Feasibility of The Health Integrated Nutrition and Kidney Wellness Program (THINK-Well)

The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program- Phase 2

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Disease; Chronic Kidney Disease
• Intervention / Treatment: Behavioral: THINK-Well; Other: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manisha Jhamb, MD, MPH; Phone Number: 412-647-7062; Email: jhambm@upmc.edu
• Study Contact Backup: Name: Linda-Marie Lavenburg, DO, MS; Phone Number: 12679807722; Email: lavenburglu@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15090
      • Recruiting
      • UPMC Kidney Clinic - Wexford
      • Contact: Linda-Marie Lavenburg, DO; Phone Number: 412-663-5528; Email: lavenburglu@upmc.edu
    • Pittsburgh, Pennsylvania, United States, 15146
      • Recruiting
      • UPMC Kidney Clinic - Monroeville
      • Contact: Christopher Passero, MD; Phone Number: 412-578-9551; Email: passerocj@upmc.edu
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Kidney Clinic - Oakland
      • Contact: Jyotsana Thakkar, MD; Phone Number: 412-756-3228; Email: thakkarj@upmc.edu
    • Pittsburgh, Pennsylvania, United States, 15219
      • Not yet recruiting
      • UPMC Matilda H. Theiss Health Center
      • Contact: Mylynda Massart, MD, PhD; Phone Number: 412-647-9304; Email: massartmb@upmc.edu
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • UPMC Kidney Clinic - Shadyside
      • Contact: Christopher Passero, MD; Phone Number: 412-578-9551; Email: passerocj@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THINK-Well; Hybrid (in-person and virtual) practical nutrition education with people living with kidney disease. Group sessions will enable social support from others with kidney disease, facilitate goal-setting and individualized problem-solving, discuss an integrated approach to nutrition for people with multiple health conditions, and develop basic culinary skills while encouraging a whole-food, heart-healthy diet. Participants will also receive financial assistance to purchase produce and opt-out 1:1 nutrition counseling.	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.
Active Comparator: Enhanced Usual Care; The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12 weeks.	Other: Enhanced Usual Care; Two virtual group nutrition educational sessions provided by a trained educator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the study recruitment period (anticipated up to 6 months)
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	Baseline to end of the 12-week intervention
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.	During the 12-week intervention period
Participant satisfaction	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.	End of the 12-week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to end of 12-week intervention
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.	From baseline to end of 12-week intervention
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.	From baseline to end of 12-week intervention
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: Symptoms and Problems of Kidney Disease (12 items); Effects of Kidney Disease on Daily Life (8 items); Burden of Kidney Disease (4 items); Physical Component Summary (PCS) derived from the Short Form-12; 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.	From baseline to end of 12-weeks intervention
Change from Baseline in Mediterranean Diet adherence at 12-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.	From baseline to end of 12-week intervention
Change from baseline in Body Composition at 12-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).	Baseline to after 12-weeks
Change in Body Mass Index (BMI)	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.	From baseline to the end of the 12-week intervention.
Change in Waist-to-Hip Ratio	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).	From baseline to the end of the 12-week intervention
Change in Body Composition (Fat Mass)	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 from baseline to the end of the 12 week intervention
Change in Body Composition (Muscle Mass)	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 from baseline to the end of 12-week intervention
Change in Body Composition (Percent Body Fat)	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 from baseline to the end of the 12 week intervention
Change in Body Composition (Percent Muscle Mass)	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.	Change from baseline to the end of the 12 week intervention

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Linda-Marie U Lavenburg, DO, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: nutrition; lifestyle intervention; culinary medicine; community partnered
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: STUDY25050072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Upon study completion, a de-identified dataset including PAM scores and supporting demographic, self-reported, or clinical data is submitted to Insignia Health as part of our research license to use Patient Activation Measure-13 survey.

De-identified data will be retained for at least 7 years. Requests for IPD sharing will be accepted, and the decision to share data will be under the discretion of the Study Principal Investigator.

• IPD Sharing Time Frame: De-identified IPD will be made available upon study completion. Supporting information will be available at the trial end. The data will be retained for at least 7 years in accordance with the University of Pittsburgh's data retention policy.
• IPD Sharing Access Criteria: Insignia Health will have access to de-identified IPD and the supporting information. They will be able to access a dataset including PAM scores and supporting demographic, self-reported, or clinical data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No