The Effect of a Multi-Component Behavior Change Technique Intervention on Physical Activity Among Individuals on Primary Prevention Statin Therapy: A Dose-Finding Pilot Study
Phase: PHASE1
Conditions: Insufficient Physical Activity
Sponsor: Northwell Health

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A BCT Intervention for Physical Activity Among Individuals on Statins 
NCT05273723 
PI: Karina Davidson, PhD, MASc 
Version Date: 6/30/2023 
 
 

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RESEARCH PROTOCOL 
 
 
Protocol Title: 
The Effect of a Multi-Component Behavior Change Technique 
Intervention on Physical Activity Among Individuals on Primary 
Prevention Statin Therapy: A Dose-Finding Pilot Study 
Principal Investigator: 
Karina Davidson, PhD 
Primary Contact Name: 
Challace Pahlevan-Ibrekic, MBE, CIP 
Primary Contact Phone: 
347-751-2306 
Primary Contact E-mail: 
cpahlevanibr@northwell.edu 
Date Revised: 
6/30/23 
IRB Number: 
21-0674-MRB 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
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You do not need to complete this document if you are submitting an Application for 
Exemption or Application for a Chart Review.   
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Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical Trial 
Protocol Template. 
o Your study has a protocol from a sponsor or cooperative group.  In this case, use the 
Protocol Plus.   
o Your study is a registry or repository for data and/or samples,  In this case, use 
Protocol Template – Registry Studies. 
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If a section of this protocol is not applicable, please indicate such. 
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Do not delete any of the text contained within this document. 
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Please make sure to keep an electronic copy of this document.  You will need to use it, if you 
make modifications in the future.   
• 
Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
o Date Revised:  Indicate the date at which the protocol was last revised 
o IRB Number:  Indicate the assigned IRB number, when known.  At initial submission, 
this row will be left blank.   
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Once the table information in entered, proceed to page 2 and complete the rest of the form. 
 
 
 
â Continue to next page to begin entering information about this study â 
 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 

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 No  
 Yes -  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• 
The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• 
It should contain a clear statement of the rationale and hypothesis of your study, a concise 
description of the methodology, with an emphasis on what will happen to the subjects, and 
a discussion of the results.  
• 
This section should be ½ page 
 
 
The purpose of this project is to identify the minimum effective dose (MED) of a 
multi-component behavioral change intervention required to increase levels of 
physical activity (PA) among participants on primary prevention statin therapy who 
are at elevated risk for cardiovascular disease (CVD). The long-term goal is to prevent 
CVD. The current project will utilize a modified version of the time- to- event 
continual reassessment method method (TiTE-CRM) [1,2] , a state-of-the-art dose 
finding methodology, to determine the MED of a multi-component behavioral change 
technique (BCT) intervention required to increase PA by an average of 2,000 steps 
per day. The intervention will be comprised of 5 BCTs which have previously shown 
to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-
Monitoring, Feedback, and Prompts/Cues [3-6].  
 
The sample will include individuals prescribed primary prevention statin therapy 
with self-reported low levels of physical activity. Participants will complete a 2-week 
baseline run-in period where PA levels will be measured using Fitbit wearable 
devices and levels of adherence to statin medications will be assessed using eCAP 
smart pill bottles. During the baseline period, data from the Fitbit wearable devices 
will be used to verify participant’s level of objective sedentary behavior. Individuals 
who are non-adherent to the protocol will be excluded and will not be randomized to 
the intervention. Following baseline, we will randomize 42 participants into 
14 cohorts of 3 participants each for the intervention period. During the intervention 
period, participants will receive a BCT intervention, the length of which varies 
between 1 and 10 weeks depending on the assigned dose of a multi-BCT 
intervention. Assignment to doses will utilize modified TiTE-CRM methodology to 
adjust the dose for each cohort based on the results from the previous 
cohort. Following the intervention, all participants will be assessed over a 2-
week follow-up period which includes passive data collection from the activity 
monitor, answering surveys and use of eCAP smart pill bottles to track medication 
adherence. 
 
All collected data will be stored in the REDCap program, which is a Northwell IRB and 
Research IT security approved application, housed on the Northwell IT approved 
server. The MED will be defined as the smallest BCT dose duration associated with 
80% of participants having a successful PA increase between the run-in and the 
follow-up periods. Change in PA will be defined as the difference in average daily PA 
between the run-in and follow-up periods. We will also assess Mechanisms of Action 
(MoAs) to determine potential mediators of the BCT intervention on PA. As increasing 

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PA may change statin adherence [7, 8], we will utilize eCAP smart pill bottles to 
measure adherence to statin medications.  
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
• 
Describe and provide the results of previous work by yourself or others, including animal 
studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies involving the 
compound or device to be studied.  
• 
Include information as to why you are conducting the study and how the study differs from 
what has been previously researched, including what the knowledge gaps are. 
• 
Describe the importance of the knowledge expected to result 
 
Cardiovascular disease (CVD) remains the leading cause of mortality [9] and 
morbidity [10]in the United States. Statin therapy is a mainstay of CVD prevention, 
with multiple, large randomized controlled trials (RCTs) demonstrating that statin 
therapy decreases the probability of CVD events [11-13]. . However, research has 
shown that statin therapy alone is insufficient for preventing incident CVD 
and mortality  [8-11][14-16].  
 
Walking an additional 2,000 steps per day has been found to have a clinically 
significant impact on CVD risk [16]. Combining statin medication with physical 
activity (PA) can lower mortality risk more than either statin or PA alone[14,15]. 
Further, the addition of PA to statin therapy can have additional benefits, such as 
increased cognitive functioning [17]  and reduced side effects for statin therapy 
[18.19].  Despite the importance of increasing PA while on statins, PA levels often 
remain the same following statin prescription [20] and may even decline [21]. 
 
Multi-component behavioral change technique (BCT) interventions have 
demonstrated modest efficacy for increasing PA [22-24] and medication adherence 
[3,25]. However, no research has examined the dose of a multi-BCT intervention 
required to produce a clinically meaningful increase in PA. By using a modified 
version of the time-to-event continual reassessment method (TiTE-CRM), the current 
study can identify the required dose of a BCT intervention to increase PA by an 
average of 2,000 steps per day among individuals on primary prevention statin 
therapy at elevated risk for CVD. 
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
• 
A concise statement of the goal(s) of the current study.  
• 
The rationale for and specific objectives of the study.  
• 
The goals and the hypothesis to be tested should be stated. 
 
