A Personalized Trial Pilot to Test Habit Formation Theory for Low Intensity Physical Exercise in Older Adults
Phase: PHASE1
Conditions: Sedentary Behavior, Aging, Activity, Motor, Behavior, Health
Sponsor: Northwell Health

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RESEARCH PROTOCOL 
 
 
Protocol Title: 
A Randomized, Controlled Trial to Test Habit Formation Theory 
for Low Intensity Physical Exercise in Older Adults 
Principal Investigator: 
Karina W. Davidson 
Primary Contact Name: 
Joan Duer-Hefele 
Primary Contact Phone: 
845-642-2399 
Primary Contact E-mail: 
jduerhefele@northwell.edu 
Date Revised: 
12/23/2021 
IRB Number: 
20-1182 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
• You do not need to complete this document if you are submitting an Application for 
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 
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.  .   
• 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. 
 
 
 
 Continue to next page to begin entering information about this study  
 
 

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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 
 
 
 
This pilot study uses Personalized Trials (N-of-1) to evaluate the effects of the five 
behavioral change techniques (BCTs) described in Habit Formation Theory (Goal 
setting, Action Planning, Self-Monitoring, Rehearsal and Rehearsal in a Familiar 
Context) delivered by text message to enhance low-intensity walking by 2,000 
steps per day/5 days per week in healthy Northwell employees aged 45-75 years 
old. In preliminary phases, participants, via a Microsoft teams focus group meeting, 
1:1 feedback discussion and/or Northwell email exchange, will provide their 
impressions about materials created for future implementation of a personalized 
trial to increase walking. Up to10 participants will provide feedback on materials, 
up to10 participants will try various aspects of our instructions and provide 
feedback, and up to10 participants will interact with study materials remotely, from 
their home or office, and provide feedback. In the next or intervention phase of the 
study, up to sixty participants will then complete a 12 week personalized trial of 
their walking behavior and assess all five behavioral change techniques described 
in habit formation theory. A time-sensitive text will signal to begin walking when 
the context (eg. day of week, time of day) that they pre-selected is encountered. 
Participants will be sent a Fitbit® activity tracking watch that monitors number of 
steps per day. Participants will receive a text message with a link to a secure survey 
in which they will note whether they engaged in each of the five behavioral change 
techniques which were prompted. At the end of their trial, participants will receive 
a personalized summary of their step data to help them learn more about their 
responses to the five behavioral change techniques and to inform investigators as to 
the feasibility of N-of-1 study design for future research and clinical applications. 
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICACE 

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• 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 
 
This study is a pilot project under the umbrella of the NIH-funded grant “Roybal 
Center for Personalized Trials: Physical Activity Promotion to Foster Healthy 
Aging." (Northwell IRB 20-0355 ) which is funded to test exercise promotion use 
cases appropriate for N-of-1 methodology and evaluate them for acceptability and 
scalability. 
 
The overarching objective of our parent grant is to develop, test, and implement an 
innovative technology platform for conducting N-of-1 trials that transforms 
precision therapeutics for exercise promotion in older adults. Right now, clinicians 
are engaging in clinical encounters in which they are trying to determine the best 
therapy for individual patients. Clinicians rely on the best available evidence (e.g., 
results from parallel group, phase III randomized clinical trials; RCTs) for 
recommending therapies to a patient. Yet, conventional, between-group RCTs only 
provide estimates of the effect of therapies on the hypothetical ‘average’ patient in 
those trials. Individual patients, however, often respond differently than the 
hypothetical average patient in the phase III RCTs, and thus, heterogeneity of 
therapy response plagues clinical decisions made for an individual patient every 
day.   
 
