No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
45 (estimated)
Sponsor
University of Pittsburgh · Other
Who this trial is looking for
This trial is looking for adults with chronic kidney disease who want to improve their nutrition and health. Participants will join a series of educational sessions about healthy eating and managing their conditions.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 18 or older.
I have chronic kidney disease defined by certain lab results.
I have uncontrolled diabetes, hypertension, obesity, or food insecurity.
I am willing to participate in a program that helps me change my eating habits.
You may not be able to join if
I am currently on dialysis or plan to start dialysis soon.
I am in the early stage of deciding to change my health habits.
I do not have any health records from the last 18 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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?
…
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.
Trial Locations
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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),…
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.
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