Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
Phase: NA
Conditions: Exercise
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
Protocol: 
 
CRE 12-305 
Stay Strong: A physical activity program for Afghanistan and Iraq Veterans 
 
Funding Agency:  
HSR&D 
Clinical Trials:  
NCT02360293 
Principal Investigator/Study Chair:  
Laura Damschroder, MS, MPH 
 
Submission  
 
Version 7: July 24, 2014 
Version 9: May 14, 2015  
Version 10:  September 15, 2015 
 Version 11:  October 26, 2015  
Version12: April 17, 2017  
Version 13: January 16, 2018 
Version 14: May 2, 2018 
Version 15: July 11, 2018 
Version 16: October 18, 2018 

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Abstract 
Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming 
overweight and obese; 86% were overweight or obese at their first visit to the VA as 
reported in one recent study. However, existing VA programs are not designed for 
younger Veterans who are more comfortable with technology-mediated interventions than 
older Veterans and who may not yet have developed obesity related chronic diseases. 
Additionally, OEF/OIF/OND Veterans include a relatively high percentage of women 
compared to previous Veteran cohorts. These differences should be addressed in lifestyle 
interventions customized to OEF/OIF/OND Veterans.  
Technology-mediated lifestyle interventions that include continuous, objective home 
monitoring of physical activity, automated internet mediated feedback, and e-coaching 
increase physical activity and improve weight loss in non-Veteran populations. When 
delivered on a large scale, such interventions represent low cost but effective alternatives 
to face-to-face lifestyle change interventions. The VA health care system is in a strong 
position to implement such interventions on a national scale because of existing 
structures such as a national electronic medical records system. Such interventions can 
be centrally administered and marketed directly to Veterans, capitalizing on economies of 
scale, expanding intervention reach, and reducing the burdening of recruitment on the 
existing health care team. However, with the exception of one pilot study, prevention 
focused technology-mediated physical activity programs that include continuous, 
objective home monitoring of physical activity, automated internet or cell-phone mediated 
feedback, and e-coaching have not been customized and tested for OEF/OIF/OND 
Veterans.  
This project will test the feasibility and effectiveness of the prevention focused, internet 
mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and 
demographics of OEF/OIF/OND Veterans. If successful, the Stay Strong program could 
be implemented as a national program to augment the VA’s current panel of options for 
OEF/OIF/OND Veterans who need support to maintain a healthy lifestyle and prevent 
future disease. The specific aims of this project are to 1) evaluate the impact of an 
automated, centrally administered, internet-mediated, physical activity intervention, Stay 
Strong with coaching, on the primary outcome of average minutes of moderate to 
vigorous physical activity among OEF/OIF/OND Veterans; 2) evaluate the impact of Stay 
Strong with coaching on the secondary outcomes of weight loss, depression and pain 
among OEF/OIF/OND Veterans; and 3) test for moderation of the intervention effect of 
the Stay Strong with coaching intervention by gender with respect to the primary outcome 
of minutes of moderate to vigorous physical activity per day, as well as secondary outcomes 
of weight loss, depression and pain. 

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In this randomized controlled study, OEF/OIF/OND Veterans will be randomized into 
either a Stay Strong control arm or the Stay Strong with coach intervention arm for one 
year  The primary outcome is change in minutes of moderate to vigorous physical activity 
per day averaged over 7 days. Weight loss, pain and depression are secondary 
outcomes. Because gender moderates the impact of physical activity interventions, we 
will tailor Stay Strong on gender and over-sample women. The trial is innovative in that 
study staff will have no face-to-face contact with participants. All participant recruitment, 
eligibility screening, informed consent, baseline assessment, randomization, intervention 
delivery and outcome assessment will be internet or cell-phone mediated. A constrained 
longitudinal data model in which baseline physical activity is modeled as a dependent 
variable in conjunction with the constraint of a common baseline mean across the 
treatment group will test for a between-group comparison in physical activity from 
baseline to 12 months in the intervention and control groups. 

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List of Abbreviations 
AE – Adverse Event 
ANCOVA – Analysis of Covariance 
BMF – Bodymedia Fit device 
BMI – Body Mass Index 
CDW – VA Corporate Data Warehouse 
CIRB – Central Institutional Review Board  
cLDA – constrained longitudinal data model  
CPMP – Committee for Proprietary Medicinal Products 
DOB – Date of Birth 
DUA – Data Use Agreement  
ER – Emergency room  
FAQs – Frequently Asked Questions 
IBM – Information-Motivation-Behavior Skill Theoretical Model 
HIPAA – Health Insurance Portability and Accountability Act 
HSR&D – Health Services Research and Development 
HTTPS – Hypertext Transport Protocol Secure 
IP – Internet Protocol address 
LSI – Local Site Investigator 
NCP 
VHA National Center for Health Promotion and Disease Prevention:   
OEF – Operation Enduring Freedom  
OIF – Operation Iraqi Freedom  
OND – Operation New Dawn 
PA – Physical Activity  
PC – Project Coordinator 
PHI – Private Health Information 

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PI – Principal Investigator 
QUERI  – VA Quality Enhancement Research Initiative  
SAE – Serious Adverse Event 
SSN – Social Security Number 
SSL – Secure Socket Layer 
TLS – Transport Layer Security 
UC – Usual Care 
USB – Universal Serial Bus 
VA – Veterans Affairs  
VAMC – VA Medical Center 
VHA – Veterans Health Administration 
VINCI – VA Informatics and Computing Infrastructure 
VISN – Veterans Integrated Service Network 
VSSC – VHA Support Service Center 

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Contents 
Protocol Title: .................................................................................................................. 7 
1.0 
Study Personnel .................................................................................................... 7 
2.0 
Introduction ............................................................................................................ 8 
3.0 
Objectives ............................................................................................................ 10 
4.0 
Resources and Personnel ................................................................................... 13 
5.0 
Study Procedures ................................................................................................ 16 
5.1 Study Design ........................................................................................................ 16 
5.2 Recruitment Methods ........................................................................................... 18 
5.3 Informed Consent Procedures ............................................................................. 21 
5.4 Inclusion/Exclusion Criteria .................................................................................. 23 
5.5 Study Evaluations ................................................................................................ 23 
5.6 Data Analysis ....................................................................................................... 24 
5.7 Withdrawal of Subjects......................................................................................... 26 
6.0 
Reporting ............................................................................................................. 26 
7.0 
Privacy and Confidentiality .................................................................................. 28 
8.0 
Communication Plan ........................................................................................... 31 
9.0 
References .......................................................................................................... 33 
 

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Protocol Title:  Stay Strong: A physical activity program for 
Afghanistan and Iraq Veterans 
 
1.0 
Study Personnel 
Principal Investigator/Study Chair: 
Laura Damschroder, 
MS, MPH 
VA Ann Arbor Healthcare 
System 
HSR&D (152)    
PO Box 130170    
Ann Arbor, MI 48113-0170 
(734) 845-3603 
Laura.Damschroder@va.gov 
Research Scientist 
Ann Arbor VA Center for Clinical 
Management Research 
Implementation Research 
Coordinator, Personalizing 
Options through Veteran 
Engagement (PROVE) QUERI  
Ann Arbor VA HSR&D Center of 
Excellence 
8/8 
Co-Investigators: 
Mona AuYoung, PhD 
VA Ann Arbor Healthcare 
System 
HSR&D (152)    
PO Box 130170    
Ann Arbor, MI 48113-0170 
734- 
mona.auyoung@va.gov  
Post-doctoral Research Fellow 
8/8 
Lori Anne Bastian MD, 
MPH 
VA Connecticut Healthcare 
System 
Newington Campus 
555 Willard Avenue 
Newington, CT 06111 
Lori.Bastian@va.gov  
Senior Research Associate, VA 
Connecticut 
Professor of Medicine,  
Yale University School of 
Medicine 
5/8 
Lorraine Buis, PhD 
VA Ann Arbor Healthcare 
System 
HSR&D (152)    
PO Box 130170    
Ann Arbor, MI 48113-0170 
734-998-7120 ex 312 
Caroline.Richardson@va.gov  
Assistant Professor, Dept of  
Family Medicine, University of 
Michigan 
WOC 
Jennifer Gierisch, PhD 
Center for Health Services 
Research in Primary Care  
Durham VA Medical Center  
508 Fulton Street (152) 
Durham NC 27705 
919.668.5519  
Jennifer.gierisch@va.gov 
Research Health Science 
Specialist, HSR&D, Durham 
VA Medical Center 
Assistant Professor, Duke 
University Medical Center 
Adjunct Assistant Professor, 
Gillings School of Global 
Public Health, Univ of NC 
Chapel Hill 
7/8 
Maren Olsen, PhD 
Center for Health Services 
Research in Primary Care  
Biostatistician, HSR&D, Durham 
VA Medical Center 
7/8 

