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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Food boxes and nutrition education
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
RECRUITINGSystolic Blood Pressure
Systolic Blood Pressure
Time frame: Baseline (0-months), 3-months, and 6-months
Creatinine
Measure of kidney function
Time frame: Baseline (0-months), 3-months, 6-months
Estimated Glomerular Filtration Rate (eGFR)
Measure of kidney function
Time frame: Baseline (0-months), 3-months, and 6-months
Blood urea nitrogen (BUN)
A waster product formed from protein breakdown, also filtered by the kidneys
Time frame: Baseline (0-months), 3-months, 6-months
Albumin
A protein that may indication kidney damage, inflammation, nutritional status or other measures
Time frame: Baseline (0-months), 3-months, 6-months
HbA1c
Glycosylated hemoglobin A1c
Time frame: 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
Time frame: Baseline (0-months), 3-months, 6-months
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Enrollment
20