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RECRUITING Not applicable ClinicalTrials.gov

Feasibility of The Health Integrated Nutrition and Kidney Wellness Program

Sponsor: University of Pittsburgh • ClinicalTrials.gov ID: NCT07518719

Registry updated: 2026-09-09
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Description

Purpose of the Study: This clinical trial will test whether a nutrition and kidney health program can work well for adults with kidney disease. The program was created with help from patients and community partners. Main Questions: How many eligible patients choose to join the program? How many participants complete all 7 educational sessions? How satisfied are participants with the program? What Participants Will Do: Participants will be assigned to a diet-focused lifestyle education series (THINK-Well Intervention) or enhance usual care. THINK-Well Intervention group will take part in 7 group education sessions over 12-20 weeks. Sessions will be online and in-person. Topics include eating to promote heart-kidney-and metabolic health, managing long-term health conditions, setting health goals, and sharing experiences with others who have chronic disease. Participants will practice meal preparation through cooking classes and have opportunity to apply lessons on choosing whole foods with food bucks provided. The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12-20 weeks. Topics will be similar to standard education provided to people with kidney disease managed by a kidney doctor. Topics will be adapted from established resources from the National Kidney Foundation, American Kidney Fund, and American Heart Association.

Interventions

  • THINK-Well (Behavioral)
    Seven hybrid (online or in-person) group nutrition education sessions paired with food bucks and one individual consultation with a dietitian over 12-20 weeks.
  • Enhanced Usual Care (Other)
    Two virtual group nutrition educational sessions provided by a trained educator.

Eligibility criteria

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.

Conditions

Chronic Kidney Disease Cardiovascular Disease

Locations

  • UPMC Kidney Clinic - Wexford — Pittsburgh, Pennsylvania, United States
  • UPMC Kidney Clinic - Monroeville — Pittsburgh, Pennsylvania, United States
  • UPMC Kidney Clinic - Oakland — Pittsburgh, Pennsylvania, United States
  • UPMC Matilda H. Theiss Health Center — Pittsburgh, Pennsylvania, United States
  • UPMC Kidney Clinic - Shadyside — Pittsburgh, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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