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Durham VA Medical Center  
508 Fulton Street (152) 
Durham NC 27705 
919.668.5519  
Maren.Olsen@va.gov 
Associate Professor, Duke 
University Medical Center 
Eugene Z. Oddone, 
M.D., M.H.Sc. 
Center for Health Services 
Research in Primary Care  
Durham VA Medical Center  
508 Fulton Street (152) 
Durham NC 27705 
919.286-6936  
Eugene.oddone@va.gov 
 
Senior Researcher, HSR&D 
Coin, Durham VA Health Care 
System 
Professor of Medicine, General 
Internal Medicine, Duke 
University 
 
Phone:  919-286-6936 
 
8/8 
 
 
 
 
2.0 
Introduction 
OEF/OIF/OND Veterans have high physical and mental health burden that may 
impede physical activity participation. While active duty men and women have good 
levels of fitness, many of them find it difficult to maintain this routine in their civilian life. 
This is particularly common among younger Operation Enduring Freedom, Operation Iraqi 
Freedom and Operation New Dawn (OEF/OIF/OND) returning Veterans. In addition to the 
usual barriers to a physically active lifestyle faced by all Americans, these Veterans also 
often suffer from conditions including chronic pain, mental illness and substance abuse, 
which influence their physical activity behaviors. The type and intensity of physical 
activities performed, by the OEF/OIF/ONS population; change considerably from active 
duty to post-deployment. This is often due to relatively unstructured nature of civilian life 
as well as any service-connected illnesses or injuries.(7) The transition from being 
physically fit and active to being sedentary and disabled often results in rapid weight gain 
and increased risk of adverse health outcomes including diabetes, heart disease, joint 
disorders and some cancers. In a large cohort of OEF/OIF/OND Veterans who were seen 
frequently in the Veteran Health Administration (VHA), 86% were overweight or obese at 
their first visit.(1) Early intervention with individually tailored lifestyle program targeting 
physical activity and prevention of weight gain has the potential to improve mental and 
physical health and reduce long-term disability. Thus, there is a need to develop novel 
approaches that deliver evidence-based physical activity interventions at low cost for 
OEF/OIF/OND Veterans.  
 
Technology-mediated lifestyle interventions that employ objective monitoring 
increase physical activity and increase weight loss. Internet-mediated interventions 
have been shown to increase physical activity in non-Veteran populations.(8) Lifestyle 
change interventions that employ physical activity monitoring devices such as 
pedometers have been shown to improve health outcomes including weight loss.(9, 10) 
The combination of objectively monitored physical activity with internet-mediated 
feedback results in a potent lifestyle change intervention that is relatively inexpensive 
when implemented on a large scale.(11) Our previous research has demonstrated that by 
using remote monitoring, tailored motivational messaging and online coaching, it is 

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possible to deliver a low cost, implementation friendly, yet intensive, tailored physical 
activity intervention.(4, 5, 12, 13).  
 
In Veterans, technology-mediated pedometer-based walking programs with web-based 
feedback have been shown to increase physical activity and decrease weight. In a pilot 
study using an uploading pedometer with internet-mediated feedback for obese Veterans, 
average weight loss among the 12 participants was just over 4 lbs (paired t test, P = .004) 
and mean daily step counts increased by 1339 steps per day, or 0.6 miles per day (P = 
.04).(6).  Additionally, in Veterans Walk For Health study, 255 obese Veterans with risk 
factors for cardiovascular disease were randomized to one of three different walking 
programs (time-based walking goals, simple pedometer and uploading pedometer with 
web-based feedback). Those in the technology-mediated arm lost significantly more 
weight than those in either time-based walking goals or simple pedometer arms.(14)  
 
Two recent randomized controlled trials in non-Veteran populations used the objective 
physical activity-monitoring device, Bodymedia Fit (BMF), similar to the Fitbit device that 
will be used in this trial. In both previous trials, interventions yielded more weight loss than 
in standard group-based behavioral weight loss programs. In the first trial, by Pellegrini 
and colleagues (3), 51 subjects (age: 44.2 ± 8.7 years, BMI: 33.7 ± 3.6kg/m 2) 
participated in a 6- month behavioral weight loss program and were randomized to one of 
three groups: standard behavioral weight loss, standard behavioral weight loss plus BMF 
system or BMF system only. At 6 months, those in the BMF only arm lost 5.8 ± 6.6kg 
compared to 3.7 ± 5.7kg in the standard behavioral weight loss program (P < 0.001). 
However, more weight was lost by those randomized to BMF plus traditional counseling 
arm (8.8 ± 5.0kg). In a similar trial by Blair and colleagues (2), with 197 participants 
randomized to four arms (a no intervention control, a standard behavioral weight loss 
group, a BMF-only arm and a combination arm with both the weight loss group and the 
BMF intervention), those in the BMF-only group lost 3.55 kg compared to 1.86 kg in the 
behavioral weight loss group and .89 kg in the no-intervention control group (p < .0001).  
 
Numbers of women OEF/OIF/OND Veterans are increasing, and women respond 
differently than men to physical-activity promoting interventions. The recent wars in 
Iraq and Afghanistan have engendered a growing population of women Veterans seeking 
health care through the Veterans Affairs (VA). In the last decade, the number of women 
Veterans utilizing the VA has nearly doubled from 159,000 in FY00 to over 315,000 in 
FY10, outpacing the growth rate in the male Veteran population.(15) As the population of 
women Veterans seeking care in the VA increases and as the average age of this 
population decreases, preventive services for women Veterans become more important. 
In non-VA populations, gender is known to moderate efficacy of weight loss interventions. 
(16-18) For example, among users of a commercial web-based weight loss program, men 
using the exercise diary were more likely to lose weight, but not women. On the other 
hand, online forums were significantly associated with weight loss in women, but not for 
men.(18) Our recent pilot study of home-based weight loss programs in OEF/OIF/OND 
Veterans, (described in more detail below) provided qualitative confirmation of this 
interaction with women Veterans emphasizing the importance of the support they 
received from the online forums while men focused on the positive effect of diet and 

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exercise tracking (unpublished data). Women also differ from men in their motivational 
responses to exercise-promoting messages. For example, women have a more positive 
motivational response to exercise-promoting messages that emphasize daily wellbeing 
than they do to messages emphasizing weight loss; however, the opposite is true for 
men.(17) Because of the known gender differences in response to physical activity 
interventions, gender-tailored physical activity programs for Veterans are likely to 
serve both men and women in the OEF/OIF/OND population better than generic, 
untailored physical activity interventions.  
 
