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临床试验/NCT06263751
NCT06263751已完成不适用

NutriConnect: Enhancing Health and Food Security Through Sustainable Solutions and Partnerships

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
change in F&V intake

研究概览

简要总结

The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost.

详细描述

The Produce Prescription Program, as one type of Food is Medicine (FIM) initiatives, involves healthcare providers prescribing fruits and vegetables to patients often have low incomes, food insecurity, and diet-related illnesses. Previous systematic reviews have shown that these programs are associated with increased consumption of fruits and vegetables, improved diet quality, reduced food insecurity, and better management of diet-related diseases. However, the diversity in study designs, small sample sizes, and varied intervention intensities have limited the conclusive understanding of the full effects of these programs. Despite their potential benefits, critical gaps persist, notably in identifying the most effective strategies for socioeconomically disadvantaged patients. Additionally, challenges surrounding scalability, implementation, and sustainability hinder the widespread adoption of these programs.

To address these gaps, the NutriConnect team employs a Designing for Dissemination and Sustainability (D4DS) approach informed by the PRISM/RE-AIM framework. This involves early engagement of key partners crucial for scalability and sustainability. The study team initiated a collaborative consortium comprising Washington University in St. Louis, BJC Healthcare, and Schnucks (regional grocery chain). NutriConnect integrates multilevel, multicomponent intervention components, including in-hospital social needs screening, produce prescription, grocery rewards, and a health and wellness program, all aimed at promoting better nutrition and health in the community. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on fruits and vegetables intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes, with the following aims.

Aim 1. Evaluate and compare the effectiveness of NutriConnect Credit with NutriConnect Delivery on changes in fruit and vegetable intake, food security, and self-reported health status.

Aim 2. Explore the scalability, sustainability, and determinants of the NutriConnect program guided by PRISM/RE-AIM, aiming to identify factors crucial for future scale-up.

Aim 3. Determine the implementation costs of NutriConnect using time-driven activity-based costing approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Due to the open study design, the NutriConnect team will not be able to have either patient or research coordinator/Schnucks intervention delivers blinded on group assignment. However, the assignment will be hidden from research faculty, the study biostatistician, and study analyst.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (>= 18 years)
  • Received care at either medical floors or observation unit at the Bares Jewish Hospital (BJH), and discharged to home.
  • Being screened positive for food or financial insecurity.
  • Have elevated cardiovascular risk, i.e., self-reported diabetes, hypertension, hyperglycemia, or calculated BMI meeting obesity.

排除标准

  • Does not have competence to provide informed consent.
  • Is under suicide watch.
  • Is in police custody.
  • In hospice or palliative care.
  • Not have a stable home.
  • Is pregnant.

研究组 & 干预措施

Usual Care (Control)

No Intervention

Patient is screened for food or financial insecurity, if positive, social worker will refer him/her to community service programs.

NutriConnect Credit

Experimental

Patient is given $20 credit to their Schnucks (grocery) Reward account every other week for F&V shopping.

干预措施: Product prescription program- NutriConnect Credit (Other)

NutriConnect Delivery

Experimental

Patient receives produce (F&V) box (with equivalent $20 value) delivered to home every other week.

干预措施: Product prescription program- NutriConnect Delivery (Other)

结局指标

主要结局

change in F&V intake

时间窗: 6-month

pre- and post-changes in F\&V consumption (cups/day, continuous).

次要结局

  • Household food insecurity(6-month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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