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临床试验/NCT07534501
NCT07534501招募中不适用

Assessing the Impact of Implementing the 'Eat Well' Produce Prescription for Veterans At-Risk of Food Insecurity With a Diet-Sensitive Chronic Condition: A Pragmatic Randomized Controlled Trial

Institute for Medical Research, Inc.1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2026年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Systolic blood pressure

研究概览

简要总结

This project, conducted within the Department of Veterans Affairs Healthcare System (VHA), will study how a produce prescription (PRx) program called "Eat Well" affects Veterans' health and how often they use healthcare services. About 1 in 4 Veteran households experience food insecurity (FI), which means they do not have reliable access to safe and healthy food. FI can make health worse in many ways, especially for people with conditions like diabetes that need a healthy diet. It also leads to higher healthcare costs. A PRx program, like Eat Well, helps by giving people money or vouchers to buy fruits and vegetables. This study will enroll 1,500 eligible Veterans in North Carolina who will be randomized to receive Eat Well for 6-months, Eat Well for 12-months, or the standard of care. This research will help VA learn important information about using produce prescriptions as a proven way to improve food security.

详细描述

Food insecurity (FI), or the limited or uncertain availability of nutritionally adequate and safe foods, is common among Veteran households (approximately 1 in 4). FI worsens health across multiple dimensions, particularly for those with related diet-sensitive cardiometabolic conditions (e.g., diabetes) and is associated with higher healthcare costs. A produce prescription (PRx) program is an evidence-based food security intervention that reduces cost barriers to healthy food purchases by providing a regular subsidy for fruits and vegetables. PRx programs improve food security, diet, and health outcomes. This pragmatic randomized controlled trial will evaluate the impact of a PRx program called "Eat Well", which provides $100 per month subsidy via a debit card for healthy foods, on Veteran cardiometabolic health and utilization patterns. This study will enroll 1,500 eligible Veterans in North Carolina who will be randomized to receive Eat Well for 6-months, Eat Well for 12-months, or the standard of care (e.g., resources for healthy living). The primary outcome of interest is change in systolic blood pressure (from baseline to 12-months). Secondary outcomes of interest include change in hemoglobin A1c levels (from baseline to 12-months) and mean inpatient, outpatient, ED, and health promotion program visits from the beginning of the program. This research will generate crucial knowledge about the offering of PRx as an evidence-based food security intervention.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Food Insecurity Risk
  • Hypertension AND diabetes or obesity
  • Hospitalization, ED visit, OR outpatient visit in the past 12-months
  • NC resident
  • Valid email address

排除标准

  • Living in a nursing home or residential facility where meals are prepared

研究组 & 干预措施

Eat Well 6-months

Experimental

Participants will receive $100/month of Eat Well benefits for 6- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education.

干预措施: Eat Well 6-months (Behavioral)

Eat Well 12-months

Experimental

Participants will receive $100/month of Eat Well benefits for 12- months and instructions on enrolling in existing VA programs designed to improve health self-management and nutrition education.

干预措施: Eat Well 12-months (Behavioral)

Standard of Care

No Intervention

The standard of care arm will not receive the Eat Well program with referrals to VA resources and program. They will only continue to receive standard VA health care services that they regularly engage with.

结局指标

主要结局

Systolic blood pressure

时间窗: 12 months

Changes in systolic blood pressure (from baseline to 12-months) will be compared between the treatment and control groups. Primary and secondary data will be abstracted from the VA Electronic Health Record (EHR)

次要结局

  • Hemoglobin A1c(12 months)
  • Healthcare utilization(12 months)
  • Enrollment in VA Nutrition/Wellness programs(12 months)

研究者

发起方
Institute for Medical Research, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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