NCT05970341 · University of Texas at Austin
Kidney Health: Eat Well, Live Well
What this study is about
This two-treatment group$1, parallel randomly assigned trial study will assess the effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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
BEHAVIORAL
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.
BEHAVIORAL
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.
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Urine albumin:creatinine ratio (UACR)
Time frame: Baseline, 3 months, 6 months
Marker of kidney damage and a useful predictor of cardiovascular (CV) events in adults. Uses spot urine to estimate 24-hour urine albumin excretion. UACR \> 30 mg/g indicates kidney damage.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Collaborators
Harris Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 26, 2025 · Source of record for eligibility and locations