Chronic Kidney Disease
Conditions
Keywords
medically tailored meals, chronic kidney disease, hypertension, nutrition, diet, Veterans
Brief summary
This study will study if medically tailored meals can improve health and well-being among Veterans with kidney disease. Participants will be randomly assigned to receive either medically tailored meals or usual care (wait-list control) for 3 months, followed by follow-up/crossover period. The study will evaluate blood pressure, kidney health, diet, quality of life, and other health outcomes, as well as the feasibility and acceptability of providing medically tailored meals to Veterans with kidney disease.
Detailed description
This pilot randomized clinical trial will evaluate the feasibility, acceptability, and preliminary effects of medically tailored meals among Veterans with chronic kidney disease. Approximately 100 Veterans with stage 3b or 4 chronic kidney disease and elevated systolic blood pressure will be enrolled and randomized 1:1 to receive medically tailored meals or usual care during an initial 3-month intervention period. Participants initially assigned to usual care will subsequently receive medically tailored meals during a 3-month crossover period. All participants will be followed for 6 months. The medically tailored meal intervention will provide prepared meals designed to support dietary recommendations for chronic kidney disease and cardiovascular health. The study will assess intervention feasibility and acceptability, including recruitment, adherence, retention, completion of study assessments, and participant experiences with the meals. Clinical outcomes will include systolic blood pressure, kidney function and injury measures, cardiometabolic laboratory markers, and vascular function. Dietary intake and diet quality will be assessed using 24-hour dietary recalls. Patient-reported and behavioral outcomes will include kidney disease-related quality of life, general health and well-being, treatment burden, and measures related to dietary behavior and self-management. Healthcare utilization and medication use will also be evaluated. Assessments will generally occur at baseline, 3 months, and 6 months.
Interventions
Medically tailored meals are prepared to support dietary recommendations for chronic kidney disease and cardiovascular health while considering individual dietary needs and preferences. The intervention also included nutrition education and study-related dietary support.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical outcome assessments will be conducted by study personnel who are masked to participant treatment assignment when feasible. Participants and intervention personnel will not be masked due to the nature of the dietary intervention.
Intervention model description
Participants will be randomized 1:1 to the medically tailored meal intervention or wait-list control group and followed in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Veteran enrolled in the Veterans Health Administration * Stage 3b or stage 4 Chronic Kidney Disease (CKD) ((estimated glomerular filtration rate (eGFR) 15-44 milliliter (mL)/minute/1.73 square meter (m²)) * Systolic blood pressure 140-160 mmHg (millimeters of mercury); with a ± 5 mmHg tolerance range * Body mass index (BMI) between 18.5 and 40.0 kilogram (kg)/square meter (m²) * Able and willing to provide informed consent * Able and willing to participate in study visits and study procedures * Able to receive medically tailored meal deliveries within the study service area
Exclusion criteria
* Inability to communicate in English or severe hearing impairment either, preventing study participation * Participation in a medically tailored meal program within the previous 6 months * Diagnosis of heart failure * Major active gastrointestinal disorder that would interfere with participation or nutritional management * Active cancer treatment (chemotherapy) or anticipated treatment within the next 12 months * Pregnancy * Current homelessness preventing meal delivery * Active substance use disorder not in remission * Active psychosis or another condition that would impair participation * Terminal illness or life expectancy less than 12 months * Any other medical, psychiatric, or social condition that, in the opinion of the investigators, would make participation unsafe or interfere with completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure (SBP) | 3 months | Change in systolic blood pressure (SBP), measured in mmHg, from baseline to the 3-month assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine albumin-to-creatinine ratio (UACR) | 3 months | Change in urine albumin-to-creatinine ratio (UACR; milligrams/gram) from baseline to 3 months, measured using urine laboratory testing through the VA clinical laboratory. |
| Estimated glomerular filtration rate (eGFR) | 3 months | Change in estimated glomerular filtration rate (eGFR; milliliter/minute/1.73\^square meter) from baseline to 3 months, based on serum creatinine OR cystatin C, measured through the VA clinical laboratory. |
Countries
United States
Contacts
CONTACTLuis M Perez, PhD RD
CONTACTMaryam I Nuriyeva, MPH
PRINCIPAL_INVESTIGATORLuis M Perez, PhD RD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Outcome results
None listed