The current study aims to identify the required dose of a behavioral change 
technique (BCT) intervention to increase physical activity (PA) by an average of 
2,000 steps per day among individuals on primary prevention statin therapy with 
elevated risk for cardiovascular disease (CVD). The study will utilize the modified 
time-to-event  continual reassessment method (TiTE-CRM). 
 

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Primary Aim: Identify the MED of a multi-BCT intervention required to increase PA 
by an average of 2,000 steps per day between run-in and follow-up periods in at least 
80% of participants. 
Secondary Aim 1: To identify effect sizes for mediating MoAs of the BCT intervention on 
PA.  
Secondary Aim 2: Identify additional benefits of the BCT intervention on statin 
adherence. 
Exploratory Aim: Identify between-person heterogeneity in Treatment Response.  
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
• 
Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• 
Describe your process to ensure that all persons assisting with the trial are adequately 
informed about the protocol and their trial related duties and functions 
 
Northwell Health employs over 77,000 individuals. Inter-departmental support has 
been shown across Northwell to assist the researchers in meeting recruitment goals. 
Their extensive electronic communication system will allow for the rapid delivery of 
recruitment materials directly to potentially-eligible participants. Virtual electronic 
screening and consent processes, employment of participant smart phones for 
protocol reminders and notifications, and integration with existing Northwell Health 
policies will minimize burden to participate for those who are interested in the study.   
 
Center for Personalized Health staff must meet certain eligibility criteria before 
assisting with this study. All staff members must be listed on the IRB and be up-to-
date with trainings and attestations as required by the Northwell Health Human 
Research Protection Program. Additionally, staff will be required to participate in 
weekly meetings with the Principal Investigator and an additional weekly meeting 
with the Project Manager, in order to stay informed about the study protocol, staff 
duties and functions, and to answer any questions that come up within the group. 
Staff will have daily access to the Project Manager, Director of Clinical Research, and 
Principal Investigator to answer any protocol questions they may have outside these 
established weekly meetings. 
 
 
6.  RECRUITMENT METHODS 
• 
Describe the source of potential subjects 
• 
Describe the methods that will be used to identify potential subjects 
• 
Describe any materials that will be used to recruit subjects.  A copy of any advertisements 
(flyers, radio scripts, etc.) should be submitted along with the protocol.  
• 
If monetary compensation is to be offered, this should be indicated in the protocol 
 
The study will be advertised to potential participants (those taking statin 
medication) via established Northwell communication channels, including email. This 
extensive electronic communication system allows for the rapid delivery of 
recruitment materials directly to potentially eligible participants including, but not 

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limited to, advertisement on TV monitors in office locations in collaboration 
with Northwell Marketing.  
For additional recruitment, we will utilize the Quantitative Intelligence (QI) group to 
identify potential participants via history of statin medication prescription (to meet 
inclusion criteria) and diagnostic codes for cardiovascular disease and severe mental 
illness, via Touchworks. Potential participant’s phone number and emails will also be 
collected. Once identified, eligible participants will be called directly and/or sent an 
email that provides a link to review the consent document if they are interested in 
participating or contact study personnel if they have questions.  In situations where 
an individual is upset they have been contacted and/or the study team has their 
information for that purpose, we will clarify that no one on the study team has 
reviewed their records, but that we respect their privacy and they will not be 
contacted for this study again. 
Recruitment links will lead to a study web page with more information about study 
requirements, eligibility, and who to contact for more information.  There is no 
payment to subjects for participation in this research, however participants will be 
allowed to keep their commercially available Fitbit device at the end of the study . 
Participants will be required to return their eCAP smart pill bottle at the end of the 
research study. 
 
 
 
7.  ELIGIBILITY CRITERIA 
• 
Describe the characteristics of the subject population, including their anticipated number, 
age, ranges, sex, ethnic background, and health status. Identify the criteria for inclusion or 
exclusion of any subpopulation.  
• 
Explain the rationale for the involvement of special classes of subjects, such as fetuses, 
pregnant women, children, prisoners or other institutionalized individuals, or others who 
are likely to be vulnerable.   You cannot include these populations in your research, unless 
you indicate such in the protocol 
• 
Similarly, detail exclusionary criteria: age limits, special populations (minors, pregnant 
women, decisionally impaired), use of concomitant medications, subjects with other 
diseases, severity of illness, etc. 
 
Inclusion Criteria:  
• 
Ages 18 or older;  
• 
Ambulatory without limitations: has never been advised by a clinician that 
increasing low-intensity walking would be unsafe;  
• 
Prescribed statin medication;  
• 
Self-reported low levels of physical activity;  
• 
Access to and capable of using a smart cellular phone;   
• 
After 2-week run-in, objectively-verified low levels of physical activity as 
documented by a commercially available Fitbit device;  
• 
English speaking.    
 
  
Exclusion Criteria   

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• 
Age less than 18 years;  
• 
Non-ambulatory or unsafe/not recommended to participate in a 
walking program;  
• 
Not prescribed statin medication;  
• 
History of CVD;  
• 
Inability to comply with study protocol during 2 week run-in;  
• 
Does not speak English;  
• 
Unavailable for follow-up;  
• 
Cognitive impairment;  
• 
Severe mental illness (e.g., bipolar disorder or schizophrenia);    
• 
Pregnancy  
 
 
8.  NUMBER OF SUBJECTS 
• 
Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled (consent 
obtained), randomized and complete the research procedures. 
• 
If your study includes different cohorts, include the total number of subjects in each cohort. 
• 
If this is multisite study, include total number of subjects across all sites.   
 
For this research, we will enroll up to 100 participants, with the goal of randomizing 
42 individuals to the study intervention  (14 cohorts of 3).   
 
 
9. STUDY TIMELINES 
• 
Describe the duration of an individuals participation in the study 
• 
Describe the duration anticipated to enroll all study subjects 
• 
The estimated date of study completion 
 
Participants in this research could remain on study for up to 14 weeks.  
 
All participants will undergo a 2 week run-in period and will then be enrolled in 
cohorts of 3.  The first cohort will be given BCT intervention with a duration of 5 
weeks. Subsequent cohorts will be given a BCT intervention duration (from 1-week to 
10-week) based on the updated MED estimate according to the modified TiTE-CRM 
model and data from the previously enrolled participants.  The process will continue 
until we reach a total of 42 participants (14 cohorts) randomized to the intervention; 
see sample size justification below.  
 
All participants will then undergo 2 weeks of observation.  In summary, participation 
will be between 5– 14 weeks depending on BCT dose assignment. 
 
 
10.  ENDPOINTS 
• 
Describe the primary and secondary study endpoints 
• 
Describe any primary or secondary safety endpoints  
 
This study is a pilot whose primary purpose is to identify the MED of a multi-
component BCT intervention needed to increase PA among participants on primary 

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prevention statin therapy. Secondary endpoints include pooling trial results across all 
participants to assess the mediation of MoAs for BCTs on physical activity and to 
identify any potential benefit of BCTs on increasing statin adherence. 
 
 
 
11.  RESEARCH PROCEDURES 
• 
Include a detailed description of all procedures to be performed on the research subject 
and the schedule for each procedure. 
• 
Include any screening procedures for eligibility and/or baseline diagnostic tests 
• 
Include procedures being performed to monitor subjects for safety or minimize risks 
• 
Include information about drug washout periods 
• 
If drugs or biologics are being administered provide information on dosing and route of 
administration 
• 
Clearly indicate which procedures are only being conducted for research purposes. 
• 
If any specimens will be used for this research, explain whether they are being collected 
specifically for research purposes.   
• 
Describe any source records that will be used to collect data about subjects 
• 
Indicate the data to be collected, including long term follow-up 
 
Potential participants will be first linked to an authorization form, allowing the study 
team to collect PHI necessary for the study. Participants who authorize PHI collection 
will then be asked to provide demographic information needed to comply with NIA 
reporting requirements. This basic demographic information (including age, sex, race, 
and ethnicity) will be used by the study sponsor for the purpose of determining 
equity and representativeness in recruitment for clinical trials. This demographic 
information is collected prior to eligibility screening to ensure that the study is not 
excluding potential participant groups. Afterwards, participants will be directed to an 
electronic screening questionnaire administered via REDCap to determine their 
eligibility.   If eligible, participants will be automatically allowed to review and sign an 
informed consent form.   Those who have signed the informed consent form are 
encouraged to discuss study procedures and address any questions with a clinical 
research coordinator. Prior to receiving study devices, participants will read and sign 
a device allocation document letting them know which devices they may keep upon 
study completion and which devices should be returned to study staff. Both eligible 
and ineligible participants will be presented with a series of optional demographic 
questions. Asking these questions is required by the study sponsor (NIA) with the 
intention of improving equity and representativeness in clinical trial recruitment. The 
optional questions are presented regardless of eligibility to ensure that the study is 
not excluding potential participant groups.  These demographic questions will be 
provided to the NIA, the study sponsor, as part of the continuing report process. 
Study staff will set up the eCAP device and assign it to participants as they are 
enrolled and consented. Participants who sign consent will then be asked to answer 
some demographic questions during onboarding and will be mailed a commercially 
available Fitbit device and eCAP smart pill bottle after onboarding is complete.  Upon 
receiving the smart pill bottle, participants will fill the eCAP pill bottle using their 
existing statin prescription.  
 
The intervention will utilize the modified TiTE-CRM design as well as 5 BCTs, which 

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have previously been shown to be effective on increasing health behaviors: Goal 
Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Goal setting is 
setting a goal defined in terms of the behavior to be achieved. For example, an 
individual may set a goal to walk 6,000 steps per day. Action planning is detailing the 
plan of where, for how long, and at what time physical activity is going to be 
performed.  This BCT involves encouraging one to decide to act or set a behavioral 
resolution by forming detailed plans that link the behavior to specific situational cues. 
For example, a participant can decide they will walk for 30 minutes on weekdays 
following breakfast. Self-monitoring of behavior is defined as monitoring and 
recording behavior. For example, a person can keep a record of when they walk and 
the number of steps walked. Feedback on behavior is defined as providing informative 
or evaluative feedback on the performance of the behavior. For example, a person 
may receive a text message informing them they walked 42,000 steps over the past 
week, an average of 6,000 steps per day. Prompts/cues is defined as introducing or 
defining environmental and social stimuli with the purpose of prompting or cueing 
behavior. For example, texting a patient 30 minutes prior to a scheduled time for 
walking is an example of this BCT. 
 
Participants begin the trial with a 2-week run-in period during which their baseline 
levels of PA (assessed using a Fitbit device) and compliance with study protocol will 
be assessed. Participants will also complete one questionnaire at the end of their 
baseline period to assess MoAs.  
 
Mechanisms of action (MoAs): This study will assess 5 potential MoAs by which BCTs 
may influence physical activity (walking) behavior. All MoA measures will be 
assessed bi-weekly (if applicable according to BCT package) via one electronic survey 
presented using RedCap  
 
Beliefs about capabilities / self-efficacy for walking is defined as beliefs about one’s 
ability to successfully perform a behavior. Beliefs about capabilities/self-efficacy will 
be assessed using the Self-Efficacy for Walking (SE-W) scale,[26]   a 10-item measure 
assessing patient’s capabilities to walk for durations of 5 to 50 minutes. Items are 
scored from 0 to 100%, with scores of 0% indicating participants are “not at all 
confident” they could walk for that duration and scores of 100% indicating the 
participants are “highly confident” they could walk that duration. Items are averaged 
to create a total score, with higher scores indicating higher levels of beliefs about 
capabilities/self-efficacy.  
 
Behavioral regulation/ intrinsic regulation is defined as behavioral, cognitive, and/or 
emotional skills for managing or changing behavior. Behavioral regulation will be 
assessed using a 4-item measure assessing intrinsic regulation, a subscale of the 
Behavioral Regulations in Exercise Questionnaire Version 2 (BREQ-2) [27]. Items are 
scored on a 0 (Not true for me) to 4 (Very true for me) scale, and averaged to create a 
total score, with higher scores indicating greater behavioral regulation capability.  
 
Feedback processes/discrepancy in behavior   is defined as processes through which 
current behavior is compared against a particular standard. Feedback processes will 
be assessed with a single item measuring discrepancy in behavior adapted from 

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Curtin and colleagues [28]. The text of the measure is “How large is the difference 
between your current walking behavior and your goal concerning your walking?”  
The question is rated from 0 (Not at all different) to 7 (very different) with higher 
scores indicating greater levels of discrepancy in behavior.  
 
