Supporting VETerans With Kidney Disease Through Food As Medicine

NCT ID: NCT07194733

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Kidney Diseases Food/Nutrition Insecurity Diabetes Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VET FAM Product Box and Nutrition Education

Intervention Type OTHER

Food boxes and nutrition education

Interventions

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VET FAM Product Box and Nutrition Education

Food boxes and nutrition education

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food Bank of the Rockies

UNKNOWN

Sponsor Role collaborator

National Kidney Foundation, United States

OTHER

Sponsor Role collaborator

VA Eastern Colorado Health Care System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis M Perez, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Locations

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Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Luis M Perez, PhD, RD

Role: CONTACT

720-467-0757

Facility Contacts

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Luis M Perez, PhD, RD

Role: primary

Other Identifiers

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25-1288

Identifier Type: -

Identifier Source: org_study_id

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