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Veteran Centered Meal Intervention in Chronic Kidney Disease

A Veteran-Centered Medically Tailored Meal Intervention to Improve Clinical and Patient Reported Outcomes in Chronic Kidney Disease (VETCKD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months, 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "All participants will be followed for 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether meals made for health needs can improve health and well-being in Veterans with long-term kidney disease. Veterans will be assigned by chance to get these meals or their usual care for 3 months, with more follow-up afterward. The study will check blood pressure, kidney health, diet, and quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a Veteran enrolled in the Veterans Health Administration.
  • You have stage 3b or stage 4 long-term kidney disease, with an eGFR (a measure of kidney filtering) of 15–44.
  • Your top blood pressure number is 140–160 mmHg, with up to 5 points above or below this range allowed.
  • Your BMI (a measure of weight compared with height) is 18.5–40.0.
  • You can and want to give informed consent, meaning you understand and agree to join.
  • You can and want to take part in study visits and activities.
  • You can receive meal deliveries within the study's service area.

Who can't join

  • Trouble communicating in English or severe hearing loss keeps you from taking part.
  • You received meals made for health needs through a program in the past 6 months.
  • You have heart failure, or a serious, ongoing digestive problem that affects participation or nutrition care.
  • You are receiving chemotherapy for cancer or expect to receive it in the next 12 months, or you are pregnant.
  • You are currently homeless and cannot receive meal deliveries.
  • You have an active substance use disorder that is not in remission, meaning it has not improved or stopped.
  • You have active psychosis (trouble knowing what is real) or another condition that affects participation, or an illness expected to end your life or a life expectancy under 12 months.
  • The study team believes another health, mental health, or social issue would make joining unsafe or keep you from finishing.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

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