Feasibility of The Health Integrated Nutrition and Kidney Wellness Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- THINK-Well
- Enhanced Usual Care
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pittsburgh
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov