Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking
Phase: NA
Conditions: Sedentary Behavior, Exercise, Walking, Motivation, Hypertension, Depression, Body Mass Index
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
IIR 19-450 Multiphase Optimization Trial of Incentives for Veterans to Encourage 
Walking 
MIRB #01930, IRBNet 1588237 
Funding Agency: HSR&D 
Version 12.0 
 
 
 
 
Human Subjects Protocol 
VA Puget Sound IRB 

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Abstract 
 
Regular physical activity (PA) is essential to healthy aging. Unfortunately, only 5% of US adults 
meet guideline of 150 minutes of moderate exercise; Veterans and non-Veterans have similar 
levels of PA. A patient incentive program for PA may help. Behavioral economics suggests that 
our chronic inability to start and maintain a PA routine may be the result of “present bias,” which 
is a tendency to value immediate rewards over rewards in the future. With present bias, it is 
always better to exercise tomorrow because the immediate gratification of watching television or 
surfing the internet is a more powerful motivator than the intangible and delayed benefit of future 
health. Patient incentives may overcome present bias by moving the rewards for exercise 
forward in time.  
Recent randomized trials suggest that incentives for PA can be effective, but substantial gaps in 
our knowledge prevent the implementation of a PA incentive program in Veterans Affairs (VA). 
First, incentive designs vary considerably. They vary by the size of the incentive, the type of 
incentive (cash or non-financial), the probability of earning an incentive (an assured payment for 
effort or a lottery-based incentive), or whether the incentive is earned after the effort is given (a 
gain-framed incentive) or awarded up-front and lost if the effort is not given (a loss-framed 
incentive). The optimal combination of these components for a Veteran population is unknown. 
Second, the evidence about the effective components of incentives comes from studies 
conducted in populations that were overwhelmingly female; often employees at large companies, 
with high levels of education and income. VA users, in contrast, are mostly male and lower 
income, and most are not employed. This is important because we have theoretical reasons to 
believe that the effects of components of incentives are likely to vary by income and gender. 
Finally, few studies have managed to design an incentive such that the physical activity was 
maintained after the incentive was removed. Indeed, a common theme in incentivizing health 
behavior change is the difficulty in sustaining behavior change once the incentives are removed. 
We propose to fill the research gaps through a Multiphase Optimization Strategy (MOST) trial of 
incentives for walking. A MOST trial is ideally suited for situations in which a proposed 
intervention has many potential intervention components. A MOST trial consists of three phases. 
A screening phase trial is used to efficiently identify—through a factorial designed randomized 
trial—the effective components of a complex intervention like incentives. A refining phase trial 
tests the optimal dose (size or duration) of the incentives. A confirmatory phase trial tests the 
optimal components and dose against a usual care control. The goal of the proposed study is to 
conduct the screening phase trial in 128 Veterans to identify the optimal components of 
incentives for increasing walking among physically inactive Veterans. All Veterans in this phase 
will be given various components of incentives for increasing average steps per day by 15% per 
week over a 12-week habit-building period, and then maintaining the increase through a 12-week 
habit maintenance period.  
 
 

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List of Abbreviations 
Provide a list of all abbreviations used in the protocol and their associated meanings. 
PA 
 
Physical Activity 
IPA 
 
Intergovernmental Personnel Act  
DUA 
 
Data Use Agreement 
MOST  
Multiphase Optimization Strategy  
NHANES 
National Health Examination Survey  
BMI 
 
Body Mass Index 
VA 
 
Veterans Affairs 
ERIC  
Epidemiologic Research and Information Center  
CDW  
Corporate Data Warehouse  
IRS 
 
Internal Revenue Service  
MPAM  
Motivation for Physical Activity Measurement  
ENRICHD  
Social Support Instrument  
HSR&D 
Health Services Research & Development 
PA 
 
