Phase 1 Clinical Trial to Develop a Personalized Adaptive Text Message Intervention Using Control Systems Engineering Tools to Increase Physical Activity in Early Adulthood
Phase: PHASE1
Conditions: Cardiovascular Risk Factor
Sponsor: Penn State University

 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
Random Assignment of Intervention Messages for 
Developing Personalized Decision Rules to Promote 
Physical Activity  
Protocol Number*: STUDY00009455 
National Clinical Trial (NCT) Identified Number:  NCT03907683 
Principal Investigator*: David E. Conroy, PhD 
Sponsor: The Pennsylvania State University 
“Sponsor” indicates an institution, foundation, or individual who takes responsibility for and initiates a 
clinical investigation; often times this is the university with which the Principal Investigator is affiliated.  
Grant Title: Phase 1 clinical trial to develop a personalized adaptive text 
message intervention using control systems engineering tools to increase 
physical activity in early adulthood 
Grant Number*: HL142732 
Funded by: NIH/NHLBI  
Version Number:  v.1.0 
August 5, 2022 
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 4 
1.3 
Schedule of Activities .......................................................................................................................... 4 
2 
INTRODUCTION ............................................................................................................................................ 5 
2.1 
Study Rationale .................................................................................................................................... 5 
2.2 
Background........................................................................................................................................... 5 
2.3 
Risk/Benefit Assessment .................................................................................................................... 6 
2.3.1 
Known Potential Risks ..................................................................................................... 6 
2.3.2 
Known Potential Benefits ................................................................................................ 6 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 6 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 7 
4 
STUDY DESIGN ............................................................................................................................................. 8 
4.1 
Overall Design ...................................................................................................................................... 8 
4.2 
Scientific Rationale for Study Design................................................................................................ 8 
4.3 
Justification for Intervention ............................................................................................................... 8 
4.4 
End-of-Study Definition ....................................................................................................................... 8 
5 
STUDY POPULATION .................................................................................................................................. 9 
5.1 
Inclusion Criteria ................................................................................................................................ 10 
5.2 
Exclusion Criteria ............................................................................................................................... 10 
5.3 
Lifestyle Considerations .................................................................................................................... 10 
5.4 
Screen Failures .................................................................................................................................. 10 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 11 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 11 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 11 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 12 
6.1.2 
Administration and/or Dosing ....................................................................................... 12 
6.2 
Fidelity ................................................................................................................................................. 12 
6.2.1 
Interventionist Training and Tracking .......................................................................... 12 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 12 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 12 
6.5 
Concomitant Therapy ........................................................................................................................ 12 
6.5.1 
Rescue Therapy ............................................................................................................. 12 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 13 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 13 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 13 
7.3 
Lost to Follow-Up ............................................................................................................................... 13 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 14 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 14 
8.2 
Safety Assessments .......................................................................................................................... 14 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 14 
8.3.1 
Definition of Adverse Events ........................................................................................ 14 

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8.3.2 
Definition of Serious Adverse Events .......................................................................... 14 
8.3.3 
Classification of an Adverse Event .............................................................................. 15 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 16 
8.3.5 
Adverse Event Reporting .............................................................................................. 17 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 17 
8.3.7 
Reporting Events to Participants ................................................................................. 17 
8.3.8 
Events of Special Interest ............................................................................................. 17 
8.3.9 
Reporting of Pregnancy ................................................................................................ 17 
8.4 
Unanticipated Problems .................................................................................................................... 17 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 17 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 18 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 18 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 18 
9.1 
Statistical Hypotheses ....................................................................................................................... 19 
9.2 
Sample Size Determination .............................................................................................................. 19 
9.3 
Populations for Analyses .................................................................................................................. 19 
9.4 
Statistical Analyses............................................................................................................................ 19 
9.4.1 
General Approach .......................................................................................................... 19 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 19 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 20 
9.4.4 
Safety Analyses .............................................................................................................. 20 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 20 
9.4.6 
Planned Interim Analyses ............................................................................................. 20 
9.4.7 
Sub-Group Analyses ..................................................................................................... 20 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 20 
9.4.9 
Exploratory Analyses ..................................................................................................... 20 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 20 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 20 
10.1.1 
Informed Consent Process ........................................................................................... 21 
10.1.2 
Study Discontinuation and Closure ............................................................................. 21 
10.1.3 
Confidentiality and Privacy ........................................................................................... 22 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 23 
10.1.5 
Key Roles and Study Governance .............................................................................. 23 
10.1.6 
Safety Oversight ............................................................................................................. 23 
10.1.7 
Clinical Monitoring .......................................................................................................... 23 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 23 
10.1.9 
Data Handling and Record Keeping ............................................................................ 24 
10.1.10 
Protocol Deviations ........................................................................................................ 25 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 25 
10.1.12 
Conflict of Interest Policy .............................................................................................. 26 
10.2 
Additional Considerations ................................................................................................................. 26 
10.3 
Abbreviations and Special Terms ................................................................................................... 26 
10.4 
Protocol Amendment History ........................................................................................................... 28 
11 
REFERENCES ............................................................................................................................................. 28 
 

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STATEMENT OF COMPLIANCE 
 
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials have 
been submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) was obtained before any participant was consented. Any amendment to the protocol was 
reviewed and approved by the IRB before the changes were implemented to the study. All 
changes to the consent form(s) were IRB approved. 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
Aug 5, 2022 
 
Name*: David E. Conroy 
 
Title*: Professor 
 
Investigator Contact Information 
Affiliation*: The Pennsylvania State University 
Address: 266 Rec Hall 
Telephone: 814-863-3451 
Email: conroy@psu.edu 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Random Assignment of Intervention Messages for Developing 
Personalized Decision Rules to Promote Physical Activity 
Grant Number: 
R01 HL142732 
Study Description: 
This study aims to develop a method for characterizing the dynamics of 
person-specific behavioral responses of a behavioral intervention. Our 
long-term goal is to evaluate a personalized adaptive messaging 
intervention for PA based on dynamical models of historical responses 
to intervention (and other inputs such as weather). 
Objectives*: 
 
Primary Objective: The aim of this project is to develop personalized 
dynamical models of physical activity (PA) under different weather and 
temporal conditions. 
Endpoints*: 
Primary Endpoint: change in minutes of moderate-to-vigorous physical 
activity following each of three types of micro-interventions on 
weekdays and weekends 
Study Population: 
80 female and male adults aged 18-29 years from the United States who 
engage in insufficient physical activity 
Phase* or Stage: 
Phase 1 
Description of 
Sites/Facilities Enrolling 
Participants: 
N/A 
Description of Study 
Intervention/Experimental 
Manipulation: 
Baseline education and self-regulatory training; provision of smartwatch 
that provides ad libitum behavioral feedback throughout study; 0-6 
micro-intervention messages/day for 6 months 
Study Duration*: 
18 months 
Participant Duration: 
6 months 
 
 

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1.2 
SCHEMA  
 
 
1.3 
SCHEDULE OF ACTIVITIES  
 
 
 
 
 
 
 
Pre-screening 
(Pre-consent) 
 
Visit 1 
Day 1 
Intervention & 
Ambulatory 
monitoring 
Visit  2 
End of Month 6 
Review Eligibility (questionnaires and accelerometer) 
X 
 
 
 
Informed Consent 
 
X 
 
 
Baseline assessment (demographics, motivation) 
 
X 
 
 
Randomization 
 
X 
 
 
Intervention 
 
 
X 
X 
Adverse Events Reporting 
 
 
X 
X 

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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
Just-in-time adaptive interventions are a new strategy for delivering interventions to patients at moments 
when they are receptive and have an opportunity (or vulnerability) for behavior change. These 
interventions are often delivered using technology to reach people in the natural context of their daily 
lives. They require decision rules to specify which interventions are delivered, when they are delivered, 
and how often they are delivered. Our prior results raise questions about the sufficiency of a single 
decision rule for diverse populations. Those results showed that different people respond to different 
message content, responses varied on weekends and weekdays, and the timing and magnitude of 
responses varied. We seek to extend these results by collecting data on a larger sample of participants 
and enriching the model with additional data to reduce uncertainty. We focus on location-specific 
weather indices to enrich our models. Extensive data link physical activity with weather but, to the best 
of our knowledge, weather indices have never been used to inform physical activity intervention delivery. 
We will determine whether behavioral responses to text messages vary, for example, on sunny vs cloudy 
days, warm vs cool days, or rainy vs dry days. To achieve this aim, we need to collect intensive longitudinal 
data on behavioral responses to text messages under a variety of weather conditions. 
 
2.2 
BACKGROUND  
 
Physical activity (PA) reduces the risk for cardiovascular disease, diabetes, and many cancers. Yet national 
data indicate that less than 5% of US adults attain the recommended level of PA, and activity levels 
consistently decrease across adulthood. Physical inactivity is also part of a constellation of lifestyle factors 
– with smoking and diet – that contribute to weight gain in early adulthood. This developmental period is 
critical because risk factors that compromise cardiovascular health begin to accumulate. Interventions 
that prevent decreases in PA during this time can reduce long-term chronic disease risk. 
 
Young adults often elude preventive health interventions because they are often underinsured and do 
not have consistent contact with health care systems. Technological advances have made it possible to 
reach this segment of the population and shown promise for increasing PA. For example, short message 
service (SMS) interventions, have shown a consistent positive effect on PA. Yet efforts to increase SMS 
intervention effects via tailoring, targeting or personalizing have not realized their potential. Other 
approaches have emerged for tailoring interventions based on treatment responses or contextual factors 
that increase vulnerability/ opportunity (e.g., stepped care, just-in-time adaptive interventions). The 
decision rules in these approaches are assumed to generalize across the population (i.e., one rule for all 
participants). But behavior is complex and multiply determined so it is possible that treatment responses 
are idiosyncratic, necessitating personalized decision rules. Existing approaches also fail to capitalize fully 
on the rich information from the intensive longitudinal data available from pervasive wearable sensors. 
Building on interest in precision medicine, we propose a method to develop personalized adaptive 
messaging interventions using tools from control systems engineering (system identification and robust 
control synthesis). This approach can ensure that an individual only receives content to which s/he 

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responds when s/he is likely to respond and only as often as needed to achieve specified behavioral goals. 
Our long-term goal is to evaluate a personalized adaptive messaging intervention for PA based on 
dynamical models of historical responses to intervention (and other inputs such as weather). 
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
 
Participants may find the Actigraph activity monitor worn at the waist for the run-in part of the study, 
uncomfortable.  Participants may find wearing a Fitbit Versa slightly uncomfortable or bulky if they do not 
usually wear a watch.   Both devices may be removed when showering/bathing.  There may be some mild 
discomfort associated with answering some of the interview or survey questions.  The participants will be 
instructed that they have the right to refuse to answer any questions that they find too uncomfortable.  
There may be a risk of feeling self-conscious or embarrassment when receiving message notifications on 
their smartphone.  Participants will be instructed not to answer any notifications when it is not safe to do 
so (e.g. driving, attending meeting at work) and that the message be available for acknowledgment within 
30 minutes if their situation should change.  The small amount of compensation associated with the 
acknowledgment ($0.25) will not persuade the participant to risk their safety to respond to the message.  
The app collects data on the participant’s location and the weather conditions at this location when 
messages are received and acknowledged to determine their impact on your physical activity levels at any 
given time throughout your day.  Participants may find the disclosure of their location unsettling. There is 
a slight risk of soreness if physical activity is increased in sedentary participants.  Participants will be given 
information regarding progressive adaption to minimize this risk. 
 
There is a risk of loss of confidentiality if your information or your identity is obtained by someone other 
than the study team, but precautions will be taken to prevent this from happening and all information 
obtained from this research will be kept as confidential as possible.  Code numbers rather than names will 
be used on all research records and the information linking these codes to the participants’ identities will 
be kept separate from the research records.  The confidentiality of the electronic data created by 
participants or the researchers will be maintained to the degree permitted by the technology used and is 
securely encrypted at all stages of the study.  Despite our best efforts, it is not possible to guarantee 
absolute confidentiality. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
There is no guarantee that participants will benefit from this research. The possible benefits that 
participants may experience from the interventional research study include increasing their physical 
activity and associated health benefits. 
The research may lead to the creation of personalized interventions that create long-term behavior 
changes in physical activity levels for young adults. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 

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Risks involved low severity and low likelihood, and were outweighed by potential benefits of the 
knowledge gained. 
 
3 
OBJECTIVES AND ENDPOINTS  
Provide a description of the study objectives and endpoints, as well as a justification for selecting the 
particular endpoints, in the table format included below. This will provide clear articulation of how the 
selected primary and secondary endpoint(s) are linked to achieving the primary and secondary objectives 
and an explanation of why endpoint(s) were chosen. Data points collected in the study should support an 
objective or have a regulatory purpose. Therefore, careful consideration should be given prospectively to 
the amount of data needed to support the study’s objectives. 
 
