The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program- Phase 2
Phase: NA
Conditions: Chronic Kidney Disease, Cardiovascular Disease
Sponsor: University of Pittsburgh

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program- Phase 2 
 
 
 
 
Funding Sponsor: 
AHA Career Development Award  
 
Protocol Contact: 
Linda-Marie Lavenburg 
 
 
 
Lavenburglu@upmc.edu 
 
 
 
200 Lothrop St 
PUH, C1100 
Pittsburgh, PA 15213 
 
Investigators:  
Dr. Linda-Marie Lavenburg, University of Pittsburgh 
 
 
 
 
Protocol Number: 
STUDY25050072  
Protocol Version: 
V5.0 
 
Last Updated: February 23, 2026 
 
 
 
 
 

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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TABLE OF CONTENTS 
 
Principal Investigator Signature………………………………………………………………………………3 
Abbreviations…………………………………………………………………………………………………...4 
Study Summary………………………………………………………………………………………………...5 
Background and Significance…………………………………………………………………………………5 
Objectives……………………………………………………………………………………………………….6 
Study Design………………………………………………………………………………………………….   6 
Participants……………………………………………………………………………………………………...6 
Intervention……………………………………………………………………………………………………...6-7 
Study Procedures and Assessments…………………………………………………………………………8 
Duration………………………………………………………………………………………………………….8 
Fidelity………………………………………………………………………………………………………….. 8 
Evaluation…………………………………………………………………………………………………….... 8 
Data Analysis Plan…………………………………………………………………………………………….. 8 
Human Subjects……………………………………………………………………………………………….. 8-9 
Regulatory, Ethics and Oversight……………………………………………………………………………  9 
References………………………………………………………………………………………………………10-11 
 
 

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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PRINCIPAL INVESTIGATOR SIGNATURE 
 
Study Sponsor:  AHA Career Development Award  
 
Study Title: 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2)  
 
 
Protocol Version: 
V5.0 2/23/2026 
 
I, the Investigator, acknowledge that I have read and understood this protocol. I agree to conduct and supervise 
the educational study according to all applicable regulations for protecting the rights, safety, and welfare of the 
subjects under my care. I will adhere to the study requirements as presented in the protocol and agree to start 
the study only after IRB approval is obtained or this activity is deemed exempt. I will maintain accurate, complete, 
and current records relating to my participation in the study, consistent with good scientific and ethical practices.  
 
Name:  
 
 
Dr. Linda-Marie Lavenburg 
 
Institution: 
 
 
University of Pittsburgh 
 
Signature: 
 
 
_____________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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ABBREVIATIONS 
 
AHA  
 
American Health Association  
  
CKD  
 
Chronic Kidney Disease  
COM-B 
 
Capability, Opportunity, Motivation-Behavior model 
CVD 
 
Cardiovascular Disease 
 
 
EHR  
 
Electronic Health Record  
eGFR  
 
Estimated Glomerular Filtration Rate   
HIPAA  
 
Health Insurance Portability and Accountability Act  
IRB  
 
Institutional Review Board 
KDOQI 
 
Kidney Disease Outcome and Qualify Initiative 
PHI 
 
Protected Health Information 
UPMC 
 
University of Pittsburgh Medical Center  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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STUDY SUMMARY 
 
Title 
The Health Integrated, Nutrition and Kidney-Wellness Program (Phase 2) 
Short Title 
THINK-Well Program (Phase 2) 
 
Description/Objectives 
We will conduct a 12-week, two-arm 2:1 randomized controlled pilot feasibility 
study of THINK-Well intervention compared to enhanced usual care in  patients 
with non-dialysis CKD   
 
Primary Outcome 
Primary outcome is feasibility (i.e., recruitment, retention, and satisfaction). 
Secondary Outcome 
Secondary outcomes include change in Life’s Essential 8 score, diet intake, self-
efficacy, activation, quality of life, change in anthropometric measures, change 
in body composition (e.g., fat mass, muscle mass, % fat, % muscle mass). 
Study Population 
45 Adult (age ≥ 18 years) patients of UPMC Kidney Clinic and the presence of 
non-dialysis CKD. 
Study Site 
UPMC Clinics 
Intervention 
THINK-Well Program- In-person and virtual educational workshop series 
Study Duration 
18 months 
 
