Kidney DiseasesVETFAMNCT07194733
Supporting VETerans With Kidney Disease Through Food As Medicine
A study testing VET FAM Product Box and Nutrition Education in people with Kidney Diseases and Food/Nutrition Insecurity, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Food/Nutrition Insecurity, Diabetes
- What is being tested?
- VET FAM Product Box and Nutrition Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
Luis M Perez, PhD, RD
Luis M Perez, PhD, RD
About this study
Official title: Supporting VETerans With Kidney Disease Through Food As Medicine: the Community-based VET FAM Study
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.
Read the detailed description
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
- Kidney Diseases, Food/Nutrition Insecurity, Diabetes, Hypertension
- Being tested
- VET FAM Product Box and Nutrition Education
- Medical subject headings
- Kidney Diseases, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VET FAM Product Box and Nutrition EducationOther
Food boxes and nutrition education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: VET FAM Product Box and Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Systolic Blood Pressure
Measured: Baseline (0-months), 3-months, and 6-months
Secondary outcomes (6)
Creatinine
Measure of kidney function
Measured: Baseline (0-months), 3-months, 6-months
Estimated Glomerular Filtration Rate (eGFR)
Measure of kidney function
Measured: Baseline (0-months), 3-months, and 6-months
Blood urea nitrogen (BUN)
A waster product formed from protein breakdown, also filtered by the kidneys
Measured: Baseline (0-months), 3-months, 6-months
Albumin
A protein that may indication kidney damage, inflammation, nutritional status or other measures
Measured: Baseline (0-months), 3-months, 6-months
HbA1c
Glycosylated hemoglobin A1c
Measured: Baseline (0-months), 3-months, and 6-months
Kidney disease quality of life (KDQOL)
Kidney disease quality of life measured by the KDQOL short form instrument
Measured: Baseline (0-months), 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Food Bank of the Rockies, National Kidney Foundation, United States
- Responsible party
- Sponsor
- Investigators
- Luis M Perez, PhD, RD, Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194733
- Sponsor's protocol ID
- 25-1288
- Acronym
- VETFAM
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Veterans Affairs data may only be shared with VA approved investigators and per VA policy.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting VETerans With Kidney Disease Through Food As Medicine: the Community-based VET FAM Study
- ClinicalTrials.gov ID
- NCT07194733
- Acronym / sponsor ID
- VETFAM / 25-1288
- Conditions
- Kidney Diseases, Food/Nutrition Insecurity, Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- Food Bank of the Rockies, National Kidney Foundation, United States
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VET FAM Product Box and Nutrition Education | Experimental | Other: VET FAM Product Box and Nutrition EducationVeterans 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VET FAM Product Box and Nutrition EducationFood boxes and nutrition education | Other | VET FAM Product Box and Nutrition Education |
Primary outcome
Systolic Blood Pressure
Time frame: Baseline (0-months), 3-months, and 6-months
Systolic Blood Pressure
6 secondary outcomes
Creatinine
Time frame: Baseline (0-months), 3-months, 6-months
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline (0-months), 3-months, and 6-months
Blood urea nitrogen (BUN)
Time frame: Baseline (0-months), 3-months, 6-months
Albumin
Time frame: Baseline (0-months), 3-months, 6-months
HbA1c
Time frame: Baseline (0-months), 3-months, and 6-months
Kidney disease quality of life (KDQOL)
Time frame: Baseline (0-months), 3-months, 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. Veterans Affairs data may only be shared with VA approved investigators and per VA policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis M Perez, PhD, RD principal investigator
US Department of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VET FAM Product Box and Nutrition Education in people with Kidney Diseases and Food/Nutrition Insecurity, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis M Perez, PhD, RD (720-467-0757, luis.perez2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline (0-months), 3-months, and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.