Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALFruit 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.
Sponsors
United States Department of Agriculture (USDA)
Rady Children's Hospital, San Diego
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants upon enrollment will be randomized into two groups, either to immediately receive up to $105 per month in vouchers for 12 months (intervention group) or to receive $105 per month in incentives for 12 months after a 6-month delay (delayed-intervention group)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Household food security | Survey will be completed at baseline and 12 months | 18-item US Household Food Security Survey Module |
| Change in Hemoglobin A1c | Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months | Point of care A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI z-score | Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic | BMI calculated by measured height and weight and converted to BMI z-score |
| Change in Total cholesterol | Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic | Serum Total cholesterol |
| Change in fruit and vegetable intake | Survey will be completed at baseline and 12 months. | Change in child fruit and vegetable intake as measured by the DSQ |
| Change in Blood pressure | Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic | Systolic and diastolic BP |
| Change in HDL cholesterol | Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic | Serum HDL cholesterol |
| Change in Liver function tests | Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic | Serum aspartate transaminase (AST), serum alanine transaminase (ALT) |
| Change in beta carotene | Measured at baseline and 12 months | serum beta carotene levels |
Countries
United States
Contacts
Primary ContactKay Rhee, MD, MS, MA
Backup ContactSarah Hiller-Venegas, MPH
Outcome results
None listed