 
BACKGROUND AND SIGNIFICANCE 
 
An estimated 1 in 7 US adults have chronic kidney disease (CKD) and the prevalence is projected to increase, 
due in large part to obesity, hypertension, diabetes and aging.1,2 Patients with CKD have high cardiovascular 
disease (CVD) morbidity and mortality.1,3 Due to the intricate interplay between CKD and CVD, the American 
Heart Association (AHA) proposed a new cardiovascular-kidney-metabolic phenotype and released a 
Presidential Advisory calling for holistic and equitable approaches to manage CKD, CVD and metabolic risk 
factors.3,4 Health goals set by the AHA’s Life’s Essential 8 for cardiovascular health align well the National Kidney 
Foundation’s Kidney Disease Outcome and Quality Initiative (KDOQI) guidelines for optimal CKD management, 
especially for nutrition and physical activity.5 However, despite Medical Nutrition Therapy for CKD being a 
Medicare benefit since 2002, 9 out of 10 patients with CKD do not receive nutrition counseling until they start 
dialysis.6 Furthermore, available CKD management programs typically do not unify the complex dietary needs 
of competing comorbidities, or offer support to overcome barriers to diet, physical activity, behavior change, or 
address social needs such as food insecurity, reported by 1 in 4 adults with CKD.  
 
Comprehensive lifestyle intervention programs offer a promising approach to unify health promoting behavior 
change for multimorbid conditions, like CKD and CVD. Lifestyle intervention programs that encourage balanced 
eating to promote weight management, and physical activity, are a first line intervention therapy recommended 
for diabetes and CVD prevention.7-10 Lifestyle intervention programs, such as the Diabetes Prevention Program, 
are now reimbursable through Medicare.8,11,12 However, CKD lifestyle intervention programs are not yet widely 
available.13-15 Medical Nutrition Therapy is a covered benefit for CKD, but estimates suggest only one in ten 
patients receive this benefit, likely due to several reasons including lack of awareness, referral, and/or scarcity 
of Medical Nutrition Therapy providers.10,15 Thus, an equitable diet-focused lifestyle intervention rooted in 
behavior change theory may provide an effective and personalized approach to CKD and CVD risk reduction 
meanwhile, also addressing complex dietary needs of competing comorbidities and providing support to 
overcome barriers to food access or behavior change, such as food insecurity.16 AHA’s Life’s Essential 83 (Table 
1) is a measure of cardiovascular health and aligns well with CKD management guidelines (i.e., KDOQI) 17 and 
thus can serve as an important educational tool for goal setting in a diet-focused CKD lifestyle intervention 
program.18 
 
 

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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OBJECTIVES 
The goal of the current proposal is to pilot test THINK-Well Program, which will offer practical, culturally aware 
guidance on affordable and sustainable strategies to nutrition optimization, which may potentiate improvements 
in other kidney and cardiovascular health behaviors (e.g., physical activity). 
 
Primary outcomes: (Table 1) 
• 
Feasibility (i.e., recruitment, retention, and satisfaction).  
 
Secondary outcomes: 
• 
Change in Life’s Essential 8 score, diet intake, self-efficacy, activation, quality of life, change in 
anthropometric measures, change in body composition (e.g., fat mass, muscle mass, % fat, % muscle 
mass. 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
STUDY DESIGN 
We will conduct a 12-week two-arm 2:1 randomized pilot feasibility study of THINK-Well intervention compared 
to enhanced usual care. We will recruit patients with non-dialysis CKD from the UPMC Clinics. 
 
PARTICIPANTS   
45 Adult (age ≥ 18 years) patients with non-dialysis CKD defined by lab values (eGFR ≤ 60 ml/min/1.73m2). 
 
INTERVENTION 
THINK-Well Program is a workshop series of seven alternating virtual and in-person group activities led by a 
trained interventionist every two weeks aimed to promote capability, opportunity and motivation to change kidney 
health promoting behavior. Group activities will include education, goal setting, peer support, cooking classes, 
physical activity coaching, and provision of functional retention items (such as food vouchers, cooking supplies, 
etc.). We will also provide a one-time opt-out 1:1 dietitian counseling to facilitate goal attainment and 
personalized meal planning.  
 