VA MOVE! and other available physical activity programs are not optimized to 
serve OEF/OIF/OND Veterans. The VA Health Systems’ MOVE! Program, initiated and 
supported by the National Center for Health Promotion and Disease Prevention (NCP), is 
an innovative and broad-reaching program of lifestyle modification targeting Veterans with 
body mass index (BMI) > 30 or those who already have multiple cardiovascular disease 
risk factors. The MOVE! Program is generally delivered in facility-based group classes 
and it emphasizes moderate-intensity physical activity such as walking. MOVE! 
participants are given a pedometer to track walking. While MOVE! is a well-designed 
standard group-based behavioral weight loss program, it was designed for older and 
sicker Veterans. Younger OEF/OIF/OND Veterans have different needs, preferences and 
demographics and may be better served by a program like Stay Strong. Stay Strong is a 
remotely delivered, internet- and smart-phone-mediated intervention that is more 
convenient for Veterans who are often employed and who may find it difficult to attend a 
facility-based program regularly. Stay Strong is not limited to Veterans who are already 
obese or who already have cardiovascular risk factors. Instead it emphasizes both weight 
loss for obese Veterans as well as primary prevention of obesity for those who have not 
yet gained a significant amount of weight. Rather than providing participants with a 
pedometer that tracks walking, Stay Strong uses newer technology, the Fitbit device that 
can objectively assess wider range of physical activity preferred by OEF/OIF/OND 
Veterans including  higher intensity physical activity and resistance exercise such as 
weight lifting.(7). Stay Strong is designed to address the unique needs, preferences, 
and demographics of OEF/OIF/OND Veterans. 
3.0 
Objectives 
 
SPECIFIC AIMS 
Anticipated Impacts on Veteran's Healthcare: Veterans from Afghanistan and Iraq 
(OEF/OIF), despite their relatively recent active duty status, are at high risk for becoming 
overweight and obese, with 86% overweight or obese at their first visit to the VA in one 
recent study.(1) However, existing VA programs such as MOVE! are not designed for 
these younger Veterans who are more comfortable with technology-mediated 
interventions than older Veterans and who may not yet have developed obesity-related 
chronic disease. Additionally, OEF/OIF/OND Veterans include a relatively high 
percentage of women compared to previous Veteran cohorts. These differences between 

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OEF/OIF/OND Veterans and older Veteran cohorts have important implications for 
lifestyle intervention design. This project will test the feasibility and effectiveness of the 
prevention-focused, internet-mediated healthy lifestyle Stay Strong program tailored to 
the needs, preferences and demographics of OEF/OIF/OND Veterans. If successful, the 
Stay Strong program could be implemented as a national program to augment the VA’s 
current panel of options for OEF/OIF/OND Veterans who need support to maintain a 
healthy lifestyle and prevent future disease.  
Project Background: Technology-mediated lifestyle interventions that include 
continuous, objective home monitoring of physical activity, automated internet-mediated 
feedback, and e-coaching increase physical activity and improve weight loss in non-
Veteran populations.(2, 3) When delivered on a large scale, such interventions represent 
low cost but effective alternatives to face-to-face lifestyle change interventions. The VA 
health care system, with its national electronic medical records system and well 
established patient facing e-Health portal is in a strong position to implement such 
interventions on a national scale. Such interventions can be centrally administered and 
marketed directly to Veterans, capitalizing on economies of scale, expanding intervention 
reach and reducing the burdening of recruitment on the existing health care team. 
Technology-mediated physical activity programs that include continuous, objective 
home monitoring of physical activity, automated internet or cell-phone mediated 
feedback and e-coaching (4-6) have been tested in Veterans, but with the exception of 
one pilot study, such interventions have not been prevention focused and have not 
addressed differences in needs, demographics and preferences specific to OEF/OIF/OND 
Veterans.  
Barriers and facilitators to implementation of centrally administered, automated, internet- 
or cell-phone mediated interventions employing objective physical activity monitoring 
devices and marketed directly to Veterans are likely to be different than those for face-to-
face interventions. In such interventions, issues of scalability, data security, privacy and 
patient safety overshadow traditional implementation issues such as facility buy-in, 
provider work flow and intervention fidelity. Implementation barriers unique to this type of 
automated, centrally administered and remotely delivered, prevention-focused 
intervention have not been studied in the VA.  
Stay Strong Specific Aims:  
1. To evaluate in a randomized control trial the impact of an automated, centrally 
administered, internet-mediated, physical activity intervention, Stay Strong with coaching, 
on the primary outcome of average minutes of moderate to vigorous physical activity 
among OEF/OIF/OND Veterans who receive care in the VA health system.  

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2. To evaluate the impact of Stay Strong with coaching on the secondary outcomes of 
weight loss, depression and pain among OEF/OIF/OND Veterans who receive care in 
the VA health system.  
3. To test for moderation of the intervention effect of the Stay Strong with coaching 
intervention by gender with respect to the primary outcome of minutes of moderate to 
vigorous physical activity per day, as well as secondary outcomes of weight loss, 
depression and pain. 
Hypotheses: 
H1: OEF/OIF/OND Veterans who participate in the Stay Strong with coaching intervention 
will increase their mean daily minutes of moderate to vigorous physical activity by 10 
minutes or more at 1 year compared to a Stay Strong control group. 
H2: OEF/OIF/OND Veterans who participate in the Stay Strong with coaching intervention 
will lose 4 lbs more on average at 1 year compared to a Stay Strong control group. 
H3: The Stay Strong with coaching intervention will be equally effective for both men and 
women OEF/OIF/OND Veterans and there will be no statistically significant interaction 
between gender and treatment arm on the primary outcome of mean minutes of moderate 
to vigorous physical activity per day 
The theoretical orientation of Stay Strong with coaching is informed by the information-
motivation-behavioral skills (IMB) model and self-regulatory theory.  Both models have 
been successfully applied to physical activity and describe processes of behavior change 
mediated through goal attainment and skills mastery and acknowledge the central role 
that self-efficacy plays in sustained behavior change. 
The IMB hypothesizes that cognitive and behavioral skills are a prerequisite for any health 
behavior change like increasing physical activity. However, skills are the product of 
information that is relevant to health problem and personal and social (i.e. social support) 
motivation to change behavior. Thus, information interacts with motivation to enhance 
self-efficacy and build skills mastery to facilitate sustained behavior change. Informed by 
our pilot data and the IMB, we will boost social support and information transfer though a 
key strategy of Stay Strong, the e-coaching support component. E-coaches will act as a 
source of social support. Also e-coaches will provide information to enhance motivation 
and facilitate goal setting through 1) helping interpret Fitbit device feedback about past 
goal attainment and assistance in setting realistic future goals grounded in the objective 
physical activity monitoring provided through Fitbit device; 2) providing tailored 
motivational messages to help overcome barriers to lifestyle changes; and 3) facilitating 
connections with local VA and community resources. 

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The theory of self-regulation also informs the core components of Stay Strong with 
coaching. In self-regulation, individuals participate in self-directed behaviors. These self-
directed behaviors are thought to be managed through a dynamic feedback loop in which 
individual process information about their past behavior and integrate that information into 
their goals and motivation to change future behaviors (i.e., self-monitoring). Thus, similar 
to IMB, self-regulation involves both cognitive and behavioral processes to facilitate goal 
attainment. A key strategy of Stay Strong with coaching is enhancing motivation and 
facilitating goal setting though enhanced self-monitoring. The Fitbit device will provide 
detailed self-monitoring information through the objective measurement of physical 
activity. The self-monitoring and feedback loop will act on self-efficacy via two pathways: 
1) influencing participants’ goal setting and motivation to adhere to goals and 2) providing 
data for the e-coaches to customize motivational messages about goal attainment and 
future goal setting. Increased self-efficacy will mediate positive changes in physical 
activity and healthy eating which will, in turn, lead to secondary outcomes of weight 
control and improved overall mental and physical health status. 
4.0 
Resources and Personnel 
• Study Staff for this project will be located at 3 sites: 
o Ann Arbor 
o Durham 
o VA New England Healthcare System Newington Campus 
o VA Puget Sound Health Care System 
 
Project Team 
Member   
Project Role  
Involvement 
Access to 
Identifiable 
data? Yes/No 
Obtaining 
Informed 
Consent?  
Yes/No 
Ann Arbor  HSRD COIN Staff  
Laura 
Damschroder, 
MS, MPH 
PI 
Responsible for the 
scientific integrity and 
oversight of all aspects of 
the study 
Yes 
No 
Mona AuYoung, 
PhD 
Co-
Investigator 
Advise PI on manuscript 
preparation. 
Yes 
No 
Lorraine Buis, 
PhD 
Co-
Investigator 
Advise PI, particularly on 
mHealth technologies and 
manuscript preparation.  
Yes 
No 
Jennifer Burns,  
Data Analyst 
Obtaining  recruitment list 
and VA data about 
consented participants, 
Assisting with cleaning and 
Yes 
No 

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analyzing study data  
Richard Evans 
Data Analyst 
Assisting with cleaning and 
analyzing study data 
Yes 
No 
Gwendolyn 
Hooks, MA  
Research 
Assistant 
Mailing recruitment and 
study material, weekly 
incentive mailings, and 
technical support for 
participants. Administer the 
medical clearance protocol. 
Assisting with cleaning and 
analyzing study data. 
Yes 
No 
Reema Kadri 
Consultant 
Advise PIs on all aspects of 
study management.   
No 
No 
Hyungjin (Myra) 
Kim 
Co- 
Investigator/ 
Biostatistician 
Assisting with analyzing 
study data 
Yes 
No 
Caroline 
Richardson, MD 
Consultant 
Advise PI on all aspects of 
study design 
No 
No 
 
Durham HSRD COIN Staff 
Project Team 
Member   
Project Role  
Involvement 
Access to 
Identifiable 
data? Yes/No 
Obtaining 
Informed 
Consent?  
Yes/No 
Aviel Alkon, BS 
Software 
Developer 
Lead on database design 
and management 
Yes 
No 
Bradley Dokter, 
BS 
Computer 
Scientist 
Ensuring database set-up 
and ongoing data security 
and storage requirements 
are maintained 
No 
No 
Jennifer Gierisch, 
PhD 
Site PI/ Co-
Investigator 
Training and supervision of 
the e-coaches, messaging 
content creation, advise PI, 
manuscript preparation. 
Yes 
No 
Karen Juntilla, 
M.Ed. 
e-coach 
Responsible for conducting 
telephone sessions with the 
veterans in the intervention 
arm 
Yes 
No 
Felicia McCant, 
MSSW 
Project 
Coordinator 
/Durham Site 
PC  
Assist the PIs with all 
aspects of study 
management. Assist RA with 
medical clearance protocol. 
Assist with cleaning and 
analyzing of study data. 
Facilitate Study and Durham 
regulatory documentation/ 
maintenance 
Yes 
No 
Eugene Oddone, 
MD 
Co-
Investigator/ 
Advise PI, focus on 
prevention, Adverse Event 
Yes 
No 

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Study MD 
and medical clearance 
oversite and manuscript 
preparation 
Maren Olsen, 
PhD 
Co-
Investigator 
and Senior 
statistician 
Advise PI, Senior statistician 
performing data analysis, 
collaborating with database 
design and management 
Yes 
No 
Lesa Powell, BS 
Programmer 
Database setup and 
management 
Yes 
No 
Courtney White-
Clark, MS 
e-coach 
Responsible for conducting   
telephone sessions with the 
veterans in the intervention 
arm 
Yes 
No 
 
VA New England HCS - Newington Campus Staff 
Project Team 
Member   
Project Role  
Involvement 
Access to 
Identifiable 
data? Yes/No 
Obtaining 
Informed 
Consent?  
Yes/No 
Lori Anne Bastian 
MD, MPH 
Co-
Investigator/ 
Study MD 
Advise PI, particularly on 
gender issues and Adverse 
Event and medical clearance 
oversite, and manuscript 
preparation  
Yes 
No 
Rebecca 
Czlapinski 
Research 
coordinator 
in Newington 
Facilitate Newington 
regulatory 
documentation/maintenance 
No 
No  
Eric DeRycke 
Research 
coordinator 
in Newington 
Facilitate Newington 
regulatory 
documentation/maintenance 
No 
No 
 
VA Puget Sound Health Care System 
Project Team 
Member   
Project Role  
Involvement 
Access to 
Identifiable 
data? Yes/No 
Obtaining 
Informed 
Consent?  
Yes/No 
Kristen Gray, PhD Consultant  
Advise PI in analysis of PA 
and technology data, and 
manuscript preparation.  
No 
No 
•  We will also be utilizing the services of two vendors: 
o Qualtrics will be the vendor for our online surveys for data collection 
and to obtain informed consent.  We will be using a contract to 
ensure Qualtrics protects our research data as required.  

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o Vibrent Health will be the Stay Strong platform vendor for the 
intervention and control group. We will be using a contract to ensure 
Vibrent Health protects our research data as required. 
5.0 
Study Procedures 
 
5.1 Study Design 
Study Design: In this randomized controlled study, OEF/OIF/OND Veterans will be 
randomized into either a Stay Strong control arm or the Stay Strong with coaching 
intervention arm with equal probability for one year.  The use of a control group is 
necessary because the effect of the intervention is unknown and the control group will be 
receiving current standard of care. The primary outcome is change in average daily 
physical activity. Weight loss, pain and depression are secondary outcomes. Because 
gender moderates the impact of physical activity interventions, we will tailor Stay Strong 
on gender and oversample women. The trial will be unusual in that we will have no face-
to-face contact with participants. All participant recruitment, eligibility screening, informed 
consent, baseline assessment, randomization, intervention delivery and outcome 
assessment will be internet or phone mediated. We will mail study materials to 
participants from the Ann Arbor location.  The Stay Strong app for both groups will remain 
active for an extra 30 days to ensure that sufficient endpoint physical activity and weight 
data are uploaded. 
Risk: We identify the following risks to participation. 
• Musculoskeletal injuries including minor injuries like strains or 
sprains, and more serious injuries like fractures from slipping or 
falling if running or walking 
o Can occur from exercise for the research intervention or at the 
advice of their primary care provider. 
• Adverse cardiovascular events 
o Can occur from exercise for the research intervention or at the 
advice of their primary care provider. 
• Weight loss which could lead to changes in blood glucose or blood 
pressure requiring modifications to existing medication regimens and 
possibly causing dizziness and/or light headedness. 
o Can occur from exercise for the research intervention or at the 
advice of their primary care provider. 
• Risks associated with transmitting data online including loss of 
confidentiality 
o A risk of the research intervention alone 

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• Risks associated with use of the Fitbit device including development 
of an allergic reaction or contact dermatitis associated with the 
materials in the band 
o A risk of the research intervention alone 
• Participant frustration with any technical problems or barriers in using 
the Fitbit device or the Fitbit Connect syncing software necessary to 
transmit the data to the Fitbit servers, or the Vibrent Health app, 
necessary to view the intervention or control platform 
o A risk of the research intervention alone 
To minimize the risk associated with starting a diet and exercise program, 
automated goals and health coaches will guide participants to gradually increment 
their physical activity and to maintain a healthy balanced diet. This proposal targets 
younger Veterans all of whom have recently returned from active duty. As such 
their risk for adverse cardiovascular events even with vigorous exercise is very 
low. To mitigate even this small risk, health coaches and research staff will be 
trained to screen for and respond to any reports of chest pain or other concerning 
cardiovascular symptoms reported by participants during the study. If a patient is 
temporarily suspended from the study due to a serious adverse event that may be 
a contraindication to diet, exercise or weight loss, we will require medical clearance 
from a provider before returning to active status in the study. Additionally, health 
coaches will assist veterans with setting gradually incrementing physical activity 
and diet goals. 
To minimize the risk of loss of confidentiality, identifying data will be stored on a secure 
VA server behind the VA firewall, on vendor servers covered under a contract (Qualtrics 
or Vibrent Health), or on the Fitbit servers.  The Fitbit Connect software, which collects 
and stores IP address at each data transmission, is not covered under a contract, but we 
will require the participants to complete an online HIPAA form to authorize this collection 
and temporary storage.  Additionally, to protect participants PII, we will direct that they 
participants use a nickname that is not their real name when registering in the Stay 
Strong app. Email is not required anywhere. The study team will use aliases info to 
register the participants with a study Fitbit account prior to sending devices to 
participants. 
 
Participants will be warned in FAQs to monitor for a rash related to the band. 
Participants who report a rash from the band will be removed from the study. 
If successful this intervention will add to VHA’s prevention “toolkit” and will improve 
physical functioning for OEF/OIF/OND Veterans, which, in turn, will reduce the 
burden of chronic illnesses. 
 
