Actively Recruiting
Kidney Health: Eat Well, Live Well
Led by University of Texas at Austin · Updated on 2025-03-26
330
Participants Needed
3
Research Sites
125 weeks
Total Duration
On this page
Sponsors
U
University of Texas at Austin
Lead Sponsor
H
Harris Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Kidney Health: Eat Well, Live Well
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, or Martin Luther King Jr. Health Center)
- Primary care patient within Harris Health System
- At least 1 visit in the past 18 months with prior history in the clinic
- Diagnosis of CKD Stage 2, 3a, or 3b (eGFR 63 30 and <90 mL/min/1.73 m2) OR CKD 1 or undiagnosed with urine Albumin Creatinine Ratio 63 30 mg/g
- Serum potassium 64 4.6 mEq/L within the past 12 months
- English or Spanish speaking
- Ability to participate in the program for at least 6 months
- Ability to clean, prepare, refrigerate/freeze food products that are given to them
- Access to receive SMS text messages
- Location of preferred produce bag delivery within an available delivery zone
You will not qualify if you...
- CKD stage 4, end-stage renal disease, or on dialysis
- Taking medications chronically (more than twice a week for 90 days) that interfere with potassium metabolism (e.g., NSAIDs)
- Taking mineralocorticoid receptor antagonists
- Taking Warfarin
- Diagnosis of specific kidney conditions contraindicating participation (e.g., polycystic kidney disease, glomerulonephritis, lupus-associated nephritis, ANCA-associated vasculitis)
- Medical history of organ transplant contraindicating participation
- Received immunotherapy for primary or secondary kidney disease within 6 months prior to enrollment
- New York Heart Association Class IV heart failure
- Recent myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment
- Recent coronary revascularization or valvular repair within 12 weeks prior to enrollment
- On active hospice care
- Diagnosis of active malignancy requiring treatment contraindicating participation
- Decompensated cirrhosis
- Cognitive impairment contraindicating participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Harris Health System's Outpatient Center
Houston, Texas, United States, 77026
Actively Recruiting
2
Harris Health System's Martin Luther King Jr. Health Center
Houston, Texas, United States, 77047
Actively Recruiting
3
Harris Health System's Smith Clinic
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
C
Courtney Mulligan, MA
CONTACT
N
Nicole Clark, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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