Supporting VETerans With Kidney Disease Through Food As Medicine

Not Applicable

Recruiting

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

• Registration Number: NCT07194733
• Lead Sponsor: VA Eastern Colorado Health Care System

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	Baseline (0-months), 3-months, and 6-months	Systolic Blood Pressure

Secondary Outcome Measures

Name	Time	Method
Renal Function Panel	Baseline (0-months), 3-months, and 6-months	Renal Function Panel
HbA1c	Baseline (0-months), 3-months, and 6-months	Glycosylated hemoglobin A1c

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center; 🇺🇸 Aurora, Colorado, United States