Trial Summary
What is the purpose of this trial?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
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.Inclusion Criteria
I have visited this clinic before, at least once in the last 18 months.
I am 18 years old or older.
I have chronic kidney disease in stages 2, 3a, or 3b.
+7 more
Exclusion Criteria
My doctor has diagnosed me with advanced liver disease.
I haven't had a heart attack, unstable angina, stroke, or TIA in the last 3 months.
You are currently receiving hospice care.
+11 more
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Harris Health System's Outpatient CenterHouston, TX
Harris Health System's Martin Luther King Jr. Health CenterHouston, TX
Harris Health System's Smith ClinicHouston, TX
Loading ...
Who Is Running the Clinical Trial?
University of Texas at AustinLead Sponsor
Harris HealthCollaborator