Study Population: The proposed population for Stay Strong are OEF/OIF/OND 
Veterans who may also be students, could be employed by the VA, are women 
who are in their childbearing years, or may be economically or educationally 

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disadvantaged due to the poor job market for returning Veterans.  While highly 
unlikely, some of our OEF/OIF/OND Veterans could have terminal diagnoses but if 
they self-report they have not been told by a healthcare provider that it is unsafe 
for them to participate in an exercise program, they can participate in this minimal 
risk program. 
Our recruitment pool will include up to 30,000 individuals, but we will consent up to 
750, and randomize 350. 
Vulnerable population protection – pregnant women: Pregnant women will always 
be reminded to consult with their healthcare provider on appropriate diet and 
exercise first.  Women who self-report as pregnant at any of the three assessment 
points (baseline, 6 month and 12 month) will not be included in physical activity 
and weight loss analyses. 
 
Potential Study contacts:  
The study will use the following methods to contact participants during the course of the 
study: 
• Recruitment/Invitation letter:   
• Welcome letter 
• Technical call: Call to provide technical assistance with using the Fitbit device, 
Fitbit connect software, Vibrent App or weight scale connection to the Vibrent App.  
• Vibrent App Reminder messages  
• Outcome Assessment Due ltr/call/text message: Used to proactively inform 
participant that it is time to complete their 6 & 12 month outcome assessments and 
to watch for a notification within the Stay Strong app.   
• Unable to contact letter/call/text message: If necessary used in case we are unable 
to reach participants prior to baseline randomization or at 6 & 12 month outcome 
assessments and they were not responsive to program messages from phone or 
app. If participants respond to call we will offer to complete survey on the phone 
with them for their convenience.  Also used by coach to reach intervention 
participants for coach calls if necessary. 
• Thank you letter 6 &12 month: Used to thank participant for completion of outcome 
assessment and provide a method to deliver study payment.  
• Baseline Feedback letter: A template for providing participants with overview of the 
baseline characteristics of study participants.  
• Study results Feedback letter:  A template for providing participants with final study 
results. 
 
5.2 Recruitment Methods 
Number of Subjects: 

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We plan to consent up to 750 Veterans.  Due to the lengthy process of randomization and 
the steps involved, we are anticipating a drop-out rate of up to 50% of those consented.  
We plan to block randomize 350 Veterans by gender, physical activity level and smart 
phone operating system into the two groups on a 1:1 ratio, with 175 per arm.      
Subject Identification: 
To identify up to 30,000 OEF/OIF/OND Veterans under the age of 65, we will use 
the OEF/OIF/OND Roster from the VHA Support Service Center (VSSC) or the 
current VA resources in CDW to identify the necessary participants.  Using the 
scrambled SSNs from the OEF/OIF/OND Roster we will retrieve current mailing 
addresses via the VHA Corporate Data Warehouse (CDW) dataset, located at the 
Austin Information Technology Center via the VINCI or another secure platform.  In 
the event we are unable to use the OEF/OIF/OND Roster, we will use CDW data 
fields related to OEF/OIF/OND status. 
 
Recruitment Steps: 
Participants will be mailed an invitation letter with steps to enrollment and a brief 
study overview sheet.  Those who complete the online eligibility screening and 
screen eligible will be invited to complete the Informed Consent document by 
clicking “yes” on a radio button.  Those who consent to participate will then be 
directed to an online HIPAA form to complete by clicking a “yes” radio button.  After 
completion of both the consent and online HIPAA the participants are directed to 
complete the baseline survey online and to provide their contact information.    
Those who complete the baseline survey and contact information form will be 
directed to install and use the Stay Strong app administered by Vibrent Health to 
verify that they are able to use the system. A welcome package will then be sent to 
the participants. It will contain a welcome letter, devices (Fitbit device & Scale), 
instructions for syncing devices, FAQs document. Participants will be instructed to 
set up the devices and use them for next two weeks. Participants will use the Fitbit 
device and scale throughout the year of program participation. If the participant has 
not met the required amount of daily wear in order to be randomized, Ann Arbor 
study staff members will call the participant to follow-up, and a new date for data 
transmission will be set to attempt to obtain the required data.  Staff will work with 
the participant to set transmission dates which are sensitive to the needs of the 
participant, with the final call to set a new date of transmission to occur 
approximately 6 weeks since the device was issued to the participant.  After 3 total 
attempts to collect data have failed, the participant will be withdrawn from the 
study. 
If the participant is unable to install or use the Fitbit Connect software to transmit 
the device data, or to install or use the Stay Strong app to view the data, the 
participant will be withdrawn from the study. 
Groups: 
Stay Strong Description:  

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Participants randomly placed in the Stay Strong group will be encouraged to 
wear the Fitbit device during waking hours and to upload the device data via 
the Fitbit Connect software on their computer weekly.   Participants will also 
be reminded to follow-up with their healthcare provider as needed for the 
next 12 months.  Participants will be asked to complete a survey on the 
Qualtrics website at 6 months and 12 months after the date of 
randomization. Participants will have access to the Stay Strong mobile app 
showing a dashboard based on their uploaded data. Throughout the 
program period, the app will send reminder messages asking the participant 
to inform the study staff of any changes to in their medical condition. 
After completing the 12-month survey and a final Fitbit device upload, the 
participants’ study-issued Fitbit accounts are deactivated, and the 
participant will be able to setup their own personal account at their 
discretion.    The Fitbit device and scale are kept by the participant at the 
end of the study.  At this time, the use of the Fitbit device and access to the 
data uploaded to the Fitbit servers is free for the lifetime of the device.  We 
cannot guarantee indefinite access to the Fitbit system after participation in 
the study is complete.   
 
Stay Strong with coaching Description: 
Participants randomly placed in the Stay Strong with coaching group, will receive 
everything described for the Stay Strong Program.  In addition, each week the 
participant will receive a new physical activity goal that has been automatically 
calculated and personalized for the participant. They will also receive tips to help 
them stay engaged in healthy lifestyle habits and personalized motivational 
messages through the Stay Strong app approximately 3 days per week.  
Participants will have up to 3 phone calls with the Stay Strong e-coach within the 
first 9 weeks of the study. The coach will have access to participants’ survey 
responses and synced Fitbit data and will work with them to help them meet their 
physical activity goals. The e-coaches calls will be recorded for quality control and 
education purposes for our VA coaching staff.  
Recruitment materials: 
• All participants will be sent a recruitment letter that includes a brief overview 
of the project and instructions to log onto the survey site for more details on 
the study and how to enroll for participation.    
• The other recruitment documents will be embedded in the Qualtrics survey 
site that the participants log into and will contain the approved HIPAA 
authorization and study information sheet, as well as the screening eligibility 
survey, baseline survey, contact information survey and instructions for 
downloading the Stay Strong app administered by Vibrent Health.    

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• The welcome package will include the welcome letter with instructions for 
syncing devices (Fitbit device & Scale), the devices, a copy of the Study 
information sheet, HIPAA form and a FAQs document. 
• Communication materials and FAQs within the app may be periodically 
updated to reflect changes in technology that are outside study control  
 
 
Medical Clearance: 
The designated study staff administers the medical clearance process. The Medical 
Clearance form is provided to participants who are suspended from the study due to 
concerns about participant safety.  The form is mailed to the Veteran at the time of 
suspension (or after the Veteran indicates ability to return to exercise) and the Veteran is 
directed to complete the form and take it to their provider for signature.  The provider may 
fax the form back to designated study staff that can reactivate the participant as indicated, 
or the participant can return the completed form in a provided postage paid and pre-
addressed envelope.  We expect few medical suspensions for this project due to this 
younger and healthier cohort.   Participants will require a new medical clearance form for 
each suspension. If a participant calls or responds in survey that they are in crisis 
(suicidal) we will us the Ann Arbor VA standard operating procedures to assist the 
participant. These events will be considered a serious adverse event and will need to be 
reported by the study team. 
Payments: 
Participants are provided with a $25 gift card at 6 and 12 months as compensation 
for the time and inconvenience of completing the study surveys.  The full survey 
must be submitted, but blank surveys will be accepted as “completed” surveys.   
The $25 gift cards will be from a national or online retailer (e.g. WalMart, 
Amazon.com) and will be mailed from the Ann Arbor VA to the mailing address on 
file on a weekly basis using the 6 or 12 month thank you letter. 
 
