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NCT Number: NCT07194733

Supporting VETerans With Kidney Disease Through Food As Medicine

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.

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Key information

Conditions

Kidney Diseases Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Food/Nutrition Insecurity Glucose Metabolism Disorders Hypertension Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Luis M Perez, PhD, RD

CONTACT

Luis M Perez, PhD, RD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VET FAM Product Box and Nutrition Education

Other

Food boxes and nutrition education

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: Baseline (0-months), 3-months, and 6-months

    Systolic Blood Pressure

Secondary outcomes

  1. Creatinine

    Time frame: Baseline (0-months), 3-months, 6-months

    Measure of kidney function

  2. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline (0-months), 3-months, and 6-months

    Measure of kidney function

  3. Blood urea nitrogen (BUN)

    Time frame: Baseline (0-months), 3-months, 6-months

    A waster product formed from protein breakdown, also filtered by the kidneys

  4. Albumin

    Time frame: Baseline (0-months), 3-months, 6-months

    A protein that may indication kidney damage, inflammation, nutritional status or other measures

  5. HbA1c

    Time frame: Baseline (0-months), 3-months, and 6-months

    Glycosylated hemoglobin A1c

  6. Kidney disease quality of life (KDQOL)

    Time frame: Baseline (0-months), 3-months, 6-months

    Kidney disease quality of life measured by the KDQOL short form instrument

Other outcomes

  1. Qualitative participant perspectives, experiences, and engagement themes

    Time frame: 3-months and 6-months

    Qualitative semi-structured recorded interviews capturing participant perspectives for themes.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis M Perez, PhD, RD

CONTACT

[email protected]

720-467-0757

Sponsors and collaborators

Lead sponsor

VA Eastern Colorado Health Care System

Fed

Collaborators

  • Food Bank of the Rockies
  • National Kidney Foundation, United States

Registry information

Official study title

Supporting VETerans With Kidney Disease Through Food As Medicine: the Community-based VET FAM Study

Acronym: VETFAM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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