An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and Modify Daily Inactivity Among Adults Over Age 60
Phase: EARLY_PHASE1
Conditions: Exercise, Physical Activity
Sponsor: Northeastern University

 
 
 
 
 
 
 
An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and Modify 
Daily Inactivity among Adults Over Age 60  
Protocol Number: CompRoy1 
Principal Investigator: Dinesh John 
Sponsor: Northeastern University 
 
Grant Title: An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and 
Modify Daily Inactivity among Adults Over Age 60  
 
Grant Number: 5P30AG048785-07 
Funded by: National Institute on Aging  
Version Number:  ver. 2020-9-23 
23rd September 2020 
 
By NU IRB at 10:29 am, May 03, 2021

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
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 ............................................................................................................... 5 
2 
INTRODUCTION ................................................................................................................................. 6 
2.1 
Study Rationale ........................................................................................................................ 6 
2.2 
Background .............................................................................................................................. 6 
2.3 
Risk/Benefit Assessment .......................................................................................................... 7 
2.3.1 
Known Potential Risks ............................................................................................ 7 
2.3.2 
Known Potential Benefits ...................................................................................... 7 
2.3.3 
Assessment of Potential Risks and Benefits .......................................................... 7 
3 
OBJECTIVES AND ENDPOINTS ............................................................................................................ 7 
4 
STUDY DESIGN ................................................................................................................................... 8 
4.1 
Overall Design .......................................................................................................................... 8 
4.2 
Scientific Rationale for Study Design ....................................................................................... 9 
4.3 
Justification for Intervention ................................................................................................... 9 
4.4 
End-of-Study Definition ........................................................................................................... 9 
5 
STUDY POPULATION .......................................................................................................................... 9 
5.1 
Inclusion Criteria ...................................................................................................................... 9 
5.2 
Exclusion Criteria ..................................................................................................................... 9 
5.3 
Lifestyle Considerations ......................................................................................................... 10 
5.4 
Screen Failures ....................................................................................................................... 10 
5.5 
Strategies for Recruitment and Retention ............................................................................. 10 
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 .......................... 11 
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 .................................................... 13 
6.4 
Study Intervention/Experimental Manipulation Adherence ................................................. 13 
6.5 
Concomitant Therapy ............................................................................................................ 13 
6.5.1 
Rescue Therapy .................................................................................................... 13 
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 ..................................................... 14 
7.3 
Lost to Follow-Up ................................................................................................................... 14 
8 
STUDY ASSESSMENTS AND PROCEDURES ....................................................................................... 14 
8.1 
Endpoint and Other Non-Safety Assessments ....................................................................... 14 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
8.2 
Safety Assessments ................................................................................................................ 20 
8.3 
Adverse Events and Serious Adverse Events ......................................................................... 20 
8.3.1 
Definition of Adverse Events ............................................................................... 20 
8.3.2 
Definition of Serious Adverse Events ................................................................... 20 
8.3.3 
Classification of an Adverse Event ....................................................................... 20 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ..................... 21 
8.3.5 
Adverse Event Reporting ..................................................................................... 21 
8.3.6 
Serious Adverse Event Reporting ........................................................................ 22 
8.3.7 
Reporting Events to Participants ......................................................................... 22 
8.3.8 
Events of Special Interest ..................................................................................... 22 
8.3.9 
Reporting of Pregnancy ....................................................................................... 22 
8.4 
Unanticipated Problems ........................................................................................................ 22 
8.4.1 
Definition of Unanticipated Problems ................................................................. 22 
8.4.2 
Unanticipated Problems Reporting ..................................................................... 22 
8.4.3 
Reporting Unanticipated Problems to Participants ............................................. 23 
9 
STATISTICAL CONSIDERATIONS ....................................................................................................... 23 
9.1 
Statistical Hypotheses ............................................................................................................ 23 
9.2 
Sample Size Determination .................................................................................................... 23 
9.3 
Populations for Analyses ....................................................................................................... 23 
9.4 
Statistical Analyses ................................................................................................................. 23 
9.4.1 
General Approach ................................................................................................ 23 
9.4.2 
Analysis of the Primary Endpoint(s) ..................................................................... 24 
9.4.3 
Analysis of the Secondary Endpoint(s) ................................................................ 24 
9.4.4 
Safety Analyses .................................................................................................... 24 
9.4.5 
Baseline Descriptive Statistics ............................................................................. 24 
9.4.6 
Planned Interim Analyses .................................................................................... 24 
9.4.7 
Sub-Group Analyses ............................................................................................. 24 
9.4.8 
Tabulation of Individual Participant Data ............................................................ 24 
9.4.9 
Exploratory Analyses ............................................................................................ 25 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ...................................... 25 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ..................................................... 25 
10.1.1 
Informed Consent Process ................................................................................... 25 
10.1.2 
Study Discontinuation and Closure ...................................................................... 25 
10.1.3 
Confidentiality and Privacy .................................................................................. 26 
10.1.4 
Future Use of Stored Specimens and Data .......................................................... 27 
10.1.5 
Key Roles and Study Governance ........................................................................ 27 
10.1.6 
Safety Oversight ................................................................................................... 27 
10.1.7 
Clinical Monitoring ............................................................................................... 27 
10.1.8 
Quality Assurance and Quality Control ................................................................ 27 
10.1.9 
Data Handling and Record Keeping ..................................................................... 28 
10.1.10 
Protocol Deviations .............................................................................................. 29 
10.1.11 
Publication and Data Sharing Policy .................................................................... 30 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
10.1.12 
Conflict of Interest Policy ..................................................................................... 30 
10.2 
Additional Considerations ..................................................................................................... 30 
10.3 
Abbreviations and Special Terms ........................................................................................... 30 
10.4 
Protocol Amendment History ................................................................................................ 32 
11 
REFERENCES ..................................................................................................................................... 33 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
1 
STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and 
the NIA Terms and Conditions of Award. The Principal Investigator will assure that no deviation 
from, or changes to the protocol will take place without prior agreement from the funding agency 
and documented approval from the Institutional Review Board (IRB), except where necessary to 
eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct 
of this study have completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
2 
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: 
4-27-2021 
 
Name*:  Dinesh John 
 
Title*: Associate Professor 
 
Investigator Contact Information 
Affiliation*: Northeastern University 
Address: 316 Robinson Hall, 360 Huntington Ave., Boston, Massachusetts 
Telephone: 617373-5695 
Email: d.john@northeastern.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
3 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
An Integrated Two-Way Communication and Near-Real-Time Sensing 
System to Detect and Modify Daily Inactivity among Adults Over Age 60  
 
Grant Number: 
5P30AG048785-07 
Study Description: 
The objective is to test if Companion, an Integrated Two-Way 
Communication and Near-Real-Time Sensing System, improves and 
sustains overall daily free-living activity and sedentary behavior in 
adults over 60 y. The central hypothesis is that Companion will improve 
overall daily free-living activity and sedentary behavior in adults>60 y 
and thereby improve their health. 
Objectives*: 
 
Primary Objective: Determine if Companion improves free-living activity 
and sedentary behavior and sustains this change in adults >60y. In this 
RCT (n=46), both treatment and control groups will engage in a 16-week 
supervised exercise program and then be followed-up after 24 weeks.1,2 
Companion will be deployed in the treatment group (n=23) only. Primary 
outcomes are daily total and bouts of physical activity and sedentary 
time. 
Exploratory Objective: Explore if supplementing supervised exercise with 
Companion further improves and sustains cardiometabolic health, body 
composition, cognition, and psychosocial outcomes. 
Endpoints*: 
 
Primary Endpoint: Physical activity and sedentary time: Daily total and 
bouts 
Exploratory Endpoints: Anthropometrics; Plasma glucose; HbA1C; 
Insulin; Lipids; Lean and fat mass; Physical function; Muscular and 
aerobic fitness; Cognition; perceptions of competence related to health 
behavior; Autonomy support (from companion); Autonomous 
motivation (for physical activity); Relatedness (to the Companion); 
General satisfaction. 
Study Population: 
N= 46, gender- NA, age>60 y, demographic group- older adults; general 
health status- healthy; geographic location- Boston and surrounding 
neighborhoods. 
Phase* or Stage: 
1A 
Description of 
Sites/Facilities Enrolling 
Participants: 
The Human Performance and Exercise Science (HPES) Laboratory is 
located in the Behrakis Health Science Center at Northeastern 
University, which will be the sole site for the study. Participants who do 
not prefer to have their measurements conducted at their residence 
will come to the lab to have measurements completed. The study is not 
intended to include sites outside of the United States.   