5.3 Informed Consent Procedures 
Due to the nature of the recruitment strategy for this project, obtaining written informed 
consent and the documentation of it is impracticable and we are requesting a waiver for 
the entire study.  Participants will not be meeting with study staff in person.  Instead, they 
will receive a brief overview of the project with the study recruitment/invitation letter. Full 
study information will be provided on the Qualtrics website.  Additionally, a full copy of the 
study information document as well as the HIPAA form will be mailed with the welcome 
package.  The recruitment letter invites interested participants to go to the Qualtrics study 

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web address and enter a participant-specific code listed in their recruitment letter to gain 
more information about the study and to take a brief eligibility survey.  
Participants who are eligible and who wish to enroll in the study must first review a digital 
version of the Study Information Sheet and then click a radio button on the website with 
their decision to participate.  The options: 
1) 
“Yes, I consent and agree to participate in this research study.”  
2) 
“No, I do not consent and do not wish to participate in the research study.”  
3) 
“Not yet.  I am interested but I have questions and would like to talk to a member of 
the study staff.” 
Those who choose 1 will proceed on to review the online HIPAA Authorization page.  
Those who choose option 2 are thanked for their time and consideration via a message 
on the website with no staff follow-up/contact.  Those who choose option 3 are directed to 
call the study hotline to speak with a staff member and may not continue beyond that 
point until a staff member talks with them and re-sets the question for them on the 
website.  The participant could then choose 1, 2, or 3 again as desired. 
Participants who have consented must next review a digital version of the HIPAA 
Authorization sheet and then click a radio button on the Qualtrics website with their 
decision to participate.   
The options: 
1) 
Yes, I give my authorization (permission) for the use and disclosure of my 
individually identifiable health information per VA Form 10-0493.  
2) 
No, I do not give my authorization (permission) and do not wish to participate in the 
research study per VA Form 10-0493. 
3) 
Not yet.  I am interested but I have questions and would like to talk to a member of 
the study staff. 
Those who choose 1 proceed on to the baseline survey.  Those who choose option 2 are 
thanked for their time and consideration via a message on the website with no staff 
follow-up/contact.  Those who choose option 3 are directed to call the study hotline to 
speak with a staff member and may not continue beyond that point until a staff member 
re-sets the question for them on the website.  The participant could then choose 1, 2, or 3 
again as desired.   
Study team members do not obtain informed consent or HIPAA authorization over the 
phone, but instead review the study protocol and answer any participant questions before 

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directing the participant back to the Qualtrics website.  At no time will the participant be 
directed to contact Qualtrics staff to discuss the study or surveys. 
Those who consent and who complete the baseline surveys are sent a written copy of the 
Study Information Sheet and HIPAA form with their study materials. 
Participants who do not respond to the recruitment mailing will not be contacted by study 
staff. 
5.4 Inclusion/Exclusion Criteria 
 
Inclusion criteria 
1. OEF/OIF/OND Veteran 
2. Can identify a VA Medical Center and VA Health Care Provider responsible for his/her 
care in the system 
3. Interested in starting a physical activity program in the next 30 days 
4. Access to a computer with an internet connection and a working USB port 
5. A smartphone running a compatible iOS or Android operating system 
6. Younger than age 65 
 
Exclusion criteria 
1. Veteran self-reports that a health care provider has told the patient that it is currently 
unsafe to exercise in an unsupervised or unmonitored setting.  
2. History of eating disorders or a BMI < 20 
3. Not competent to consent to a research study by self-reporting a legal guardian who 
makes medical decisions for the Veteran. 
4. Have worn a Fitbit device or other physical activity sensor within the last 30 days (we 
will allow users of lifestyle (including PA) apps who do not use a wearable device) 
 
Justification:  The inclusion criteria ensure our participants are OEF/OIF/OND Veterans 
who are current users of VA Healthcare (our target population) who would be willing to 
participate in an exercise program and have the computer and Internet access and skills 
necessary to interact with the Stay Strong app and therefore the entire intervention.  The 
exclusion criteria ensure that our participants can safely participant in an exercise 
program. 
5.5 Study Evaluations – see attached. 
• Eligibility screener (Qualtrics) 

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• Baseline survey (Qualtrics) 
• Contact information update sheet (Qualtrics) 
• 6 month survey (Qualtrics)  
• 12 month survey (Qualtrics)  
 
5.6 Data Analysis 
 
All data will be analyzed by the statistical team in Ann Arbor unless specified otherwise.   
Recruitment Pool: A research study conducted by Dr. Richardson which used a similar 
recruitment strategy had a 2.5% response rate, so we feel that 30,000 potential subjects 
will be required to reach our target Consented number. 
Sample Size – Consented:   Due to the lengthy process of randomization and the steps 
involved, we are anticipating a drop-out rate of up to 50% of those consented.  In order to 
meet our target number of randomized Veterans, we will be consenting up to 750 
Veterans.   
Sample Size – Randomized: The sample size estimate is based on the primary 
hypothesis: OEF/OIF/OND Veterans randomized to the Stay Strong with coaching 
intervention arm will have greater mean minutes of moderate to vigorous physical activity 
at 12 months than OEF/OIF/OND Veterans randomized to the Stay Strong control arm. A 
10 minute differential improvement at 12 months will be the definition of a minimally 
clinically significant difference. This represents the differential between the intervention 
and control arms at 12 months; therefore, the power and sample size considerations 
apply even if the control arm mean also improves over the 12-month study period (i.e., 
“volunteer” or “placebo” effect). For example, if the Stay Strong control arm improves from 
53 to 60 minutes, we will have adequate power to detect a 10 minute differential 
improvement – the Stay Strong with coaching intervention arm improves from 53 to 70 
minutes. Sample size calculations are based on ANCOVA methods as presented in Borm 
et al.(76) We used data from the LEAN study(2) and our feasibility study (unpublished 
data) to estimate quantities needed for the sample size calculation. We anticipate a 
common mean 53 minutes, a standard deviation of 28 minutes in both treatment groups 
at baseline, and a correlation between baseline and 12 months equal to 0.49. Finally, 
based on previous studies, we estimate a 25% attrition rate by 12 months. To be 
conservative against deviations from our assumptions, we set our power to be 90%. From 
the calculation, we determined that we will need to enroll and randomize 350 patients 
(175 in each group) to detect a 10 minute improvement at 12 months with 90% power 
and a type-I error of 5%. 

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Descriptive statistics, including graphical displays, will be used to summarize all study 
variables overall and by intervention arm. Evidence of imbalance in baseline 
characteristics will be noted and discussed as to whether they are clinically significant. As 
recommended by CPMP guidelines we will consider sensitivity analyses adjusting for 
these baseline characteristics to ensure that an observed intervention effect is not due to 
this baseline imbalance. 
Intent-to-Treat Analysis. All of the proposed primary and secondary analyses focus on the 
effect of Stay Strong as compared to control. We, therefore, plan to use the intent-to-treat 
assumption for all analyses; participants will be analyzed as part of the group to which 
they are randomized, regardless of intervention adherence. Women who self-report 
pregnancy at any of the three assessments (baseline, 6 month, 12 month) will not be 
included in the analyses for the primary outcome of physical activity or for weight loss. 
Primary Analyses. The first primary outcome is mean number of minutes per day of 
moderate to vigorous physical activity as measured by the Fitbit device at baseline and 12 
months. The between-group comparison in physical activity from baseline to 12 months 
will be examined with the following model: 
Yit = β0 + β1StayStrong*month12 + β2*obese*month12 + β3*gender*month12 + 
β3*physical_activity*month12 
Where Yit is minutes of physical activity for subject i at t=month0, month12. This model is 
often referred to as a constrained longitudinal data model (cLDA)(75) in which baseline 
physical activity is modeled as a dependent variable in conjunction with the constraint of a 
common baseline mean across the treatment groups. In this way, the cLDA model is 
comparable to an ANCOVA model. However, unlike an ANCOVA, subjects who are 
missing the month 12 physical activity measurement are included in the model because 
baseline is part of the response vector. The between-group comparison will also be 
adjusted for the dichotomous stratification variables: obese, gender, and physical activity 
level. We will estimate the parameters in the model using the SAS procedure MIXED 
(Cary, NC), and we will test to see if there is a difference in mean physical activity at the 
end of the intervention period between the Stay Strong and control groups. 
Secondary Analyses. The secondary outcomes of weight loss, depression and pain will 
be analyzed using the same methods and models as presented above for the primary 
outcome of physical activity. To test for moderation of the intervention effect of the Stay 
Strong intervention by gender, the model specified above will be expanded to include the 
gender by Stay Strong interaction. 
VA utilization and expenditures. To determine which programs are most effective, 
historical and future VA utilization and expenditures will be examined by the Durham 
team.   Medical records data (using approved VA data bases) will be reviewed for up to 

