: Fruit and Vegetable Prescription Voucher

Delayed Intervention Group

Other group

Description:

Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period.

Treatment:

Behavioral: Fruit and Vegetable Prescription Voucher