Kidney Health: Eat Well, Live Well
Recruiting now · Not applicable
Conditions studied: Chronic Kidney Diseases
In brief
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.
Key facts
- Study ID
- NCT05970341
- Run by
- University of Texas at Austin
- People needed
- 330
- Starts
- 2023-12-06
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-03-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- CKD 4, ESRD or on dialysis.
- 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
- Taking mineralocorticoid receptor antagonists
- Taking Warfarin
- 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
- Received immunotherapy for primary or secondary kidney disease within 6 months prior to enrolment
- Diagnostic of heart failure conditions Class IV in the New York Heart Association (NYHA) functional classification
- 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
- On active hospice care as self-reported during enrollment screening
- Diagnosis of active malignancy requiring treatment that would contraindicate study participation as determined by physician
- Has decompensated cirrhosis as determined by physician
- Cognitive impairment that would contraindicate study participation as self-reported during enrollment screening
Where it is running
- Harris Health System's Outpatient Center — Houston, Texas, United States (enrolling)
- Harris Health System's Martin Luther King Jr. Health Center — Houston, Texas, United States (enrolling)
- Harris Health System's Smith Clinic — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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