Recruiting

Observational Study

Sponsor:

VA Eastern Colorado Health Care System

Code:

NCT07194733

Conditions

Kidney Diseases

Food/Nutrition Insecurity

Diabetes

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VET FAM Product Box and Nutrition Education

Study Details

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.

Conditions

Kidney Diseases

Food/Nutrition Insecurity

Diabetes

Hypertension

Study ID

NCT07194733

Start date

Jan 1, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

VET FAM Product Box and Nutrition Education

Food boxes and nutrition education

Primary outcome measure

  • Systolic Blood Pressure [ Time Frame: Baseline (0-months), 3-months, and 6-months ]

Central Contacts and Locations

Central contacts

Luis M Perez, PhD, RD

720-467-0757luis.perez2@va.gov

Locations

Rocky Mountain Regional VA Medical Center

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Luis M Perez, PhD, RD

More Information

Sponsor

VA Eastern Colorado Health Care System

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Eastern Colorado Health Care System on 2026-05-04.