Kidney Health: Eat Well, Live Well

Last updated: March 25, 2025
Sponsor: University of Texas at Austin
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

5. Personalized practical & emotional support through a dedicated health partner

1. Welcome package

2. Welcome information (phone or text)

Clinical Study ID

NCT05970341
STUDY00002253
  • Ages > 18
  • All Genders

Study 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), 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.

Eligibility Criteria

Inclusion

Inclusion 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), orMartin Luther King Jr. Health Center (MLK)] and a primary care patient within HarrisHealth 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 FiltrationRate (eGFR) ≥ 30 and <90 mL/min/1.73 m2 OR CDK 1 or undiagnosed with urine AlbuminCreatinine 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

Exclusion Criteria:

  • CKD 4, ESRD or on dialysis.

  • Taking certain medications chronically (more than twice a week for 90 days) that mayinterfere 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 cytoplasmicantibody (ANCA)-associated vasculitis (AAV)) that would contraindicate studyparticipation as determined by physician

  • Medical history of organ transplant that would contraindicate study participation asdetermined by physician

  • Received immunotherapy for primary or secondary kidney disease within 6 months priorto 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 priorto enrolment

  • On active hospice care as self-reported during enrollment screening

  • Diagnosis of active malignancy requiring treatment that would contraindicate studyparticipation as determined by physician

  • Has decompensated cirrhosis as determined by physician

  • Cognitive impairment that would contraindicate study participation as self-reportedduring enrollment screening

Study Design

Total Participants: 330
Treatment Group(s): 5
Primary Treatment: 5. Personalized practical & emotional support through a dedicated health partner
Phase:
Study Start date:
December 06, 2023
Estimated Completion Date:
May 31, 2026

Study 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 program components were design to reduce barriers to a) eating healthier, kidney-friendly foods through the direct provision of fruits and vegetables, grocery store e-gift cards, kidney-friendly recipes, and food preparation tips; b) learning about kidney disease and the role of healthy eating in slowing its progression through educational materials; and c) social connection through empathetic relational phone calls and SMS texts from a dedicated "Health Partner".

Over a period of 6 months (26 weeks), participants randomized to the intervention arm will receive:

  • kidney-friendly produce (fruits and vegetables) delivered at their preferred location

  • recipes and tips on food preparation tailored to the produce

  • grocery store electronic gift cards

  • educational materials on CKD and disease management

  • personalized practical and emotional support through a dedicated Health Partner

Researchers will see if participation in the program (intervention) reduces markers of kidney injury (Albumin:Creatinin ratio) and cardiovascular disease risk and improves diet (particularly fruits and vegetables intake) and mental health when compared to usual care (control).

Connect with a study center

  • Harris Health System's Martin Luther King Jr. Health Center

    Houston, Texas 77047
    United States

    Active - Recruiting

  • Harris Health System's Outpatient Center

    Houston, Texas 77026
    United States

    Active - Recruiting

  • Harris Health System's Smith Clinic

    Houston, Texas 77054
    United States

    Active - Recruiting

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