Influencing Basic Behavioral Mechanisms of Action While Targeting Daily Walking in Those at Risk for Cardiovascular Disease: Science of Behavior Change Factorial Experiment of Behavioral Change
Phase: PHASE2
Conditions: Cardiovascular Diseases, Physical Inactivity
Sponsor: Northwell Health

 
 
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RESEARCH PROTOCOL 
 
 
Protocol Title: 
Influencing Basic Behavioral Mechanisms of Action while 
targeting Daily Walking in Those at Risk for Cardiovascular 
Disease: Science of Behavior Change Factorial Experiment of 
Behavioral Change (MOST Study) 
Principal Investigator: 
Karina W. Davidson, PhD 
Primary Contact Name: 
Joan Duer-Hefele 
Primary Contact Phone: 
845-642-2399 
Primary Contact E-mail: 
jduerhefele@northwell.edu 
Date Revised: 
   02/21/2024 
IRB Number: 
21-0467 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
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Exemption or Application for a Chart Review.   
• Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical 
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Protocol Template – Registry Studies.  .   
• If a section of this protocol is not applicable, please indicate such. 
• Do not delete any of the text contained within this document. 
• 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.   
• Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 
 

 
 
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â Continue to next page to begin entering information about this study  
 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 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 
 
 
Increasing physical activity (PA) in sedentary people at risk for 
cardiovascular disease related to elevated blood pressure, 
elevated body mass index (BMI)  high cholesterol levels or other 
CVD risk factors such as diabetes and smoking  is of high public 
health significance. This study will advance knowledge about which 
behavior change techniques (BCTs) are most important for 
behavior change to reduce sedentary behavior. The study applies 
an experimental medicine approach to identify and assess the 
mechanism of action (MoA) potentially underlying a physical 
activity behavior change. The study hypothesizes that  self-efficacy 
for physical activity will significantly impact the relationship 
between each one of 4 BCTs (randomly introduced) used in the 
study and increased walking behavior at 6 months 
 
 
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 
 

 
 
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The U.S. population has experienced a shift in the causes and types of diseases that 
compromise quality and quantity of life.(1) The prevalence of "degenerative and 
man-made diseases" has increased.(2) And, recent estimates reveal a slowdown in 
the decline of these chronic diseases’ occurrence and impact; we are experiencing 
worse health, and for some, shorter lives.(3) Rates of myocardial infarction, stroke, 
and other cardiovascular disease (CVD) events have plateaued,(4) but are common, 
costly, and preventable events. From 2016 to 2021, 3.3 million per year of these 
preventable events are projected to occur, including 2.2 million emergency visits, 
2.1 million deaths, and 11.8 million hospitalizations. These preventable events 
would result in estimated care costs of $170 billion, with about half of these events 
projected to occur among 18- to 64-year-old adults.(5) Although the reasons are 
complex for the plateau in CVD incidence, Mokdad and others provocatively 
suggest that the main causes of death in the U.S. are now behavioral.(6-7) Although 
tobacco use is the biggest cause, physical (in)activity and poor diet combined are 
the second most common causes. Physical inactivity and poor diet are projected to 
soon overtake tobacco as the leading cause of death for Americans.(1-2) Consistent 
with these projections, improvements in several protective factors, such as 
engaging in regular physical activity (PA), have stalled in recent years for most 
American adults,(8-9) although any increase in activity is preventive of future 
disease.(10-11)   For those at risk for CVD, all major guidelines and 
recommendations include the importance of adults engaging in regular PA.(12-15) 
And, engaging in even low-intensity PA improves intermediate outcomes 8,6 that, 
in turn, prevents   CVD in those at risk for developing CVD.(13)  In the National 
Health Interview Study (2016), physical inactivity was defined as not even 
engaging in light leisure-time PA for at least 10 minutes, 29% of all adults reported 
that they were inactive (16) Hence, an estimated 71 million adults do not engage in 
even 10 minutes of leisure-time or very low-intensity PA.(16) This extreme level of 
physical inactivity is higher among women (31%) than among men (27%), and is 
higher among blacks (37%) and Hispanics (36%) than among whites (26%).(17) 
For those 18-64 years of age, many of whom are starting to be at elevated risk for 
CVD,(16) physical inactivity prevalence is estimated to be 28%.18 Thus, millions 
of Americans will likely develop a preventable disease—CVD. Evidence indicates 
that those who engage in even low-intensity PA are at less risk for developing 
CVD, and that PA is already recommended to the millions who are inactive. But 
few in the U.S. regularly engage in any level of intensity of PA.(16) . Observational 
evidence has accumulated that low-intensity PA can confer health benefits(19) 
Currently inactive persons, who increase even their low intensity activity, will 
benefit.(19)Those who walk 1000-1900 steps per day, versus 0-1000 steps per day 
have a lower mortality rate.(20)  As a result, interest has grown for increasing even 
low-intensity activity. Fewer behavior change PA interventions, but still many, 
have focused on low-intensity activity, or walking,(21-23) with  some reporting 
that even an increase of 1000 steps per day at low-intensity is associated with a 7% 
reduction in death and a 3% reduction in hospitalization in patient populations 
(e.g., heart failure patients), after controlling for traditional predictors of these 
endpoints.24 The addition of some efficacious, low-intensity PA interventions, at 
least for currently sedentary populations is warranted(19) Guidelines both to 

 
 
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promote physical activity (PA)(12) and prevent CVD recommend behavioral 
counselling to increase moderate-to-vigorous PA.(15-17) And, although engaging 
in moderate-to-high intensity PA improves intermediate outcomes (19,10) that, in 
turn, prevent CVD,(13) adherence to these recommended levels of moderate 
intensity PA is poor,(21,25) and has plateaued.(26) As a result, persons at risk for 
CVD, who receive full guideline-based physical activity counselling, remain 
predominately sedentary, and continue at increased risk for morbidity and 
mortality, compared to their more active counterparts.(26) Hundreds of BCT 
interventions support the efficacy of walking and other low-intensity PA 
interventions.(27-29) But these interventions have predominantly included a 
combination of many BCTs, and so cannot identify the individual effect for each 
BCT on the resulting behavior change.(29) Further, these multi-BCT randomized 
interventions, although usually stating the mechanism of action (MoA) 
hypothesized to play a causal role in producing behavior change, did not actually 
test whether the MoA was engaged, and whether it, in turn, influenced the 
behavior.(30 -32)   The benefits of even low-intensity PA,(18) the poor adherence 
to higher intensity PA interventions, and the inefficiency of using multi-BCT RCTs 
to elucidate the efficacy of individual intervention components, all argue for using 
an experimental medicine approach to determine which BCTs influence self-
efficacy, and in turn, improve walking. This is the gap in basic behavioral 
mechanism research that we will address. 
 
 
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. 
 
We will use a randomized, factorial experiment utilizing the Science of Behavior 
Change (SOBC) approach to efficiently test the effects of four distinct behavior 
change techniques (BCTs) thought to engage one key behavioral mechanism of 
action (MoA) for improving daily walking by at least 1000 steps per day.  
Overarching Aim:  Conduct a randomized factorial experiment to test a 
mediational model of four BCTs targeting changes in self-efficacy for PA, which 
are, in turn, hypothesized to cause increased walking in sedentary adults, 18 to 74 
years of age  who are at risk for CVD.  Hypothesis: Self-efficacy for physical 
activity (mediator) will significantly mediate the relationship between 
randomization to each BCT (independent variable) and increased walking 
(dependent variable) at 6 months.  Exploratory Aim: Explore effect moderation in 
the mediational model of the BCTs by actual use or enactment of a BCT and for 
whom and under what conditions mediation occurred. 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 

 
 
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• 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 
 
Given that this study is conducted virtually, the opportunity for enrollment is 
widely available.. National statistics support both the prevalence of sedentary 
behavior (enhanced by the pandemic) and elevated risk for cardiovascular disease 
in the adult population, allowing for achievement of recruitment milestones over 
the course of the project. The Institute of Health System Science personnel are 
experts in the conduct of virtual research using monitoring technology. Staff must 
meet certain eligibility criteria before implementing 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, Co-I and an additional weekly meeting with the Project 
Coordinator, 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 Coordinator, Director of Clinical Research, and 
Principal Investigator to answer any protocol questions they may have outside 
these established weekly meetings. Weekly meetings with project personnel, under 
the direction of the PI and including representatives from the Institute’s data team 
will ensure that all implementation, safety and data tasks are performed according 
to established timelines.  
 
 
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 
 
Initial study participants will be recruited electronically through online networks, 
through dissemination of fliers, and electronic communication updates from 
Northwell Health Wellness programs. Participants will also be recruited from  
social media sites and other sources to ensure the widest and most diverse potential 
participant pool possible. This will include electronic communications throughout 
the Northwell employee network, which offers research volunteer opportunities to 
over 74,000 employees. We will use other strategies as needed to ensure that our 
participant pool is diverse on many dimensions including potentially translating 
materials into Spanish. The study will also accept referrals from the 
clincialtrials.gov posting. The study web pages will contain detailed descriptions of 

 
 
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the study, including study objectives, procedures, risks, benefits, voluntary status, 
privacy and data security assurances. Our group has successfully piloted the 
creation of in-house videos of skilled clinical research coordinators’ discussing all 
the above, demonstrating study devices and procedures, and facilitating remote 
study enrollment, with high levels of participant satisfaction. 
 
Participants will have the opportunity to have questions answered by clinical 
research coordinators via email or text message, or have a video/phone 
conversation, according to participant preference and comfort level. Once it is 
confirmed that the participant has no further questions, they will be required to 
respond to three questions about the study designed to ascertain comprehension of 
their rights and responsibilities as research participants. Those found eligible and 
consented will be mailed a FitBit  activity monitor, and access to onboarding study 
instructions. 
 
Participants will receive $100 at the completion of the intervention (Month 3) and 
$150 for successful study completion.  Additionally, they will be able to keep their 
FitBit, valued at approximately $150.  Participants in the study follow-up period 
(Months 4-6) may be eligible for a random, weekly lottery of $100 should they 
maintain adherence to Fitbit activity watch wear and responses to texts messages 
and surveys. 
 
 
 
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. 
 
Participants must be  able to read/comprehend English and own a smart phone 
capable of receiving text messages. Participants must be fully ambulatory and have 
never been advised that it would be unsafe to participate in a walking program. 
Individuals with a diagnosis of a serious mental health condition or psychiatric 
disorder will be excluded. Additionally, individuals who are pregnant or who plan 
to become pregnant in the 5 months following enrollment will be excluded. 
Participants must be 18 to 74 years of age, sedentary, and have a risk factor for 
CVD. Sedentary behavior will be assessed via potential participants’ self-reports 
during screening and confirmed by the FitBit Fitness Tracker, during the four week 
baseline run-in period. To define ‘at risk for CVD’ we will follow the criteria of the 

 
 
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United States Preventive Services Task Force: 
www.uspreventiveservicestaskforce.org. These are: diagnosed hypertension, 
dyslipidemia, body mass index ≥ 30, diabetes or pre-diabetes, or 10-year CVD risk 
> 7.5 (using the Pooled Cohort Equations or Framingham Risk Score). Potential 
participants will be considered sedentary, if, in the baseline period, they are 
considered objectively sedentary, and they will be considered adherent  if they have 
≥ 10 hours of device wear time and answer daily texts on at least 21 of the 28 days 
of the baseline period, submit 3 onboarding surveys, and submit at least 1 of the 3 
self-efficacy surveys sent via text message during the baseline period. 
 
 
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.   
 
The study plans to enroll 820 participants. It is anticipated 624 will successfully 
complete baseline and be randomized, and that 480 participants will complete the 
trial 
 
 
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 
 
Individuals will participate in the study for a total of 24 weeks. Four weeks of 
baseline monitoring of physical activity level and 2 months of study intervention 
(randomization to one of 15 possible combinations of behavior change techniques 
or the control group receiving no BCTs, delivered via daily text message with a 
link to a secure survey) and 3 months of follow-up monitoring. It is estimated that 
the last participants will be enrolled in September, 2025 to ensure study completion 
by March 31, 2026 
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
Self-efficacy for physical activity (mediator) will significantly mediate the 
relationship between randomization to each BCT (independent variable) and 
increased walking (dependent variable) at 6 months 
 

 
 
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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 who self-identify as sedentary will be directed to an 
information screen with details about the study. Those who are interested in 
participating in this study will provide basic contact information and demographics 
and complete general inclusion/exclusion screening criteria. They will then be 
directed to sign a HIPAA Authorization form before completing the screening 
survey process that includes additional validated questions pertaining to inclusion 
and exclusion criteria. Participants with answers that make them ineligible will be 
directed to a page thanking them for their interest but informing them that they do 
not qualify for participation in this study. Those who are eligible will receive an 
electronic copy of the consent form. After reviewing the study overview, potential 
participants may speak or email study personnel to ensure all their questions are 
answered. Before being able to sign and submit the consent form, potential 
participants must demonstrate understanding of the protocol by correctly answering 
3 questions pertaining to the information presented in the consent form. The 
participant will  electronically sign the consent form via RedCap which meets 21 
CFR 11 standards for collecting electronic signature.   A consenting coordinator 
will review this information and send the potential participant an email which will 
include a copy of their signed consent form and HIPAA Authorization, as well as 
information explaining what to expect during onboarding to the study if eligible. 
They will be mailed an initial study kit with a Fitbit Activity Tracker device. 
Potential participants will be asked to download the Fitbit app to their smart phone. 
All baseline periods will begin on a Monday.  
 
The baseline period will take place over the course of 4 weeks. Potential 
participants will not receive any interventions during this period, but they will be 
sent a daily text asking them to acknowledge that they have received the message. 
During the baseline period, potential participants will be asked to wear their Fitbit 
for at least 10 hours or more per day. Baseline participants will be instructed to 
sync their Fitbit device by opening the Fitbit app on their phone at least every 24 
hours. Participants will receive a bi-weekly self-efficacy survey and three 

 
 
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onboarding surveys assessing neighborhood walkability, social support, and 
comorbidities.  
 
After completing 28 days in the baseline period, a consenting coordinator will 
review individual adherence to Fitbit wear. Adherence to Fitbit wear will be 
defined as recorded heart rate data for at least 10 hours a day. Survey adherence 
will be defined as submission of a given survey. Baseline participants that do not 
achieve at least 75% adherence of Fitbit wear, daily survey submission for 21 out 
of 28 days of the baseline period, and submission of 3 onboarding surveys and at 
least 1 self-efficacy survey will be withdrawn from the study. Those that maintain 
adherence and are objectively confirmed as sedentary will be randomized to one of 
sixteen treatment sequences in the study. Participants who are randomized to 
receive treatment sequences will receive a text message notifying them of their 
protocol timeline. Enrollment will continue until up to 624 participants have been 
randomized into one of 16 possible intervention sequences. 
 
Each intervention sequence contains zero to four of the following Behavior Change 
Techniques: Goal setting, Action Planning, Self-Monitoring of Behavior and 
Feedback. One group (control) receives no BCT messages. The intervention phase 
is 8 weeks in duration. 
 
Daily, all randomized participants will receive one text message from N-1-Thrive. 
It will provide a link to a secure survey. The survey will contain 0-4 BCT 
interventions. Responses will be coded as BCT enactment.  
 
The Goal Setting survey item is: “Is your goal today to walk an extra 1,000 steps 
more than your baseline average? Responding with a yes or no is BCT enactment.  
The Action Planning survey item is: “Take one minute and plan for today how, 
where and when you can walk an extra 1,000 steps more than your baseline 
average. Have you planned for today?” Responding yes/no is BCT enactment.  
 
The Self-Monitoring of Behavior survey item is: “Check your fitbit for yesterday. 
Type in the number of steps you did yesterday.” Entering a number is BCT 
enactment.  
 
The Feedback on Behavior survey item is dependent on whether or not the 
participant met their walking goal the day prior.  
If their goal was not met the survey item is: “Your goal is to walk 1,000 steps more 
than your baseline average. Yesterday you did not meet your goal. If you think this 
is incorrect, you can check your step count from yesterday on your fitbit app to 
confirm.”  
 
If their goal was met the survey item is: “Your goal is to walk 1,000 steps more 
than your baseline average. Yesterday you met your goal. If you think this is 
incorrect, you can check your step count from yesterday on your fitbit app to 
confirm.” Opening the message is BCT enactment.  

 
 
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A study phone number and email address will be available if a participant is 
concerned about any side effects they are experiencing and wishes to contact the 
clinical research coordinator. 
 
Participants will be asked to wear their FitBit tracker for a minimum of 10 hours 
per day. They will also be asked to complete a validated bi-weekly Self-Efficacy 
questionnaire. Participants that are not in the control arm will be asked to complete 
a satisfaction with the BCT survey each month. 
 
Participants may receive additional text messages to those outlined above to remind 
participants to sync their data, charge their Fitbit or answer surveys. We will send 
study onboarding instructions in multiple text messages, but during the course of 
the study we will send a maximum of 5 text messages per day including these 
reminders and the survey questions outlined above.   
 
In the event of an unanticipated circumstance that temporarily prevents a 
participant from completing study activities (illness, injury, death in the family, 
etc.), the participant will have the option of pausing their study to resume once their 
circumstance has been positively resolved. 
 
Participants will complete remote data monitoring after they have gone through one 
baseline period (four weeks), 8 weeks of randomized exposure to BCTs or control 
arm messaging, and 12 weeks of follow-up monitoring. Alternatively, a participant 
may choose to completely withdraw from the study, or be withdrawn from the 
study by the research team. Participants who seek to withdraw may decide to only 
partially withdraw from the study: they will continue to wear the Fitbit tracker and 
allow the study to record and use their step data, but they will receive no text 
messages or reminders. If participants decide to partially withdraw, they will not be 
eligible for compensation. Upon completion of data monitoring, participant Fitbit 
data will no longer be collected by the study team. Daily text messages and survey 
prompts will be cancelled for participants who are withdrawn from the study.  
  
We will compile the self-reported data from questionnaires, treatment adherence, 
side effects, and self-efficacy  assessments, as well as information from the Fitbit 
regarding activity (steps, flights climbed and intensity), sleep (duration, estimated 
sleep stages) for each individual participant.  
 
As per the consent form, de-identified data will be posted on the following data 
sharing website: https://cos.io/. The Open Science Framework is a free, open-
source web application built to provide researchers with a free platform for data 
and materials sharing. There will be no identifiable data posted to this website or 
used in future studies. 
 
 
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.  
 
Overall Aim: To conduct a randomized factorial experiment to test a mediational 
model of four BCTs targeting changes in self-efficacy for PA, which are, in turn, 
hypothesized to cause increased walking in sedentary adults, 18 to 74 years of age 
at risk for CVD.  To achieve this aim, specifically, we will  determine, in three 
steps: (a).   Whether randomization to a BCT will result in increased longitudinal 
self-efficacy for PA; (b).Whether randomization to a BCT will result in increased 
Fitbit-assessed average daily step counts in the 6th month, compared to the baseline 
period; and (c). Whether longitudinal self-efficacy mediates increase in walking by 
performing sequential mediation analysis en bloc, using the natural effects 
modeling approach. Whereas Step b determines the total effect of a BCT on PA, 
Steps a and c together establish the natural direct effect of a BCT on PA, and the 
natural indirect effect mediated via self-efficacy for PA. Exploratory Aim: 
Explore effect moderation in the mediational model of the BCTs by actual use or 
enactment of a BCT and for whom and under what conditions mediation occurred. 
Specifically, we will: (a)N.   Explore possible baseline moderators (age, identified 
gender, race, ethnicity, baseline PA, ted in model (c-i): Month-6 self-efficacy 
neighborhood walkability score, personal history of walking) that moderate self-
efficacy mediation; b.   Assess whether BCT adherence moderates the mediation.  
 
Primary Analysis -Modified Intent-to-Treat (ITT) Population: These data will 
include all randomized participants, who have at least one self-efficacy measure 
post randomization.  Accounting for ineligibility (about 24%) after one-month 
baseline screening, we expect about N=624 in this data set, which will be used in 
the primary analysis for the Overall Aim.  Furthermore, in the modified ITT 
population, we expect about N=480 will have all twelve self-efficacy outcomes in 
the completer-only subset.  In the modified ITT data and its completer-only subset, 
the BCT will be recorded as randomized.  As-treated population: This will consist 
of the participants as in the modified ITT Population.  However, the degrees of 
BCT adherence will be used to determine the BCT exposure; see Exploratory 
Analysis below.   
 
Primary Outcomes and Primary Analysis Self-efficacy for physical activity: 
The SEW_DUR  Self-Efficacy Scale for Walking will be sent electronically Bi-
weekly throughout the study starting the first day of baseline. Physical activity 
assessed by Fitbit: The PA of each randomized participant will be measured 
continuously for 6 months using the FitBit Tracker. The average daily step counts   
of each month will be used as the primary PA endpoint.  Specifically, the primary 
PA endpoint in the mediation analysis for the Overall Aim will be the increase in 
average daily step counts at month 6 from baseline. To test the mediational model 
hypothesis for the Overall Aim, we perform the analysis in three steps: Step A: The 

 
 
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effects of each randomized BCT on the longitudinal self-efficacy for PA will be 
assessed using linear mixed effects models, which include a random participant 
effect, fixed BCT effects, a fixed time effect, and fixed BCT-time interactions. For 
the Overall Aim, we consider additive BCT main effects and additive BCT-time 
interaction. The effects of a BCT on self-efficacy for PA will be estimated by the 
coefficient of the interaction term.  As sensitivity analysis, we will perform 
generalized estimating equations analysis to obtain the robust “sandwich” variance 
estimation. Step B: The effects of each randomized BCT on average daily step 
counts at Month 6 will be assessed using linear regression of the four BCTs.  Step 
C:  As Step B yields an estimation of the total effect of a BCT on average daily step 
counts   at   Month 6,   For Step C, natural effects models will be used for effect 
decomposition into direct effect and indirect effect mediated by increase in self-
efficacy relative to baseline. In addition, in order to assess how the timing of 
increase in self-efficacy mediates BCT effects, we will perform sequential 
mediation analysis en bloc under the natural effects modeling framework, as 
follows: We will include increases in self-efficacy at Months 2, 3, 4, 5,and 6 
relatively to Month 1 (baseline) in the model, and use them as mediators en bloc. 
This will give the total mediation effect estimates via all post-randomization self-
efficacy, as well as the direct effect of BCT. We will include increases in self-
efficacy at Months 2—5 en bloc in the model.  This will estimate the mediation 
effect due to Month 2 to Month 5 self-efficacy.  And, by contrasting the indirect 
effect in this model with that in (c-i), we can estimate the BCT effect mediated by 
Month 6 self -efficacy alone; right of Figure 3. Likewise, we will proceed to 
sequentially fit the natural effects model with subsequently fewer self-efficacy 
mediators.  By contrasting the indirect effects in the appropriate natural effect 
models, this state-of-the-art sequential mediation analysis approach will allow us to 
identify the self-efficacy mediation pathway temporally.  We note that not all 
pathways are identifiable (e.g., mediation effect of Month 2 self-efficacy that is not 
through self-efficacy in the later months cannot be identified). Under the natural 
effect model framework, we will estimate the proportion of mediated effects 
relative to the total effects. 
 
Sample size calculation: We determined the sample size of this study to have 
adequate power in Steps A and B in the primary analysis, so that the mediation 
pathways identified in the primary analysis will likely yield meaningful results.   
Specifically, we determined the sample size based on power considerations   in 
Step A: We considered conservatively the power of detecting a main BCT effect in 
linear regression of increase in self-efficacy at one post-randomization time point.  
(As this is equivalent to fitting a linear mixed effect model of self-efficacy at 
baseline and one post-randomization time point, the power of the linear mixed 
effect model that uses self-efficacy at all time points will have more power.)  
Assuming an effect size of Cohen’s d=0.26, to have 80% power for a main BCT 
effect at 5% significance using Wald test (two-sided), under balanced 
randomization, we obtained the required total sample size to be N=480.  That is, for 
a given BCT, 240 participants will be randomized to having it, and 240 to not 
having it; 30 participants will be in each of the 16 BCT combinations.  As noted 

 
 
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above, this sample size estimate is conservative, as we anticipate the mixed effects 
model that used data at all time points in the entire modified ITT population (with 
N=624) will have substantially greater power.  In addition, various meta-analyses 
estimate the effect size of BCT on self-efficacy for PA to be in the range of 0.19 to 
0.26,61,88,100averaged over a wide range BCTs; we used the most recent estimate 
0.26 61(Tang et al. 2019) to anchor our sample size determination.  Importantly, in 
this project, because we select BCTs (e.g., Feedback on Behavior) that have shown 
large effect sizes, we expect the true effect size to be greater than this average of 
0.26, and our sample size will yield greater power than 80% in Step A. In  the 
process of determining sample size, we also considered the power for Step B, based 
on a recent meta-analysis88 that gives an effect size of Cohen’s d=0.5.  With an 
effect size greater than that reported for self-efficacy, powering Step A was the 
driver of sample size.  With N=480, the power in Step B is >99% under d=0.5  
     
Analyses for Exploratory Aims Baseline moderators: To explore the moderation 
effect of baseline variables, such as demographics, we will include the interaction 
between these and BCTs in the regression models in the sequential mediation 
analyses described above. To be parsimonious, we will first add baseline variables 
one at a time, as main effects in the models; only variables that demonstrate 
significant main effects will be considered in the moderation analysis Joint BCT 
effects: Leveraging the full factorial experimental design, we will explore (for 
hypothesis generation) all six possible two-way interactions and four possible 
three-way interactions   among BCTs in the sequential mediation analyses, 
recognizing that we have limited power to detect anything but a large effect. 
Effects of BCT adherence: Whether or not a BCT was used on a given day will be 
determined based on the response to the daily automated texts.  For the period 
spanning from randomization to the end of a given month (say t for t = 2, 3, 4, 5), 
we will define non-adherence as response rate below 75% for that period.  The 
moderation of adherence (or the lack thereof) will be examined by including an 
interaction between BCT and its adherence status in the mediation models; due to 
temporal causation, we will only consider the mediation of self-efficacy after time 
t. That is, for a given t, we will look at: a: the effects of interaction between each 
BCT and its adherence up to time t on the longitudinal self-efficacy after time t 
using linear mixed effects models; b: the effects of interaction between each BCT 
and its adherence up to time t on average daily step counts at month 6 using linear 
regression; c: sequential mediation analysis en bloc of self-efficacy after time t.  
We note that this analysis is equivalent to conducting a mediation analysis under 
the as- treated population with a main BCT effect coded as 0 for non-adherence. 
 
General Statistical Analytical Approach, Sensitivity Analyses, and Subgroup 
Analyses Baseline measurements will be summarized with descriptive statistics, 
including mean, median, and standard deviation for continuous variables (e.g., age) 
and proportions for categorical variables (e.g., sex, self-identified gender, 
race/ethnicity).  In regression models, all coefficients will be estimated with 95% 
confidence intervals, and the point estimates, and will be tested using two-sided p 
values.  The modified ITT population will be used for the primary analysis 

 
 
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specified above.  To handle missing self-efficacy and step data in the analysis, our 
primary approach will use last-observation-carried forward (LOCF) imputations.  
We will also take various analytical approaches for missing data, so as to evaluate 
how the main conclusions are sensitive to the underlying missing data mechanism.  
Specifically, for the longitudinal analyses of self-efficacy and BCT (Step A), we 
will perform the mixed effects models with: 1) observed data only; 2) worst-score 
imputations; 3) complete data only; and 4) multiple imputations. Note: observed-
only analysis (1) is valid under missingness-at-random, whereas complete-data 
only analysis (3) corresponds to the modified ITT completer-only subset.  These 
four approaches serve as sensitivity analyses to the LOCF analysis and will provide 
estimates under different missingness assumptions.  In addition, we will explore the 
missingness patterns of self-efficacy data by BCT groups.  Similarly, for the 
analysis of PA and BCT (Step B), we will use these same four methods 
analogously, in addition to LOCF.  For the sequential mediation analysis (Step C), 
we will adopt methods 2—4 in the natural effect models. We will also perform 
subgroup analyses by the baseline demographics. In particular, we will test the 
mediational model by sex-defined subgroup. 
 
 
 
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. 
 
Not applicable 
 
 
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  

 
 
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This study uses non-NFC, Fitbit devices to remotely monitor 
participant activity and sleep. All enrolled participants will 
beprovided with instructions to use or create a Google account to log 
into the Fitbit app with. Data collected will include activity data 
(daily steps, floors climbed, activity, intensity, heart rate), sleep data 
(duration/total sleep minutes, sleep and wake times, estimated 
minutes in sleep stages), and device data (last sync date and Fitbit 
battery level).  
 
Data Retrieval 
This study will retrieve Fitbit data from participants directly from 
Fitbit or through use of Fitabase. Fitabase is a secure, online portal. 
The participant’s Google account 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. 
  
The Quantitative Intelligence (QI) team at Northwell Health will 
retrieve participant data directly from Fitbit through an authentication 
token passed to the Fitbit API, and data resulting from the API call 
will be stored in an OCIO-approved HIPAA-compliant environment. 
 
The QI team will be provided with participants’ study IDs to 
associate the data to the correct Fitbit account for distribution to the 
study team.   
 
Data collected from Fitabase and directly from Fitbit will include 
device data (last sync date, battery charge status), daily activity 
(steps, floors climbed, activity, intensity, heart rate), sleep data 
(duration/total sleep minutes, sleep and wake times, and estimated 
minutes in sleep stages/sleep stage estimates). Both Fitabase and QI 
will stop tracking participant data at the trial end date selected by the 
research coordinator.  
 
Intervention Delivery 
The study’s statistician will create the randomization schedule at the 
initiation of the study. Only the research team will have access to data 
that will be able to connect participant name with intervention 
assignment. The intervention will be delivered by a text with a link to 
a secure online browser and will be delivered to the individual’s 
personal cell phone. All protocol messaging and data will be 
delivered/collected via the secure browser (N1Thrive). Data will be 
stored on the N1Thrive system and delivered back to Northwell via 
SFTP.  
 

 
 
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Eligibility, Consent, and Survey Data 
Screening and consenting will be done in RedCap. We are partnering 
with a company (N1Thrive by 4Peacocks) that was formed 
specifically for the development of technology to support N-of-1 
methodology. Survey data will be collected and stored using 
N1Thrive by 4Peacocks, 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. Coded data using unique generic participant IDs will be shared 
with 4Peacocks in order to assist with preparing data for analysis by 
the study statistician..    
 
The study team takes data confidentiality very seriously. The 
participant will be made aware of all data collected and the 
companies/technology employed to collect the data via the consent 
process. Any identifying information will be destroyed once a 
participant completes their study involvement in the N1Thrive by 
4Peacocks database. All data, including 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. Regular meetings will take place with the PI 
and other members of the study team to ensure protocol adherence 
and data accuracy. 
 
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.   

 
 
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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.   
 
This study has been determined by the Northwell IRB to present no more than  
minimal risks to participants. As such, utilization of a DSMB is not appropriate.  
 
However, attention to data and safety monitoring is of paramount importance to 
ensure participant safety and data integrity. Primary responsibility for data and 
safety monitoring will rest with the study physician, Dr. Sal Crusco. Dr. Crusco 
will ensure medical eligibility and consult with the study exercise physiologist 
concerning any reported AEs. Dr. Crusco will receive quarterly reports of 
enrollment numbers and participant demographics, in addition to monthly reports 
of AEs. Dr. Crusco will provide final approval for the Manual of Operations and all 
procedures related to ensuring medical eligibility and safe participation in the trial.  
  
The Data Manager (Mr. Vicari), under the direction of the trial’s biostatistician Dr. 
Cheung (Co- Investigator), will provide investigative team with numbers of 
participants recruited into the trial, demographic breakdowns and reported serious 
adverse reactions, and data completeness on a monthly basis during team 
meetings.  
  
The PI, in consultation with the study exercise physiologist and study physician 
will determine whether unanticipated events are related to the study, whether the 
study’s informed consent form and process needs to be modified, whether the 
study’s procedures need to be modified, and whether the study should be 
discontinued due to serious adverse outcomes in either the control group or in the 
intervention groups. All data provided will be provided in a blinded fashion.  
 
There is no provision for early stopping due to efficacy in the primary outcomes. 
However, as NHLBI will monitor trial progress, they may choose to stop the trial 
due to safety concerns, not reaching recruitment milestones, much higher drop-out 
rates than expected, and/or study adherence issues.   
  

 
 
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How safety will be assessed. The study population will be drawn from a 
pool of actively working adults, without mobility impairments. Participants 
with high-risk features as detailed in the exclusion criteria will be excluded to 
minimize risk. Side effects related to the intervention will be assessed bi-
weekly , tracked and reported to the PI and investigative team, IRB and 
NHLBI according to pre-established policies. All assessments or consultations 
if needed will be performed by trained personnel  
  
Plan for reporting adverse events. Any adverse event (AE) or unanticipated 
problem will be identified, responded to, and recorded by the research 
coordinator, who will in turn ensure that the information is passed on to the study 
physician. If the AE or problem is unexpected or serious, is related to study 
involvement, and puts the participant at increased risk, it will be reported to the 
Institutional Review Board of Northwell Health immediately, in accordance with 
local policies.  
  
Responsible individual for safety monitoring. The study physician and 
exercise physiologist (Co-Is Dr. Cruscoand Dr.Friel, respectively) will be 
responsible for evaluating each AE/problem and determining whether it 
affects the risk/benefit ratio of the study, and whether modifications to the 
protocol and consent form are required. Dr.Crusco (Co-I) will be the 
physician responsible for overall safety monitoring, and will coordinate the 
training and communication for this function.  
 
Plans for assuring data accuracy and protocol compliance. Dr. Davidson 
will supervise this study at all times and will be in close and frequent contact 
with the other Co-Is. In particular, Dr. Davidson will ensure adherence to 
established federal and institutional patient safety and protection guidelines. To 
assure data accuracy, Drs. Davidson and Cheung will review the computer data 
files on a monthly basis. Mr. Vicari (Data Manager) will process the study 
database monthly to search for errors and generate basic reports for 
dissemination at regular meetings. Protocol compliance will be reviewed 
during both weekly meetings between Dr. Davidson, Ms. Duer-Hefele, RN 
(Director of Operations) and the research coordinators, and during monthly 
meetings (more frequent if required) between Dr. Davidson and the other co- Is 
(Drs. Crusco.Friel, Cheung, Suls and Vrany). Finally, Ms. Duer-Hefele will 
perform a random audit of 5% of study records and provide continual feedback 
to improve the quality of informed consent and data collection.  
  
We have a number of strategies to ensure the quality of the data. First, the study 
electronic data entry system we will use “forces” responses to most questionnaire 
items before allowing progression through the particular assessment’s template, 
thereby avoiding problems with missing data. For some items, delayed data entry 
is possible. Further, each time the research coordinator logs into the secure data 
entry system, it prompts a popup on the initial screen, showing what data 
elements remain incomplete, to encourage complete data capture.  

 
 
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Wireless data is regularly downloaded from the Fitbit and auto-generated 
messages are sent to remind participants to charge their device. Text messages 
and emails will record time of transmission and verification of receipt, and 
responses where indicated. Research assistants will be able to observe in real time 
participant unresponsiveness and will contact participants to ensure that they are 
not experiencing technical difficulties with data collection.  
  
After enrollment of the first 5 participants, Dr. Cheung will examine the data to 
ensure adequacy and accuracy of data collection. Then, data accuracy will be 
audited monthly. Finally, as mentioned above, the investigative team will also 
review data completeness, accuracy, and timeliness on a monthly basis.  
 
 
 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 
 
Not applicable 
  
 
 
 
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 self-
reported adverse side effects to walking. A potential participant will not be 
randomized to receive the treatment protocol until he/she has demonstrated at least 
75% adherence to continuous Fitbit monitoring (heart rate recorded ≥ 10 
hours/day) and response to survey questionnaires during the baseline period.  
 
Potential participants will be notified of the possibility of being removed from the 
study before treatment randomization 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 21or more days of baseline participation.  

 
 
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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. 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 and a pre-
paid mailer to return their Fitbit device. Participants who are not eligible after 
baseline because they did not meet objective sedentary behavior criteria will be 
able to keep their Fitbit and provided instructions how to un-link their device from 
the study.  
 
Should a participant choose to withdraw from the research study, they will be 
instructed to send an e-mail to the attention of the Principal Investigator at 
kdavidson2@northwell.edu or to email mostwalkingsstudy@northwell.edu an e-
mail account monitored by IRB-approved members of the research team. They may 
also message the research team through Twistle. Participants will be contacted by a 
member of the research team confirming their study withdrawal, and to answer any 
questions they may have. The participant will stop receiving notification and 
survey prompts, and will be sent instructions to un-link their Fitbit device. Data 
collection will stop the day the email is received. All data up until the receipt date 
of the letter will be included in the research study.   
 
 Participants may also decide to “partially withdraw” from the study. This would 
allow the study to continue to passively collect their step data, but no text 
messaging would occur. Participants will be provided the following option in 
Twistle at time of elective withdrawal 
 
Can we continue to collect your fitbit 
activity data for the remainder of the 
study? This means that we will 
continue to see your fitbit activity 
data but you will not receive any 
further text messages until the final 
day of the study. You will no longer 
be eligible for study compensation. 
Yes, you can continue to collect my fitbit 
activity for the remainder of the study 
 
No, you cannot continue to collect my 
fitbit activity for the remainder of the 
study. Please fully withdraw me from 
the study 
 
 
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) 

 
 
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• 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.   
 
Risks of Low-Intensity Walking 
Risks of low intensity walking in ambulatory but sedentary individuals may include 
muscle fatigue and soreness and are generally treatable with rest. Any adverse 
event (AE) or unanticipated problem will be identified, responded to, and recorded 
by the research coordinator, who will in turn ensure that the information is passed 
on to a study investigator. If the AE or problem is unexpected or serious, is related 
to study involvement, and puts the participant at increased risk,  it will be reported 
to the Institutional Review Board of Northwell Health immediately, in accordance 
with policies. All other AEs and problems will be reported at the time of the annual 
IRB review 
 
Fitbit Wear: 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) or soreness, tingling, numbness, burning or 
stiffness in hands or wrists from wearing the Fitbit, particularly if the Fitbit wrist 
band is too tight, which occurs among a small proportion of users. Participants will 
be instructed via the consent form on methods to reduce irritation (e.g. keep the 
band clean and dry) and/or hand or wrist senstations (e.g. wear band loosely) and 
that they can remove the band for a short period of time or stop wearing and 
contact the study team if the methods outlined in the consent form do not resolve 
the issue 
Loss of Confidentiality or Privacy 
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. To ensure 
confidentiality, all data containing personal identifiers, and used to track contact 
with patients, will be kept in a secure, password-protected, encrypted Northwell-
approved database. No paper documents with personal identifiers will be kept. The 
PI will be responsible for ensuring that the confidentiality of the data is maintained 
at all times. All data will be obtained specifically for research purposes. 
 
Personal or identifiable information is not stored on any of the devices used in this 
study. No information about the participants or the participants’ health history will 

 
 
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be shared with Fitbit, except for the information the participants directly share 
themselves as per Google and Fitbit Terms of Service and Privacy Policies outlined 
in the consent form.There is no additional risk with using Fitbit as part of this 
research study as compared to using the device as a consumer. 
 
 
 
 
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.   
 
Should a participant experience an adverse event, they will be advised to contact 
their primary care provider. The PI, Dr. Crusco and the IRB will be notified 
according to established timelines. Should a participant report emotional distress in 
responding to survey questions, the research coordinators will refer to our Principal 
Investigator (a licensed clinical psychologist), who will recommend follow-up. 
 
 
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 
 
There are no known direct benefits for participating in this study. It is possible that 
participation may result in increased low-intensity walking and decreased sedentary 
time, both of which convey benefits to the participant’s overall cardiovascular 
health. 
 
 
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).   
 
Names and email addresses from potential study participants will not be collected 
until participants have read through web information explaining the research study 

 
 
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and protocol and indicated their interest in the study. This information will be 
stored in a Northwell-approved database store PHI, and it will only be accessible to 
research staff listed on the approved IRB protocol. Names or other identifying 
information will not be shared with those outside the research team. Phone 
numbers and email will only be used for study-related communications, and 
individuals will only be contacted outside the study if they indicate interest in 
participating in a future study at the Institute of Health Systems Science. 
 
 
 
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 and platforms 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. 
 
 
 
22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
Participants will receive $100 at the completion of the intervention (Month 3) and 
$150 for successful study completion (Month 6).  Additionally, they will be able to 
keep their FitBit, valued at approximately $150.  Participants in the study follow-up 
period (Months 4-6) may be eligible for a random, weekly lottery of $100 should 
they maintain adherence to Fitbit activity watch wear and responses to texts 
messages and surveys. 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 

 
 
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• 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.   
 
Consent and written authorization will be obtained electronically via the 21 
CFR 11-approved RedCap platform, with a copy of the electronically signed 
form emailed to the participants. Before receiving a copy of the consent form, 
potential participants will be sent through a series of web pages that summarize 
the study, as well as collect pre-screening information with written 
authorization.  
 
If a potential participant is deemed ineligible, or if the potential participant is 
eligible but needs to be waitlisted due to demand, the consenting coordinator 
will notify the potential participant via email within 2 business days of the 
initial completion date of the pre-screen.  
 
If the potential participant is deemed eligible, they will have access to the 
research team email address which can be used to schedule a phone call to go 
over study details with a consenting coordinator, and have the opportunity to 
have any of their questions answered. Or they may proceed to read and 
electronically sign the consent form. Included in this survey will be a short 
animated video that explains key aspects of the protocol and consent process. 
Included in these materials will be contact information to reach a consenting 
coordinator to answer any additional questions before signing the consent form. 
In order for the consent form to be signed and submitted successfully, potential 
participants will need to correctly answer 3 questions about the protocol to 
demonstrate their understanding. PDF versions of signed consent forms will be 
maintained electronically on a HIPAA-compliant, Northwell Health-approved 
share drive, accessible only to members of the research team listed on the IRB 
protocol. A copy of the consent form and signed signature page will be made 
available electronically to the potential participant. 
 
 
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 

 
 
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• 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.   
 
N/A 
 
 
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 
 
N/A 
 
 
If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• 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. However, the study will proceed with Spanish language 

 
 
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translations should we have difficulty enrolling a sample with the required 
representativeness.  
 
 
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.  
 
 
 
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. 
• 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. 
 
 

 
 
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Page 27 of 32 
 
. 
 
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 
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  

 
 
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Page 28 of 32 
  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. 
 
All employees of the health system will be eligible to participate in the study. Potential 
participants will go through online documents explaining that participation in this 
research will not impact their employment or standing with Northwell Health. 
Individuals with a supervisory relationship over an employee will not enroll any 
individual who reports to them in this study. Employee participation or non-
participation in this study will have no bearing on an individual’s position at Northwell 
Health.  
 
 
 
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. Armstrong GL, Conn LA, Pinner RW. Trends in infectious disease 
mortality in the United States during the 20th century. JAMA 1999;281:61-6. 
2. U. S. Burden of Disease Collaborators, Mokdad AH, Ballestros K, et al. 
The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk 
Factors Among US States. JAMA 2018;319:1444-72. PMCID: PMC5933332 

 
 
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Page 29 of 32 
3.. Institute of Medicine and National Research Council. U.S. Health in 
International Perspective: Shorter Lives, Poorer Health. National Academies 
Press: Washington, DC 2013. 
4. Vaughan AS, Ritchey MD, Hannan J, Kramer MR, Casper M. Widespread 
recent increases in county-level heart disease mortality across age groups. 
Ann Epidemiol 2017;27:796-800. PMCID: PMC5733620 
5. Wright JS, Wall HK, Ritchey MD. Million Hearts 2022: Small Steps Are 
Needed for Cardiovascular Disease Prevention. JAMA 2018;320:1857-8. 
6.. Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death 
in the United States, 2000. JAMA 2004;291:1238-45. 
7. Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Correction: actual 
causes of death in the United States, 2000. JAMA 2005;293:293-4. 
8. Brownson RC, Boehmer TK, Luke DA. Declining rates of physical 
activity in the United States: what are the contributors? Ann Rev Public 
Health 2005;26:421-43. 
9. Johnson NB, Hayes LD, Brown K, et al. CDC National Health Report: 
leading causes of morbidity and mortality and associated behavioral risk and 
protective factors--United States, 2005-2013. MMWR Suppl 2014;63:3-27. 
10. Stubbs B, Chen LJ, Chang CY, Sun WJ, Ku PW. Accelerometer-assessed 
light physical activity is protective of future cognitive ability: A longitudinal 
study among community dwelling older adults. Exp Gerontol 2017;91:104-9. 
11. Cigolle CT, Langa KM, Kabeto MU, Tian Z, Blaum CS. Geriatric 
conditions and disability: the Health and Retirement Study. Ann Intern Med 
2007;147:156-64. 
12. US Department of Health and Human Services. Physical activity 
guidelines advisory committee report. Washington, D.C.: U.S. Department of 
Health and Human Services; 2008. 
13. LeFevre ML, Force USPST. Behavioral counseling to promote a 
healthful diet and physical activity for cardiovascular disease prevention in 
adults with cardiovascular risk factors: U.S. Preventive Services Task Force 
Recommendation Statement. Ann Intern Med 2014;161:587-93. 

 
 
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14. Lin JS, O'Connor E, Evans CV, Senger CA, Rowland MG, Groom HC. 
Behavioral counseling to promote a healthy lifestyle in persons with 
cardiovascular risk factors: a systematic review for the U.S. Preventive 
Services Task Force. Ann Intern Med 2014;161:568-78. 
15. Moyer VA, Force USPST. Screening for and management of obesity in 
adults: U.S. Preventive Services Task Force recommendation statement. Ann 
Intern Med 2012;157:373-8. 
16. Wall HK, Ritchey MD, Gillespie C, Omura JD, Jamal A, George MG. 
Vital Signs: Prevalence of Key Cardiovascular Disease Risk Factors for 
Million Hearts 2022 - United States, 2011-2016. MMWR Morb Mortal Wkly 
Rep 2018;67:983-91. PMCID: PMC6132182 
17. Rhodes RE, Pfaeffli LA. Mediators of physical activity behaviour change 
among adult non-clinical populations: a review update. Int J Behav Nutr Phys 
Act 2010;7:37. PMCID: PMC2876989 
18. Buman MP, Winkler EA, Kurka JM, et al. Reallocating time to sleep, 
sedentary behaviors, or active behaviors: associations with cardiovascular 
disease risk biomarkers, NHANES 2005-2006. Am J Epidemiol 
2014;179:323-34. 
  19. Fuzeki E, Engeroff T, Banzer W. Health Benefits of Light-Intensity 
Physical Activity: A Systematic Review of Accelerometer Data of the 
National Health and Nutrition Examination Survey (NHANES). Sports Med 
2017;47:1769-93. 
20. Lee LL, Arthur A, Avis M. Evaluating a community-based walking 
intervention for hypertensive older people in Taiwan: a randomized 
controlled trial. Prev Med 2007;44:160-6. 
21. Rhodes RE, Warburton DE, Murray H. Characteristics of physical 
activity guidelines and their effect on adherence: a review of randomized 
trials. Sports Med 2009;39:355-75. 
22. Oka RK, De Marco T, Haskell WL, et al. Impact of a home-based 
walking and resistance training program on quality of life in patients with 
heart failure. Am J Cardiol 2000;85:365-9. 

 
 
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23. Sniehotta FF, Presseau J, Hobbs N, Araujo-Soares V. Testing self-
regulation interventions to increase walking using factorial randomized N-of-
1 trials. Health Psychol 2012;31:733-7. 
24. Conraads VM, Spruit MA, Braunschweig F, et al. Physical activity 
measured with implanted devices predicts patient outcome in chronic heart 
failure. Circ Heart failure 2014;7:279-87. 
25. Tucker JM, Welk GJ, Beyler NK. Physical activity in U.S.: adults 
compliance with the Physical Activity Guidelines for Americans. Am J Prev 
Med 2011;40:454-61. 
26. Dinger MK, Heesch KC, Cipriani G, Qualls M. Comparison of two 
email-delivered, pedometer-based interventions to promote walking among 
insufficiently active women. J Sci Med Sport 2007;10:297-302. 
27. Harris T, Kerry SM, Limb ES, et al. Effect of a Primary Care Walking 
Intervention with and without Nurse Support on Physical Activity Levels in 
45- to 75-Year-Olds: The Pedometer And Consultation Evaluation (PACE-
UP) Cluster Randomised Clinical Trial. PLoS Med 2017;14:e1002210. 
PMCID: PMC5207642 
28. Richardson CR, Newton TL, Abraham JJ, Sen A, Jimbo M, Swartz AM. 
A meta-analysis of pedometer-based walking interventions and weight loss. 
Ann Fam Med 2008;6:69-77. PMCID: PMC2203404 
29. Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective 
techniques in healthy eating and physical activity interventions: a meta-
regression. Health Psychol 2009;28:690-701 
30. Dunn EE, Robertson-Wilson J. Behavior Change Techniques and 
Physical Activity Using the Fitbit Flex®. Int J Exerc Sci 2018;11. PMCID: 
PMC6043935 
31. French DP, Olander EK, Chisholm A, Mc Sharry J. Which behaviour 
change techniques are most effective at increasing older adults' self-efficacy 
and physical activity behaviour? A systematic review. Ann Behav Med 
2014;48:225-34. 
32. Samdal GB, Eide GE, Barth T, Williams G, Meland E. Effective 
behaviour change techniques for physical activity and healthy eating in 

 
 
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overweight and obese adults; systematic review and meta-regression 
analyses. Int J Behav Nutr Phys Act 2017;14:42. PMCID: PMC5370453