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
4 
Description of Study 
Intervention/Experimental 
Manipulation: 
The study intervention consists of wearable sensors integrated with the 
smartphone to develop a behavior-aware, virtual “Companion” that 
uses a “human-in-the-loop” approach to enable meaningful two-way 
communication. Companion builds rich models of typical behavior 
using sensors and context sensitive ecological momentary assessment 
(CS-EMA) to deliver intervention components and behavior change 
strategies using socially engaging, contextually salient, and tailored 
text-message conversations in near-real-time. The duration of the 
intervention is 4 months. 
 
Study Duration*: 
Estimated time (in months) from when the study opens to enrollment 
until completion of data collection is 6.5 months. 
Participant Duration: 
Time for each individual participant to complete all study-related tasks 
is 6.5 months. 
1.2 
SCHEMA  
 
 
Total N: 46
Pre-screen potential participants by inclusion and exclusion criteria; schedule Visit 1.
Conduct informed consent process. 
Perform baseline assessments.
•
Anthropometrics/Heart rate/Blood pressure
•
Sensor-based physical activity and sedentary behavior
•
Body composition
•
Blood biomarkers
•
Cognition
•
Physical function
•
Muscular and aerobic fitness
•
Self-Competed Questionnaires
Randomize
Intervention
N= 23
Control
N= 23 
Follow-up 1 (4 month)
Repeat all baseline measures
Virtual visit 30 min- counselling on 
benefits of increasing activity and 
reducing sitting
Virtual visit 60 min- counselling on 
benefits of increasing activity and 
reducing sitting and intervention 
personalization
Follow-up 2 (6 month)
Repeat all baseline measures

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
5 
1.3 
SCHEDULE OF ACTIVITIES  
 
 
 
 
 
 
Pre-screening 
(Pre-consent) 
 
Measurement 1 
Day 1 
Virtual visit  
Day 7-14 
Measurement 2 
 Day 120-130  
Measurement 3 
Day 240-250 
Review Eligibility 
X 
 
 
 
 
Informed Consent 
 
X 
 
 
 
Demographics 
 
X 
 
 
 
Outcome Evaluation 
 
X 
 
X 
X 
Randomization 
 
X 
 
 
 
Control & Experimental Interventions 
 
 
 
Counselling 
 
 
X 
 
 
Adverse Events Reporting 
 
X 
X 
X 
X 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
6 
2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
This work will result in a new approach to extend the efficacy of supervised training beyond brief periods 
of direct exposure and prolong engagement in positive behaviors after program completion. 
2.2 
BACKGROUND  
Supervised exercise with a trained instructor3,4 is most effective in maximizing health benefits, is popular 
among adults>60y, and is most common in aging research .5-10 Supervision results in higher training 
effects and program adherence7,8,11,12 due to personal attention and interaction with the trainer that 
motivate participants.8,11 Drawbacks of the model include a low frequency of trainer contact (60 min, ~1 
to 3 times/week) and ineffectiveness in changing behavior outside weekly sessions.8 Additionally, 
adults>60y compensate for increased exercise by increasing sedentary behavior outside training 
sessions, which attenuates positive gains in health from supervised exercise.10,13-19 Independent of 
physical activity, reducing sedentary time improves cardiometabolic and functional health in 
adults>60y.20,21 Thus, federal guidelines recommend that older adults move more and sit less during the 
day.22 Strategies to motivate adults>60y who participate in supervised programs to be more active and 
sit less outside structured weekly training sessions are necessary.  
Technologies including wearables and smartphones have great potential to promote daily positive 
behaviors in adults>60y.23 Nonetheless, a significant research gap is that “such technologies rarely 
integrate meaningful two-way communication,24” which allows an interventionist to successfully engage 
an adult via an intelligent, context-sensitive dialogue to problem-solve and motivate change.24 Available 
two-way communication interventions (e.g., text message and internet-based strategies) have limited 
meaningfulness due to an inability to appropriately time the communication and tailor it based on 
ongoing or recent behavior.  
Awareness of: (i) ongoing or recent behavior (from sensors), (ii) situational contexts of the behavior, (iii) 
past conversation, and (iv) the adult’s preferences (# ii, iii, and iv gathered via two-way communication) 
will help in generating meaningful discourse that allows the creation of an adaptive intervention at a 
level that was not previously possible. We have integrated wearable sensors with the smartphone to 
develop a behavior-aware, virtual “Companion” that uses a “human-in-the-loop” approach to enable 
meaningful two-way communication. Companion builds rich models of typical behavior using sensors 
and context sensitive ecological momentary assessment (CS-EMA) to deliver intervention components 
and behavior change strategies using socially engaging, contextually salient, and tailored text-message 
conversations in near-real-time.  
In our feasibility testing (3 m) of Companion, adults>60y (n=6) reduced daily sitting by ~2.1 h and 
improved health.25 Independent of disease, an active lifestyle also improves cognition in older adults.26,27 
Thus, an investigation of the impact of Companion on behavioral, cognitive, and physiological outcomes 
is required.  
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
7 
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
There is a risk of physical injury during exercise, particularly if participants have little to no previous 
experience. Fatigue and muscle soreness may also occur in participants who do not normally engage in 
physical activity. Exercise is associated with a very small risk of serious medical complications including 
heart attack and sudden death, although this risk is particularly small in healthy older adults.  
 
There is a potential risk of breach of confidentiality that is inherent in all research protocols.  
Some inconvenience and or anxiety may occur due to time required to complete formal rating scales 
and questionnaires. The cognitive assessments impose some risk of emotional discomfort. Fatigue 
associated with performing the cognitive tasks- These items will be scored within 24 hours of 
completion by the subject.  
Participants may experience red skin or discomfort from wearing body-worn sensor devices for an 
extended period of time. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Increasing physical activity, regular structured exercise, and reduced sedentary behavior, improves 
cognitive and physiological health.1-3 Supervised exercise programs (group/individual) involving direct 
contact with a trainer are most effective in maximizing health benefits in adults >60 y; hence, such 
programs are popular in adults >60 y and are widely offered by aging-related interest groups.2,4-8 
Supervision results in fewer injuries, higher training effects, and program adherence.5,6,9,10 Adherence is 
due to personal attention and interaction between the participant and supervisor during sessions, which 
motivate the participant.6,9 mHealth technologies including mobile phones and wearables hold immense 
potential to engage adults >60 y and promote positive behavior change throughout the day.21 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
The risks are minimal and outweighed by the potential benefits to individuals and society 
All experimenters involved in the project will be CPR certified. 
 