Motivation is defined as processes relating to the impetus that gives purpose or 
direction to behavior, and operates at a conscious or unconscious level. Motivation 
will be assessed with a message stating “I feel motivated to walk each day.” 
Participants will rate  this item on a scale of 0 (Not true at all)  to 7 (Very true)  with 
higher scores indicating higher levels of motivation. 
 
Environmental context and resources is defined as aspects of a person’s situation or 
environment that discourage or encourage the behavior. This MoA will be assessed 
using a checklist of 7 potential barriers to physical activity identified by Steinhardt 
and colleagues [29] Barriers are coded on a 1 (Not often at all) to 5 (Very often) scale, 
and averaged to create a total score, with higher scores indicating that the listed 
barriers had greater effects on walking. 
 
Following completion of the 2-week run-in period, participants will receive a variable 
duration BCT intervention, and the length of the intervention is determined by 
utilization of the modified TiTE-CRM design. During the BCT intervention, 
participants will receive 5 daily BCTs via text message. Content of the text message 
will be specific for each BCT (e.g. a Goal Setting text message will encourage 
participants to develop a walking goal for the day). Initially, 3 participants will be 
treated at a moderate dose level, which is five weeks of the multi-BCT intervention to 
increase PA. Based on the calculated MED for the first cohort, subsequent cohorts will 
be administered a longer or shorter dose of the intervention. The BCT dose for each 
cohort will be determined by the study statistician based on the proportion of 
individuals in the prior cohort exhibiting the target behavior (in this case, a 2,000 
step per day increase between baseline and follow-up periods).  As the MED involves 
comparing PA levels between the run-in and follow-up periods, participants will not 
be assigned to subsequent  cohorts unless all of the participants in the prior cohort 
have completed some of the intervention period. The treatment response for the 
prior cohort will be used to guide the dose administered to the subsequent cohort 
using modified TiTE-CRM methodology.   
 
Following the completion of the intervention, all cohorts will be assessed for a 2 week 
follow-up period. Follow-up consists of wearing the activity monitor continuously, 
and use of electronic pill bottle to assess adherence. No interventions will be 
delivered during this period.   At the end of the study, participants will be asked to 
complete the same questionnaire completed during baseline and the intervention 
phase as well as a satisfaction survey regarding the BCT intervention. Participants 
will also be reminded/instructed to return their eCAP smart pill bottle to the study 
team via addressed packaging included in their study materials.   
 
  
 
 
12.  STATISTICAL ANALYSIS 

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• 
Describe how your data will be used to test the hypotheses.  
• 
State clearly what variables will be tested and what statistical tests will be used. 
• 
Include sample size calculations.  
• 
If this is a pilot study, state which variables will be examined for hypothesis generation in 
later studies.  
 
Analysis for the Primary Aim: The minimum effective dose (MED) will be defined as 
the smallest BCT dose duration associated with a successful PA increase (defined as 
an average increase of 2,000 steps per day) between the 2-week run-in and 2-week 
follow-up periods in at least 80% of participants. The MED will be estimated based on 
the modified TiTE-CRM, which is an adaptive model-based, dose-finding design for 
estimating the maximum tolerated dose in pharmacologic agents.  In this study, we 
will adapt the TiTE-CRM for the purpose of MED estimation.  Briefly, the TiTE-CRM 
operates as follows during a study.  Participants will be enrolled in cohorts of 3.  The 
first cohort will be given a BCT intervention with a duration of 5 weeks. Subsequent 
cohorts will be given a BCT intervention duration (from 1-week to 10-week) based on 
the updated MED estimate according to the modified TiTE-CRM model and data from 
the previously enrolled participants.  The process will continue until we reach a total 
of 42 participants (14 cohorts) randomized to the intervention. Once the study has 
completed enrollment, we will identify which dose of the BCT intervention (in weeks) 
is associated with ≥80% of participants achieving the goal of an average of 2,000 
steps per day increase between the baseline and follow-up periods. Means and 
standard deviations of step scores for baseline versus behavioral change strategy 
treatment period will be visualized using a column graph. The statistical significance 
of differences will be adjusted for time interval. The effects of treatment on number of 
steps will be assessed using generalized linear mixed models (GLMM). This model 
will account for possible autocorrelation and linear trends between steps across time.  
 
Analysis for Secondary Aim 1:  To identify estimates of the indirect effect of the BCT 
intervention on PA via potential mediator MoAs, we will conduct the analysis in 3 
steps using mixed effects regression models. First, we will estimate the direct effect of 
the BCT intervention on PA. Second, we will estimate the effect of the BCT 
intervention on each potential MoA. Third, we will estimate the indirect effect of the 
BCT intervention on PA.   
 
Analysis for Secondary Aim 2: The effect of the multi-BCT intervention on adherence 
to statins will be examined across the study duration. Participant steps will be 
assessed continuously using a Fitbit mobile device. Daily steps for participants will be 
aggregated by run-in and follow-up periods to generate average daily steps in each 
period. Changes in daily steps between run-un and intervention periods will be 
compared using Generalized Linear Mixed Model Analyses. 
 
Analysis for Exploratory Aim: Participant heterogeneity in amount of time required to 
reach a successful increase in daily steps (defined as an increase of 2,000 or more 
steps per day over a 2-week period compared to run-in) will be examined. Average 
step counts will be calculated for each 2-week block during the intervention and 
follow-up periods. Average steps per day in these blocks will be compared with the 
average daily steps in the run-in period. Once a successful increase has been detected, 
the time to achieve this treatment response will be recorded. Differences in duration 

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to successful increases in physical activity will be examined between participants 
using mixed effects regression models. 
 
The sample size of 42 participants randomized was chosen to have a sufficient 
number of participants to obtain a preliminary assessment of the MED for the five-
component behavioral change intervention to increase walking between baseline and 
follow-up periods. The duration of dose and number of measurements/reports were 
based on expert recommendations and estimations about maximal duration of the 
trial to maintain patient engagement. Data will be reported transparently so that 
individual level heterogeneity can be assessed. 
 
The dose-efficacy model is calibrated such as that the modified TiTE-CRM will 
eventually select a BCT duration associated with 75%-85% successful PA success, i.e., 
within 5 percentage points of our target [30]. The sample size (n=42) is determined 
to achieve 60% probability of correct selection (PCS) under logistic dose-efficacy 
curves with slope = 0.69 (i.e., an OR = 2) [31]. As this is small-scale pilot study, power 
and sample size will be calculated solely for the primary aim. 
 
