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

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.

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).

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