Kidney Health: Eat Well, Live Well

Description

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

Chronic Kidney Diseases

Study Overview

Study Details

Study overview

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.

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

Kidney Health: Eat Well, Live Well

Condition
Chronic Kidney Diseases
Intervention / Treatment

-

Contacts and Locations

Houston

Harris Health System's Outpatient Center, Houston, Texas, United States, 77026

Houston

Harris Health System's Martin Luther King Jr. Health Center, Houston, Texas, United States, 77047

Houston

Harris Health System's Smith Clinic, Houston, Texas, United States, 77054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas at Austin,

Maninder Kahlon, PhD, PRINCIPAL_INVESTIGATOR, University of Texas at Austin

Study Record Dates

2026-05