3 
OBJECTIVES AND ENDPOINTS  
  
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
Determine if Companion 
improves free-living activity 
and sedentary behavior and 
Daily total and 
bouts of physical 
These physical behaviors are 
directly impacted by 
motivation communication 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
8 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
sustains this change in adults 
>60y.  
 
activity and 
sedentary time. 
aimed at promoting positive 
behavior change. 
Tertiary/Exploratory  
 
 
(1) Explore if 
supplementing 
supervised exercise 
with Companion 
further improves and 
sustains 
cardiometabolic 
health, body 
composition, physical 
function, muscular 
and aerobic fitness, 
and cognition. 
(2) Examine factors that 
mediate and 
moderate change in 
physical activity and 
sedentary behavior. 
Cardiometabolic 
health (Plasma 
glucose, HbA1C, 
insulin, and lipids; 
lean and fat mass; 
Physical function; 
Cognition; 
Perceptions of 
competence 
related to health 
behaviors; 
Autonomy support 
(from companion); 
Autonomous 
motivation (for 
physical activity); 
Relatedness (to 
the Companion); 
General 
satisfaction. 
These outcomes may be 
impacted by change in 
behavior and communication 
with Companion   
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
Hypothesis (Aim 1): The treatment group will show greater improvements in daily activity and sedentary 
behavior outcomes than controls after 16 and 24 weeks. 
Hypothesis (Aim 2): The treatment group will show greater improvements in health and psychosocial 
outcomes than controls after 16 and 24 weeks. 
Phase: 1A. 
Design: Randomized control trial 
Participant assignment: 1:1 Simple Randomization conducted by graduate assistant 
Number of study group: 2 (control/treatment); intervention period= 4 months; follow-ups after 4 and 6 
months. 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
9 
Number of sites= Single site trial. 
Name and description of intervention: Companion; An integrated system of wearable sensors and the 
smartphone. It is a behavior-aware, virtual “Companion” that uses a “human-in-the-loop” approach to 
enable meaningful two-way communication. Companion builds rich models of typical behavior using 
sensors and context sensitive ecological momentary assessment (CS-EMA) to deliver intervention 
components and behavior change strategies using socially engaging, contextually salient, and tailored 
text-message conversations in near-real-time. 
Description of control group: This group will not receive the Companion, which will be the only 
difference with the treatment group. I.e., the control group will receive standard treatment– the 
supervised training program and an exercise prescription for those days without supervision. 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
An RCT design where the control group does not receive the Companion intervention will enable to 
tease apart the efficacy of the Companion. The design will minimize the risk of confounding and help to 
increase confidence in the findings, and thus, are more likely to be representative of the true effect of 
the intervention. 
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
The intervention is delivered via text messaging as it is an mHealth intervention that targets behavior 
improvement when participants are on their own. Participants will receive 4-7 messages from the 
Companion in intervals of 1-4 hours each day. This limited interval will retain the novelty of the 
communication and thus interest of the participant in engaging in the study while yielding evaluable data. 
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 the 4-month follow-up assessment.  
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
 
1. Provision of signed and dated informed consent form 
2. Age >60 y 
3. Have a body mass index greater than 25 kg/m2 
4. No conditions preventing participation in physical activity lasting 10 to 30 min  
5. Have a smart phone 
 
5.2 
EXCLUSION CRITERIA 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
10 
1. Engage in structured physical activity for more than 2 days/week lasting 30 min/session-  
2. Regularly use any assistive device for walking. 
3. Likely to alter medications pertaining to cardiovascular or metabolic health 
5.3 
LIFESTYLE CONSIDERATIONS 
 
NA 
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/not meeting one or more 
exclusion/inclusion criteria, respectively will not be enrolled in the study. 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Anticipated number of people to be screened =56; Women and Minorities= at least 50 and 20% 
respectively; Anticipated number of people to be enrolled =46; Women and Minorities= at least 50 and 
20% respectively; 
Participation in this study will be sought using flyers (see attached flyer) and email (see attached 
recruitment email template) to identify interested individuals. We will identify potentially eligible 
Northeastern employees from University department’s online staff directories and obtain individual 
email addresses from employee directories to contact individual’s directly in seeking participation in our 
study using the aforementioned recruitment email and flyer. Recruitment materials (email and flyer) will 
include the self-inclusion criteria. Should the conditions not apply to individuals who are contacted, he 
or she may exclude himself or herself without the need to reveal his or her reasons to the researchers. 
Recruitment emails will be sent a second time a week later if there is no response on the initial invite. 
People who meet the self-inclusion criteria and express interest in further information will be asked to 
set up a time to meet briefly at their Northeastern office/home/virtually with the researchers. 
This strategy is appropriate because Northeastern University has over 2000 employees engaged in 
seated work and will yield the necessary sample size for the study. Additionally, Northeastern University 
is located in close proximity to several other academic institutions such as the Massachusetts College of 
Arts, Wentworth Institute of Technology, the New England Conservatory of Music, and Harvard School 
of Public Health and its Medical School. We will direct recruiting efforts at these institutions as well, 
which are all less that ¼ mile from NU’s campus. Additionally, we will reach out to senior centers in 
Boston and surrounding areas and other resources including social media and listservs that are publicly 
available. 
The targeted distribution of the subjects’ racial and ethnic makeup is anticipated to be successful given 
the demographic distribution in the city of Boston based on estimates obtained from United States 
Census bureau. According to these data, the distribution of minorities in the general population in 
Massachusetts is 47.4%, Hispanic or Latino of any race is 19.7%, Black or African American alone is 
25.3%, American Indian or Alaska native is 0.3%, Asian alone is 9.6%, and those identifying as being of 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
11 
two or more races is 5.1%. White adults are the majority at 52.6%. The proportion of women in the city 
of Boston is 51.9%.  
Participants may receive up to $120 in remuneration, consisting of $40 for completing 3 measurements 
either at the Human Performance and Exercise Science Lab or in their place of residence. Payment will 
be provided after completion of the study, either after the month-6 follow up follow-up or at an earlier 
point should the participant drop out of the study prior to moth 6 follow up, consistent with the 
measurement completion criteria. The incentive is appropriate and will not be viewed as coercive. 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
The Companion: Companion is based on Self Determination Theory (SDT) and the application of 
Motivational Interviewing (MI) to creatively use information on behaviors, attitudes, and environmental 
contexts to create user-Companion interactions that are tailored to participant needs. SDT addresses 
cognitive and affective factors in human motivation and posits three innate psychological needs that 
form the basis for optimal self-motivation: competence, relatedness, and autonomy.30 MI is a client-
centered counseling method to explore and resolve uncertainty towards changing behavior and to 
enhance intrinsic motivation to effect change.31 SDT and MI are successfully combined to improve 
physical activity32 because of a common underlying assumption that people have a tendency for 
personal growth toward psychological integration.33,34  
Next, we describe Companion’s technological components, their integration, and integrated function: 
(1) Continuously worn wireless ActiGraph® wrist sensor capture raw motion data. (2) These data are 
transmitted hourly to a backend. (3) Motion data are processed immediately at the backend using 
validated machine learning algorithms to characterize data as physical activity (e.g. walking or other) or 
sedentary. (4) Processed data are visualized by a health coach using a backend interface that temporally 
displays estimated behavior types. (5) Research assistants will enquire about major automatically detected 
behaviors (e.g. movement >10 min; sitting >20 min) to determine context (e.g. walk during lunch; in a 
weekly meeting) using CS-EMA. (6) They can also choose to determine behavior context of any other 
automatically detected behavior. (7) These automated and manual records will incrementally yield a 
reliable visual model of major habitual daily behaviors at the backend. Such information will be richer than 
what was previously available to an interventionist. (8) Based on the model, coaches will use the CS-EMA 
two-way communication app to intervene and promote prescription component delivery at opportune 
times (i.e., near-real-time) to help develop routines.  
Supervised Exercise Program: For the first 16 weeks, all participants will engage in ~45 to 60 min of 
aerobic, strength, flexibility and balance training, twice/week.29,35 Participants will either visit 
Northeastern’s Exercise Science Lab for supervised personal training or engage  virtually over Zoom 
during the training session. The lead trainers will be an exercise physiologist or a trained graduate 
student. After the session, the trainer and participant will outline goals and prescription plan for the 
days prior the next training session and those to be performed by the participant on their own. The plan 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
12 
will be based on guidelines from the American College of Sports Medicine.36,37 Supervised training 
sessions for the two groups will be scheduled on different days and allocation of participants to a trainer 
will be at random. 
Treatment Group: This group will receive the Companion. Communication during weeks 1 to 4, will focus 
on gathering information on the participant’s motivations, preferences, habits, contexts, and usual 
behavior patterns to build a typical behavior model for the participant. We expect a decreasing level of 
change in behavior models that are built using information accrued incrementally over these 4 weeks.23  
Companion will monitor ongoing and recent behavior, communicate with the participant (if necessary) 
to deliver contextually salient intervention strategies. Additionally, there will be a fixed Companion-
initiated communication in the early evening (~4 to 6 pm) to discuss the achievement of that day’s goals 
and prescribe strategies to achieve pending goals.  
The nature of the first communication the next morning will be based on participant performance 
during all waking hours of the preceding day- e.g., encouraging, problem-solving. This is possible 
because the participant will be instructed to continuously wear the wrist device, which stores motion 
data in its internal memory. These data will be downloaded to Companion and analyzed. 
Regular interaction will enable a corresponding incremental personalization of communication based on 
knowledge of each participant’s communication style and personality. Similarly, such frequent 
interaction will also enable an incremental knowledge of the participant’s changing physical ability and 
activity preferences, which will facilitate a corresponding increase in personalizing activity prescription.    
Control Group: This group will not receive the Companion, which will be the only difference with the 
treatment group. I.e., the control group will receive standard treatment– the supervised training 
program and an exercise prescription for those days when they are on their own. This will be done on 
the two days when control group participants meet face-to-face with the trainer for supervised training.  
Primary Outcomes: Total duration and number of bouts of: (i) light and moderate-to-vigorous physical 
activity and (ii) sedentary behavior measured over a period of one week using accelerometry.38,39 Week-
long measures will be made at baseline, and weeks 16 and 24.  
Exploratory Outcomes: Cardiometabolic health: Plasma glucose, HbA1C, insulin, and lipids. Body 
composition: lean and fat mass. Physical function. Muscular and aerobic fitness. Cognition.42 Perceptions 
of competence related to health behaviors. Autonomy support (from companion). Autonomous 
motivation (for physical activity). Relatedness (to the Companion). General satisfaction. 
6.1.2 ADMINISTRATION AND/OR DOSING 
Please see section 6.1.1. 
6.2 
FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
Specific to the intervention the table below identifies the frequency of monitoring intervention fidelity: 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
13 
 
