NCT07518719 · University of Pittsburgh
Feasibility of The Health Integrated Nutrition and Kidney Wellness Program
(THINK-Well)
What this study is about
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.
View original scientific 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 finish the full 12-week program? 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 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 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
BEHAVIORAL
THINK-Well
Seven hybrid (online or in-person) group nutrition education sessions paired with food bucks and one individual consultation with a dietitian over 12-weeks.
OTHER
Enhanced Usual Care
Two virtual group nutrition educational sessions provided by a trained educator.
Primary outcome measures
Feasibility of Recruitment
Time frame: During the study recruitment period (anticipated up to 6 months)
Recruitment feasibility will be assessed using screening, eligibility, and enrollment metrics. The total number of patients screened for study eligibility will be recorded. The eligibility rate will be calculated as the number of patients who meet study eligibility criteria divided by the total number of patients screened. The enrollment rate will be calculated as the number of patients enrolled divided by the number of eligible patients and expressed as a percentage per month.
Participant retention
Time frame: Baseline to end of the 12-week intervention
Retention will be assessed as the proportion of enrolled participants who complete the 12-week THINK-Well program and the end-of-study assessment. Retention rate will be calculated as the number of participants who complete the final study assessment divided by the total number of participants enrolled, expressed as a percentage. Monthly dropout rate and reason for dropout
Intervention adherence
Time frame: During the 12-week intervention period
Intervention adherence will be assessed by participant attendance at scheduled program sessions. Adherence will be calculated as the number of sessions attended divided by the total number of planned sessions for each participant and summarized as the mean percentage of sessions attended across participants.
Participant satisfaction
Time frame: End of the 12-week intervention period
Participant satisfaction with the THINK-Well program will be assessed using a post-intervention questionnaire administered at the end of the 12-week program. The survey will assess participants' perceptions of the usefulness, relevance, and overall satisfaction with the program content, delivery format (virtual and in-person sessions), and program activities. Satisfaction will be summarized using descriptive statistics, including mean scores and the proportion of participants reporting high satisfaction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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.
Where
- Pittsburgh, Pennsylvania
Collaborators
American Heart Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations