Kidney Health: Eat Well, Live Well

Official title

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

Overview

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.

Detailed description

This study tests a community-based program aimed at supporting adults with early-stage chronic kidney disease to change their eating habits to reduce the likelihood of kidney injury progression.

The program components were design to reduce barriers to a) eating healthier, kidney-friendly foods through the direct provision of fruits and vegetables, grocery store e-gift cards, kidney-friendly recipes, and food preparation tips; b) learning about kidney disease and the role of healthy eating in slowing its progression through educational materials; and c) social connection through empathetic relational phone calls and SMS texts from a dedicated "Health Partner".

Over a period of 6 months (26 weeks), participants randomized to the intervention arm will receive:

* kidney-friendly produce (fruits and vegetables) delivered at their preferred location * recipes and tips on food preparation tailored to the produce * grocery store electronic gift cards * educational materials on CKD and disease management * personalized practical and emotional support through a dedicated Health Partner

Researchers will see if participation in the program (intervention) reduces markers of kidney injury (Albumin:Creatinin ratio) and cardiovascular disease risk and improves diet (particularly fruits and vegetables intake) and mental health when compared to usual care (control).

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
• 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 guida

Primary outcome measures

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

Secondary outcome measures (7)

• Hemoglobin A1C [Time frame: Baseline, 3 months, 6 months]
• Blood pressure (systolic/diastolic) [Time frame: Baseline, 3 months, 6 months]
• Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10 [Time frame: Baseline, 3 months, 6 months]
• Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption [Time frame: Baseline, 3 months, 6 months]
• Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7) [Time frame: Baseline, 3 months, 6 months]
• Depressive symptoms as measured by scores on the Patient Health Questionnaire 8-item (PHQ-8) [Time frame: Baseline, 3 months, 6 months]
• Loneliness measured by scores on the 3-item UCLA Loneliness Scale [Time frame: Baseline, 3 months, 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

United States · 3 centers

• Harris Health System's Outpatient Center — Houston
• Harris Health System's Martin Luther King Jr. Health Center — Houston
• Harris Health System's Smith Clinic — Houston

Identifiers

NCT: NCT05970341 · STUDY00002253

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