NCT07194733

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jan 2025Mar 2027

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

September 18, 2025

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    Systolic Blood Pressure

    Baseline (0-months), 3-months, and 6-months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • Qualitative participant perspectives, experiences, and engagement themes

    3-months and 6-months

Study Arms (1)

VET FAM Product Box and Nutrition Education

EXPERIMENTAL

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.

Other: VET FAM Product Box and Nutrition Education

Interventions

Food boxes and nutrition education

VET FAM Product Box and Nutrition Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Kidney DiseasesDiabetes MellitusHypertension

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Luis M Perez, PhD, RD

    US Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis M Perez, PhD, RD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2025

First Posted

September 26, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Veterans Affairs data may only be shared with VA approved investigators and per VA policy.

Locations