More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- University of California, San Diego
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in Household food security
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Investigators
Kay Rhee
Professor of Pediatrics
University of California, San Diego
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in Liver function tests(Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic)
- Change in HDL cholesterol(Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic)
- Change in BMI z-score(Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic)
- Change in Total cholesterol(Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic)
- Change in fruit and vegetable intake(Survey will be completed at baseline and 12 months.)
- Change in Blood pressure(Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic)
- Change in beta carotene(Measured at baseline and 12 months)