The most scientifically rigorous — and potentially transformative — method for 
determining optimal therapy for a patient is a single-patient (N-of-1) trial. N-of-1 
trials are multiple crossover trials, usually randomized, and often masked, 
conducted within a single patient, with data collected objectively, continuously, 
and in the real-world, for a sufficient time period to determine whether the therapy, 
compared to a placebo, usual care or other active therapy, is optimal for a particular 
patient. They also yield information on off-target actions, such as side-effects or 
unintended consequences, so that a more complex picture can emerge about the 
overall benefits and harms of the therapy for that one individual patient. In many 
ways, Personalized or N-of-1 Trials are the foundational design for a truly 
patient-centered approach by serving as a clinical decision tool for patients. 
Historically, in introducing evidence-based medicine, Guyatt and others have 
described Personalized Trials as the pinnacle of the evidence-based design 
pyramid. Personalized Trials are specifically designed to help patients and their 
clinicians make healthcare decisions that are informed by high-integrity, evidence-
based information uniquely relevant to the outcomes and values important to them. 
     Yet, clinicians and patients do not routinely engage in this type of scientific 
endeavor because they lack the tools and resources to implement efficiently.  In 
post-mortem assessments as to why Personalized Trials had yet to 
become commonly employed, proponents concluded that they were insufficiently 

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appealing to patients or clinicians to justify the cost and effort needed to design and 
implement them. Specifically, Personalized Trial design specifications had mostly 
been driven by clinicians or researchers, with little input from patients.  
 
Rationale for Selecting Five Behavioral Change Interventions Described in 
Habit Formation Theory as an N-of-1 Trial for Increasing Low Intensity 
Physical Activity in Older Adults  
Guidelines and recommendations focus on increasing moderate activity for older 
adults, but adherence to recommendations remains low. This is despite the fact that 
any increase in physical activity is associated with benefit (LIFE trial) Increasing 
physical activity meets all of our criteria for selection as a use case as outlined in 
our umbrella grant: it has high public health burden, high heterogeneity of therapy 
response, and is high priority for a Personalized Trial approach as determined by 
previously interviewed clinicians and patients. This instance will adapt our N-of-1 
trial platform to testing the efficacy of five behavioral change interventions- goal 
setting, action planning, rehearsal, rehearsal in a consistent context and self-
monitoring -as described in  habit formation theory (Lally & Gardner, 2013) and 
randomized clinical trials (Lally et al., 2010). This pilot test will enable us to 
expand our N-of-1 trial platform of behavioral interventions. Of note, it is possible 
that N-of-1 trials of behavioral change techniques could eventually be conducted at 
the direct-to-consumer level.  
    Without development of innovative platforms for conducting Personalized 
Trials, with within-participant randomization to eligible wellness management 
options, patients and clinicians cannot obtain the objective data they need to 
empirically choose the optimal precise therapy. Scientists may be able to use 
Personalized or N-of-1 trials to better understand the uniqueness of responders 
versus non-responders. Should this study demonstrate scalable implementation, 
acceptability and satisfaction with this methodology amongst participants, it will be 
a critical step in broadening the application and utilization of this methodology to 
promote wellness behaviors. 
 
 
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 specific aims of this study are to: 
-Elicit and incorporate participant feedback in the development of required content 
and study procedures for implementation of N-of-1 interventional trial to enhance 
low-intensity walking utilizing five behavioral techniques: goal setting, action 
planning, rehearsal, rehearsal in a consistent context and self-monitoring, as 
described in Habit Formation Theory. 
-Determine the feasibility of conducting a virtual, randomized, control trial using 
N-of-1 design and five behavioral change techniques described in Habit Formation 
Theory as interventions. 

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- Examine the novel individual-level heterogeneity of treatment effect made 
possible by the N-of-1 trial design, and pool results across patients to efficiently 
estimate the overall efficacy of the five behavioral change techniques in habit 
formation that results in increasing participant low-intensity walking by 2,000 
steps, five days per week 
 -Elicit participant attitudes and opinions toward using Personalized Trials to help 
inform their personal wellness strategy 
 
 
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 72,000 employees, a vast number of whom are 
between the ages of 45-75 years. As an organization committed to the promotion of 
wellness as a means of decreasing disease and disability, our colleagues in both the 
Employee Wellness Department and Occupational Health Services have agreed to 
support promotion of this study. Northwell social media groups and electronic 
communications remain a rich resource for research participant recruitment. Our 
team has demonstrated exceptional success in virtual, personalized trial recruitment 
using these employee recruitment pathways, and boasts high levels of participant 
satisfaction with virtual participation in N-of-1 trials. 
 
All study personnel are fully trained in Human Subjects Protections and 
HIPAA/Privacy protections. All engaged staff members are listed on the IRB and 
compliant 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 

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Since the proposed study will take place virtually, potential participants can be 
recruited from any Northwell Health facility 
 
Potential participants may be recruited via the following avenues: 
-E -mail advertisement through employee communication channels, within the 
Northwell Health network.  
-E-mail advertisements through existing email lists from those who have previously 
expressed an interest in participation in a Personalized Trial with the Center for 
Personalized Health. 
-Flyers, shared within the Northwell Health network. 
-Northwell Health employee social media (Facebook) site.  
 
Potential participants will be Northwell Health employees who are community-
residing, 45-75 years old, healthy, report that they walk regularly without 
health/safety issues, and express interest in participating in a Personalized Trial to 
increase their walking by a minimum of 2000 steps five to seven days each week . 
Study activities are divided into Phases. Participants in the first three preliminary 
phases will receive 5,000 points credited to their Northwell "My Recognition" 
account. In the 4th phase (interventional), involving 12 weeks of study 
participation, participants will receive a pay card valued at $100 for completing all 
study requirements. Additionally, they will be able to keep their FitBit valued at 
$150. 
 
 
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:  
Inclusion criteria:  
-Northwell Health Employee 
-At least 45 years of age 
-Fluent in English 
-Community-dwelling 
-Report they  are in good general health, walk regularly and have never been 
informed by a clinician that it was not advisable/safe to participate in a low-
intensity in a walking program 

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-Owns and can regularly access a smartphone capable of receiving text messages 
-Owns and can regularly access an e-mail account 
 
Exclusion criteria: 
Not employed by Northwell Health 
Unable to speak/comprehend English 
Less than 45 years of age or greater than 75 years of age 
Have self-reported poor health, limited mobility and/or have been advised by a 
clinician not to increase their low-intensity walking 
Pregnancy 
-Previous diagnosis of a serious mental health condition or psychiatric disorder, 
such as bipolar disorder 
-  
 
 
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.   
 
We expect to pre-screen up to 750 potential participants in this study. Up to 90 
participants will be randomized to complete research procedures for one of the (4) 
study phases. Up to ten participants will be recruited for each of three preliminary 
(brief duration) phases. A sample of up to sixty participants then will undergo a 2 
week baseline of monitoring their walking behavior, followed by 12 weeks of 
monitoring their walking in response to daily prompts delivered via text message 
for each of the five behavioral change techniques being utilized. 
 
 
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 
 
The initial two phases of study participation will involve a single session of 45-60 
minutes via e-mail/Microsoft Teams or telephone meeting engagement. The third 
phase of the study will involve up to 10 subjects in evaluating study procedures at 
home or office and requiring about 10 minutes per day for 5 consecutive days. The 
final study phase, a personalized trial with up to 60 participants, will involve a total 
of 14 weeks of study participation: activity tracking using the FitBit wrist watch for 
14 weeks and responding to behavior change strategy prompts and surveys 
delivered via text message to a secure electronic link for 12weeks. At the end of the 
14 week intervention period, a report containing the individual’s step data 

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responsiveness to each of the five behavior change techniques will be sent to each 
participant, along with a satisfaction survey. This report will be sent within 3 
months of study completion. After the satisfaction survey is completed, study 
coordinators will reach out to each participant via REDCap survey to collect 
information about their experience with Personalized Trials. We will collect their 
responses via phone or video call (e.g. Microsoft Teams) if they prefer.  
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
This study is a feasibility pilot whose primary objective is to assess the acceptability, 
scalability of implementation and participant satisfaction with a personalized trial 
methodology using behavior change techniques to promote low-intensity physical 
activity.  Secondary endpoints include pooling personalized trial results to assess 
efficacy of BCTs utilized to promote walking behavior. 
 
 
11. 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 self-identify as Northwell employees who are 45-75 
years of age, community-dwelling, are in good general health, report walking 
regularly, and have never been advised by a clinician that it is unsafe/not advisable 
for them to increase low-intensity walking, and are interested in increasing their 
low-intensity walking by a minimum of 2000 steps 5 out of 7 days each week. 
Those who are interested in participating in this pilot study will be directed to an 
initial screening survey that includes questions pertaining to inclusion and 
exclusion criteria. Those who are eligible will be able to access the electronic 
participant information sheet (preliminary study phases) or the electronic informed 
consent form (Personalized Trial participants). Clinical research coordinators will 
present key details from the consent form, as well as provide an electronic copy of 
the consent form to personalized trial participants. Before being able to sign and 
submit the consent form, potential personalized trial participants must demonstrate 

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understanding of the protocol by correctly answering 4 questions pertaining to the 
information presented in the consent form. Contact information (name, age, 
Northwell email, cell phone number and service provider) will be obtained from all 
consented participants. 
  
In the three preliminary phases (with up to 10 participants each in phase), virtual 
focus groups and/or 1:1 discussions will be held to answer questions and elicit 
feedback about the comprehensibility of behavior change strategy descriptions, 
special study website content and videos, the ability to receive “sample” study 
messages in home and work settings, the virtual informed consent process, and 
study tools with attention toward for clarity and ease of use. 
  
Potential participants for the Personalized Trial (maximum n = 60) will receive an 
onboarding questionnaire to collect a home address. A clinical research coordinator 
will confirm the start date of their baseline period, as well as provide a review of 
what to expect during onboarding to the study. They will be mailed an initial study 
kit including a Fitbit Charge 3   device and a printed copy of their electronically-
signed consent form. Potential participants will be asked to download the Fitbit app 
to their smart phone. All baseline periods will begin on a Monday. No more than 
20 participants will be permitted to begin on the same day.  
  
The baseline period will take place over the course of two weeks. During the 
baseline period, potential participants will be asked to wear their Fitbit all day and 
night, even while they are sleeping, as tolerated and to acknowledge receipt of a 
daily text message that is not an activity prompt. Baseline participants will be 
instructed to sync their Fitbit device by opening the Fitbit app on their phone at 
least every two days.  
  
10 days into the baseline period, a clinical research coordinator will review 
individual adherence to Fitbit wear and to survey responses. Adherence to Fitbit 
wear will be defined as recorded activity of greater than10 hours a day. Survey 
adherence will be defined as responding to a given survey delivered by a text 
message link. Baseline participants that do not achieve at least 80% adherence of 
Fitbit wear and survey responsiveness during the first 10 days of the baseline 
period will be withdrawn from the study. Those that maintain at least 80% 
adherence will be randomized to their intervention sequences to begin their pilot 
personalized trial. Participants who are randomized to receive intervention 
sequences will receive email confirmation including their protocol timeline. 
Enrollment will continue until up to 60 participants have been randomized  
 
During all intervention weeks (10 weeks total), participants will be asked to 
continue wearing their Fitbit device for a minimum of 10 waking hours per day and 
encouraged to wear their FitBit at night. They will receive up to 4 text messages 
each day prompting them with the five behavioral intervention techniques and will 
also be asked to respond to a 4-item questionnaire about the degree of automaticity 

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(e.g., "Walking my 2000 steps is something I do without thinking," "I do 
automatically ").  Intervention Habit Formation BCTS are:  
Goal setting: set or agree on a goal defined in terms of behavior to be achieved. 
 
Action planning: prompt detailed planning of performance of behavior (must 
include a setting [walking to the mailbox], frequency, duration, and intensity. 
 
Self-Monitoring of behavior: establish a method for person to monitor and record 
their number of steps based on their Fitbit. 
 
Behavioral rehearsal: prompt practice or rehearsal of walking one or more times 
in a context when the performance may not be necessary, in order to increase habit 
and skill. 
 
Rehearsal conducted in a consistent context:  
Prompt rehearsal & repetition of walking 2000 steps or more in the same context 
repeatedly so that the context elicits the behavior. 
 
A study phone number and email address will be available to contact the study 
team if a participant has questions or concerns about the study procedures.  
 
Participants may receive additional text messages to those outlined above with 
important reminders about their protocol or to remind participants to sync their 
data. We will send a maximum of 6 text messages per day during the study, 
including these reminders and the survey questions outlined above.   
 
 
 
 
12.  STATISTICAL ANALYSIS 
• 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.  
 
The sample size of 60 participants for testing the Personalized Trial was chosen to 
have a sufficient number of participants to obtain a preliminary assessment of the 
feasibility of Personalized Trials of the five behavioral change techniques as 
compared to baseline. The numbers of prompts and 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. 
 
Means and standard deviations of step scores for baseline versus behavioral change 
strategy treatment period will be visualized using a column graph. The statistical 

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significance of differences will be adjusted for time interval. The effects of 
treatment on number of steps will be assessed using generalized estimating 
equations (GEE) with an unstructured variance-covariance matrix for measures on 
the same day. This model accounts for possible autocorrelation and linear trends 
between steps across time.  
Data from the three small sample preliminary phases will be considered as 
descriptive data/information and will not be statistically analyzed.   
 
 
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. 
 
Data management in this study varies according to phase of study participation. 
Individuals who are participating in preliminary study phases will engage with the 
study team through secure Northwell emails, by telephone or via Northwell’s 
Office 365 Microsoft Teams application. Email communication and documentation 
of feedback shared during feedback discussions will be retained in a Sharepoint 
folder on the Northwell network, accessible only to IRB approved study personnel. 
Electronic informed consent and demographic information will be retained in the 
study database (RedCap).  
 
Fitbit 
This pilot study uses Fitbit Charge4devices 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 

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email address of the study account contains a unique identifier (e.g. northwellf25). 
Data collected by the activity monitor may include daily steps, floors climbed, 
activity intensity, heart rate, sleep duration, 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. De-identified data from Fitbit will remain 
stored in a Northwell-approved drive indefinitely, but the file linking the Fitbit 
identifier to the study participant will be destroyed upon completion of an 
individual’s participation with the study.  
 
Fitabase 
The Personalized Trial Study (N of 1) will use Fitabase to retrieve Fitbit data from 
participant activity tracking devices. 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 may include last sync date, battery charge status, daily steps, 
floors climbed, activity intensity, heart rate, 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 to keep 
the Fitbit. 
 
Messages and Surveys  
This study will utilize technology platform to support the delivery of Personalized 
Trials. To achieve this goal, we are partnering with a company ( N-1 Thrive) that 
was formed specifically for the development of technology to support N-of-1 
methodology. Text messages will be delivered via a HIPAA compliant manner to 
participants through N-1 Thrive. Data will be collected and stored using a 
Northwell-approved system for collecting and storing research data, including 
PHI.   
 
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 the study is terminated. All coded data will be maintained on a Northwell-
approved drive to store PHI. All members of the research team with access to 
directly identifiable and 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. 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 

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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. Although it is not anticipated 
that increased low-intensity walking by healthy employees poses greater risk than 
daily life, participants will be advised to report any potential adverse events such as 
increased fatigue or muscle soreness related to increased walking. Dr. Brown will 
be immediately informed of any participant adverse events along with the PI. 
Events will be reported to the IRB and NIA as indicated. Events will be tracked and 
a formal, cumulative review will take place each quarter.  Additionally, Dr. Brown 
will review participation in and attrition from the personalized trial to ensure 
efficacy 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. 
 
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. 
 
 

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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.   
 
