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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
THINK-Well
BehavioralSeven 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 interventionTwo virtual group nutrition educational sessions provided by a trained educator.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: THINK-WellExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Recruitment
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.
Time frame
During the study recruitment period (anticipated up to 6 months)2
Participant retention
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
Time frame
From baseline to end of the intervention period (12-20 weeks)3
Intervention adherence
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.
Time frame
From baseline to end of the intervention period (12-20 weeks)4
Participant satisfaction
Participant satisfaction with the THINK-Well program will be assessed using a post-intervention questionnaire administered at the end of the intervention. 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.
Time frame
From baseline to end of the intervention period (12-20 weeks)Secondary outcomes
1
Change from Baseline in Life's Essential 8 score at 12-weeks
Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health. Interpretation of the composite score usually follows these general categories: 0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health
Time frame
From baseline to end of the intervention period (12-20 weeks)2
Change from Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) at 12-weeks
Self-efficacy will be assessed using the Chronic Disease Self-Efficacy Scale (Self-Efficacy for Managing Chronic Disease 6-Item Scale). This instrument measures an individual's confidence in their ability to manage symptoms, fatigue, emotional distress, and health tasks associated with chronic disease. The scale includes 6 items, each rated on a 10-point numeric scale ranging from 1 ("not at all confident") to 10 ("totally confident"). Scores are calculated as the mean of the six items, producing a final score ranging from 1 to 10. Higher scores indicate greater confidence in the ability to manage chronic disease-related health challenges.
Time frame
From baseline to end of the intervention period (12-20 weeks)3
Change from Baseline Patient Activation Measure, 13-item version (PAM-13) at 12-weeks
Patient activation will be measured using the Patient Activation Measure-13 (PAM-13), which assesses an individual's knowledge, skills, and confidence in managing their health and healthcare. The PAM-13 consists of 13 statements rated on a 4-point Likert scale (strongly disagree to strongly agree) with an additional "not applicable" option. Responses are summed and converted using a proprietary scoring algorithm to a standardized activation score ranging from 0 to 100. Higher scores indicate greater patient activation.
Time frame
From baseline to end of the intervention period (12-20 weeks)4
Change from Baseline Kidney Disease Quality of Life - 36 at 12-weeks
KDQOL is a kidney disease-specific quality-of-life instrument that combines a generic core with targeted modules to measure how CKD and its treatments impact patients' well-being across physical, emotional, and social dimensions. The instrument contains five subscales: 1. Symptoms and Problems of Kidney Disease (12 items) 2. Effects of Kidney Disease on Daily Life (8 items) 3. Burden of Kidney Disease (4 items) 4. Physical Component Summary (PCS) derived from the Short Form-12 5. Mental Component Summary (MCS) derived from the Short Form-12 Each subscale is scored on a 0-100 scale after standard scoring transformation according to KDQOL-36 scoring guidelines. Higher scores indicate better quality of life or fewer symptoms/burdens. The KDQOL-36 does not produce a single total score; results are reported for each subscale.
Time frame
From baseline to end of the intervention period (12-20 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov