Supporting VETerans With Kidney Disease Through Food As Medicine (VETFAM)

VA Eastern Colorado Health Care System

Status: Enrolling

Conditions: Food/Nutrition Insecurity; Hypertension; Diabetes; Kidney Diseases

Treatments: Other: VET FAM Product Box and Nutrition Education

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07194733

25-1288

Details and patient eligibility

About

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.

Full description

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):

• Investigate Veterans' long-term program experiences, perspectives, satisfaction, and preferences.
• Understand participant confidence, self-efficacy, ability to sustain dietary habits, plans and resources needed post-intervention.
• Examine Veterans' nutrition security status and quality of life from baseline, 3-months, to 6-months.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18+
• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

VET FAM Product Box and Nutrition Education

Experimental group

Description:

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.

Treatment:

Other: VET FAM Product Box and Nutrition Education