Veteran Centered Meal Intervention in Chronic Kidney Disease

NCT07793591 | Not Yet Recruiting

• 2 other identifiers: NEPH-008-26S1IK2RD002463
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

medically tailored meals; chronic kidney disease; hypertension; nutrition; diet; Veterans

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure (SBP)

  Change in systolic blood pressure (SBP), measured in mmHg, from baseline to the 3-month assessment.

  3 months

Secondary Outcomes (2)

• Urine albumin-to-creatinine ratio (UACR)

  3 months

• Estimated glomerular filtration rate (eGFR)

  3 months

Other Outcomes (3)

• Diet quality and intake

  3 months, 6 months

• Kidney Disease-Related Quality of Life

  3 months, 6 months

• Medically Tailored Meal Adherence

  3 months, 6 months

Study Arms (2)

Medically tailored meals

EXPERIMENTAL

Participants randomized to this arm will receive medically tailored meals for 3 months in addition to usual clinical care. Meals will be designed to support dietary recommendations for chronic kidney disease, kidney and cardiovascular health. Participants will also receive nutrition education and study-related dietary support.

Other: Medically tailored meals (MTMs)

Wait-list control

OTHER

Participants randomized to this arm will continue usual clinical care without study-provided medically tailored meals during the initial 3-month randomized period. After completing the 3-month assessment, participants will cross over to receive the medically tailored meals intervention for 3 months.

Other: Medically tailored meals (MTMs)

Interventions

Medically tailored meals (MTMs) OTHER

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.

Also known as: MTM

Medically tailored meals; Wait-list control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luis M Perez, PhD RD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis M Perez, PhD RD

CONTACT

(719) 244-4805; luis.perez2@va.gov

Maryam I Nuriyeva, MPH

CONTACT

(720) 857-2712; Maryam.Nuriyeva@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to the medically tailored meal intervention or wait-list control group and followed in parallel.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)