More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Household food security
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Another immediate family member living in the same household who is already recruited into the study
结局指标
主要结局
Change in Household food security
时间窗: Survey will be completed at baseline and 12 months
18-item US Household Food Security Survey Module
Change in Hemoglobin A1c
时间窗: Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months
Point of care A1c
次要结局
- 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)
研究者
Kay Rhee
Professor of Pediatrics
University of California, San Diego