RECRUITING

Kidney Health: Eat Well, Live Well

Conditions

Chronic Kidney Diseases phone calls Telehealth Fruits and vegetables Produce Home delivery grocery vouchers gift cards Community-based trial Proteinuria Diet mental health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-06

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05970341

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Courtney Mulligan, MA

CONTACT

512-522-4349

Courtney.Mulligan@austin.utexas.edu

Nicole Clark, MBA

CONTACT

210-316-5443

nicole.clark@austin.utexas.edu

Principal Investigator

Maninder Kahlon, PhD

PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Texas at Austin

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06

Study Completion Date2026-05

Study Record Updates

Study Start Date2023-12-06

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

phone calls
Telehealth
Fruits and vegetables
Produce
Home delivery
grocery vouchers
gift cards
Community-based trial
Proteinuria
Diet
mental health

Additional Relevant MeSH Terms

Chronic Kidney Diseases