Physical Activity 
PII 
 
Personally identifiable information  
PHI 
 
Personal Health Information  
WOC  
Without Compensation Contents 

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Protocol Title: ............................................................................................................................... 4 
1.0 
Study Personnel ................................................................................................................ 4 
2.0 
Introduction ....................................................................................................................... 4 
3.0 
Objectives .......................................................................... Error! Bookmark not defined. 
4.0 
Resources and Personnel ............................................................................................... 11 
5.0 
Study Procedures ............................................................................................................ 15 
5.1 Study Design .................................................................................................................... 15 
5.2 Recruitment Methods........................................................................................................ 19 
5.3 Informed Consent Procedures .......................................................................................... 22 
5.4 Inclusion/Exclusion Criteria ............................................................................................... 24 
5.5 Study Evaluations ............................................................................................................. 25 
5.6 Data Analysis ................................................................................................................... 28 
5.7 Withdrawal of Subjects ..................................................................................................... 29 
6.0 
Reporting ......................................................................................................................... 29 
7.0 
Privacy and Confidentiality .............................................................................................. 30 
8.0 
Communication Plan ....................................................................................................... 31 
10.0 
References ...................................................................................................................... 31 
 
Protocol Title:   
 
1.0 
Study Personnel  
[REDACTED] 
Collaborators (at other institutions, not covered under the VA IRB approval): 
Qualtrics XM: We have obtained VA licenses through central office to use the Qualtrics XM 
software to administer the participant surveys and to collect responses (interested/opt-out) from 
potential participants after receiving the recruitment letter. The opportunity to let participants 
complete the surveys online is much more patient centered and will be much easier for 
participants to fully participate in the study. Participants will choose if they want to receive study 
updates by either text/email or both. Coordinators will enter that information into Qualtrics along 
with the participant’s first name and first letter in their last name to field the survey. All responses 
will be recorded in Qualtrics and research coordinators and analysts will pull down the results 
and save them on the secure study folder in the J:drive.  
2.0 
Introduction 

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Physical activity (PA) is an inexpensive health behavior with numerous health benefits. Meta 
analyses of randomized trials have found higher levels of PA are associated with lower incidence 
of diabetes;1 fewer depressive symptoms;2 reduced blood pressure,3 cholesterol,4 and HbA1c 
levels;5 and recovery from atherosclerotic disease.6 Exercise is as effective as medication for the 
prevention of diabetes, and has benefits of life expectancy similar to those of medical therapy for 
the secondary prevention of coronary disease and rehabilitation after stroke.7 Guidelines suggest 
adults should engage in moderate exercise, such as walking, for 150 minutes per week, more 
vigorous activities, such as running, for 75 minutes, or an equivalent combination of the two.8 
The walking pace to maintain a moderate level of activity is approximately 100 steps per minute 
(30 minutes of activity translates to 3,000 steps per day). This activity should be in addition to 
normal steps taken in the course of daily activities, which leads to the familiar recommendation of 
10,000 steps per day on 5 days of each week9, or roughly 7,000 steps per day. There is nothing 
clinically significant about the 10,000-step recommendation; it is only promoted because it is an 
easy number to remember. For the present study, which includes daily incentives for walking, we 
will use 7,000 steps per day as the target.  Participants will be given a 15% increase in daily step 
count each week. 
Despite the clear benefits of moderate exercise, most adults do not achieve the recommended 
dose of PA. Accelerometer data from the National Health Examination Survey (NHANES) 
suggest that 1 in 20 adults accumulate the amount of exercise necessary to maintain health,10 
and there are no significant differences between Veterans and non-Veterans in accelerometer-
measured physical activity.11   
Patient incentives might help. Behavioral economics suggests that our chronic inability to start 
and maintain a PA routine may be the result of “present bias,” which is a tendency to value 
immediate gratification over gratification in the future. We fail to exercise today because the 
gratification associated with watching TV or surfing the web is immediate and tangible, while the 
gratification of long-run health is distant and intangible. Patient incentives may overcome present 
bias by moving the rewards for healthy behaviors forward in time. In a patient incentive program, 
patients are given tangible, timely rewards for achieving specific health goals, such as increasing 
their steps by 15% per week.  
 