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two years prior and two years following each subject’s study participation to assess VA 
utilization and VA total expenditures.  Medical record data will include: name, scrambled 
SSN, DOB, race, sex; lab results and dates; vitals and dates; date and nature of all 
clinical visits or encounters, and tests; cost information.   Data from this part of the study 
will be analyzed by study staff at the Durham VA as part of the CREATE- Project 4 - Risk 
Stratification; CRE-306, Durham IRB 01771.   
 
5.7 Withdrawal of Subjects 
• Participants may be withdrawn from the study without their consent if 
the PI feels that it is unsafe for the participant to continue to 
participate. 
• Participants may be withdrawn from the study without their consent 
for failure to comply with study protocol.   
• Participants may be withdrawn from the study without their consent if 
they are unable to provide Fitbit device data that meets the minimum 
number of hours of required wear for randomization purposes, or if 
they are unable to access the Vibrent app.  Participants can withdraw 
from the study at any time by contacting the study staff via the study 
hotline or by written request. 
6.0 
Reporting 
 
Because this is a minimal risk study involving a telephone and app-based intervention 
similar to those commonly available to any U.S. adult, we do not anticipate serious 
adverse events triggered by participation in the study. However, safety information will be 
monitored at each interaction with the patient by the Prevention Coach via telephone 
sessions and participants will be requested to call the study toll-free voicemail hotline to 
report any adverse events or unanticipated problems. Due to the age range and relative 
health of the participants identified for participation in the study, hospitalizations and other 
health events, including diagnosis of new medical conditions, surgeries, ER visits, 
unrelated  to the study are expected.   Any events that fall into one of these categories will 
be reported at continuing review.  It is also expected that participants will miss phone calls 
during the required time window and the 6 or 12 month outcome assessment survey and 
we will not consider either of these events protocol deviations.   Study physicians (Drs. 
Bastian and Oddone) will be on call at all times.  
Every 90 days for all randomized participants, to begin after the first participant is 
randomized, a notification within the app will be sent to remind participants to report any 

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adverse events.  Those participants who have been in the program fewer than 30 days 
will not receive a notification, so their first AE notification will be within 120 days of their 
randomization to reduce burden on those participants who have not been in the study 
very long.  Monitoring of the hotline and mailing of all study materials will occur at the Ann 
Arbor site by the project team. 
A study physician (co-investigator) will review all adverse events identified by the 
research team.  All adverse events reported will be briefly summarized in a tracking 
database form with an alert flag added to prompt a return call to the participant by the 
designated project team member for full classification of the AE and to initiate SAE or 
other CIRB required reporting, and medical suspension and re-clearance process initiated 
as required. The staff will use the CIRB Adverse Event protocol and Ann Arbor suicide 
protocol to ensure standardization of reporting.  
• 
Neither the Ann Arbor staff monitoring the study hotline nor the e-coaches in 
Durham are clinicians. 
• 
The first response to any participant complaining of new or worsening symptoms is 
to advise the participant to speak with their provider – this is to occur whether the 
participant is speaking with an e-coach at the Durham site or to Ann Arbor staff.  The 
study team members do NOT provide medical care or provide medical advice to 
participants except to direct participants to seek medical attention.   
• 
Participant study materials will have the following notice at the bottom of all 
messages, technical instruction documents, or incentive letters, etc.: “Any changes in 
your medical condition should first be reported to your primary healthcare provider. 
We also want you to report changes in your medical condition to us by telephone”. 
• 
The staff that will be following up on AEs have a combined 7 years of experience in 
working with participants participating in Internet-mediated physical activity 
interventions under the study physician.  
• 
All AEs are classified by research team, under the study physician’s supervision 
and continued monitoring, by the following criteria: seriousness, severity, 
expectedness, relatedness, whether the incident occurred during or after exercising 
for the program, and whether the participant has contacted their medical provider.  All 
of the classifications and general information about the incident (including date/time of 
the incident and location) are entered into a database restricted to study staff which 
allows tracking and prompts follow-up of unresolved issues. 
• 
All AEs meeting or possibly meeting Central IRB definitions of serious are 
reviewed with the study physician within 24 hours of first receipt. 

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• 
All AEs which indicate that it might not be safe for the patient to continue an 
exercise program (repeated falls, low blood sugar episodes, dizziness, etc.) are also 
reviewed by the study physician with 24 hour of first receipt. 
• 
The staff are trained to “suspend first, ask questions later”:  Upon learning of a new 
AE, the participant is advised to seek medical attention and that they are currently 
suspended from the program, to NOT exercise to meet any study-provided goals, and 
that the study physician may require that the medical clearance process be completed 
before the patient may resume active participation. 
All SAEs will be continuously monitored, and total number of AEs will be tabulated every 
six months by the study groups and by their relatedness.  We will also utilize graphs to 
display the data such as relative risks of presence of any related AEs in one group over 
the other, and similar summary measures over time.  In general, the safety data will be 
assessed using descriptive summaries as the study is not powered to detect safety 
difference. 
We will have monthly conference calls with all staff to monitor research activities, with 
weekly calls as needed.  All staff will be directed to report any SAEs, protocol deviations, 
and unanticipated problems to the Project Coordinator as soon as possible.  The Project 
Coordinator or the PI will submit the appropriate forms via the VA Central IRB SharePoint 
or contact a VA Central IRB representative for guidance if the concerning issue does not 
appear to correspond to existing reporting forms. Privacy complaints will be reported to 
the Privacy Officer within one-hour of discovery. 
7.0 
Privacy and Confidentiality 
 
PHI will be obtained from existing sources including medical records and clinical 
databases for recruitment purposes and looking at VA expenditures and utilization.  PHI 
will be obtained directly from participants as they are screened over the Qualtrics web 
survey. We will be obtaining scrambled SSNs for recruitment purposes.  We will also use 
those scrambled SSNs from randomized participants to obtain missing weight values.  
We will be obtaining Service Connected status and information about co-morbidities from 
the participants VA medical record.  To determine which programs are most effective, 
historical and future VA utilization and expenditures will be examined.   Medical records 
data (using approved VA data bases) will be reviewed for up to two years prior and two 
years following each participant’s study participation to assess VA utilization and VA total 
expenditures.  Medical record data will include: name, scrambled SSN, DOB, race, sex; 
lab results and dates; vitals and dates; date and nature of all clinical visits or encounters, 

