Supporting VETerans With Kidney Disease Through Food As Medicine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Eastern Colorado Health Care System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
VET FAM Product Box and Nutrition Education
Other interventionFood boxes and nutrition education
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: VET FAM Product Box and Nutrition EducationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Systolic Blood Pressure
Systolic Blood Pressure
Time frame
Baseline (0-months), 3-months, and 6-monthsSecondary outcomes
1
Creatinine
Measure of kidney function
Time frame
Baseline (0-months), 3-months, 6-months2
Estimated Glomerular Filtration Rate (eGFR)
Measure of kidney function
Time frame
Baseline (0-months), 3-months, and 6-months3
Blood urea nitrogen (BUN)
A waster product formed from protein breakdown, also filtered by the kidneys
Time frame
Baseline (0-months), 3-months, 6-months4
Albumin
A protein that may indication kidney damage, inflammation, nutritional status or other measures
Time frame
Baseline (0-months), 3-months, 6-monthsOther outcomes
1
Qualitative participant perspectives, experiences, and engagement themes
Qualitative semi-structured recorded interviews capturing participant perspectives for themes.
Time frame
3-months and 6-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Eastern Colorado Health Care System
Lead sponsor
Food Bank of the Rockies
Collaborator
National Kidney Foundation, United States
Collaborator
Source ClinicalTrials.gov