An objective is the purpose for performing the study in terms of the scientific question to be answered. 
Express each objective as a statement of purpose (e.g., to assess, to determine, to compare, to evaluate) 
and include the general purpose (e.g., feasibility, acceptability, engagement of the intervention target, 
identifying mechanisms of action, mediation, moderation, efficacy, effectiveness, dissemination, 
implementation). 
 
A study endpoint is a specific measurement or observation to assess the effect of the study intervention. 
Study endpoints should be prioritized and should correspond to the study objectives and hypotheses being 
tested. Give succinct and precise definitions of the study endpoints used to address the study’s primary 
objective and secondary objectives (e.g., specific diagnostic tests that define safety or efficacy, clinical 
assessments of disease status, assessments of psychosocial characteristics, patient reported outcomes, 
behaviors or health outcomes). A full description of study endpoints, including administration, scoring, 
psychometrics, adjudication of endpoints, etc., belongs in Section 8, Study Assessments and Procedures.   
 
A putative mechanism of action is the theorized explanation for how the intervention functions.   
 
Consider whether primary and secondary endpoints should be adjusted for multiple comparisons, family-
wise error rates, alpha inflation, etc. Details of any such adjustments should be included in Section 9.4.2, 
Analysis of the Primary Endpoint(s) and Section 9.4.3, Analysis of the Secondary Endpoint(s).   
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
 
 
 
Develop and test method 
for estimating person-
specific effects of micro-
interventions on health-
enhancing physical activity. 
Change in 
moderate(or 
higher) physical 
activity duration 
following 
message receipt 
Moderate-to-vigorous 
intensity physical activity is 
health enhancing. 
N/A 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
is the primary 
endpoint 
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
This single-site trial is in Phase 1 of behavioral intervention development with the goal of developing a 
method for optimizing person-specific intervention dosing to promote health-enhancing physical activity. 
To test the null hypothesis that each message type will not lead to increased moderate-to-vigorous 
physical activity, we use a within-person randomized trial design. All participants received 0-6 
messages/day drawn from three content libraries (Move More, Sit Less, Inspirational Quotes). The 
number of messages and content source for each message was determined randomly for each participant 
every day. The allocation ratio was set so participants would receive approximately 40% Move More 
messages, 40% Sit Less messages, and 20% Inspirational Quote messages. Randomization was conducted 
automatically by custom software developed to deliver messages. This intervention is referred to as 
Random Assignment of Intervention Messages (Random AIM).  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
This design was selected to evaluate the heterogeneity of person-specific responses to treatment. 
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
The intervention was delivered via smartphone notifications from a mobile application that received data 
from (and transmitted data to) a custom server developed for intervention delivery. A 6-month period 
was selected because it ensured variation in weather conditions which are associated with physical 
activity. The number of micro-interventions (individual digital messages) was varied to limit burden on 
research participants. 
 
4.4 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, and 6 months of intervention and ambulatory monitoring of physical activity.  
 

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5 
STUDY POPULATION 
If the study design requires clarification of various groups of study participants, that clarification can be 
included directly under Section 5. For example, for a feasibility study that includes therapist-participants 
and patient-participants, clarify the distinction of those populations here. Subsequent subsections should 
also differentiate by participant type, where relevant. 
 
The following subsections should include a description of the study population(s) and participant 
recruitment. The study population should be appropriate for clinical trial phase/stage of the study 
intervention. It is essential that the population’s characteristics be considered during the trial planning 
phase to ensure the trial can adequately meet its objectives and provide evidence for the total population 
that will potentially utilize the study intervention under evaluation (e.g., elderly and pediatric populations, 
women, and minorities). 
 
Behavioral studies often have unique units of measurement. For example, the study may evaluate at the 
clinic or classroom level, rather than at a patient or student level. In other cases, the care provider could 
be the subject of the intervention. It may even evaluate at multiple levels within the same protocol. The 
description of the study population should match the unit of measurement or level of analysis; there is no 
expectation that characteristics of individual participants be described if inclusion/exclusion criteria are 
based on group characteristics.  
 