Concern for withdrawal of study participants is likely only relevant to participants 
engaged in the 10 week personalized trial. Circumstances under which participants 
will be withdrawn from the research without their consent include failure to 
maintain protocol adherence, repeated failure to respond to text prompts or self-
reported adverse side effects of increased walking. A participant will not be 
randomized to receive the (10 week ) intervention protocol until he/she has 
demonstrated at least 80% adherence to continuous Fitbit monitoring (activity 
recorded at least 10 waking  hours/day and survey responsiveness during the two 
week baseline period of the personalized trial. 
 
Participants will be notified of the possibility of being removed from the study 
before the end of the 10week treatment period 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 monitor 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.  
 
Should a participant choose to withdraw from research, they will be instructed to 
send a letter or e-mail to the attention of the Principal Investigator at our 130 East 
59th Street office, or to email personalizedtrials@northwell.edu, an e-mail account 
monitored by IRB-approved members of the research team. 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 business day the letter or email is received. All 
data up until the receipt date of the letter will be included in the research study.   
 
 
 
17. RISKS TO SUBJECTS 

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• 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 as participants are 
community-dwelling  employees, report themselves as  healthy, walk regularly and 
have never been advised by a clinician that increasing low-intensity walking would 
be unadvisable/present a  safety issue.  The primary risk to participants is the 
potential risk of loss of privacy of information pertaining to research material 
collected by the study, we will take precautions, described below, to minimize 
these risks. 
 
We will emphasize to subjects involved in all study phases that they can stop and 
withdraw from the preliminary phases and/or the N-of-1 trial completely at any 
point, Although no walking-related adverse events are anticipated in this 
population, the study has engaged a safety monitor, Dr. Zenobia Brown who, along 
with the Principal Investigator, will be immediately informed by research 
coordinators of any adverse events. Any serious adverse effects will also be 
reported to the IRB and the NIA (funding agency) in accordance with established 
policies.  
 
The study team plans to protect privacy by only sharing necessary information 
about participants with those who receive IRB approval to join the study team  
All participants 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 
employment, ability to receive health care or to participate in other research 
studies. 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 participants will be kept in a secure, password-protected, 
encrypted Northwell-approved database (REDCap). 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 study devices used 
in this study. No information about the participants or the participants’ health 
history will be shared with Fitbit, except for the information the participants 

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directly share themselves should they choose to use the device for personal use at 
the conclusion of the study. 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 notify a 
study coordinator and contact their primary care provider. The study will 
immediately notify the safety monitor, Dr. Brown, the PI and the IRB according to 
timelines established in the study’s manual of operations. 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 
 
Individuals may have no direct benefit from participating in this study. Participants 
randomized to the intervention may gain a better understanding of how following 
certain behavioral change techniques (e.g., goal-setting, self-monitoring) personally 
affects them. This may result in their being more satisfied with their walking 
regimen and in achieving benefits of increased walking. Through pooling N-of-1 
trial data, a greater understanding of the effectiveness of systematic use of self-
regulatory behavioral change techniques to promote walking may be obtained, This 
knowledge may contribute to the incorporation of N-of-1 trials into health 
promotion. Additionally, the information collected from participant involvement 
will inform the development of future Personalized Trials to help other research 
participants and eventually patients discover which treatment options are best for 
them as an individual. 
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 

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• 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).   
 
Participants in this study will be self-referred in response to advertisements aimed 
at employees within the Northwell Health network. Names and email addresses 
from potential study participants will not be collected until participants have read 
through web information explaining the research study and protocol, filled out pre-
screening data, and indicated their interest in the study. This information will be 
stored in a Northwell-approved database (REDCap), 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 
employees will only be contacted outside the study if they indicate interest in 
participating in a future Personalized Trial 
 
 
 
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 Institute for Aging (NIA), part of 
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 of the three preliminary phases will receive 5000 points credited to 
their Northwell  "MY Recognition" account. Study participants in the full 
Personalized Trial will receive a paycard valued at $100 after successful 

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completion of this study. As a thank you, they will also be able to keep their Fitbit 
Charge 4 (a value of $150). 
 
