Supporting VETerans With Kidney Disease Through Food As Medicine: the Community-based VET FAM Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
The goal of this pilot clinical trial is primarily learn if produce boxes improve clinical outcomes among Veterans with kidney disease and food or nutrition insecurity. Secondly, the study will capture Veterans qualitative perspectives, experience, and engagement through semi-structured interviews.
详细描述
This study aims to address kidney health disparities by implementing and evaluating a Food is/as Medicine intervention tailored for up to 20 Veterans with CKD. These community-engaged efforts seek to better understand the interrelation of nutrition, health, and socioeconomic factors affecting kidney related or patient-centered, along with quantitative clinical, outcomes. The long-term goal of this work is to develop and demonstrate community-based interventions or efforts that improve dietary adherence/quality, reduce food insecurity, improve nutrition security, and enhance kidney health outcomes while providing sustainability, scalable insights for broader public/kidney health and VA healthcare policies or programs.
Objectives:
Objective 1: Evaluate the short-term impact of culturally and medically tailored food boxes and produce (3-month mid-point):
- Understand Veterans' perceptions of food access, intervention acceptability, education effectiveness, and dietary challenges through semi-structured interviews.
- Investigate participant satisfaction, perceived barriers, and facilitators within the food box program and towards healthy/kidney diet adherence or practices.
- Examine Veterans' nutrition security status and quality of life from baseline to 3-months.
Objective 2: Assess the longitudinal impact and perceived future long-term impact of food boxes (6- month endpoint):
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
- •CKD stage 3b or 4
- •Positive screen for nutrition insecurity (e.g., Tufts screener)
- •Receiving care at the VA and residing in Food Bank of the Rockies service area
- •Ability to provide informed consent, English
排除标准
- •Stage 1-3a CKD and stage 5 CKD/ESRD (dialysis or transplant)
- •Currently enrolled in a conflicting dietary trial
- •Unwilling or unable to provide informed consent
研究组 & 干预措施
VET FAM Product Box and Nutrition Education
Veterans with kidney disease stages 3b-4 will receive weekly produce boxes through the Food Bank of the Rockies Food for Health program. Boxes include fresh/canned fruits, vegetables, and other items. Participants will also receive nutrition education materials and brief support to encourage preparation and consumption of the provided foods over the study period.
干预措施: VET FAM Product Box and Nutrition Education (Other)
结局指标
主要结局
Systolic Blood Pressure
时间窗: Baseline (0-months), 3-months, and 6-months
Systolic Blood Pressure
次要结局
- Creatinine(Baseline (0-months), 3-months, 6-months)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline (0-months), 3-months, and 6-months)
- Blood urea nitrogen (BUN)(Baseline (0-months), 3-months, 6-months)
- Albumin(Baseline (0-months), 3-months, 6-months)
- HbA1c(Baseline (0-months), 3-months, and 6-months)
- Kidney disease quality of life (KDQOL)(Baseline (0-months), 3-months, 6-months)