THINK-Well intervention components described in Table 2 were developed using:  
a) A conceptual framework often used to design behavior change interventions.27,28 We used the Capability, 
Opportunity, Motivation- Behavior (COM-B) model, a behavior change theory embodied in the Behavior 
Change Wheel, to ensure program components fulfill behavior change functions.29 The COM-B model 
theorizes that behavior is the result of an interaction between three components: capability, opportunity, and 
motivation.  
b) Human centered design approach. Patient recruitment, engagement and retention are major barriers to 
impacting patients, especially in populations with socioeconomic disadvantages. To overcome these 
Table 1. Primary Outcomes 
Benchmarks 
Feasibility 
Recruitment  
# patients screened 
# eligible patients / # patients screened 
# patients enrolled / number of eligible patients x 100 (per month) 
>40% of eligible patients provide 
informed consent, and complete 
baseline assessments 
Retention 
Monthly dropout rate and reason for dropout 
# patients who complete post-questionnaires / Number of patients enrolled x 100 
>70% retention of participants at 12 
weeks 
Satisfaction 
Patient and provider satisfaction reported using client satisfaction questionnaires 
>80% satisfaction on survey 
Secondary Outcomes 
Mediterranean Eating Pattern for Americans tool20,  Life’s Essential 8 score21, Hunger vital sign22, Chronic Disease Self-
Efficacy23,24, Patient Activation Measure-1325, and Kidney Disease Quality of Life-3626, Change in anthropometric measures 
(e.g., weight, body mass index, waist to hip ratio), Change in fat mass, muscle mass, percent body fat, and percent muscle 
mass  

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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challenges, we used a human centered design approach to incorporate lived experiences and input from a 
Community Partner Advisory Panel to design THINK-Well intervention and solve challenges.  
c) Community Partnerships. THINK-Well intervention was developed with a Community Partner Advisory Panel 
including patients, nephrologists, a Women, Infants, and Children Director, Giant Eagle Grocery, a public 
health and lifestyle intervention expert, local National Kidney Foundation executive director, and a Health 
Plan representative. 
 
COMPARATOR 
The comparator arm will be enhanced usual care. Standard of care for people with kidney disease is an optional 
30–60-minute one-time educational session with a nurse educator during which topics such as kidney disease 
stages, nutrition, physical activity, medications to avoid, and renal replacement therapy are discussed. The 
comparator group will receive two group virtual educational sessions delivered by a trained educator. Educational 
topics will include Nutrition and Kidney Disease, Dining out with confidence, and will direct participants to the 
websites, such as National Kidney Foundation, American Kidney Fund, and American Heart Association to find 
more nutrition guidance.  
 
Table 2. THINK-Well Intervention 
Week Activity (Proposed facility if in-person) 
In-person or Virtual 
Retention item* 
1 
Welcome and Overview / Goal setting  
(at Phipps Teaching Kitchen) 
In-person 
Swag bag with 
Cooking Supplies 
2 
Education: Diet Approaches for Heart-Kidney-Metabolic Health 
/ Goal Progress 
Virtual (Zoom) 
Food Voucher 
4 
Activity: Cooking with Salt alternatives  
(Location to be determined) 
In-person 
Food Voucher 
6 
Education: Reading labels and portion control/ Goal Progress 
Virtual (Zoom) 
Food Voucher 
8 
Activity: Physical activity and self-monitoring and Goal 
Progress (Location to be determined) 
In-person 
Stress ball 
10 
Education: Dining out and Eating with a budget/ Goal Progress Virtual (Zoom) 
Food Voucher 
12 
Activity: Cooking Class /Goal Progress/ Graduation  
(at Phipps Teaching Kitchen) 
In-person 
T-shirt 
Sessions led by a trained health coach. Reminder text message sent 24-and 48 hours prior to Activity 
Opt-out virtual 1:1 dietitian counseling to facilitate goal attainment and personalized meal planning 
* Retention items are proposed and subject to change  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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STUDY PROCEDURES AND ASSESSMENTS 
 
