Diabetes, Food/Nutrition Insecurity, Hypertension, Kidney Diseases
Conditions
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.
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
OTHERVET FAM Product Box and Nutrition Education
Food boxes and nutrition education
Sponsors
VA Eastern Colorado Health Care System
Food Bank of the Rockies
National Kidney Foundation, United States
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | Baseline (0-months), 3-months, and 6-months | Systolic Blood Pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine | Baseline (0-months), 3-months, 6-months | Measure of kidney function |
| Estimated Glomerular Filtration Rate (eGFR) | Baseline (0-months), 3-months, and 6-months | Measure of kidney function |
| Blood urea nitrogen (BUN) | Baseline (0-months), 3-months, 6-months | A waster product formed from protein breakdown, also filtered by the kidneys |
| Albumin | Baseline (0-months), 3-months, 6-months | A protein that may indication kidney damage, inflammation, nutritional status or other measures |
| HbA1c | Baseline (0-months), 3-months, and 6-months | Glycosylated hemoglobin A1c |
| Kidney disease quality of life (KDQOL) | Baseline (0-months), 3-months, 6-months | Kidney disease quality of life measured by the KDQOL short form instrument |
Countries
United States
Contacts
CONTACTLuis M Perez, PhD, RD
PRINCIPAL_INVESTIGATORLuis M Perez, PhD, RD
US Department of Veterans Affairs
Outcome results
None listed