 
 
 
13. SPECIMEN BANKING 
• 
If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have access to 
the specimens 
• 
List the information that will be stored with each specimen, including how specimens are 
labeled/coded 
• 
Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the information 
to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• 
Describe the data and specimens to be sent out or received.  As applicable, describe: 
o What information will be included in that data or associated with the specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• 
Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
Fitbit 
This pilot study uses commercially available, non-NFC, Fitbit devices to remotely 
monitor participant activity. All enrolled participants will be provided with a study 
account that has been created by the research team with no identifying information 
to the participant. The email address of the study account contains a unique identifier 

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(e.g. northwellf25). Data collected will include daily steps, floors climbed, activity 
intensity, sleep duration, battery life, last sync, and estimated minutes in sleep stages. 
A file linking the Fitbit identifier to the study participant will be housed in a 
Northwell-approved drive to store PHI, and be accessible only by members of the 
study team listed in the IRB application. Coded data from Fitbit will remain stored in 
a Northwell-approved drive indefinitely.  
 
Fitabase 
This pilot study will use Fitabase to retrieve Fitbit data from participants. Fitabase is 
a secure, online portal. The Fitbit study account provided to the participants will be 
linked to an identification number in the Fitabase system (e.g. FLT01). No 
information that could be used to identify a participant will be stored on Fitabase. 
Only the research team will have access to data that will be able to connect a research 
participant to their Fitabase ID. Data collected will include last sync date, battery 
charge status, daily steps, floors climbed, activity intensity, sleep duration, and 
estimated minutes in sleep stages. Fitabase will stop tracking participant data at the 
trial end date selected by the research coordinator. As an added measure, 
participants will be instructed to remove the Fitbit study account from their device if 
they plan on keeping the Fitbit. 
 
Medication Adherence 
We will monitor daily adherence to clinically prescribed statins using the eCAP smart 
pill bottle by Information Mediation Corporation.  eCAP smart pill bottles are a type of 
medication adherence tracking device. The eCAP is an electronic content monitor 
(ECM)  that tracks medication usage without active participant input and without the 
use of any downloadable app.  While the eCAP ECM system does have the capability to 
integrate with android or iOs phones, the study team will not utilize this feature.  
eCAP stores information about the opening of the pill bottle but no patient 
information or identifying data is stored on the device.  Compliance data will be 
available for download by the study team upon receipt of the eCAP smart pill bottle at 
the end of the research.  
 
Eligibility, Consent, and Survey and Fitbit Data 
Survey and Fitbit data will be collected and stored using  RedCap,  which is a 
Northwell security-review approved system for collecting and storing research data, 
including PHI. The study team will have access to all data, including PHI, throughout 
the study. Pooled results will be used to assess gaps in phenotypic understanding to 
empirically determine if modeling precise therapy is feasible. 
 
The study team takes data confidentiality very seriously.  Data collected for this 
research will be  maintained  on a HIPAA-compliant Northwell-approved SQL 
database.  All members of the research team with access to identifiable and coded 
data will be trained and included on the IRB submission for approval. Regular 
meetings will take place with the PI and other members of the study team to ensure 
protocol adherence and data accuracy. Data collected for this study will be 
maintained in its original and unaltered source data state in a Northwell-approved 
SQL database on a Northwell-approved drive to store PHI indefinitely. Data collected 
under this research may be used for future research in coded format without 
additional consent as per the consent form participants sign and with appropriate 
IRB approval as required. Any additional data that must be shared will be done so 

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according to the consent form participants signed.  Only research staff listed within 
this IRB submission will have access to identifiable information. Anonymized data 
may be stored indefinitely for reference following the conclusion of the study.  The 
participant will be made aware of all data collected in the consenting process.    
 
This research is funded by the NIH, thus a Certificate of Confidentiality has been issued 
for this research. Certificates of Confidentiality (CoCs) protect the privacy of research 
subjects by prohibiting disclosure of identifiable, sensitive research information to 
anyone not connected to the research except when the subject consents or in a few 
other specific situations.  
 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the HRPP 
website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and Safety 
Monitoring Board or Committee (DSMB/C) as part of your Data and Safety 
Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 
• 
 Indicate who will perform the data and safety monitoring for this study.   
• 
Justify your choice of monitor, in terms of assessed risk to the research subject’s health and 
well being.  In studies where the monitor is independent of the study staff, indicate the 
individual’s credentials, relationship to the PI, and rationale for selection 
• 
List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• 
Indicate the frequency at which accumulated safety and data information (items listed in 
# above) will be reviewed by the monitor (s) or the DSMB/C.   
• 
Where applicable, describe rules which will guide interruption or alteration of the study 
design.   
• 
Where applicable, indicate dose selection procedures that will be used to minimize toxicity. 
• 
Should a temporary or permanent suspension of your study occur, in addition to the IRB, 
indicate to whom will you report the occurrence.   
 
Given that study activities involve no more than risks encountered in daily life 
(increased time spent walking by healthy, working individuals), the study has 
received approval from the NIA for a safety monitor. Dr. Zenobia Brown has been 
approved to provide safety monitoring for this pilot. Dr. Brown is a family medicine 
clinician and oversees Northwell’s Health Solutions programs.   
 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
• 
 When appropriate, attach a description of the DSMB.   

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• 
Provide the number of members and area of professional expertise.   
• 
Provide confirmation that the members of the board are all independent of the study. 
 
Given that study activities involve no more than risks encountered in daily life 
(increased time spent walking by healthy, working individuals), the study has not 
convened a DSMB.  
 
 
 
16. WITHDRAWAL OF SUBJECTS 
• 
Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• 
Describe procedures for orderly termination 
• 
Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
Circumstances under which participants will be withdrawn from the research 
without their consent include failure to maintain protocol adherence and repeated 
failure to complete the assigned BCT intervention.  
 
Potential participants will be notified of the possibility of being removed from the 
study before or during the BCT intervention phase due to adherence issues in the 
informed consent. Participants who fail to maintain minimum adherence during 
baseline will be notified by the research team after 10 days of baseline participation.  
 
Participants who fail to maintain protocol adherence or who deviate from the 
protocol will be contacted by a member of the study team with a reminder of the 
study protocol, and warning that this may impact their continued study eligibility. 
Once a protocol deviation has been repeatedly recorded, the Principal Investigator 
will determine the participant’s continued eligibility in the study, with consultation of 
the Safety Officer if needed. If it is determined that the participant will be withdrawn 
from the study, the participant will be notified by the research team via email and 
phone call. The participant will stop receiving notifications and survey prompts, and 
will be sent instructions to un-link their Fitbit device. The participant will be able to 
keep their Fitbit device but will be required to return their eCAP smart pill bottle. 
 
