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NCT05970341Active, not recruiting

Kidney Health: Eat Well, Live Well

"Kidney Health: Eat Well, Live Well": A Program to Reduce Kidney Injury and Early CKD Progression Through Nutrition & Empathetic Support From a Health Partner

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

This two-arm, parallel randomized trial study will assess the efficacy of a 6-month (26 weeks) community-based program in reducing kidney injury (as Urine Albumin to Creatinine ratio, uACR), cardiovascular risk (as Hemoglobin A1C and blood pressure), mental health (as PHQ-8) and diet quality (as fruits and vegetables intake and Healthy Eating Index) in community-dwelling, low-income adults diagnosed with early chronic kidney disease (stages 2 or 3 and not on kidney replacement therapies) compared to educational materials and usual care alone.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
330 (estimated)
First submitted
24 Jul 2023
Start date
6 Dec 2023
Primary completion date
30 Nov 2026
Lead sponsor
University of Texas at Austin
NCT number
NCT05970341

What you commit to

  • Study type: Interventional
  • Planned participants: 330
  • From 6 Dec 2023 to the primary completion date, 30 Nov 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking certain medications chronically (more than twice a week for 90 days) that may interfere with K+ metabolism (such as non-steroidal anti-inflammatory drugs (NSAIDs), as self-reported during enrollment screening
  • Received immunotherapy for primary or secondary kidney disease within 6 months prior to enrolment
  • Had myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA) within 12 weeks prior to enrolment
  • Had coronary revascularization (PCI, CABG) or valvular repair within 12 weeks prior to enrolment

Other illness

  • Diagnosis of any specific kidney conditions (such as polycystic kidney disease, glomerulonephritis, Lupus associated with Nephritis, Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)) that would contraindicate study participation as determined by physician
  • Medical history of organ transplant that would contraindicate study participation as determined by physician
  • Diagnostic of heart failure conditions Class IV in the New York Heart Association (NYHA) functional classification
  • Diagnosis of active malignancy requiring treatment that would contraindicate study participation as determined by physician
  • Cognitive impairment that would contraindicate study participation as self-reported during enrollment screening

Other

  • CKD 4, ESRD or on dialysis.
  • Taking mineralocorticoid receptor antagonists
  • Taking Warfarin
  • On active hospice care as self-reported during enrollment screening
  • Has decompensated cirrhosis as determined by physician

Who the study is looking for

  • Adult (18 years of age or older)
  • Primary care visit at either one of the three partner clinics from Harris Health \[Smith Clinic, Harris Health Outpatient Center (located on the LBJ campus), or Martin Luther King Jr. Health Center (MLK)\] and a primary care patient within Harris Health System
  • Have had at least 1 visit in the past 18 months with prior history in the clinic (i.e., not first visit)
  • Diagnosis of CKD (Stage 2, 3a, and 3b) as defined by estimated Glomerular Filtration Rate (eGFR) ≥ 30 and \<90 mL/min/1.73 m2 OR CDK 1 or undiagnosed with urine Albumin Creatinine Ratio ≥ 30 mg/g
  • Within the past 12 months, the most current serum K+ ≤ 4.6 mEq/L
  • English or Spanish speaking
  • Ability to participate in the program at least 6 months
  • Ability to clean, prepare, refrigerate/freeze food products that are given to them
  • Have access to receive SMS text messages
  • Location of preferred produce bag delivery within an available delivery zone

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Harris Health System's Outpatient Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Harris Health System's Martin Luther King Jr. Health Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Harris Health System's Smith Clinic
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.