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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
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I have chronic kidney disease in stages 2, 3a, or 3b.
Select...
I can manage food preparation and storage on my own.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urine albumin:creatinine ratio (UACR)
Secondary outcome measures
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 moreOther outcome measures
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 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Educational materials + usual careExperimental Treatment2 Interventions
Welcome package
Welcome information: SMS/Text
Group II: Arm 1: Intervention + usual careExperimental Treatment5 Interventions
Welcome package
Welcome information: telephone call
Produce delivered at their choice of time and location + Recipes customized to produce
E-gift cards to a grocery store of choice
Personalized practical, emotional & educational support through a dedicated health partner
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
350 Previous Clinical Trials
80,654 Total Patients Enrolled
Harris HealthUNKNOWN
1 Previous Clinical Trials
1,038 Total Patients Enrolled
Maninder Kahlon, PhDPrincipal InvestigatorUniversity of Texas at Austin
4 Previous Clinical Trials
687 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has diagnosed me with advanced liver disease.I have visited this clinic before, at least once in the last 18 months.I haven't had a heart attack, unstable angina, stroke, or TIA in the last 3 months.You are currently receiving hospice care.I am 18 years old or older.My doctor has confirmed I don't have specific kidney conditions that would stop me from joining the study.I received immunotherapy for kidney disease within the last 6 months.I had heart surgery or a procedure to improve blood flow within the last 3 months.My doctor says my cancer treatment conflicts with joining the study.I have chronic kidney disease in stages 2, 3a, or 3b.I speak English or Spanish.I can manage food preparation and storage on my own.My address is within the delivery zone for the produce bag.My heart condition severely limits my physical activity.I have advanced kidney disease or am on dialysis.I am taking medication that affects my body's salt and water balance.I am currently taking Warfarin.My doctor says my organ transplant doesn't allow me to join this study.I do not have any cognitive issues that would prevent me from participating.I have been taking medication regularly that could affect my potassium levels.In the last year, your blood potassium level has been no higher than 4.6 mEq/L.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Intervention + usual care
- Group 2: Arm 2: Educational materials + usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts underway for this trial?
"According to clinicaltrials.gov, the original posting of this medical trial was on 8/1/2023 and it is no longer in need of candidates. Nonetheless, there are still 535 other trials seeking participants at present."
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