 
Additionally, prior to commencing the study, research staff will undergo training on how to maintain 
consistency when communicating via Companion and during outcome measurement. Communication 
training will be based on guidelines for motivational interviewing. After training on outcome 
measurement, a skill test will be conducted on a test individual by research staff to determine inter-tester 
agreement.  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
1:1 Simple Randomization conducted by graduate assistant.  
It has been suggested that blinding in behavioral interventions such as those involving physical activity 
and exercise is comparatively more challenging than in pharmacological or medical studies;  this may be 
more relevant to pilot trials that are not conducted as part of a larger trial, which aim to assess the 
conceivable benefits of an intervention and the potential of conducting a future definitive RCT.7-9 While 
the health coaches and participants will not be blinded to treatment allocation, we minimize bias via the 
use of objectively measured outcome variables in both aims. Furthermore, the statistical analyst will be 
blinded to treatment allocation during analyses.  
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
Adherence to the study intervention will be monitored using multiple sources of information. These 
include (1) the frequency of messages sent and received using the Companion, which will be tracked 
weekly (2) attendance in the personal training sessions, which will be tracked weekly, and (3) outcome 
assessment attendance, which will be tracked at the end of the study. 
6.5 
CONCOMITANT THERAPY 
 
6.5.1 RESCUE THERAPY 
 
NA 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
The criteria for discontinuing the intervention include the participant's request, as well as any life-
threatening or potentially disabling event, including acute illness, an injurious non-accidental fall, or 
Data source
Monitoring frequency
Study design Treatment delivery
Personal training checklist
Weekly
x
x
Review of two-way messaging
2 to 4 days
x
x
Team meetings to discuss participant progress and protocol adherence
Weekly
x
Area of fidelity 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
14 
hospitalization. These adverse events will be recorded in accordance with the Northeastern IRB 
requirements.  
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
  
The criteria for discontinuing the intervention include the participant's request, as well as any life-
threatening or potentially disabling event, including acute illness, an injurious non-accidental fall, or 
hospitalization. These adverse events will be recorded in accordance with the Northeastern IRB 
requirements.  
Additionally, an investigator may discontinue a participant if: 
 
 
Lost-to-follow up; unable to contact subject.  
 
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 but do not receive the study 
intervention may be replaced.  Subjects who sign the informed consent form, are randomized and receive 
the study intervention, and subsequently withdraw or are discontinued from the study, will not be 
replaced. 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return for both follow-up 
measurements and if study staff are unable to contact the participant after at least 3 attempts.  
 
If a participant fails to be available for a follow-up: 
 
 
The researchers will attempt to contact the participant, reschedule the missed measurement with 
a week, counsel the participant on the importance of maintaining the measurement schedule and 
ascertain if the participant wishes to and/or should continue in the study 
 
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 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 
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
15 
Table 1. Measures in Laboratory or Home 
Measure 
Measurement 1: Baseline 
(1-2 h) 
Measurement 2: Follow-
up 1 
(4 months) 
(1-2 h) 
Measurement 3: End of 
study (6 months)  
(1-2 h)  
Heart rate and blood 
pressure 
✔ 
✔ 
✔ 
Anthropometrics 
(Height, weight, waist, 
and hip 
circumference) 
✔ 
✔ 
✔ 
Body composition 
(Bioelectrical 
impedance) 
✔ 
✔ 
✔ 
Fasting blood glucose, 
and lipid profile  
✔ 
✔ 
✔ 
Cognitive tests 
✔ 
✔ 
✔ 
Physical function tasks 
✔ 
✔ 
✔ 
Muscular and aerobic 
fitness  
✔ 
✔ 
✔ 
Other  
 
 
✔ 
The following tests and procedures will be conducted in the numbered order. All measurements will be made 
in a secure location to ensure privacy.  

