Clinical Trials

Kidney Health: Eat Well, Live Well

Study Status: Recruiting

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).

  • Sex: ALL
  • Minimum Age: 18 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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

Conditions

Chronic Kidney Diseases

Intervention/Treatment

Intervention/Treatment

  • BEHAVIORAL : 1. Welcome package
  • BEHAVIORAL : 2. Welcome information (phone or text)
  • BEHAVIORAL : 3. Produce delivery + Recipes customized to produce
  • BEHAVIORAL : 4. E-gift cards to a grocery store of choice
  • BEHAVIORAL : 5. Personalized practical & emotional support through a dedicated health partner

Sponsor

University of Texas at Austin

Principal Investigator(s)

  • Maninder Kahlon, PhD, PRINCIPAL_INVESTIGATOR, University of Texas at Austin

Phase

  • NA