GusNIP Produce Prescription Project
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in Fruit and Vegetable Intake
概览
简要总结
The goal of this clinical trial is to assess nutrition incentives and produce vouchers to measure the impacts of food insecurity-related chronic health conditions in adults with hypertension and/or diabetes. The main questions it aims to answer are:
- Does participation increase fruit and vegetable consumption for participants?
- Does participation reduce individual and household food insecurity?
- Does participation reduce healthcare utilization and associated costs?
- Does participation lead to improvements in diet-related health outcomes (e.g., hypertension, diabetes)?
- Does participation support the local economy by increasing participant spending at local food vendors?
Participants will:
- Receive 6 months home delivered produce prescription boxes
- Receive 6 months match of produce vouchers
- Receive nutrition education and participate in Chronic Disease Self-Management classes
详细描述
The clinical trial will serve up to 400 participants over the GusNIP Produce Prescription project. The primary outcome measure one is to strengthen food systems access and improve participant level dietary health quality through increased fruit and vegetable consumption; reduce overall individual and household level food insecurity; reduce healthcare use and associated costs; and support local economies through local food procurement. Rush participants with or at risk of diabetes and/or hypertension who screen positive for food insecurity and meet the requirements to participate in a Produce Prescription project are referred to the Veggie Rx program for one year participation. Vouchers for up to $40 dollars match can be used concurrently with SNAP EBT benefits at a local grocer, the project's SNAP firm partner. Data will measure improvements in fruit and vegetable consumption, food security status, diet quality, knowledge and behaviors, self-efficacy, healthcare utilization and associated costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age
- •Participants receiving medical care at Rush
- •Participants with a diagnosis of hypertension and/or diabetes
- •Participants with a positive screen for food insecurity
- •Participants eligible for medical assistance through a state plan
- •Participants eligible for benefits through the SNAP program
- •Participants are member of a low-income household
- •Participants willing to participate for duration of the program (12-months)
- •Participants residing in service area of the referring Rush clinic
排除标准
- •Adults unable to consent
- •Individuals not yet adults - infants, children, teenagers
- •Incarcerated individuals
研究组 & 干预措施
Produce Prescription
Receipt of fresh produce prescription boxes and produce vouchers redeemable using SNAP, alongside nutrition education and chronic disease management education.
干预措施: Food is Medicine (Behavioral)
结局指标
主要结局
Change in Fruit and Vegetable Intake
时间窗: 6 months, 12 months
Mean change in daily servings of fruits and vegetables (FV) determined by self-reported data using 10-item Dietary Screener Questionnaire (DSQ). The 10-item DSQ scale collects intake frequency of FV including the quantity (i.e., amount) and variety (i.e., kinds) through retrospective observance of the past 30-days. Scale values range from decreased, stayed the same, increased, or does not apply, with increased FV intake correlating with improved intake, and decreased correlating with less intake. A higher score means a better outcome.
Change in Food Security Status
时间窗: 6months, 12 months
Individual and household level food security as measured using the United States Department of Agriculture 10-item United States Adult Food Security Module. Measured on a scale of severity from high to low food security, including high food security, marginal food security, low food security and very low food security with very low food security meaning a worse outcome.
Change in Healthcare Utilization and Associated Costs
时间窗: 6 months, 12 months
Changes in healthcare utilization including hospital, emergency department, and outpatient visits using Electronic Health Records and claims data.
Change in Health Outcomes Associated with Hypertension
时间窗: 6 months, 12 months
Changes in hypertension clinical biomarkers through Electronic Health Records, self-reported pre and post assessments for chronic disease self-management classes. Measured by 10 mm Hg reduction in systolic BP for participants with uncontrolled hypertension, as targeted by the intervention.
Change in Health Outcome Associated with Diabetes
时间窗: 6 months, 12 months
Changes in diabetes clinical biomarkers through Electronic Health Records, self-reported pre and post assessments for chronic disease self-management classes. Measured by changes in hemoglobin A1c (HbA1c), as targeted by the intervention.
Local Economic Support
时间窗: Monthly for 1 year
Change in participant spending through use of produce vouchers at local food vendors using Supplemental Nutrition Assistance Program/Electronic Benefits Transfer leads to local economic support. Measured by point of sale dollar value of produce voucher, dollar value of Supplemental Nutrition Assistance Program purchase (Electronic Benefits Transfer sales).
次要结局
未报告次要终点
研究者
Traci Simmons
Director Community Health and Engagement
Rush University Medical Center