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
16 
1. Resting heart rate and blood pressure: Heart rate and blood pressure will be measured using an 
automatically inflatable blood pressure arm cuff and monitor. These measures will be conducted in 
triplicate after a rest of 5 minutes between each measure. 
2. Anthropometrics: Height and weight will be measured using a stadiometer and a standard digital 
weight scale, respectively, and circumferences will be measured by a trained research staff member 
using a measuring tape (in triplicate). 
3. Body composition: Whole body percent fat and lean mass will be measured using Bioelectrical 
Impedance (BIA) and will be conducted by trained research staff. During the test, the participant will 
step bare feet on an electronic scale and hold handheld conduction electrodes. A weak electric 
current will flow through the body and the voltage is measured in order to calculate impedance of the 
body and thereby, the % of body fat and lean mass. The test will be completed within 30 s. The 
participant will not feel anything, and this test is similar to stepping on a weighing scale. 
4. Blood glucose and lipid profiles: We will measure this using finger-stick blood analyses with a 
CardioChek Plus device (PTS Diagnostics). The CardioChek Plus is a certified fast, accurate and efficient 
portable analyzer capable of obtaining a full lipid profile and glucose readings in 90 seconds from a 
finger stick strip blood sample (15 – 40 micro Liters). The participant’s blood will not be stored, as the 
finger stick analyses are immediate, and the measuring strips are discarded appropriately after the 
test.  
5. Cognitive tests: The participant will complete a computer-administered test that measures various 
aspects of his or her cognitive abilities (attention, mental skills, memory, and processing speed). 
6. Physical function tasks: The participants’ pattern of walking (Gait), endurance, strength and balance 
will be evaluated by a series of performance assessments, which are safe and practical. These 
assessments mimic daily activities. Details of these performance assessments are as follows: 
(i) Gait: the participant will be asked to walk at his or her usual pace on a 4-meter course twice. The 
researchers will time each of these walks with a stopwatch.  
(ii) Endurance: the participant will first be asked to perform a series of chair stands. Beginning from a 
sitting position, the participant will be asked to stand up and then sit down five times in a row, as fast 
as he or she can, without using his or her arms to help.  
(iii) Strength: the participant will be asked to squeeze a hand-held device to determine the maximum 
force he or she can produce with each hand repeating the test three times for the left and right hands.  
(iv) Balance: the participant will first be asked to stand in different positions while keeping his or her 
balance first with eyes open and then with eyes closed. The tester will demonstrate what to do and 
will be nearby to steady the participant if he or she needs it.  
7. Muscular and Aerobic Fitness: We will assess the participant’s fitness with a series of short 
assessments explained below. A trained exercise physiologist will spot and supervise all exercises to 
ensure safety and proper technique. All testing procedures will be preceded with proper warm-up and 
instructions to minimize any risks. Details of these assessments are as follows:  
(i) Muscular endurance: We will assess the endurance of the participant’s lower and upper body by 
asking he or she to perform as many repetitions as possible. For the upper body we will do the 
Standard Push Up test where participants will perform as many pushups as possible. For the lower 
body we will use the Repetitive Squat Test where the participant stands with feet 15 cm apart, squats 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
17 
until the thighs are parallel to the floor, and returns to an upright position. We will record the number 
of repetitions. The participant is free to terminate the tests at any moment either upon voluntary 
exhaustion or lack of desire to continue.  
(ii) Aerobic Fitness- We will assess aerobic fitness using the 6-minute walk test. This is a simple test 
that requires no specialized equipment and only requires the participant to walk on a flat, hard 
surface for a period of 6 min. The total distance walked during this duration is measured using a 
measuring wheel. 
8. Other: (i) 7-14 days after baseline, participants in the general exercise intervention group will have a 
virtual 30-min face-to-face counseling session with the researchers on: i) benefits of reducing 
sedentary behavior and increasing physical activity, and ii) various strategies to decrease workplace 
and home sedentary behaviors and initiate a physically active lifestyle.  
(ii) Participants in the lifestyle physical activity intervention group will have a virtual 60-min face-to-
face counseling session via a HIPAA complaint ZOOM session. This session will include the same 
components received by the general exercise intervention group supplemented with an additional 30-
min of conversation to further personalize his or her physical activity prescription plan and create 
goals related to physical activity and sedentary behavior lifestyle choices. During this time the 
researcher will ask the participant in the lifestyle physical activity intervention group questions about 
his or her schedule, preferences, health-related behaviors, and other behaviors related to work 
schedule, hobbies/leisure interests, family dynamics, home and work environment, means of daily 
transportation, etc. that can be used to help support the participant towards achieving his or her 
physical activity and sedentary behavior lifestyle goals.  
(iii) After study completion, participants will be asked to complete a follow-up interview in person 
during the end of study follow-up (month 6). The interview will take no longer than 15-20 minutes. 
The conversations may be recorded only with the participant’s permission. Once the audio recordings 
are transcribed, the audio recordings will be immediately destroyed.  
 
Table 2. Self-completed Measures (1 – 1.5 hours) 
Measure  
Baseline 
Month 4 follow up 
Month 6 follow up 
General Health and 
Health Related 
Quality of Life 
✔ 
 
 
Perceived 
Competence Scale 
for Participating in 
✔ 
✔ 
✔ 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
18 
Regular Physical 
Activity 
Short Health Care 
Climate 
Questionnaire 
✔ 
✔ 
✔ 
Exercise Self-
Regulation 
Questionnaire 
✔ 
✔ 
✔ 
Basic Need 
Satisfaction in 
Relationships Scale 
✔ 
✔ 
✔ 
Diet  
✔ 
✔ 
✔ 
Activity Monitoring 
✔ 
✔ 
✔ 
After completing the measurements in Table 1, participants will be given questionnaires and small activity 
monitors. It will take approximately 1-1.5 hours to complete the questionnaires. A research staff member will 
collect the questionnaires from the participant after a week.  
1. Perceived Competence Scale for Participating in Regular Physical Activity: This is a 4-item 
questionnaire that assesses a participant’s feelings of competence about engaging in physical activity. 
2. Short Health Care Climate Questionnaire: This questionnaire has 6 items that assess a participant’s 
perceptions of the degree to which the companion is supportive of autonomy; i.e., that the 
Companion considers the participants perspective and provides appropriate and meaningful feedback 
and opportunities for choice.  
3. Exercise Self-Regulation Questionnaire: This is a 31- item self-report to measure the ability of the 
participant to regulate behavior to achieve one’s goals 
4. Basic Need Satisfaction in Relationships Scale: This scale addresses need satisfaction in general in 
one’s life. It has 21 items assessing the three needs for competence, autonomy, and relatedness. 
5. Diet: The participant will report frequency and portion size of foods consumed during the past month 
from a list of 70 commonly consumed food items on a questionnaire.   
6. Activity Monitoring: physical activity measurement will be conducted in two ways.  
o Firstly, using a thigh worn monitor. This measurement will be conducted for a period of 7-days at 
baseline and after 4 and 6 months. For this measurement the participant will wear 1 small lightweight 
(≈ 0.5 ounces) activity monitor (activPAL3TM, PAL Technologies, Glasgow, UK; product specs: 
http://www.palt.com/pals/ )on his or her dominant thigh, which will be adhered to his or her skin 
using a hypoallergenic medical grade tape (3M Tegaderm TM Film, 3M, Minneapolis, MN; product 
specs: https://www.3m.com/3M/en_US/company-us/all-3m-products/~/3M-Tegaderm-Transparent-