Participants may withdraw from participation in the research at any time.  Given the 
non-invasive nature of study-specific monitoring, there are no significant anticipated 
direct adverse effects related to withdrawal. Participants may easily elect to 
withdraw by emailing Research personnel directly at:   
   
Dr. Catherine Alfano  
130 East 59th Street, Suite 14C    
New York, NY 10022   
stepcohort@northwell.edu 
  
If a participant withdraws from the study, previously collected data will not be 
deleted. However, no new information will be collected from a participant after 
he/she has withdrawn from the study.  We will clarify how to transfer the Fitbit 

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to a personal account and will ask participants to complete a satisfaction survey at 
the time of their withdrawal (as proposed for all participants who complete the 
research) to tell us about their experience in the study.  The participant will be sent 
an electronic survey including questions regarding their experience during the study, 
or will be contacted by phone or teleconference if they do not complete the electronic 
survey. Completion of this survey is voluntary and will help us design better research 
in the future.    
 
Participants will be considered to be “active” until we are notified of their request to 
terminate participation.  
 
 
 
17. RISKS TO SUBJECTS 
• 
Describe any potential risks and discomforts to the subject (physical, psychological, social, 
legal, or other) and assess their likelihood and seriousness and whether side effects are 
reversible. Where appropriate, describe alternative treatments and procedures that might 
be advantageous to the subjects.  
• 
Include risks to others , like sexual partners (if appropriate) 
• 
Discuss why the risks to subjects are reasonable in relation to the anticipated benefits and 
in relation to the importance of the knowledge that may reasonably be expected to results 
• 
Describe the procedures for protecting against or minimizing any potential risks, including 
risks to confidentiality, and assess their likely effectiveness.   
 
This study poses low risk of physical harm to subjects.  
 
One risk of taking part in this study is the possibility of a loss of confidentiality or 
privacy. The study team plans to protect privacy by only sharing necessary 
information about participants to those outlined in the consent form. All subjects will 
be informed that their responses are confidential and that they may refuse to 
participate in the project or withdraw at any time without explanation, and that such 
action will not affect their future interactions with their health care providers, 
employment, educational studies, or the research study. The risk of loss of 
confidentiality will be minimized by securely storing data including PHI in a 
Northwell-approved database and minimizing the use of PHI.  
 
There is no additional risk with using a Fitbit activity monitor for research as 
compared to using the device as a consumer, including mild skin irritation (i.e. 
contact dermatitis) which occurs among a small proportion of users. Participants 
will be instructed via the consent form on methods to reduce irritation (i.e. keep the 
band clean and dry) and that they can remove the band for a short period of time. 
 

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There are no known risks associated with utilization of the BCTs employed in this 
intervention. It is possible that messages prompting physical activity may cause mild 
stress in participants who are ambivalent about increasing their step count. 
Increasing step count by 2,000 steps per day in ambulatory persons without mobility 
impairments or safety limitations represents no more than minimal risk. Mild 
symptoms of increased activity such as fatigue or muscle soreness may be 
experienced.  
 
There are no known risks to utilizing eCAP smart pill bottle. The vial smart cap meets 
all federal stands for safety (childproof). No patient information or identifying data is 
stored on the device.  There is no GPS tracking from the eCAP device.   
 
The proposed questionnaires are not anticipated to pose risk to the participants. 
Participants will receive text message notifications with a secure link to a survey that 
can be can be accessed via a smartphone. All survey responses will be directly 
entered by participants in an electronic format (secure, HIPAA compliant RedCap 
database). 
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• 
Describe the availability of medical or psychological resources that subjects might need as 
a result of anticipated problems that may be known to be associated with the research. 
• 
If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, and 
who will pay for it.   
 
Research-related injuries are not expected for this no greater than minimal risk 
project. 
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• 
Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration instead 
of four times a day, an oral formulation over an IV administration).  
• 
Also state if there are no known benefits to subjects, but detail the value of knowledge to 
be gained 
 
Participating could improve physical activity and subsequently reduce cardiovascular 
risk.  In addition, the information collected from participant involvement will inform 
the development of future BCTs to help other research participants, and eventually 
patients, discover which behavioral treatment options are best for them as an 
individual. 
 

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20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• 
Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• 
In addition consider privacy protections that may be needed due to communications with 
subjects (such as phone messages or mail).   
 
The study will be advertised to potential participants 
via established Northwell communication channels, including via NWH secure email 
and secure communication with Quantitative Intelligence (QI). Inter-departmental 
support has been shown across Northwell to assist the researchers in meeting 
recruitment goals.   Their extensive electronic communication system will allow for 
the rapid delivery of recruitment materials directly to potentially-
eligible participants.      
  
Recruitment links will lead to a study web page asking potential participants to sign 
authorization to undergo brief screening to assess if they are eligible for 
participation and to provide demographic information needed to comply with NIA 
regulations. Participants who authorize the study team will be provided with more 
information about study requirements, eligibility, and who to contact for more 
information.  Interested individuals will be asked to sign consent via a 21 CFR Part 11 
and HIPAA compliant Northwell Health approved electronic platform.  Individuals 
may call the research team at any time to ask questions prior to signing 
consent.  Should this occur, research personnel will ensure that the individual is in a 
private location for open conversation to protect the privacy interests of the 
individual.  All study-related communications will be delivered via a secure, NWH 
email or via the NWH approved e-platform.     
 
 
 
 
21.  COSTS TO SUBJECTS 
 
• 
Describe any foreseeable costs that subjects may incur through participation in the 
research 
• 
Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
This research study is funded by the National Institutes for Health (NIH). All study 
related devices will be provided to participants at no cost. Participant insurance will 
not be billed. 
 
This study uses text messaging to deliver notifications, reminders, and study 
questionnaires. Standard message and data rates from the participant’s wireless 
carrier may apply to the study participant. Study participants will not be 
compensated for any costs related to data usage or sending or receiving text 
messages by the study or by members of the study team. 
 
 

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22. PAYMENT TO SUBJECTS  
 
• 
Describe the amount of payment to subjects, in what form payment will be received and 
the timing of the payments.   
 
