Cardiovascular Disease, Chronic Kidney Disease
Conditions
Keywords
lifestyle intervention, community partnered, nutrition, culinary medicine
Brief summary
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.
Interventions
BEHAVIORALTHINK-Well
Seven hybrid (online or in-person) group nutrition education sessions paired with food bucks and one individual consultation with a dietitian over 12-20 weeks.
OTHEREnhanced Usual Care
Two virtual group nutrition educational sessions provided by a trained educator.
Sponsors
University of Pittsburgh
American Heart Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | 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 | From baseline to end of the intervention period (12-20 weeks) | 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 | From baseline to end of the intervention period (12-20 weeks) | 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 | From baseline to end of the intervention period (12-20 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Life's Essential 8 score at 12-weeks | From baseline to end of the intervention period (12-20 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 |
| Change from Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) at 12-weeks | From baseline to end of the intervention period (12-20 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. |
| Change from Baseline Patient Activation Measure, 13-item version (PAM-13) at 12-weeks | From baseline to end of the intervention period (12-20 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. |
| Change from Baseline Kidney Disease Quality of Life - 36 at 12-weeks | From baseline to end of the intervention period (12-20 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. |
| Change from Baseline in Mediterranean Diet adherence at 12-weeks | From baseline to end of the intervention period (12-20 weeks) | Diet quality will be assessed using the Mediterranean Eating Pattern for Americans (MEPA) tool, which is an instrument developed to assess how closely a person's diet aligns with the Mediterranean dietary pattern adapted for U.S. populations. Total scores are summed to produce a composite Mediterranean diet adherence score. Higher scores indicate closer alignment with the Mediterranean Eating Pattern. The screener consists of 16 items assessing frequency or quantity of consumption of key Mediterranean diet components including fruits, vegetables, whole grains, legumes, nuts, fish, olive oil, and red or processed meats. Each item contributes 0 or 1 point based on whether the recommended intake threshold is met. Scores are summed to produce a total score ranging from 0 to 16. |
| Change from baseline in Body Composition at 12-weeks | From baseline to end of the intervention period (12-20 weeks) | Using a bioimpedence scale, we will measure and collect body composition data. This will include: Fat Mass (measured in kilograms), Muscle Mass (measured in kilograms), Percent Fat Mass (measured as a percentage), and Percent Muscle Mass (measured as a percentage). |
| Change in Body Mass Index (BMI) | From baseline to end of the intervention period (12-20 weeks) | Body Mass Index (BMI) will be calculated from two anthropometric measures, body weight and reported height. These two measures will be collected using standardized measurement procedures. The following measures will be assessed: Body weight (kg): Body weight will be measured in kilograms using a calibrated digital scale with participants wearing light clothing and no shoes. Reported height will be taken from an average of the patient's three most recent electronic medical record heights. Body mass index (BMI) (kg/m²): BMI will be calculated as weight in kilograms divided by reported height in meters squared. |
| Change in Waist-to-Hip Ratio | From baseline to end of the intervention period (12-20 weeks) | Waist-to-hip ratio measures will be collected using standardized measurement procedures and measured in centimeters. Waist circumference and hip circumference will be measured in centimeters using a flexible measuring tape. Waist circumference will be measured at the midpoint between the lower rib and the iliac crest. Hip circumference will be measured at the widest portion of the buttocks. Waist-to-hip ratio will be calculated as waist circumference (cm) divided by hip circumference (cm). |
| Change in Body Composition (Fat Mass) | From baseline to end of the intervention period (12-20 weeks) | Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations. The following body composition measures will be collected: Fat mass (kg): Estimated total body fat mass measured in kilograms. Reductions in fat mass represent improvements in body composition. |
| Change in Body Composition (Muscle Mass) | From baseline to end of the intervention period (12-20 weeks) | Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations. The following body composition measures will be collected: Muscle mass (kg): Estimated total skeletal muscle mass measured in kilograms. Increases in muscle mass represent improvements in body composition. |
| Change in Body Composition (Percent Body Fat) | Change from baseline to the end of the 12 week intervention | Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations. The following body composition measures will be measured and obtained from BIA: Percent body fat (%): The proportion of total body weight composed of fat tissue, expressed as a percentage ranging from 0-100%. Percent muscle mass (%): The proportion of total body weight composed of fat tissue, expressed as a percentage ranging from 0-100%. Reductions in percent body fat and increase in percent muscle mass represent improvements in body composition. |
| Change in Body Composition (Percent Muscle Mass) | From baseline to end of the intervention period (12-20 weeks) | Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations. The following body composition measures will be calculated: Percent muscle mass (%): The proportion of total body weight composed of skeletal muscle tissue, expressed as a percentage ranging from 0-100%. Percent Muscle Mass will be calculated from two collected measures: Body Mass (kg), and Muscle Mass (kg). Increases in muscle mass and percent muscle mass represent improvements in body composition. |
Countries
United States
Contacts
CONTACTLinda-Marie Lavenburg, DO, MS
CONTACTManisha Jhamb, MD, MPH
PRINCIPAL_INVESTIGATORLinda-Marie U Lavenburg, DO, MS
University of Pittsburgh
Outcome results
None listed