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Behavioral Intervention

Comprehensive Support Program for Chronic Kidney Disease

N/A

Waitlist Available

Led By Maninder Kahlon, PhD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (18 years of age or older)

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

Must not have

Has decompensated cirrhosis as determined by physician

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up as available 18 months before enrollment in the study and 15 months after study participation ends

Awards & highlights

No Placebo-Only Group

Summary

This trial study will assess if a 6-month program can reduce kidney injury, cardiovascular risk, mental health & diet quality in low-income adults with early chronic kidney disease.

Who is the study for?

Adults with early-stage chronic kidney disease (stages 2 or 3), not on dialysis, who speak English or Spanish, can prepare and store food, have SMS access, live in the delivery zone of certain clinics, and have visited one of three partner clinics within the last 18 months. Excludes those with advanced CKD, on Warfarin or certain other medications, recent severe cardiovascular events or procedures.

What is being tested?

The trial is testing a community-based program that includes personalized support from a health partner, produce deliveries with customized recipes, welcome package and information via phone/text, and grocery e-gift cards against usual care. The study measures effects on kidney injury markers like uACR as well as cardiovascular risk factors.

What are the potential side effects?

Since this trial involves dietary changes and support services rather than medication interventions directly administered by researchers there are no direct side effects associated with typical clinical trials; however individual dietary changes may affect each participant differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have chronic kidney disease in stages 2, 3a, or 3b.

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I can manage food preparation and storage on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor has diagnosed me with advanced liver disease.

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My doctor has confirmed I don't have specific kidney conditions that would stop me from joining the study.

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My doctor says my cancer treatment conflicts with joining the study.

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My heart condition severely limits my physical activity.

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I have advanced kidney disease or am on dialysis.

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I am taking medication that affects my body's salt and water balance.

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I am currently taking Warfarin.

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My doctor says my organ transplant doesn't allow me to join this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ as available 18 months before enrollment in the study and 15 months after study participation ends

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~as available 18 months before enrollment in the study and 15 months after study participation ends

This trial's timeline: 3 weeks for screening, Varies for treatment, and as available 18 months before enrollment in the study and 15 months after study participation ends for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urine albumin:creatinine ratio (UACR)

Secondary study objectives

Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)

Blood pressure (systolic/diastolic)

Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption

+4 more

Other study objectives

Changes in diet quality as estimates of individual mean dietary intake and frequency of dairy consumption

Changes in diet quality as estimates of individual mean dietary intake and frequency of whole grains

Changes in diet quality as estimates of individual mean dietary intake of added sugars

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Educational materials + usual careExperimental Treatment2 Interventions

1. Welcome package 2. Welcome information: SMS/Text

Group II: Arm 1: Intervention + usual careExperimental Treatment5 Interventions

1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner

0 / 11Eligibility criteria met