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NCT05970341NARecruiting

Kidney Health: Eat Well, Live Well

University of Texas at Austin

Start Date

12/6/2023

Completion Date

5/1/2026

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.

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 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).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult (18 years of age or older) * Primary care visit at either one of the three partner clinics from Harris Health \[Smith Clinic, Harris Health Outpatient Center (located on the LBJ campus), or Martin Luther King Jr. Health Center (MLK)\] 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 Criteria: * 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

Interventions

BEHAVIORAL

1. Welcome package

BEHAVIORAL

2. Welcome information (phone or text)

BEHAVIORAL

3. Produce delivery + Recipes customized to produce

BEHAVIORAL

4. E-gift cards to a grocery store of choice

BEHAVIORAL

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

Interested in This Trial?

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Conditions

Chronic Kidney Diseases

Locations

Harris Health System's Outpatient Center

Houston, Texas 77026

United States

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

Houston, Texas 77047

United States

Harris Health System's Smith Clinic

Houston, Texas 77054

United States