Status:
RECRUITING
Kidney Health: Eat Well, Live Well
Lead Sponsor:
University of Texas at Austin
Collaborating Sponsors:
Harris Health
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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), cardiovas...
Detailed Description
This study tests a community-based program aimed at supporting adults with early-stage chronic kidney disease to change their eating habits to reduce the likelihood of kidney injury progression. The ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT05970341
Start Date
December 6 2023
End Date
May 1 2026
Last Update
March 26 2025
Active Locations (3)
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1
Harris Health System's Outpatient Center
Houston, Texas, United States, 77026
2
Harris Health System's Martin Luther King Jr. Health Center
Houston, Texas, United States, 77047
3
Harris Health System's Smith Clinic
Houston, Texas, United States, 77054