There is a growing body of evidence suggesting that incentives work for some health behaviors, 
especially those that involve a single discrete act, such as receiving a vaccination12-14 or a 
screening test.14-15 Incentives are also effective at reducing long-term smoking rates.16 However, 
a common theme in incentive research is the difficulty in sustaining behavior change once the 
incentives are removed. For example, incentives are proven effective at promoting short-term 
abstinence and treatment adherence in substance abuse treatment, where it is referred to as 
contingency management,17 but contingency management has not demonstrated significant 
effects on long-run abstinence.18-20 Similarly, although two recent trials of incentives for weight 
loss found sustained effects,21,15 in most trials, the effects of incentives were not sustained after 
incentives were removed.16,14,22,23,24 Thus, a key challenge in incentive research is habit 
maintenance.  
Systematic reviews of incentives for PA25 have found positive short-term effects. However, there 
are several reasons why the literature to date does not inform the optimal design of a PA 
incentive for Veterans. First, the incentive designs used in trials have varied considerably, and 
this heterogeneity complicates drawing concrete recommendations on what incentive designs 
work best. Incentive designs can vary by the size, the duration of time over which the incentive is 
given, the type (cash or non-cash), how it is earned (through individual effort or group effort), the 
probability of earning (an assured payment for effort or a lottery-based incentive), whether it is 
earned after the effort is given (a gain incentive) or awarded up-front and lost if the effort is not 

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given (a loss incentive), and whether the subject risks part of their own income for not meeting 
their PA target (a deposit contract). Which of these designs work best in which populations is 
unknown.  
 
Second, most trials were conducted on study populations dissimilar to the VA. In studies to date, 
study subjects were overwhelmingly female and white, with high levels of education and income. 
Many studies enrolled students at a university or employees at large companies. VA users are 
mostly male and lower income, most are not employed, and likely have a higher burden of 
physical and mental health conditions. Veterans may not have access to a gym or other social 
and physical resources that could facilitate their increasing PA in response to incentives. 
Moreover, the effects of features of incentives are likely to vary by income and gender. The 
economic principle of a declining marginal utility of income suggests that cash and loss 
incentives may be more salient to lower income Veterans. On the other hand, lotteries are more 
popular among low than high income people26 and men tend to have a higher risk preference 
than women.27 Thus, the results of the previous study may be poor indicators of the optimal 
design of incentives for Veterans. Finally, few studies have managed to design an incentives trial 
where the physical activity was maintained after the incentive was removed. In sum, there is 
relatively little evidence on which design features of incentives for PA will work best for Veterans, 
especially after the incentive is removed. 
The many ways that an incentive can be configured suggest that incentives are best tested with 
a Multiphase Optimization STrategy (MOST) trial design. The MOST trial design involves 
optimizing an intervention before it is tested against a usual care control. It is optimized in the 
sense that the various components of the intervention are tested against one another in a 
screening phase to assess which components add value to the intervention, and then only the 
valuable components are included in the final intervention. It is especially useful when an 
intervention has many potential combinations of components, as is the case with incentives. In a 
traditional trial, researchers would use theory or evidence from prior studies to choose an 
incentive design and test this package against usual care. Even if this package outperforms 
usual care in a randomized trial, we cannot tell whether this was the optimal package. Some 
components could have provided no benefit to subjects or delivered in too small a dose to be 
effective but were an administrative burden to study or clinic personnel. Other components could 
have been detrimental to subjects. There is no way to know if the components are all tested as a 
single package.  
A MOST trial addresses this by breaking the experimental process into phases: a screening 
phase, a refining phase, and a confirming phase (Table 1). In the screening phase, various 
components of the intervention are tested against each other in a factorial designed randomized 
trial. In this phase, there is no usual care group; everyone in the trial receives the intervention, 
although the components of the intervention that a subject receives varies. This allows 
researchers to tease out which components of the intervention are contributing to better 
outcomes. The components that prove effective, acceptable to participants, and economical in 
the screening phase are retained for the refining phase. In the refining phase, the appropriate 
dosage—e.g., the duration or intensity of the intervention—is tested in a randomized trial. In the 
confirming phase, the components and dosages that were found to optimize the intervention are 
tested as a package against a usual care control group in a traditional randomized controlled 
trial. In the present pilot study, we focus only on the screening phase; the refining and confirming 
phases will be proposed together in a future grant submission. 
 
Table 1. Phases of the full MOST study 

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Screening phase- the present study:  
Components of the incentive intervention are tested against each other in a 24 factorial trial. 
Components to be tested: 
• 
Lottery vs. loss-framed incentive 
• 
Financial vs. non-financial incentives 
• 
Pre-commitment postcard reminder of patient’s stated intrinsic reason for commitment to PA, 
mailed during habit maintenance period vs. no pre-commitment postcard 
• 
Request for physical activity advice from Veteran vs. no request 
Refining phase:  
The intervention comprises the components of the intervention that worked best in the screening phase. 
The characteristics of the dose and frequency of the intervention are tested against each other in a 23 
factorial trial. Characteristics to be tested: 
• 
Standard ($14/week) vs. large ($21/week) incentives 
• 
Weekly vs. daily frequency of incentive 
• 
12- vs. 16-week habit formation (i.e., incentive) period 
Confirming phase: Components and dosage of the incentive from the refining phase are tested against 
a usual care control  
 
In the screening phase, a factorial designed trial28 is typically used because it is the most efficient 
way to test a variety of components of an intervention head-to-head. Factorial trials are 
underused in health research but are common in engineering and other fields that employ 
screening phase trials, as we propose in the present study. A factorial trial that tests k 
components with 2 levels for each component has 2k treatment groups. The 24 factorial design 
proposed for the screening phase of the present trial is shown in Table 1. There are 16 
combinations of factors, with 8 patients in each, for a modestly sized trial of 128 patients. 
However, each factor has 64 patients per factor level: there are 64 people receiving financial and 
non-financial incentives for meeting PA goals, respectively, and 64 patients receiving them in the 
form of a lottery and a loss-framed incentive. Every component is balanced with respect to the 
other components, which allows us to estimate the effects of all components with nearly the 
same power as if we had conducted independent trials of each component. 
 
The primary limitation of a factorial design is that the treatment factors need to be safe to use in 
combination, which is clearly the case in the proposed study. In addition, a factorial design study 
with many factors can become burdensome to administers or subjects if each factor adds 
another feature to the intervention. For example, a 24 factorial study for smoking cessation29 
included factors for nicotine gum (yes/no), nicotine patch (yes/no) behavioral counselling 
(yes/no) and motivational interviewing (yes/no) such that some patients were receiving an 
intervention with all four components. The present study only has 2 factors that are additions, 
and neither is burdensome; the other factors are variations of an element (e.g., cash/non-
financial incentive type) as described in Table 2. 
 
Another limitation of factorial designs is that interactions between factors complicate the 
interpretation of the main effects of the factors. For example, cash incentives might work better 
as a lottery than a loss incentive (although we have no theoretical reason to expect this). Cash 
would look like a favorable component among subjects randomized to the lottery incentive and 
unfavorable among subjects receiving the loss incentive, so it is not clear if cash incentives 
should survive to the refining phase or not. Moreover, because these subsamples of lottery and 
loss-incentive subjects are half the size of the full study, we have less power to detect this 
interaction effect between cash and lottery. However, interactions among factors is not a 
significant limitation of factorial designs when they are used as screening trials, as we propose 

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here. Specifically, researchers recommend choosing factors from the screening phase based on 
their main effects after controlling for all two-way interactions of the factors.28 A significant main 
effect on cash incentives, for example, means that these types of incentives perform better than 
non-financial incentives even when one takes into account the interactions between other 
factors. Interactions do not invalidate main effects. In sum, despite these limitations factorial 
designed trials are powerful tools for optimizing the design of multi-component interventions like 
incentives for PA. 
Table 2. Factorial design of the proposed screening phase trial 
 
 
Cash incentive 
 
Non-financial incentive 
Total  
subjects 
 
Mixed 
Lottery 
Loss  
Incentive 
Mixed 
Lottery 
Loss  
Incentive 
 
Request for advice- Yes 
 
 
 
 
 
Pre-commitment- Yes 
8 
8 
8 
8 
32 
Pre-commitment- No 
8 
8 
8 
8 
32 
No request for advice- No  
 
 
 
 
 
Pre-commitment- Yes 
8 
8 
8 
8 
32 
Pre-commitment- No 
8 
8 
8 
8 
32 
Total subjects 
32 
32 
32 
32 
128 
 
Eight recent and important studies are shown in Table 3. These studies were all conducted by 
the same teams of researchers and shared many characteristics. Several factors are notable. 
First, like most studies to date, 7 of the 8 studies were conducted in populations very dissimilar to 
the VA in terms of education and gender. Second, the studies clearly show that incentive design 
matters. The 8 studies included 16 incentive arms, and only 7 of the incentive designs were 
significantly different from no incentive. And some findings are not conclusive. For example, the 
combined lottery in Patel (2018) was significantly different from no incentive but the same 
incentive design in the Patel (2016a) study was not. Among the incentive designs tested, the 
design that involved incentives framed as a loss seem to have the strongest effect on PA. In this 
design, a participant is allocated points or money at the beginning of the week, and then loses 
points/money each time they fail to hit their steps goal. Third, only 4 incentive designs found step 
counts in an incentive group that were higher than the no-incentive group after incentives were 
removed. Notably, the Chokshi (2018) study had a study population that was most similar to the 
VA population in terms of education. A potential limitation of the Chokshi finding is that 
participants in the no-incentive arm did not receive daily feedback and goal setting that the 
participants in the incentive arm received, so it is not clear if the differences should be attributed 
to the incentive or other features of the incentive arm. 
Fourth, non-cash incentives can be highly motivating. The Patel (2017) study involved no cash 
incentive—only a cleverly designed social incentive. The trial enrolled teams of (generally) 2 
family members. Each week, teams in the intervention group were allocated 70 points—10 points 
for each day. Each day, one team member was chosen at random. If that person did not meet 
their goal that day the team lost 10 points. Teams that maintained a point threshold by the end of 
the study got a coffee cup. Two smaller trials, Andrade et al30 (n=30 per arm) and Petry et al31 
(n=22 per arm), found significant effects on mean step count of a lottery for gifts ranging in value 

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of $1 to $100, but these trials included twice-weekly face-to-face contacts with study personnel 
and so are difficult to compare to other studies in Table 3. 
Table 3. Recent trials of incentives for physical activity 
N= approximate number of subjects per treatment arm. IHD=ischemic heart disease. 
Sustained=step count in an incentive group higher than no-incentive group after incentives are 
removed. 
3.0 
Objectives 
Study Population: 
We will recruit physically inactive Veterans age 50-70 (69.25 at recruitment) with any of the 
following conditions: hypertension, overweight (BMI>25 and <40), diabetes or depression. These 
conditions are highly prevalent in physically inactive populations and are amenable to change 
through greater physical activity. PA confers additional benefits to people age 50+34-35,4 in part 
because of the high prevalence of these conditions2. In addition, meta-analyses of PA trials have 
Study 
Population 
Type/  
frequency 
Key finding during the incentive period 
Sustained? 
Patel 
(2016a) 
(N=70) Employees  
55% female 
98% college degree 
3 incentive arms 
Cash/ 
Daily 
• Cash Incentives framed as a loss superior to no incentive. 
• Cash Incentives framed as a gain and lottery-based 
incentive (18% change of winning $5 and 1% change of 
winning $100) were no different than no incentive.  
No 
Patel 
(2016b) 
(N=70) Employees 
60% female 
95% college degree 
3 incentive arms 
Cash/ 
Daily 
• Combined group + individual cash incentives superior to 
no incentive.   
• Individual only incentive and group-only cash incentive 
were no different than no incentive. 
No 
Patel 
(2018) 
(N=70) Employees 
75% female 
95% college 
3 incentive arms 
Cash/ 
Daily 
• Combined lottery (18% change of winning $5 and 1% 
change of winning $100) was superior to usual care.  
• A small reward lottery (25% chance to win $5) or a 
jackpot lottery (1 in 400 chance to win $500) were no 
different from usual care. 
No 
Kullgren 
(2014) 
(N=46) Employees 
72% female 
83% college degree 
3 incentive arms 
Cash/ 
Weekly 
• Group-based incentives with or without social 
reinforcement no different from usual care 
No 
Chokshi 
(2018) 
(N=50) IHD patients  
63% female  
24% college degree 
1 incentive arm 
Cash/ 
Daily 
• Cash Incentive framed as a loss superior to no incentive. 
Yes 
Patel 
(2017) 
(N=~50) Family-
based teams 
56% female 
73% college degree 
1 incentive arm 
Non-Cash/ 
Daily 
• Gamified intervention with social incentives framed as a 
loss superior to no incentive.  
Yes 
Petry 
(2013) 
(N=22) Community 
80% female 
Mean 15 yrs 
education 
1 incentive arm 
Non-cash/ 
2x-week  
• Combined lottery (42% chance of winning gifts worth $1, 
8% chance of $20 gifts, 0.2% chance of $500 gift) 
maintained a step count advantage over no incentive  
Yes 
Andrade  
(2014) 
(N=30) Community 
90% female 
Mean income $60k 
1 incentive arm 
Non-cash/ 
2x-week  
• Combined lottery of Petry (2013) with decreasing odds of 
winning over time maintained a step count advantage 
over no incentive 
Yes 

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found ample evidence that people in this age range can safely increase their level of PA through 
walking.36 We will recruit physically inactive patients because proponents of Self Determination 
Theory believe that incentives may “crowd-out” intrinsic motivation to exercise among those who 
are already intrinsically motivated to exercise at baseline. Physical inactivity is defined as a step 
count <5,000 per day.9 We are aiming to enroll physically inactive participants that walk between 
2,000-5,000 steps per day during the 2-week trial period. 
Regular physical activity (PA) is essential to healthy aging. Unfortunately, only 5% of US adults 
meet guideline of 150 minutes of moderate exercise; Veterans and non-Veterans have similar 
levels of PA. A patient incentive program for PA may help. Behavioral economics suggests that 
our chronic inability to start and maintain a PA routine may be the result of “present bias,” which 
is a tendency to value immediate rewards over rewards in the future. With present bias, it is 
always better to exercise tomorrow because the immediate gratification of watching television or 
surfing the internet is a more powerful motivator than the intangible and delayed benefit of future 
health. Patient incentives may overcome present bias by moving the rewards for exercise 
forward in time.  
Recent randomized trials suggest that incentives for PA can be effective, but substantial gaps in 
our knowledge prevent the implementation of a PA incentive program in Veterans Affairs (VA). 
First, incentive designs vary considerably. They vary by the size of the incentive, the type of 
incentive (cash or non-financial), the probability of earning an incentive (an assured payment for 
effort or a lottery-based incentive), or whether the incentive is earned after the effort is given (a 
gain-framed incentive) or awarded up-front and lost if the effort is not given (a loss-framed 
incentive). The optimal combination of these components for a Veteran population is unknown. 
Second, the evidence about the effective components of incentives comes from studies 
conducted in populations that were overwhelmingly female; often employees at large companies, 
with high levels of education and income. VA users, in contrast, are mostly male and lower 
income, and most are not employed. This is important because we have theoretical reasons to 
believe that the effects of components of incentives are likely to vary by income and gender. 
Finally, few studies have managed to design an incentive such that the physical activity was 
maintained after the incentive was removed. Indeed, a common theme in incentivizing health 
behavior change is the difficulty in sustaining behavior change once the incentives are removed. 
We propose to conduct a Multiphase Optimization Strategy (MOST) trial of incentives for 
walking. A MOST trial is ideally suited for situations in which a proposed intervention has many 
potential intervention components. A MOST trial consists of three phases. A screening phase 
trial is used to efficiently identify—through a factorial designed randomized trial—the effective 
components of a complex intervention like incentives. A refining phase trial tests the optimal 
dose (size or duration) of the incentives. A confirmatory phase trial tests the optimal components 
and dose against a usual care control. The goal of the proposed study is to conduct the 
screening phase trial in 128 Veterans to identify the optimal components of incentives for 
increasing walking among physically inactive Veterans. All Veterans in this phase will be given 
various components of incentives for increasing average steps per day by 15% per week over a 
12-week habit-building period, and then maintaining the increase through a 12-week habit 
maintenance period. The specific aims are: 
Aim 1: Conduct a 24 factorial designed screening-phase trial of incentives for increasing 
average steps per day to by 15% per week over 12 weeks among physically inactive 
Veterans. Every patient in the trial will be given a Fitbit Inspire activity monitor and assigned to a 
group that receives different components of incentives. We will test four different incentive 
factors: 1) lottery vs. loss framed incentives, 2) financial vs. non-financial incentives, 3) a pre-
commitment postcard reminder of a Veteran’s stated intrinsic reason for commitment to PA vs. 
no pre-commitment postcard, and 4) a request for PA advice from a Veteran on staying active 