Use the following guidelines when developing participant eligibility criteria to be listed in Section 5.1, 
Inclusion Criteria* and 5.2, Exclusion Criteria*: 
 
 
The eligibility criteria should provide a definition of participant characteristics required for study 
entry/enrollment  
 
For population-based interventions, indicate if study “participant” is at a broader level, such as 
schools, hospitals, churches, community organizations, or other, as appropriate 
 
If participants require screening, distinguish between screening participants vs when a participant 
is considered enrolled/entered/randomized  
 
Indicate if screening procedures will be performed under a separate screening consent form 
 
Consider the risks of the study intervention in the development of the inclusion/exclusion criteria 
so that risks are minimized 
 
The same criterion should not be listed as both an inclusion and exclusion criterion (e.g., do not 
state age >18 years old as an inclusion criterion and age ≤18 years old as an exclusion criterion) 
 
Identify specific laboratory tests or clinical, behavioral or other participant characteristics that will 
be used as criteria for enrollment or exclusion 
 
If reproductive status (e.g., pregnancy, lactation, reproductive potential) is an eligibility criterion, 
provide study requirements (e.g., contraception  methods, pregnancy testing)  
 
If the study involves more than one study population, please define the common inclusion and 
exclusion criteria followed by the specific inclusion and exclusion criteria for each subpopulation  
 

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5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Participants capable of reading, speaking and understanding English and of giving informed 
consent. 
2. Participants between the ages of 18-29 years. 
3. Participants must be free of visual impairment that would interfere with the use of a 
smartphone. 
4. Participants must own and carry an iPhone (running iOS version 10 or higher) or Android 
(running operating system 7 or higher) smartphone during waking hours. 
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Participants self-report engaging in 90 or more minutes of moderate- or greater intensity PA 
each week or who record 150 or more minutes of moderate- or greater intensity PA on the 
research accelerometer in the screening period. 
2. Participants engaged in organized programs with mandated physical activity (e.g., varsity sports, 
ROTC). 
3. Participants with contraindications to normal physical activity on the Physical Activity Readiness 
Questionnaire.  
4. Participants who require an assistive device for mobility or have any other condition that may 
limit or prevent participation in moderate-intensity physical activity. 
5. Participants who are pregnant or planning to become pregnant within the next 6 months. 
6. Participants with a prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic 
syndrome. 
5.3 
LIFESTYLE CONSIDERATIONS 
 
N/A 
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet the 
criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria that 
will not be rescreened for this trial. 
 
A new Information report (RNI) was submitted at the beginning of the study.  The run-in study was done 
to verify the self-reported activity levels of the participants with an accelerometer. The accelerometer 
was functioning properly but the software that calculates the activity was not set appropriately and did 
not accurately evaluate their activity levels. There were 3 participants whose activity levels were much 
higher than properly assessed and should have been the basis of exclusion from the intervention phase 

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of the study. They were enrolled in the intervention portion of the study when they should have been 
excluded based upon higher than reported activity levels. The participants were contacted immediately 
and notified of their ineligibility based upon these findings. They were offered an apology for this mistake 
and offered either to be compensated for their participation in the study to date. 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Recruitment of participants will be accomplished using the recruitment flier posted onto campus building 
and community bulletin boards (grocery stores, libraries and coffee houses) throughout the State College 
/ Central Pennsylvania area.   The recruitment flier advertisements will be distributed on the Motivation 
Lab Facebook page and with the aid of a Facebook self-serve advertisement, using participant study 
demographics. Recruitment will utilize Studyfinder.  Interested participants that contact the study team 
via email will be sent additional information (the Random AIM study information sheet) and will be asked 
to contact the study team via phone to go through the verbal screening process.  
We plan to recruit a sample proportional to national the national demographic profile based on sex, race, 
and ethnicity. Prospective participants will be screened via questionnaire and a 1-week ambulatory 
monitoring period with a research-grade accelerometer to determine eligibility. We anticipate screening 
160 participants to enroll 80 eligible participants. 
Participants will keep the Fitbit smartwatch and be compensated up to $295 for participating in the study 
as follows: 
 
$25 for returning the activity monitor at the end of screening 
 
$85 for protocol compliance in months 1-2 ($40 for daily Fitbit wear and $0.25 for each digital 
message they receive and acknowledge within 30 minutes) 
 
$85 for protocol compliance in months 3-4 ($40 for daily Fitbit wear and $0.25 for each digital 
message they receive and acknowledge within 30 minutes) 
 