DURATION 
 
Phase 2 of THINK-Well is anticipated to have an 18-month implementation period 
 
FIDELITY 
The research team will obtain required regulatory approvals and leadership and carry out the study 
procedures.  Fidelity checks will be conducted throughout various time intervals by auditing. 
DATA COLLECTION AND MEASURES  
 
Sociodemographic and clinical data (including medications, vital signs, weight, lab values such as urine albumin 
to creatinine ratio and serum creatinine) will be collected at baseline and end of intervention. Body composition 
and anthropometric measurements will be collected at baseline and end of intervention +/- 2 weeks. Primary and 
secondary outcomes data will be collected at baseline and after 12-weeks of intervention. Data will be collected 
in-person or by phone through patient interviews by trained research staff and supplemented with data from 
electronic record.   
 
DATA ANALYSIS PLAN 
 
We will perform descriptive statistical analyses of baseline characteristics, primary and secondary outcomes. 
Point estimates and confidence intervals will be calculated for feasibility parameters. We believe that successfully 
recruiting >40% of eligible patients (e.g., 9 patients per month) will demonstrate the capacity to recruit for a future 
trial. This study is not powered to establish the efficacy of THINK-Well Program on clinical (secondary) outcomes. 
However, we will administer questionnaires to determine feasibility of collecting these data. 
 
HUMAN SUBJECTS 
Risks to Subjects 
The risks of the proposed study are exposure to food allergies at cooking classes and through food boxes. 
However, we will collect a list of food allergies before cooking classes and food box distribution. Minor 
musculoskeletal pain may also result despite performing physical activity within individual limitations. Risks 
include the slight risk that their confidentiality may be breached. Data containing personal health information will 
be password protected behind a firewall with access limited to essential study personnel. All data for analysis 
will be de-identified. 
 
Benefits to participating in the pilot THINK-Well Program may include better understanding of nutrition for kidney 
and heart health, improved control of blood pressure, blood sugar, and cholesterol, and greater access to health 
and nutrition resources compared to usual care. 
 
Protections against Risks 
The study will be approved by the University of Pittsburgh Institutional Review Board (IRB).  All study 
personnel led by the PI are clinically competent and current on all trainings including HIPAA compliance 
certification and responsible conduct of research.   
 
Confidentiality 
This study will be conducted in compliance with all applicable rules and regulations, including the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA).   

Protocol # (STUDY 25050072) 
The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program (Phase 2) 
Version 5.0 
 
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Only the minimum data necessary for the study will be obtained.  Any data stored electronically will be 
stored on University of Pittsburgh and UPMC secure password protected computers on secure servers 
in departmental offices. All paper forms with PHI will be stored in closed cabinets in closed rooms. Only 
the principal investigator and the research team involved in the study will have access to the data. 
 
Risk-Benefit Ratio 
There is minimal risk for participants. The benefits of pilot trial participation include greater understanding of 
kidney disease and the interrelationship of nutrition with heart-kidney-metabolic health. Participants may also 
experience greater awareness and access to health resources available outside of the THINK-Well Program. As 
a result, this leads to the potential of future benefit to patients. 
 
Importance of Knowledge to be Gained 
We hypothesize that addressing food accessibility, affordability, behavior change, and education will increase 
recruitment, retention and satisfaction, meanwhile achieving short-term changes in healthy eating behavior and 
potentiating change in other health behaviors. 
REGULATORY, ETHICAL AND OVERSIGHT CONSIDERATIONS 
The Investigators will be responsible for ensuring that the study is conducted in compliance with the protocol and 
all applicable rules and regulations. This educational study will be conducted in full accordance with all applicable 
Institutional Research Policies and Procedures and all applicable Federal and state laws and regulations, 
including 45 CFR 46 and the HIPAA Privacy Rule. It is the Investigator’s responsibility to perform the study in 
accordance with the protocol and all applicable rules and regulations. Any instance of non-compliance will be 
documented and reported in accordance with the University of Pittsburgh IRB Policies and Procedures and 
federal requirements.  
 
 
 
 
 

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