RecruitingNot ApplicableNCT05970341

Kidney Health: Eat Well, Live Well

"Kidney Health: Eat Well, Live Well": A Program to Reduce Kidney Injury and Early CKD Progression Through Nutrition & Empathetic Support From a Health Partner

Sponsor

University of Texas at Austin

Enrollment

330 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called Kidney Health: Eat Well, Live Well) is a nutrition program for adults with early-to-moderate chronic kidney disease (CKD). It provides free produce and dietary education to help participants eat a kidney-friendly diet — which can slow the progression of kidney disease. The program is delivered through primary care clinics in the Harris Health System in Houston, Texas. **You may be eligible if...** - You are 18 years or older - You are a patient at a Harris Health clinic (Smith Clinic, Harris Health Outpatient Center, or MLK Health Center) - You have been diagnosed with CKD Stages 1–3b (a kidney filtration rate of 30–90 mL/min or elevated urine protein) - Your recent blood potassium level is within a safe range (≤ 4.6 mEq/L) - You speak English or Spanish - You have a phone that receives text messages - You are able to receive food deliveries in the designated area **You may NOT be eligible if...** - You have advanced CKD (Stage 4), end-stage renal disease, or are already on dialysis - You are taking certain medications regularly that affect potassium levels (such as NSAIDs, mineralocorticoid receptor antagonists, or warfarin) - You have specific types of kidney disease (such as polycystic kidney disease or lupus nephritis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORAL1. 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

BEHAVIORAL2. 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.

BEHAVIORAL3. 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.

BEHAVIORAL4. 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.

BEHAVIORAL5. 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.