Feasibility of The Health Integrated Nutrition and Kidney Wellness Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: THINK-Well, Enhanced Usual Care.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease, Cardiovascular Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program- Phase 2
Overview
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)]
- Participant retention [Time frame: Baseline to end of the 12-week intervention]
- Intervention adherence [Time frame: During the 12-week intervention period]
- Participant satisfaction [Time frame: End of the 12-week intervention period]
Secondary outcome measures (12)
- Change from Baseline in Life's Essential 8 score at 12-weeks [Time frame: From baseline to end of 12-week intervention]
- Change from Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) at 12-weeks [Time frame: From baseline to end of 12-week intervention]
- Change from Baseline Patient Activation Measure, 13-item version (PAM-13) at 12-weeks [Time frame: From baseline to end of 12-week intervention]
- Change from Baseline Kidney Disease Quality of Life - 36 at 12-weeks [Time frame: From baseline to end of 12-weeks intervention]
- Change from Baseline in Mediterranean Diet adherence at 12-weeks [Time frame: From baseline to end of 12-week intervention]
- Change from baseline in Body Composition at 12-weeks [Time frame: Baseline to after 12-weeks]
- Change in Body Mass Index (BMI) [Time frame: From baseline to the end of the 12-week intervention.]
- Change in Waist-to-Hip Ratio [Time frame: From baseline to the end of the 12-week intervention]
- Change in Body Composition (Fat Mass) [Time frame: Change from baseline to the end of the 12 week intervention]
- Change in Body Composition (Muscle Mass) [Time frame: Change from baseline to the end of 12-week intervention]
- Change in Body Composition (Percent Body Fat) [Time frame: Change from baseline to the end of the 12 week intervention]
- Change in Body Composition (Percent Muscle Mass) [Time frame: Change from baseline to the end of the 12 week intervention]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 5 centers
- UPMC Kidney Clinic - Wexford — Pittsburgh
- UPMC Kidney Clinic - Monroeville — Pittsburgh
- UPMC Kidney Clinic - Oakland — Pittsburgh
- UPMC Matilda H. Theiss Health Center — Pittsburgh
- UPMC Kidney Clinic - Shadyside — Pittsburgh
Identifiers
NCT: NCT07518719 · STUDY25050072