Supporting VETerans With Kidney Disease Through Food As Medicine
VETFAM
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 18, 2025
CompletedFirst Posted
Study publicly available on registry
September 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 4, 2026
April 1, 2026
2.2 years
September 18, 2025
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
EXPERIMENTALVeterans 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
Food boxes and nutrition education
Eligibility Criteria
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
- Food Bank of the Rockiescollaborator
- National Kidney Foundation, United Statescollaborator
- VA Eastern Colorado Health Care Systemlead
Study Sites (1)
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis M Perez, PhD, RD
US Department of Veterans Affairs
Central Study Contacts
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.