 
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.   
 
 
Consent will be obtained electronically with a copy of the electronically signed 
form available  to the participants. Potential participants will be directed 
through a series of web pages that summarize the study, and ask them to 
confirm that all of the following are true: they currently work at Northwell 
Health, are between the ages of 45 -75 years old, have never been told by a 
health care provider that it is not advisable/unsafe to increase their walking, 
they read and understand English, own a smart phone capable of receiving text 
messages and accessing the internet, are not pregnant and have never been 
diagnosed with a severe mental illness or psychiatric disorder such as bipolar 
disorder. Participants will not identify their specific exclusion to better protect 
their privacy. 
 If a prospective participant is ineligible, they will be notified immediately and 
thanked for their interest. If the potential participant is deemed eligible, they 
will be able to access either the information sheet (preliminary phases) or 
electronically sign the informed consent form (intervention phase). In order for 
the consent form to be signed and submitted successfully, potential participants 
will need to correctly answer 4 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. 
 
 We are requesting a waiver of a witness to the consent process as consent is 
being obtained remotely. As such, we are also requesting a waiver of 
investigator signature. 
 
 
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: 

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• 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.   
 
Not applicable 
 
 
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 
 
Not applicable 
 
 
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 

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• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
Not applicable 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       No 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.  
 
We request a waiver of documentation of consent for preliminary study phases 
eliciting feedback about study materials and procedures via focus group 
participation or 1:1 feedback discussions. For these participants, the only 
record linking the subject to the research would be their signature on the 
informed consent form, and the principal risk to these individuals is the 
potential harm resulting from a breach of confidentiality. In addition, the 
research presents no more than minimal risk of harm to subjects and involves 
no procedures for which written consent is normally required outside of the 
research context. We will provide an information sheet to each individual that 
describes the nature of the research and informs them that they are free to skip 
any question/refrain from any part of the discussion that they do not want to 
answer.              
 
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 

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• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
Not applicable 
 
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. 
 
Not applicable 
 
. 
 
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. 
 
Not applicable 
 
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) 

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• 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) 
Not applicable 
 
 
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. 
 
Potential participants will be asked to self-identify based on their interest from existing 
employee communications and Northwell employee resources, as well as social media 
groups. All potential participants will be informed that their decision to participate or 
not participate in the study has no impact on their employment or their ability to 
receive care from Northwell providers. Participants are free to terminate study 
participation at any time without any impact on their position or health care services 
 
 
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. 
Not applicable 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 

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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. 
 
Gardner et al.: Towards parsimony in habit measurement: Testing the convergent and 
predictive validity of an automaticity subscale of the Self-Report Habit Index. 
International Journal of Behavioral Nutrition and Physical Activity 2012 9:102. 
 
Lally P, van Jaarsveld C, Potts H, Wardle J. How are habits formed: Modeling habit 
formation in the real world. European J of Social Psychology, 2010, 40, 998-1009. 
 
Lally P, van Jaarsveld C, Potts H, Wardle J. How are habits formed: Modeling habit 
formation in the real world. European J of Social Psychology, 2010, 40, 998-1009. 
 
Ouellette JA, Wood W. Habit and intention in everyday life: The multiple processes by 
which past behavior predicts future behavior. Psychol Bull 1998;124:54-74.  
 
Pahor M, Guralnik JM, Ambrosius WT, et al. Effect of structured physical activity on 
prevention of major mobility disability in older adults: the LIFE study randomized 
clinical trial. JAMA 2014;311:2387-96. PMCID: PMC4266388  
 
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. 
Verplanken B, Orbell S. Reflections on Past Behavior: A Self-Report Index of Habit 
Strength. J Appl Soc Psychol 2003;33:1313-30.  
 
Wood W, Rünger D. Psychology of habit. Annu Rev Psychol 2016;67:289-314.