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
19 
Film-Dressing/?N=5002385+3293321979&preselect=3293786499&rt=rud). During the 7-day 
measurement periods, the participant will also complete a record of times the monitors were 
removed from his or her person. These thigh sensor data will not be transmitted wirelessly. The 
researchers will download the data from the devices upon collecting them from the participants. The 
researchers will go to the participant’s office/home to collect these. 
o Secondly, during the entire duration of the study, including the three 7-day physical measurement 
periods with the thigh activity monitor, the participant will be asked to wear a small wrist sensor (≈ 
0.64 ounces) [(i). general exercise group: ActiGraph GT9X Link; (ii). lifestyle physical activity group: 
CentrePoint Insight Watch, Actigraph Corp. LLC, Pensacola, FL; product specs for GT9X available at 
https://www.actigraphcorp.com/actigraph-link/ and for Insight Watch available at 
https://www.actigraphcorp.com/cpiw/). These devices will be worn on the non-dominant wrist on a 
watchstrap.  
Participants in the general exercise intervention group will receive a new GT9X monitor every 1-4 
weeks to ensure the devices always have enough battery life to measure physical activity. The 
researchers will go to the participant’s preferred location (office or home) to provide a new sensor. 
These wrist sensor data will not be transmitted wirelessly. The researchers will download the data 
from the devices upon collecting them from the participants. 
o Participants in the lifestyle physical activity intervention group will receive an Insight watch that is 
capable of passively uploading motion data so that the researchers may get an understanding of his or 
her daily movement patterns. This information is confidential and will be used for research purposes 
only. No other data besides data about the participant’s movement is gathered using any of the 
sensors. The researchers will come to the participant’s office or home at the beginning of the study to 
install the data capturing systems (i.e., data transfer hubs). The decision on the location to install the 
hub (i.e., home vs office) will be determined in consultation with the participant. The location will be 
where the participant spends the most part of the week during the waking day. These data hubs are 
small devices that require a power source connection to communicate wirelessly with the device the 
participant will be wearing and relay data to the researcher. The researchers will uninstall the data 
hubs following completion of study participation either after the month 6 follow up or prior to that 
should the subject decide to drop out of the study. Please see the attached PDF detailing the data 
capturing and transmission process.  
o Participants in the lifestyle physical activity intervention group will also have the battery life of his or 
her wrist-worn activity monitor frequently monitored by the researchers via the passive data transfer 
system. When the researchers detect that the device has a low battery (battery life is approximately 
2-3 weeks), the participant will be prompted to schedule a time to receive a new device from the 
researchers. The researcher will go to the participant’s office or home to collect the monitor and 
return it charged by the next day to commence the daily physical activity measurement.  
o We will encourage participants in both groups to wear the sensors as much as possible so that: 1) we 
may be able to understand the differences in daily/weekly physical behavior change effects between 
the two intervention approaches, and 2) we may be able to tailor daily recommendations of 
participants in the lifestyle physical activity intervention group to maximize and maintain his or her 
gains and to help meet his or her goals. Participants may remove the sensors for brief intervals 
throughout the day (e.g., for showering). The researchers may provide participants in the lifestyle 
physical activity intervention group with retrospective feedback of his or her physical activity 
measurements via text-message frequently (4 to 7 times a day at intervals of 1 to 4 hours between 7 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
20 
am – 10 pm), following the virtual session (Table 1 #8). To reiterate, daily retrospective feedback 
(health coaching) will last for 4 months, concluding at the month-4 follow up.  
 
Change in outcome measurements will be provided to participants after the follow up at month 6, when 
requested by the participant. 
8.2 
SAFETY ASSESSMENTS 
During the group exercise sessions, participants will be informed that if they feel tired or are uncomfortable 
to please tell the researchers and the session will be stopped or resumed after a break.  
As participants will have been fasting (no food or beverage other than water) for 12 hours prior to outcome 
measurement, participants will be asked if they are feeling physically alright and will be offered a snack after 
the finger-stick blood measure. They will be thereafter instructed to resume their regular diet. Participants 
will also be encouraged to bring their own food if the prefer when testing in the laboratory. 
Individuals with skin allergies or skin sensitivities to adhesive tape will be excluded from the study. Tape 
is required to adhere sensors to the skin to measure the primary outcome. 
Should the participant score low on cognitive function test they will asked if they would like to be 
provided with a resource handbook for dealing with cognitive dysfunction. The handbook is a publicly 
available resource from the New York public health department containing various strategies for 
addressing different forms of cognitive dysfunction, and also provides external resource lists.  
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
Adverse (AE) and Serious Adverse Events (SAE) will be defined per guidelines from the Office of Human 
Research Protections (OHRP) of the Department of Health and Human Services.  
An adverse event is any untoward medical occurrence in a participant, whether or not it is causally related 
to the study. 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
A serious adverse event is any experience that results in any of the following outcomes: death, is life 
threatening, inpatient hospitalization or prolongation of hospitalization, a persistent or significant 
disability/incapacity. Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered a serious adverse event when, based upon appropriate 
medical judgment, they may jeopardize the patient or participant and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
21 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
 
Mild: Awareness of a sign or symptom but easily tolerated.  
 
Moderate: Discomfort sufficient to cause interference with usual activity or to affect clinical 
status.  
 
Severe: Incapacitating with inability to do usual activity or to significantly affect clinical status.  
 
Life Threatening: The participant was at immediate risk of death from the adverse event as it 
occurred.  
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All AEs will have their relationship to study intervention or study participation assessed with a level of 
specificity appropriate to the study design. The clinician’s assessment of an AE's relationship to study 
intervention (drug, biologic, device, behavioral) is part of the documentation process, but it is not a factor 
in determining what is or is not recorded in the study. Describe the method of determining the 
relationship of an AE to a study intervention. If there is any doubt as to whether a clinical observation is 
an AE, the event should be recorded.  Some protocols may use a binary assessment (related/not related); 
others may have a scale of relatedness.  Evaluation of relatedness must consider etiologies such as natural 
history of the underlying disease, concurrent illness, concomitant therapy, study-related procedures, 
accidents, and other external factors.  In a clinical trial, the study intervention must always be suspect.  
The Investigator will also assess the relationship of any adverse event to study, based upon available 
information, using the following guidelines:  
 
0 = Unlikely: No temporal association, or the cause of the event has been identified. 
 
1 = Possible: Temporal association, but other etiologies are likely to be the cause; however, 
involvement of the study procedures cannot be excluded.  
 
2 = Probable: Temporal association, other etiologies are possible, but not likely.  
8.3.3.3 EXPECTEDNESS  
The safety officer in conjunction with the PI will determine if an 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 
All adverse events that are both serious and unexpected will be reported by the pilot PI and the Roybal 
Center PI to the IRB’s, NIA PO and to the Safety Officer, within 48 hours of the study's knowledge of SAE. 
The summary of all other SAEs will be reported to NIA PO and to the Safety Officer, quarterly, unless 
otherwise requested by the Safety Officer.  
8.3.5 ADVERSE EVENT REPORTING  

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
22 
Adverse events will be reported by the PI of the Pilot project to the PI of the Roybal Center and the head 
of the IRB at Northeastern. The Roybal Center PI will report the problems or events to the head of the 
IRB at Brandeis University and the NIA Program Officer, and the Safety Officer within 48 h by fax or 
email according to the Northeastern’s IRB written guidelines for interventional studies. All adverse 
events that are both serious and unexpected (i.e., that have not been previously reported for the study's 
intervention) will be reported by the pilot PI and the Roybal Center PI to the IRB’s, NIA PO and to the 
Safety Officer, within 48 hours of the study's knowledge of SAE. The summary of all other SAEs will be 
reported to NIA PO and to the Safety Officer, quarterly, unless otherwise requested by the Safety 
Officer. All deaths in greater than minimal risk studies require expedited reporting (usually within 24 
hours of study’s knowledge of death). The report of death will be submitted to NIA Program Officer and 
to the Safety Officer and the institutional IRB’s by the pilot PI and/or the Roybal Center PI. 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
 See section 8.3.5 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
NA 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
NA 
 
8.3.9 REPORTING OF PREGNANCY  
NA 
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
Unanticipated problems are those that:  
 
Are unexpected in terms of nature, severity, or frequency, given (a) the research procedures 
that are described in the protocol-related documents and (b) the characteristics of the study 
population;  
 
Are related or possibly related to participation in the research suggest that the research places 
participants and others at greater risk of harm than was previously known or recognized  
8.4.2  UNANTICIPATED PROBLEMS REPORTING  

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
23 
 
See section 8.3.5. 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
NA 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
 
 
Primary Endpoint(s): Daily total and bouts of physical. 
 
