Kidney Health: Eat Well, Live Well

Part of paid clinical trials in Houston, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT05970341
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1. Welcome package — BEHAVIORAL
    At the end of the baseline data collection visit at the clinic, the Research Staff will hand the participant a welcome packet that includes: * educational and motivational written materials (about such topics as CKD and healthy eating for early CKD stages) * a collection of recipes featuring kidney-friendly vegetables
  • 2. Welcome information (phone or text) — BEHAVIORAL
    Those allocated to the intervention arm will receive a welcome call from the Program Staff to provide further details and expectations about the program (such as delivery details and schedule). Those allocated to the control arm will receive an SMS text that informs them of their arm allocation, what to expect and a phone number to call for questions.
  • 3. Produce delivery + Recipes customized to produce — BEHAVIORAL
    * Content: Bags with kidney-friendly produce will include 2 vegetables sufficient for 2 meals for 4 people, 1 type of fruit, and 1 dried fruit. The total cost is estimated at USD 20, excluding delivery, for prices in June 2022. * Delivery: Bags will be delivered to the participant's preferred location (e.g. home or work) and period of the day (e.g., morning, evening). * Recipes: SMS texts will precede each delivery to share an URL to recipes customized to the items being delivered, and to inform of an upcoming produce bag, its content. * Frequency: 1. Weeks 1-2 (2 weeks): No bags delivered. 2. Weeks 3-10 (8 weeks): Delivered weekly, for a total of 8 bags. 3. Weeks 11-18 (8 weeks): Delivered every two weeks, for a total of 4 bags. 4. Weeks 19-26 (8 weeks): No bags delivered.
  • 4. E-gift cards to a grocery store of choice — BEHAVIORAL
    Five (5) e-gift cards to a major local grocery retailer chosen by the participant (from 3 options) at the following frequency: 1. Weeks 1-6: No e-gift card. 2. Week 7: One card of USD 30.00 value. 3. Week 11 \& 15: One card of USD 40.00, for a total of USD 80.00. 4. Week 19 \& 23: One card of USD 60.00, for a total of USD 120.00.
  • 5. Personalized practical & emotional support through a dedicated health partner — BEHAVIORAL
    * Each participant is assigned a program staff ("dedicated health partner") who call them briefly (15 min or so) over the phone for empathy-based support on the participant's health journey, and practical suggestions for shopping and food preparation. * The Health Partner will share periodically via SMS text a curated list of evidence-based, trustworthy online educational resources. * Health partners are not trained to answer medical or health-related questions and will not provide medical guidance or advice of any kind. For such questions, they will encourage participants to contact the clinic or physician. * Frequency: 1. Weeks 1-2 (2 weeks): No calls. 2. Weeks 3-7 (4 weeks): 2 calls a week, for a total of 8 calls. 3. Weeks 8-26 (18 weeks): 1 call every 2 weeks, for a total of 10. But during weeks 7, 11, and 19, participants will be given the choice to keep at 1x/week or decrease to 1x every 4 weeks.

Study Details

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.

Key Dates

Start date
Dec 6, 2023
Status verified
Mar 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Arm 1: Intervention + usual care
    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
  • Other: Arm 2: Educational materials + usual care
    1. Welcome package 2. Welcome information: SMS/Text

Primary Outcome Measure

Urine albumin:creatinine ratio (UACR) [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Harris Health System's Martin Luther King Jr. Health CenterHoustonTexas77047-
Harris Health System's Outpatient CenterHoustonTexas77026-
Harris Health System's Smith ClinicHoustonTexas77054-

Find similar trials in Houston, TX

By research site
Harris Health System's Martin Luther King Jr. Health Center· Houston, TXHarris Health System's Outpatient Center· Houston, TXHarris Health System's Smith Clinic· Houston, TX

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