A program to improve kidney health through better eating habits
"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 study is testing a program that helps low-income adults with early kidney disease improve their eating habits and overall health by providing healthy food, recipes, and support for six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas at Austin Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Trial ID | NCT05970341 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a community-based program designed to help low-income adults with early chronic kidney disease improve their diet and reduce the risk of kidney injury and cardiovascular issues. Participants will receive a variety of kidney-friendly produce delivered to their homes, along with recipes, grocery store gift cards, and personalized support from a dedicated health partner. The program aims to enhance dietary habits, mental health, and overall well-being over a 6-month period. The effectiveness of this intervention will be compared to standard educational materials and usual care.
Who should consider this trial
Good fit: Ideal candidates are low-income adults aged 18 and older with early-stage chronic kidney disease who have access to the participating clinics.
Not a fit: Patients with advanced chronic kidney disease or those currently on kidney replacement therapies may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve kidney health and quality of life for patients with early chronic kidney disease.
How similar studies have performed: Other studies have shown promising results with community-based dietary interventions for chronic diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 2 other locations
- Harris Health System's Outpatient Center — Houston, Texas, United States (Recruiting)
- Harris Health System's Martin Luther King Jr. Health Center — Houston, Texas, United States (Recruiting)
- Harris Health System's Smith Clinic — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Maninder Kahlon, PhD — University of Texas at Austin
- Study coordinator: Courtney Mulligan, MA
- Email: Courtney.Mulligan@austin.utexas.edu
- Phone: 512-522-4349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.