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and tests.   Data from this part of the study will be analyzed by study staff at both the 
Durham VA and Ann Arbor VA.   
Non-VA entities will have data access as detailed below: 
Qualtrics – vendor to obtain and temporarily store survey data for the eligibility, 
baseline, 6 month, and 12 month surveys, as well as to provide the Informed 
Consent questionnaire. Respondents submit data using HTTPS (SSLv3 also 
known as TLSv1). Data are processed by application servers and sent to database 
servers for storage. Web data are delivered to the respondent in the form of survey 
questions, graphics, and other content created in the survey design. Qualtrics uses 
Transport Layer Security (TLS) encryption (also known as HTTPS) for all 
transmitted data and protect surveys with passwords and HTTP referrer checking.  
Data is stored at their C7 Data Center in Lindon, Utah.  Data stored temporarily at 
Qualtrics will be covered by a contract. 
Vibrent Health – vendor for the Stay Strong app   Participants will be able to 
review their submitted physical activity data using the Stay Strong app.  The 
security features of this vendor meet the required VA contract requirements.  We 
will be obtaining a full copy of the Stay Strong/Vibrent data for each 
participant/account for the study, and the data will be removed from the Vibrent 
servers at the end of the study.  
Fitbit Inc – manufacturer of the physical activity monitoring device and 
transmission software. The participant will be required to authorize release of their 
IP address via an online HIPAA form prior to enrolling in the study, as Fitbit does 
not have systems which meet VA data security requirements and we will not be 
securing a VA contract with Fitbit Inc.  Participants will use the Fitbit device to 
collect their data and the Fitbit Connect software to transmit the device data. The 
study team will use aliases to register the participants with Fitbit accounts prior to 
sending the devices out. The participant’s de-identified/anonymous Fitbit account 
will be deactivated at the conclusion of the study.   The data stored at the Fitbit 
servers will be deleted at the end of the participant’s study participation.   
All VA-generated electronic study data including participant identifiers such as patient 
names, phone numbers, physical mailing address, and health data will be securely 
maintained on a VA restricted server in an access-limited folder, with access given only to 
specified project staff. 
All participant-provided electronic data except Fitbit data will be stored temporarily on the 
Qualtrics or Vibrent Health servers and copies of that data will be securely transferred 
and stored on VA restricted servers. Until transfer to the VA, all data at rest are 

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encrypted, and data on deprecated hard drives are destroyed by U.S. DOD methods and 
delivered to a third-party data destruction service. 
All paper records with patient identifiers will be kept in a locked office, in locked file 
cabinets in the Ann Arbor HSR&D offices. Access to the file cabinets will be restricted to 
approved study personnel. 
VA Servers – Data for this project will be stored at both Durham and Ann Arbor VA 
medical centers.  Both the Durham and Ann Arbor Centers for Health Services Research 
computing infrastructure is comprised of a network, end-user and server hardware, 
software and applications, PCs, laptops, printers, and scanners. The computer network 
connects the end-user hardware to shared resources such as Center specific servers, 
and to local facility, VISN, and national data warehouses and computing resources. Full-
time computer and network support staff support ensure efficient operation of computer 
equipment, network, and servers. The server rooms are equipped with dedicated climate 
control and power protection systems. Both VPN access and Citrix Access Gateway 
connections are available to networked equipment. The various servers provide file 
storage, databases and supporting tools such as report generators, web applications, and 
a .NET infrastructure to support various locally developed applications. The Centers 
maintain a full complement of sophisticated software applications for statistical analysis, 
project management, and data management including Microsoft SQL 2000, DatStat 
Illume (Durham only), ACCESS, SAS, Stata, AMOS, SPSS, and R, as well as locally 
developed intervention software. All computerized data entry systems are backed by a 
series of related SQL data tables that reside on certified and accredited VA servers which 
are accessible only by designated systems administrators. Center computers have 
access to all hospital resources such as internet/intranet connectivity, CPRS, Outlook 
email, and hospital data storage resources. 
Once data has been analyzed and final data sets created for the study, we plan to share 
data with the wider research community. Patients who participated in the project will be 
sent a summary letter to thank them for their participation as well as provide them with 
de-identified summary information regarding study participants.   We will take the 
following steps to ensure that the information shared maintains the protection of patient 
privacy.   
First publications from this research will be made available to the public through the 
National Library of Medicine PubMed Central website within one year after the date of 
publication and study results will be available on Clinical Trials.gov within 1 year of the 
final follow-up with last study participant. Next, final data sets underlying all publications 
resulting from the proposed research will be available by request to researchers outside 
the VA through the provision of a de-identified, anonymized dataset under a Data Use 
Agreement (DUA), which include a written agreement prohibiting the recipient from 

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identifying or re-identifying any individual whose data are included in the data set.   A 
study statistician will certify that the dataset contains no PHI prior to distribution. Data will 
be provided to requester in electronic form. Final data sets will be maintained locally until 
enterprise-level resources become available for long-term storage and access. Guidance 
on request and distribution processes will be provided by ORD. 
8.0 
Communication Plan 
 
• All engaged participating sites must follow the most current version of the protocol, 
and use the most current version of the study information sheet and HIPAA 
authorization.  When documents are revised, the PI ensures the local site study teams 
are notified by doing the following: 
o Reviewing the change in a meeting prior to the submission of any 
amendment/modification requests to the CIRB of that change to ensure the 
needs of the local site area considered. 
o Disseminating the revised materials via email with a formal staff meeting to 
follow prior to implementation of the changed materials. 
o Audit of practices as appropriate to ensure new materials are being used as 
required. 
o All amendments and amended documents will be posted to the study folder 
upon CIRB approval. 
o Outdated study materials will be removed immediately to an archive folder. 
 
• The PI must notify the Director of any facility deemed not to be engaged in the 
research, but on whose premises research activities will take place, before initiating 
the study (when applicable).   
o  Not applicable – no research activities will take place on the premises of 
studies not engaged in research. 
 
• All amendments and modifications to the protocol and the study information sheet 
must be communicated to the engaged participating sites.  All required local facility 
approvals will be obtained, if required, before the amendment or modification is 
implemented. This will be achieved by doing the following: 
o Reviewing the change in a meeting prior to the submission of any 
amendment/modification requests to the CIRB of that change to ensure the 
needs of the local site area considered. 
o Disseminating the revised materials via email with a formal staff meeting to 
follow prior to implementation of the changed materials. 
o All amendments and amended documents will be posted to the study folder 
upon CIRB approval. 
 
 
• All engaged participating sites will safeguard VA data as required by VA information 
security policies. The PI will ensure this is achieved by doing the following: 

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o Thorough testing of the systems in place to protect data prior to study start. 
o The PI will ask that each site maintain current records of all research staff 
members’ required training certificates. 
o Bi-annual review to ensure data safety practices are being followed  
o The Health Services Research & Development IT Group at the Durham 
VAMC will monitor all equipment and databases at Durham, while the IT 
Group at Ann Arbor will do the same there.    
o All study data stored on the VA server will be backed up on a nightly, 
monthly, and annual schedule. Monthly and annual backups will be kept on 
static media throughout the duration of the study.   
o Any paper-based documents (i.e., medical clearance form) will be stored in 
a locked filing cabinet in a locked office.  
 
• SAEs that have the potential to affect implementation of the study will be 
communicated to all engaged participating sites. This will be achieved by doing the 
following: 
o  All engaged sites will be directed to review the SAE report submitted to the 
CIRB with a conference call to follow-up to ensure all parties are aware. 
 
• Study events and interim results (if appropriate) are communicated regularly to 
engaged participating sites.  This will be achieved by doing the following: 
o  Regularly scheduled team meetings 
o  Ad-hoc meetings or email conversations as needed 
 
• LSIs must conduct the study appropriately.  This will be achieved by the PI/SC doing 
the following to ensure adequate monitoring: 
o Thorough training prior to study start and ongoing. 
o  Regularly scheduled team meetings will include discussion of any updates 
to the protocol, recruitment processes, and/or any other study procedures. 
o Minutes for these meetings, and any updated documentation, will be posted 
to the study folder, to which all study staff will have access. 
 
• All non-compliance with the study protocol or applicable requirements must be 
reported in accordance with VHA Handbook 1058.01 and the VA Central IRB Table of 
Reporting Requirements.  This will be achieved by doing the following: 
o  LSIs and team members will communicate non-compliance to the Project 
Coordinator PC) and/or the PI immediately.  The PC or PI will upload the 
appropriate reporting form to the CIRB SharePoint promptly per posted 
CIRB regulations. 
 
• All local facility directors and LSIs are notified when a multi-site study reaches the 
point that it no longer requires engagement of the local facility (e.g., all subsequent 
follow-up of subjects will be performed by the PI from another facility).  This will be 
achieved by doing the following: 
o Not applicable – the local sites will remain engaged until the study is 
terminated. 

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9.0 
References 
 
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