Recruiting

Kidney Health

Sponsor:

University of Texas at Austin

Code:

NCT05970341

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

1. Welcome package

2. Welcome information (phone or text)

3. Produce delivery + Recipes customized to produce

4. E-gift cards to a grocery store of choice

5. Personalized practical & emotional support through a dedicated health partner

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Diseases

Study ID

NCT05970341

Start date

Dec 6, 2023

Status verified date

Mar, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

1. Welcome package

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)

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

  • 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

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

  • 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Courtney Mulligan, MA

512-522-4349Courtney.Mulligan@austin.utexas.edu

Nicole Clark, MBA

210-316-5443nicole.clark@austin.utexas.edu

Locations

Harris Health System's Outpatient Center

Recruiting

Houston, Texas, United States, 77026

Harris Health System's Martin Luther King Jr. Health Center

Recruiting

Houston, Texas, United States, 77047

Harris Health System's Smith Clinic

Recruiting

Houston, Texas, United States, 77054

More Information

Sponsor

University of Texas at Austin

Last update posted

Mar 26, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-03-26.