The treatment group using Companion will show greater improvements in daily activity and sedentary 
behavior outcomes than controls after 16 and 24 weeks. Alternatively, our null hypothesis is that there 
will be no difference in the treatment group for daily activity and sedentary behavior outcomes after 
16 and 24 weeks. 
 
9.2 
SAMPLE SIZE DETERMINATION 
Sample size is based on change in HbA1C after 16 weeks of training in adults >60 y (n=22). We used a 
health outcome variable to compute sample size to examine the translational effect of behavior change 
due to Companion on the health of adults >60 y. In our data, partial η2 (effect size) for the interaction 
effect between group and time (pre – 16 week) equaled 0.5 corresponding to a medium effect size. With 
alpha of .01, power of 0.85, two groups, 3 repeated assessments, and an estimated inter-correlation 
between assessments of 0.5, the required sample is 39; we will recruit 46 participants. Hypothesis testing 
for all outcomes will entail an intent-to-treat two-tailed design with a type I error of 0.05. 
 
9.3 
POPULATIONS FOR ANALYSES 
 
Intention-to-Treat (ITT) Analysis Population (i.e., all randomized participants) 
 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
Descriptive statistics, for all normally distributed continuous data will be presented as means with 
standard deviations.  Hypothesis testing will entail an intent-to-treat two-tailed design with a nominal 
type I error of 0.05. All participants will be included in the intent-to-treat analyses according to 
randomization regardless of their subsequent status. Missing data due to losses to follow-up will be 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
24 
assumed to be at random. Random intercept mixed linear models that account for repeated measures 
will be used to compare primary and exploratory outcomes measured at various timepoints during the 
study. Models will be adjusted for covariates and the baseline value of the outcome variable where 
necessary.  
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
The primary endpoint will be summarized from body-worn sensor data and is a continuous variable. 
Hypothesis testing entailed an intent-to-treat two-tailed design with a nominal type I error of 0.05. 
Random intercept mixed linear models that account for repeated measures will be used to analyze the 
primary outcome. Models will be adjusted for covariates and the baseline value of the outcome variable 
where necessary. Post-hoc pairwise comparisons for primary outcomes will be adjusted for multiple 
testing using Bonferroni corrections. Results will be presented as Least-squares means (LSMEANS) with 
95% confidence intervals. Effect sizes and confidence intervals will be calculated for all comparisons.23,24 
Additionally, we will conduct sensitivity analyses where missing outcome data attributable to random 
factors will be imputed using joint multiple imputation and analyzed using mixed linear modelling adjusted 
for covariates.25,26  
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
NA 
 
9.4.4 SAFETY ANALYSES 
 
NA 
 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
The intervention and control group will be compared for differences in baseline characteristics using linear 
mixed models. 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
NA 
9.4.7 SUB-GROUP ANALYSES 
 
NA 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data will be listed by measure and time point in a database. 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
25 
 
9.4.9 EXPLORATORY ANALYSES 
Random intercept mixed linear models that account for repeated measures will be used to analyze 
exploratory outcomes. Results will be presented as Least-squares means (LSMEANS) with 95% confidence 
intervals. Effect sizes and confidence intervals will be calculated for all comparisons.23,24Analyses for 
exploratory outcomes will be considered to be hypothesis-generating and thus, will not be adjusted for 
multiple testing (i.e., α= 0.05). Effect sizes and confidence intervals will be calculated for all 
comparisons.23,24 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS. 
 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
 
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 
 
Recruitment Flyer 
 
Recruitment Email template 
 
Recruitment quota reached email template 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
The project manager and/or graduate student trained in the consent process will obtain informed 
consent and potential participants will receive an oral explanation regarding study procedures and 
associated risks and benefits. Participants will be made aware that their participation is voluntary, and 
they have the right to stop participation at any time. Risks associated with the study will be clearly 
outlined in the informed consent document. Participants will have time to read the consent form and 
the experimenter will address participants’ questions and concerns prior to signing the consent form. 
The participant will be explicitly told that they can take as long as needed to read over and ask 
questions. We will ensure confidentiality during the consent process and allow participants sufficient 
time to make a decision on participation. Signed consent will be obtained prior to admission to the 
study. This will include a complete description of the study and will include telephone numbers to 
contact the principal investigator and Institutional Review Board (IRB) if they have questions.  
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
26 
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, investigator, 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 measurement 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 (i.e., significant protocol violations) 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination that the primary endpoint has been met 
 
Determination of futility 
 
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 (e.g., Safety 
Officer). 
 
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 safety officer, other authorized representatives of the sponsor or funding agency, and 
representatives of IRB may inspect all documents and records required to be maintained by the 
investigator for the participants in this study. The study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at the study 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. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be stored securely on a password protected computer at Northeastern University. This will not include 
the participant’s contact or identifying information. Rather, individual participants and their research data 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
27 
will be identified by a unique study identification number. At the end of the study, all study databases will 
be de-identified and archived. 
 
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.  
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
NA 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Independent Safety Monitor 
Dinesh John, Associate Professor 
Paul Thompson, MD 
Northeastern University 
Hartford Hospital 
360 Huntington Avenue, Boston, 
MA-02115 
85 Jefferson Street, Suite 704 
Hartford, CT 06106 
6173735695 
860-972-1793 
d.john@northeastern.edu 
paul.thompson@hhchealth.org 
 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be guided by a Data and Safety Monitoring Plan under the direction of a Safety 
Monitor. The Safety Monitor will be independent from the study conduct and free of conflict of interest. 
The Safety Officer will meet biannually with the PI to review standardized reports. The Safety Officer will 
review the progress of recruitment and retention of participants, compliance with the protocol, and 
operating procedures. If he/she identifies any safety issue, they may request additional data and propose 
specific analyses and make recommendations to the PI regarding recruitment, retention, compliance, and 
safety issues 
 
10.1.7 CLINICAL MONITORING 
NA 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
28 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
the completed consent documents.  This review will evaluate compliance with Good Clinical Practice, 
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 initially captured on source documents (see Section 
10.1.9, Data Handling and Record Keeping) will ultimately be entered into the study database.  To ensure 
accuracy site staff will compare a representative sample of source data against the database, targeting 
key data points in that review. 
 
Intervention Fidelity — Consistent delivery of the study interventions 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.   
 
Hardcopies of outcome measurement worksheets will be provided for use as source document 
worksheets for recording data for each participant consented/enrolled in the study.  Data recorded on an 
electronic form derived from source documents will be consistent with the data recorded on the source 
documents. 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
29 
Hard copies of source data will be de-identified and stored in locked cabinet inside a locked office in the 
Human Performance and Exercise Science Lab. Only authorized research personnel will have access to 
this office. Signed consent forms will also be stored in this same locked cabinet 
Should the subject agree to having his or her study exit interview audio recorded, the recording will be 
destroyed immediately after the interview has been transcribed.  
Physical activity data collected from wearable sensors in the lifestyle physical activity intervention group 
will be uploaded to a secure cloud-based storage system (CentrePoint, ActiGraph LLC, Pensacola, FL), 
which will allow authorized study personnel to securely and remotely access the data. The CentrePoint 
system leverages existing cloud-based technologies to provide a robust, scalable solution that implements 
industry best practices. CentrePoint utilizes Microsoft Azure’s cloud computing platform for hosting 
sites/services, data processing, subject/study management, and data storage, and uses AWS Relational 
Database Service (RDS) for data analytics. 
Using WhatsApp for daily text-message based communication will ensure that the subjects’ 
conversations with the researchers remain secured and only visible to them and the researchers. This is 
made possible by WhatsApp's end-to-end encryption, which is automatically available to all users of the 
app. Many messaging apps only encrypt messages between the sender and the receiver, but 
WhatsApp's end-to-end encryption ensures that only the sender and the person he or she is 
communicating with, can read what is sent, and nobody in between, not even employees of WhatsApp. 
This is because messages are secured with a lock, and only the recipient and the sender have the special 
key needed to unlock and read them. For added protection, every message sent on WhatsApp has its 
own unique lock and key. All of this happens automatically. 
10.1.9.2 STUDY RECORDS RETENTION  
Study documents will be retained until at least 2 years have elapsed since the formal discontinuation of 
clinical development of the study intervention or as per IRB guidelines.  
 