There is no payment to subjects for participation in this research, however 
participants will be allowed to keep their Fitbit device if they –are randomized to the 
intervention phase.  
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• 
Who will be obtaining consent 
• 
Where consent will be obtained 
• 
Any waiting period available between informing the prospective participant and 
obtaining consent 
• 
Steps that will be taken to assure the participants’ understanding 
• 
Any tools that will be utilized during the consent process 
• 
  Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• 
Procedures for maintaining informed consent.   
 
Each subject will receive written explanations of the purposes, procedures, and 
risks of this study in language appropriate for the individual’s level of 
understanding. All questions will be answered via email or phone, and if all 
inclusion criteria are met, and the subject volunteers to participate, digital written 
informed consent will be obtained.   
  
Written, electronic consent (e-consent) will be obtained via REDCap, a web-based 
platform capable of recording electronic signature. The e-consent document will 
contain all of the elements of informed consent required by applicable federal 
regulation for the protection of human subjects and elements of authorization 
required by the HIPAA Privacy Rule, and will begin with a concise and focused 
presentation of the key information that is most likely to assist participants in 
understanding the reasons why he/she might or might not want to participate in 
the research.  
 
Because consent will be obtained remotely, the electronic platform will be 
designed such that the consent form is easy to navigate. The system will also 
incorporate electronic strategies to encourage participants to access all of the 
consent material before documenting his/her consent.   
 
We will also employ interactive electronic-based technology such as a 
comprehensive knowledge check at the end of the consent process. Participants 
may contact a member of the research team with questions about the research.   
Both the research phone and email inbox will be monitored daily by consenting 
coordinators.  

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PDF copies of signed consent forms will be electronically stored in a HIPAA-
secured, Northwell approved storage drive with protected access to only the PI 
and research personnel listed on the study protocol.  
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your study 
involves children, additional information should be provided to describe: 
• 
How parental permission will be obtained 
• 
From how many parents will parental permission be obtained 
• 
Whether permission will be obtained from individuals other than parents, and if so, 
who will be allowed to provide permission.  The process used to determine these 
individual’s authority to consent for the child should be provided 
• 
Whether or not assent will be obtained from the child 
• 
How will assent be documented 
• 
Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the research.  
If so, describe the process that will be used to obtain their legal consent to continue 
participation in the study.  Indicate what will occur if consent is not obtained from the 
now-adult subjects.   
 
 
 
 
If the study involves cognitively impaired adults, additional information should be provided to 
describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 
• 
The plan should indicate that documentation of the determination  and assessment 
will be placed in the medical record, when applicable, in addition to the research 
record. 
• 
If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an explanation as 
to why not 
o Describe whether assent will be documented and the process to document assent 
o Indicate if the subject could regain capacity and at what point you would obtain 
their consent for continued participation in the study 
 
 
 
 
If the study will enroll non-English speaking subjects: 
• 
Indicate what language(s) other than English are understood by prospective 
subjects or representatives 

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• 
Indicate whether or not consent forms will be translated into a language other 
than English 
• 
Describe the process to ensure that the oral and written information provided to 
those subjects will be in that language 
• 
If non-English speaking subjects will be excluded, provide a justification for doing 
so 
 
The study is committed to enrolling a racially and ethnically diverse 
population. We anticipate that most participants will have the competency to 
comprehend study materials produced in the English language at a 6th grade 
level, particularly when explained by trained clinical research coordinators.  
Exclusion of non-English speaking participants in this pilot study will not later 
negatively impact equitable access, participant comprehensibility or research 
design applicability to the diverse populations that may be solicited for 
participation in future clinical trials. 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
 N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 
• 
Describe the possible risks of harm to the subjects involved in this study and explain 
why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare of 
subjects 
• 
Explain why it is impracticable to conduct this research if informed consent is 
required   
• 
Explain why it is not possible to conduct this research without using the information 
or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
Since the consent process will be remote and self-directed, it is not practicable or 
feasible for the investigator to sign the consent form in REDCap. As such, 
we request a waiver of the investigator’s signature for this research which is no 
greater than minimal risk.  Individuals are encouraged to reach out to the study 
team via email and/or a direct phone line if they have any questions and prior to 
signing the consent form.  
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they wish 
to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• 
Explain how the only record linking the subject to the research would be the consent 
document. 

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• 
Explain how the principal risk of this study would be the potential harm resulting from 
a breach in the confidentiality 
• 
Indicate whether or not subjects will be provided with a written statement regarding 
the research. 
 
 
 
SUBSECTION 2 
• 
 Describe the possible risks of harm to the subjects involved in this study and explain 
why the study involves no more than minimal risk.   
• 
Confirm that the research only involves procedure for which consent is not normally 
required outside the research context.  
• 
Indicate whether or not subjects will be provided with a written statement regarding 
the research. 
 
 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
• 
Describe the risks to privacy involved in this study and explain why the study involves 
no more than minimal risk to privacy:   
• 
Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
• 
 Indicate why it is not possible to seek subjects’ authorization for use or disclosure of 
PHI. 
• 
Indicate why it is not possible to conduct this research without use or disclosure of the 
PHI.   
• 
Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization needs 
to be tracked. Please see guidance at www.nslij.com/irb for information about 
tracking disclosures. 
 
 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared or 
disclosed to any other person or entity. 
• 
Describe how data will be collected and used:  
• 
Indicate why you need the PHI (e.g.PHI is required to determine eligibility, identifiers 
are necessary to contact the individual to discuss participation, other) 
• 
Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 

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population, no treating clinician to assist in recruitment of the study population, 
other) 
 
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, submit 
the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 
 
If any of these populations are included in the study, describe additional safeguards that will 
be used to protect their rights and welfare. 
 
 
 
The Institute of Health System Science (IHSS) has established a good working 
relationship with Northwell Health Employees.  From our past enrollment of NWH 
workforce,  multiple individuals  have expressed interest in participating in future IHSS 
trials, including pilots like this one.   As such, Northwell Health Employees are ideal study 
subjects for this research.  
 
All data, including this participant information, will be maintained by the study team on a 
Northwell-approved drive to store PHI. All members of the research team with access to 
identifiable and coded data will be trained and included on the IRB submission for 
approval.   
 
The research will not interfere with NWH employees’ job obligations. An employee’s 
decision to participate or not participate will have no bearing on the employee’s 
performance evaluation or employability at NWH. In addition, participants will be able to 
withdraw from the study at any time, for any reason without influencing their ability to 
receive health care and/or affect their employment status.   
 
