Supporting VETerans With Kidney Disease Through Food As Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VET FAM Product Box and Nutrition Education.
- Who it may be relevant to
- Registry conditions: Kidney Diseases, Food/Nutrition Insecurity, Diabetes, Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Supporting VETerans With Kidney Disease Through Food As Medicine: the Community-based VET FAM Study
Overview
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.
Interventions
- Other VET FAM Product Box and Nutrition Education
Food boxes and nutrition education
Primary outcome measures
- Systolic Blood Pressure [Time frame: Baseline (0-months), 3-months, and 6-months]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Rocky Mountain Regional VA Medical Center — Aurora
Identifiers
NCT: NCT07194733 · 25-1288