10.1.10 
PROTOCOL DEVIATIONS   
A protocol deviation is defined as any noncompliance with the clinical trial protocol. 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 7 working days of identification of the protocol deviation. All deviations will be 
addressed in study source documents, reported to the funding agency. Protocol deviations will be sent to 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
30 
the reviewing Institutional Review Board (IRB) per their policies. The site investigator will be responsible 
for knowing and adhering to the reviewing IRB requirements.  
 
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 
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 4 years after the completion of 
the primary endpoint by contacting the PI.  Considerations for ensuring confidentiality of these shared 
data are described in Section 10.1.3. 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
Any 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.  
10.2 ADDITIONAL CONSIDERATIONS 
NA 
 
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 
CFR 
Code of Federal Regulations 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
31 
GCP 
Good Clinical Practice 
ICH 
International Council on Harmonisation  
IRB 
Institutional Review Board 
LSMEANS Least-squares Means 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QC 
Quality Control 
SAE 
Serious Adverse Event 
UP 
Unanticipated Problem 
US 
United States 
CPR 
Cardio-pulmonary resucitation 
 
 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
32 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
33 
11 REFERENCES  
1. 
Castaneda C, Layne JE, Munoz-Orians L, et al. A randomized controlled trial of resistance 
exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes care. 
2002;25(12):2335-2341. 
2. 
Nelson M, Layne J, Bernstein M, Nuernberger A. Castaneda C,* Kaliton D, Hausdorff J, Judge J, 
Buchner DM, Roubenoff R, Fiatarone Singh MA. The effects of multidimensional home based 
exercise on functional performance in the elderly. Journal of Gerontology A. 2004;59:154-160. 
3. 
Devereux-Fitzgerald A, Powell R, Dewhurst A, French DP. The acceptability of physical activity 
interventions to older adults: A systematic review and meta-synthesis. Social Science & 
Medicine. 2016;158:14-23. 
4. 
Erickson KI, Grove GA, Burns JM, et al. Investigating gains in neurocognition in an Intervention 
Trial of Exercise (IGNITE): Protocol. Contemporary clinical trials. 2019;85:105832. 
5. 
Exercise Programs That Promote Senior Fitness. National Council on Aging. ncoa.org/center-for-
healthy-aging/basics-of-evidence-based-programs/physical-activity-programs-for-older-adults/. 
Accessed2019. 
6. 
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 : the 
journal of the American Medical Association. 2014;311(23):2387-2396. 
7. 
Pavey T, Taylor A, Hillsdon M, et al. Levels and predictors of exercise referral scheme uptake and 
adherence: a systematic review. J Epidemiol Community Health. 2012;66(8):737-744. 
8. 
Picorelli AM, Pereira LS, Pereira DS, Felicio D, Sherrington C. Adherence to exercise programs for 
older people is influenced by program characteristics and personal factors: a systematic review. 
J Physiother. 2014;60(3):151-156. 
9. 
Shubert TE. Evidence-based exercise prescription for balance and falls prevention: a current 
review of the literature. J Geriatr Phys Ther. 2011;34(3):100-108. 
10. 
Williams NH, Hendry M, France B, Lewis R, Wilkinson C. Effectiveness of exercise-referral 
schemes to promote physical activity in adults: systematic review. Br J Gen Pract. 
2007;57(545):979-986. 
11. 
Courneya KS, Karvinen KH, McNeely ML, et al. Predictors of adherence to supervised and 
unsupervised exercise in the Alberta Physical Activity and Breast Cancer Prevention Trial. Journal 
of physical activity & health. 2012;9(6):857-866. 
12. 
Lacroix A, Kressig RW, Muehlbauer T, et al. Effects of a Supervised versus an Unsupervised 
Combined Balance and Strength Training Program on Balance and Muscle Power in Healthy 
Older Adults: A Randomized Controlled Trial. Gerontology. 2016;62(3):275-288. 
13. 
Meijer EP, Westerterp KR, Verstappen FT. Effect of exercise training on total daily physical 
activity in elderly humans. European journal of applied physiology and occupational physiology. 
1999;80(1):16-21. 

<Protocol Title: Companion Pilot> 
 
Version <2020.9.23>  
Protocol <#CompRoy1> 
 
27 April 2021 
NIH Protocol Template for Behavioral and Social Sciences 
Research 
 
34 
14. 
Meijer EP, Westerterp KR, Verstappen FT. Effect of exercise training on physical activity and 
substrate utilization in the elderly. International journal of sports medicine. 2000;21(7):499-504. 
15. 
Morio B, Montaurier C, Pickering G, et al. Effects of 14 weeks of progressive endurance training 
on energy expenditure in elderly people. The British journal of nutrition. 1998;80(6):511-519. 
16. 
Drenowatz C. Reciprocal Compensation to Changes in Dietary Intake and Energy Expenditure 
within the Concept of Energy Balance. Adv Nutr. 2015;6(5):592-599. 
17. 
Melanson EL, Keadle SK, Donnelly JE, Braun B, King NA. Resistance to exercise-induced weight 
loss: compensatory behavioral adaptations. Medicine and science in sports and exercise. 
2013;45(8):1600-1609. 
18. 
Doucet E, McInis K, Mahmoodianfard S. Compensation in response to energy deficits induced by 
exercise or diet. Obesity reviews : an official journal of the International Association for the 
Study of Obesity. 2018;19 Suppl 1:36-46. 
19. 
Melanson EL. The effect of exercise on non-exercise physical activity and sedentary behavior in 
adults. Obesity reviews : an official journal of the International Association for the Study of 
Obesity. 2017;18 Suppl 1:40-49. 
20. 
Bankoski A, Harris TB, McClain JJ, et al. Sedentary activity associated with metabolic syndrome 
independent of physical activity. Diabetes care. 2011;34(2):497-503. 
21. 
Elosua R, Bartali B, Ordovas JM, et al. Association between physical activity, physical 
performance, and inflammatory biomarkers in an elderly population: the InCHIANTI study. The 
journals of gerontology Series A, Biological sciences and medical sciences. 2005;60(6):760-767. 
22. 
Physical Activity Guidelines for Americans. Health and Human Services. 
https://www.hhs.gov/fitness/be-active/physical-activity-guidelines-for-americans/index.html. 
Published 2018. Accessed2019. 
23. 
Czaja SJ. Can technology empower older adults to manage their health? Generations. 
2015;39(1):46-51. 
24. 
Roess A. The Promise, Growth, and Reality of Mobile Health - Another Data-free Zone. The New 
England journal of medicine. 2017;377(21):2010-2011. 
25. 
Ponnada A, Arguello D, Cloutier G, Intille S, John D. Companion: A semi-automated, intelligent, 
two-way communication-based meta-intervention to promote health behaviors in older adults. 
In: Northeastern University; 2018. 
26. 
Katz P, Julian L, Tonner MC, et al. Physical activity, obesity, and cognitive impairment among 
women with systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2012;64(4):502-510. 
27. 
Napoli N, Shah K, Waters DL, Sinacore DR, Qualls C, Villareal DT. Effect of weight loss, exercise, 
or both on cognition and quality of life in obese older adults. The American journal of clinical 
nutrition. 2014;100(1):189-198.