$100 for protocol compliance in months 5-6 ($55 for daily Fitbit wear and $0.25 for each digital 
message they receive and acknowledge within 30 minutes) 
Compensation provided is an equitable amount meant to offset the time and inconvenience of 
participation in the study as well as to serve as an incentive. The compensation is not excessive to coerce 
subject participation. 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 

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6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
The intervention included education about physical activity, goal-setting, and action planning in a baseline 
session, followed by 0-6 digital micro-interventions/day for 6 months during which time the participant 
wore a Fitbit smartwatch and had access to ad libitum behavioral feedback. The micro-interventions were 
digital messages from one of three content libraries: Move More, Sit Less, or Inspirational Quotes. 
Messages in the Move More and Sit Less libraries were based on social-cognitive theory and the intended 
mechanistic target was motivation and physical activity goal pursuit. 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
The baseline intervention was delivered by the project coordinator during the initial meeting after 
participants provide informed consent. The micro-interventions were delivered via app-based 
notifications on the participants’ smartphone. 
 
6.2 
FIDELITY 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
Intervention delivery will be monitored using a web-based study dashboard that tracks message delivery 
and device wear.  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
The study used a single-group design and micro-intervention delivery was automated on a random 
schedule so the study was not masked. 
 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
Participant acknowledgement of message receipt within 30 minutes of delivery will be monitored to 
evaluate the fidelity of treatment receipt. 
 
6.5 
CONCOMITANT THERAPY 
 
N/A 
 
6.5.1 RESCUE THERAPY 
 
N/A 

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7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
When a subject discontinues from Random AIM, they will be withdrawn from the study and replaced in 
the sample. We will document the reason for study intervention discontinuation. 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives  
 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
 
Any event or medical condition or situation occurs such that continued collection of follow-up  
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study 
 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 
The reason for participant discontinuation or withdrawal from the study will be recorded. Subjects who 
sign the informed consent form, and are randomized and receive the study intervention, and 
subsequently withdraw, or are discontinued from the study, will be replaced. 
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if study staff are unable to contact the participant after 
at least 3 attempts.  
 
The following actions must be taken if a participant fails to complete a required study visit: 
 
 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s medical record or study file.  
 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up 

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8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
Participants will be asked to wear a Fitbit smartwatch during all waking hours to record ambulatory 
physical activity throughout the 6-month study period. Moderate-to-vigorous physical activity duration 
will be calculated as the number of minutes with 100 or more steps/min. 
 
8.2 
SAFETY ASSESSMENTS 
 
Participants will be contacted on a monthly basis to assure well-being and their safety in the use of the 
interventional app for the study.  Participants will be instructed to contact the study team to report any 
illnesses or injuries obtained throughout the time that they are actively participating in the research study, 
whether potentially associated with participation or not. 
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered intervention-
related. 
 
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study team 
believed to be associated with the intervention will be followed until the event (or its sequelae) or the 
abnormal test finding resolves or stabilizes at a level acceptable to the investigator. An abnormal test 
finding will be classified as an adverse event if one or more of the following criteria are met: 
• The test finding is accompanied by clinical symptoms 
• The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy 
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does not constitute 
an adverse event. 
• The test finding leads to a change in study drug dosing or discontinuation of subject participation in the 
clinical research study 
• The test finding is considered an adverse event by the investigator. 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 

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Serious Adverse Event (SAE): An untoward occurrence, whether or not considered related to a subject’s 
participation in Human Research, that results in death, a life-threatening experience, inpatient 
hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital 
anomaly or birth defect, or that requires medical, surgical, behavioral, social or other intervention to 
prevent such an outcome. 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.] 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by the principal investigator based on temporal relationship and his clinical judgment. The 
degree of certainty about causality will be graded using the categories below.  
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 

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can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician.] 
 
8.3.3.3 EXPECTEDNESS  
 
The principal investigator with appropriate expertise in lifestyle physical activity will be responsible for 
determining whether an adverse event (AE) is expected or unexpected. An AE will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the study procedures. 
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, or 
upon review by a study monitor. 
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, clinician’s assessment of 
severity, relationship to study procedures (assessed only by those with the training and authority to make 
a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
The project coordinator will record events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At 

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each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  Events 
will be followed for outcome information until resolution or stabilization. 
 
