Kidney Health: Eat Well, Live Well
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 i
| Condition(s) | Chronic Kidney Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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, pr |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Texas at Austin |
| Locations | Houston, Texas, United States; Houston, Texas, United States; Houston, Texas, United States |
| Start date | 2023-12-06 |
| NCT ID | NCT05970341 |
| Official listing | https://clinicaltrials.gov/study/NCT05970341 |