We do not intend to prevent study personnel or other employees of the Institute of 
Health System Science who express an interest in the research from participating. 
However, no supervisory personnel will be able to enroll participants who report to them 
in this research. We are not intentionally targeting minorities, but expect minorities to be 
part of those eligible for participation. 
 

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27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management of 
information (e.g. results, new information, unanticipated problems involving risks to subjects 
or others, or protocol modifications) among sites to protect subjects. 
N/A 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for new 
medical devices or brief reprints from journals might also prove useful. 
 
1. 
Garrett-Mayer, E., The continual reassessment method for dose-finding studies: 
a tutorial. Clin Trials, 2006. 3(1): p. 57-71. 
2. 
Huang, B. and P.F. Kuan, Time‐to‐event continual reassessment method 
incorporating treatment cycle information with application to an oncology 
phase I trial. Biometrical Journal, 2014. 56(6): p. 933-946. 
3. 
Morrissey, E.C., et al., Behavior Change Techniques in Apps for Medication 
Adherence: A Content Analysis. Am J Prev Med, 2016. 50(5): p. e143-e146. 
4. 
Michie, S., et al., A refined taxonomy of behaviour change techniques to help 
people change their physical activity and healthy eating behaviours: the CALO-
RE taxonomy. Psychol Health, 2011. 26(11): p. 1479-98. 
5. 
Michie, S., et al., Effective techniques in healthy eating and physical activity 
interventions: a meta-regression. Health Psychol, 2009. 28(6): p. 690-701. 
6. 
Hankonen, N., et al., Which behavior change techniques are associated with 
changes in physical activity, diet and body mass index in people with recently 
diagnosed diabetes? Ann Behav Med, 2015. 49(1): p. 7-17. 
7. 
Lee, Y.M., et al., Relationships among medication adherence, lifestyle 
modification, and health-related quality of life in patients with acute 
myocardial infarction: a cross-sectional study. Health Qual Life Outcomes, 
2018. 16(1): p. 100. 
8. 
Sin, N.L., J.T. Moskowitz, and M.A. Whooley, Positive Affect and Health 
Behaviors Across 5 Years in Patients With Coronary Heart Disease: The Heart 
and Soul Study. Psychosom Med, 2015. 77(9): p. 1058-66. 
9. 
Collaborators, U.S.B.o.D., et al., The State of US Health, 1990-2016: Burden of 
Diseases, Injuries, and Risk Factors Among US States. JAMA, 2018. 319(14): 
p. 1444-1472. 
10. 
Wilkins, J.T., et al., Lifetime risk and years lived free of total cardiovascular 
disease. JAMA, 2012. 308(17): p. 1795-801. 
11. 
Ridker, P.M., et al., Rosuvastatin to prevent vascular events in men and women 
with elevated C-reactive protein. N Engl J Med, 2008. 359(21): p. 2195-207. 
12. 
Shepherd, J., et al., Prevention of coronary heart disease with pravastatin in 
men with hypercholesterolemia. West of Scotland Coronary Prevention Study 
Group. N Engl J Med, 1995. 333(20): p. 1301-7. 

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13. 
Yusuf, S., et al., Cholesterol Lowering in Intermediate-Risk Persons without 
Cardiovascular Disease. N Engl J Med, 2016. 374(21): p. 2021-31. 
14. 
Baptista, L.C., M.T. Veríssimo, and R.A. Martins, Statin combined with 
exercise training is more effective to improve functional status in dyslipidemic 
older adults. Scand J Med Sci Sports, 2018. 28(12): p. 2659-2667. 
15. 
Kokkinos, P.F., et al., Interactive effects of fitness and statin treatment on 
mortality risk in veterans with dyslipidaemia: a cohort study. Lancet, 2013. 
381(9864): p. 394-9. 
16. 
Kraus, W.E., et al., Daily Step Counts for Measuring Physical Activity 
Exposure and Its Relation to Health. Med Sci Sports Exerc, 2019. 51(6): p. 
1206-1212. 
17. 
Toyama, K., et al., A Pilot Study: The Beneficial Effects of Combined Statin-
exercise Therapy on Cognitive Function in Patients with Coronary Artery 
Disease and Mild Cognitive Decline. Intern Med, 2017. 56(6): p. 641-649. 
18. 
Gui, Y.J., et al., Efficacy and safety of statins and exercise combination therapy 
compared to statin monotherapy in patients with dyslipidaemia: A systematic 
review and meta-analysis. Eur J Prev Cardiol, 2017. 24(9): p. 907-916. 
19. 
Murlasits, Z. and Z. Radák, The effects of statin medications on aerobic 
exercise capacity and training adaptations. Sports Med, 2014. 44(11): p. 1519-
30. 
20. 
McAleer, S.F., et al., Statin prescription initiation and lifestyle behaviour: a 
primary care cohort study. BMC Fam Pract, 2016. 17: p. 77. 
21. 
Korhonen, M.J., et al., Lifestyle Changes in Relation to Initiation of 
Antihypertensive and Lipid-Lowering Medication: A Cohort Study. J Am Heart 
Assoc, 2020. 9(4): p. e014168. 
22. 
Carey, R.N., et al., Behavior Change Techniques and Their Mechanisms of 
Action: A Synthesis of Links Described in Published Intervention Literature. 
Ann Behav Med, 2019. 53(8): p. 693-707. 
23. 
Cheung, Y.K., Sample size formulae for the Bayesian continual reassessment 
method. Clin Trials, 2013. 10(6): p. 852-61. 
24. 
Cheung, Y.K. and R. Chappell, A simple technique to evaluate model sensitivity 
in the continual reassessment method. Biometrics, 2002. 58(3): p. 671-4. 
25. 
Osborn, D., et al., Clinical and cost-effectiveness of an intervention for 
reducing cholesterol and cardiovascular risk for people with severe mental 
illness in English primary care: a cluster randomised controlled trial. Lancet 
Psychiatry, 2018. 5(2): p. 145-154. 
26. 
McAuley, E., et al., Exercise environment, self-efficacy, and affective responses 
to acute exercise in older adults. Psychology and Health, 2000. 15(3): p. 341-
355. 
27. 
Markland, D. and V. Tobin, A modification to the behavioural regulation in 
exercise questionnaire to include an assessment of amotivation. Journal of 
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