Nutrition and Kidney Health Program for adults with kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a 7-session THINK-Well education series added to enhanced usual care for adults with non-dialysis CKD and cardiovascular risk. Participants may join online or in person over 12–20 weeks and will practice meal preparation while learning strategies to improve heart, kidney, and metabolic health. The study will measure how many people enroll, how many complete all sessions, and participant satisfaction. Eligibility focuses on adults with CKD and at least one cardiovascular risk factor, with consideration of readiness to change. The trial is conducted at multiple UPMC Kidney Clinics in the Pittsburgh area with lead sponsorship from the University of Pittsburgh and collaboration with the American Heart Association.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult (age ≥ 18 years) patients of UPMC Clinic and the presence of non-dialysis CKD defined by lab values eGFR ≤ 60 ml/min/1.73m2 and any level of proteinuria (or albuminuria); or eGFR \> 60 and urine-protein-to-creatinine ratio or urine-albumin-to-creatinine ratio \> 30mg/g), and at least one of the following: uncontrolled diabetes (HbA1c ≥ 7.5%), hypertension (12-month average blood pressure ≥130/80 mmHg), overweight or obese body mass index, or positive screening for food insecurity.
* Individuals meeting inclusion criteria will be screened for readiness to change by research coordinator. Individuals in contemplation, preparation, action, and maintenance stages of change will be eligible for enrollment.

Exclusion Criteria:

* To minimize attrition, individuals on dialysis, or planned to start dialysis or receive kidney transplant in the next 6 months will be excluded.
* A larger effectiveness trial will include persons in all stages of change, but this study will exclude those in pre-contemplative stage of change because low commitment to the trial may interfere with primary goal to measure feasibility.
* We are excluding participants who have no electronic health record data within the last 18 months. Specifically, no office visits, kidney function labs (i.e.. eGFR, uACR, and uPCR values), or documentation of CKD (stage 3 or higher) or proteinuria. We believe that patients without this data will be less likely to have the necessary lab data we are collecting for the pre- and post- intervention periods.

Where it's running

• UPMC Kidney Clinic - Wexford
  Pittsburgh, Pennsylvania, United States Recruiting
• UPMC Kidney Clinic - Monroeville
  Pittsburgh, Pennsylvania, United States Recruiting
• UPMC Kidney Clinic - Oakland
  Pittsburgh, Pennsylvania, United States Recruiting
• UPMC Kidney Clinic - Shadyside
  Pittsburgh, Pennsylvania, United States Recruiting
• UPMC Matilda H. Theiss Health Center
  Pittsburgh, Pennsylvania, United States Not yet recruiting

Study contacts

• Principal investigator: Linda-Marie U Lavenburg, DO, MS — University of Pittsburgh
• Study coordinator: Linda-Marie Lavenburg, DO, MS
• Email: lavenburglu@upmc.edu
• Phone: 12679807722

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.