8.3.5 ADVERSE EVENT REPORTING  
 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) experienced 
by a subject or other individual, which in the opinion of the investigator is determined to be (1) 
unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a serious adverse event and shall report the results of such evaluation to the NIH and the 
reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 working days 
after the investigator first learns of the event. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
N/A 
 
8.3.9 REPORTING OF PREGNANCY  
 
Participants who become pregnant will be withdrawn from the study. 
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 

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• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the funding agency 
immediately upon the investigator becoming aware of the event  
• 
Any other UP will be reported to the IRB and to the DCC/study sponsor/funding agency within 10 
working days of the investigator becoming aware of the problem  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within 30 days of the IRB’s receipt of the report of the 
problem from the investigator. 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
N/A 
 
9 
STATISTICAL CONSIDERATIONS  
 

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9.1 
STATISTICAL HYPOTHESES 
State the formal and testable null and alternative hypotheses for primary and key secondary endpoints, 
specifying the type of analysis (e.g., feasibility/acceptability, efficacy, effectiveness, implementation) and 
time period for which each endpoint will be analyzed. Include this information for each hypothesis being 
tested, if multiple hypotheses are present. If the study is intended as a feasibility or pilot study, please 
consider that a formal hypothesis may not be available at the time of protocol writing. If so, include a 
statement indicating that hypotheses will be generated or that descriptive statistics only will be calculated. 
 
 
Primary Endpoint(s): change in moderate-to-vigorous intensity physical activity following receipt 
of a message from each content library. 
We hypothesize that, compared to behavior that would be expected based on the dynamic model 
without message delivery, patients who receive a Move More or Sit Less Message will have a positive 
steady state response for moderate-to-vigorous physical activity duration following message delivery. 
Alternatively, our null hypothesis is that there will be no difference in moderate-to-vigorous physical 
activity steady state responses following Move More or Sit Less messages. 
 
9.2 
SAMPLE SIZE DETERMINATION 
 
Statistical power analysis is not relevant for estimating person-specific dynamic models. Our proposed 
sample size (n=80) is based on the upper limit for phase 1 clinical trials and will enable us to capture the 
heterogeneity of PA dynamics and estimate model uncertainty within the resource constraints of early 
stage intervention development work.  
 
9.3 
POPULATIONS FOR ANALYSES 
 
All study completers will be analyzed. 
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
The steady state response (i.e., final cumulative response) to each type of intervention message will be 
recorded as the primary outcome variable. The mean and standard deviation of steady state responses 
will be calculated. 
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 

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System identification will be used to estimate coefficients for person-specific dynamic models of 
moderate-to-vigorous physical activity durations in 15-minute epochs. Model coefficients will be used to 
simulate expected responses to each type of micro-intervention (separately for weekdays and weekends). 
Steady state responses for each message type on weekdays and weekends will be extracted as the primary 
outcome. An independent-sample t-test will be used to evaluate whether the average steady state 
response to each message type on weekdays and weekends differs significantly from zero. 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
N/A 
 
9.4.4 SAFETY ANALYSES 
N/A  
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
N/A 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
N/A 
9.4.7 SUB-GROUP ANALYSES 
 
N/A 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
N/A 
 
9.4.9 EXPLORATORY ANALYSES 
 
N/A 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 

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10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
This section should demonstrate that the consent form contains all required regulatory elements. List all 
consent and/or assent documents and materials submitted with this protocol. Include consent and/or 
assent forms, printed or web-based materials, phone scripts and any other related material. 
 
If needed, describe special documents or materials (e.g., Braille, another language, audio recording). 
 
Example text provided as a guide, customize as needed:  
 
 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention. The following consent materials are submitted with this protocol: informed consent 
document. 
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Written informed consent will be a two-step process.  Written informed consent for the run-in portion of 
the study will take place at the initial study visit.   Written informed consent for the intervention portion 
of the study will take place at the second study visit upon verification of a participant’s activity levels that 
are less than 150 minutes of moderate- or greater intensity PA per week. 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, funding agency, and regulatory authorities. 
If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform 
study participants, the Institutional Review Board (IRB), and sponsor/funding agency and will provide the 
reason(s) for the termination or suspension. Study participants will be contacted, as applicable, and be 
informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Demonstration of efficacy that would warrant stopping    
 
Insufficient compliance of study staff to the protocol   (ie, significant protocol violations) 
 
Data that are not sufficiently complete and/or evaluable 

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The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies (OHRP, 
DSMB). 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator. 
 
The study participant’s contact information will be securely stored at the research site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate.  
 
Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government.  Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth 
in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 

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by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Data collected for this study will be analyzed and stored in secure cloud storage provided by The 
Pennsylvania State University.  
 
When the study is completed, access to study data will be provided through the principal investigator. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Provide the name and contact information of the Principal Investigator and the Medical Monitor or 
Independent Safety Monitor. Update table heading to remove non-relevant role. 
Principal Investigator 
Medical Monitor or Independent Safety Monitor 
David E. Conroy, Ph.D. 
Professor 
N/A 
The Pennsylvania State University 
N/A 
266 Rec Hall, University Park, PA 16802 
N/A 
814-863-3451 
N/A  
conroy@psu.edu 
N/A 
 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be under the direction of the principal investigator as approved by funder and 
institutional review board. 
 
10.1.7 CLINICAL MONITORING 
 
N/A 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Quality control (QC) procedures will be implemented as follows: 

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Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed.  
 
Source documents and the electronic data --- Data will be initially captured electronically to avoid manual 
data entry errors. 
 
Intervention Fidelity — Consistent delivery of the study interventions and device wear will be monitored 
throughout the intervention phase of the study. Procedures for ensuring fidelity of intervention delivery 
are described in Section 6.2.1, Interventionist Training and Tracking.  
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. 
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data.   
 
The data system includes password protection and internal quality checks, such as automatic range 
checks, to identify data that appear inconsistent, incomplete, or inaccurate.  
 
10.1.9.2 STUDY RECORDS RETENTION  
 
Paper consent forms and contact information sheets will be stored in a locked file cabinet of the locked 
office of the research project manager (18 A Recreation Building) for a period of three years after the end 

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of the study. De-identified data will be stored on a centralized, personal data server developed by our 
software development team, West Arete.   De-identified data is stored in a relational database and 
encrypted during transmission.  The data is stored in servers which are virtual machines hosted at a major 
provider, dedicated solely to our application on a network that is shared with other projects, and is 
protected by a host-based firewall with "default closed" policy.  The security practices that are applied to 
the servers include antivirus protection, host-based intrusion detection, uptime monitoring, strong 
authentication (private key with strong password) logins, and the operating system security updates are 
monitored and applied nightly.  Logs are monitored daily and there are encrypted off-site backups.  The 
de-identified data will be stored indefinitely.   
 
This study is funded by the National Institutes of Health and will be issued a Certificate of Confidentiality.  
Researchers will not disclose or provide any identifiable information without the subject’s prior consent 
or where permitted according to NIH’s Policy on Issuing Certificates of Confidentiality. 
 
10.1.10 
PROTOCOL DEVIATIONS   
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 5 working days of 
the scheduled protocol-required activity. All deviations will be addressed in study source documents and 
reported to the NHLBI Program Official. Protocol deviations will be sent to the reviewing Institutional 
Review Board (IRB) per their policies. The site investigator will be responsible for knowing and adhering 
to the reviewing IRB requirements. Further details about the handling of protocol deviations will be 
included in the MOP. 
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 

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manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals.  Data from this study may be requested from other researchers 2 years after the completion of 
the primary endpoint by contacting Dr. David Conroy, The Pennsylvania State University.  Considerations 
for ensuring confidentiality of these shared data are described in Section 10.1.3. 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial. The study leadership in 
conjunction with the NHLBI has established policies and procedures for all study group members to 
disclose all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest. 
 
10.2 ADDITIONAL CONSIDERATIONS 
 
N/A 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
The list below includes abbreviations utilized in this template. However, this list should be customized for 
each protocol (i.e., abbreviations not used should be removed and new abbreviations used should be added 
to this list). Special terms are those terms used in a specific way in the protocol. For instance, if the protocol 
has therapist-participants and patient-participants, those terms could be included here for purposes of 
consistency and specificity.  
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 

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CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
 
11/27/2019 
Increase enrollment of participants  
Increase number of participants 
to account for study drops to 
attain 80 participants for 
analysis  
 
1/29/2020 
Removal of web-based recruitment 
tool and removal of research staff 
Recruitment has ceased and 
personnel changed 
 
3/25/2020 
Change in the end of study visit and 
alteration in compensation delivery 
The pandemic halted in-person 
interactions so changes were 
made to collect final data and 
compensate in a remote 
fashion 
 
 
 
 
 
 
 
 
 
11 REFERENCES  
 
N/A