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vs. no request. The first factor has never been tested in a population like the VA. Factors 2-4 are 
designed specifically to sustain the effects of incentives after the incentive is removed. Factor 4 
is a novel hypothesis that has never been tested outside of educational research: specifically, 
that asking for advice from a Veteran is more motivating than giving advice to them, even if that 
Veteran is struggling with low physical activity themselves. The primary outcome is change in 
steps per week from baseline to week 24. 
 
Aim 2. Conduct cost analyses and qualitative interviews. The cost of administering each 
component and qualitative assessments of the acceptability of each component to trial 
participants will inform the decision of which components to retain for the subsequent refining 
and confirmatory phase trials.  
 
Aim 3. Convene an expert panel to choose components for the next phases of the MOST 
trial. The panel will weigh each component in terms of its effect on step counts (Aim 1), 
administrative costs and participant-reported qualitative assessments (Aim 2), and the strength 
of the theoretical basis for the component’s effect on physical activity. 
 
The proposed study has strong institutional support—the Director of MOVE! is a component of 
the intervention itself—and addresses the VA HSR&D focus area of chronic conditions with a 
novel, and theory-driven intervention and study design. The results of this study will be used in a 
future submission to conduct the refining and confirmatory phases of the MOST trial. 
4.0 
Resources and Personnel 
All in person research activities will be conducted at VA Puget Sound Health Care System, 
Seattle Campus. If the participant activities cannot be done in person, all study activities will 
occur remotely, over the phone and sending documents through the mail.  
 
Event to trigger a message Weeks 1-12 
Messages (text or email)  
Reminder 
A friendly reminder we are scheduled to complete 
your Fitbit visit today/tomorrow at ___________. 
If you need to reach us please call 206-277-4797. 
Baseline period- enrolled 
Welcome to the study 
[If needed] please remember to complete the 
[baseline/12-week/32-week] survey 
Participant day of the week 
Acknowledging steps 
New step goal 
Financial lottery group: financial winnings & 
cumulative winnings 
Non-financial lottery: point winnings & cumulative 
winnings 
Loss-framed: Start of week total, updated daily 
(ideal), weekly minimum  
Throughout the study 
1 text a week encouraging participants. Day will 
be random.  
Reminders (surveys, syncing, return Fitbit (if early 
withdraw), return postcards, return advice)  
 

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Messages week 12-24 
Message 
Participant day of the week 
Message acknowledging steps, encouragement to 
continue, maintaining gains 
Week 12 & 24 
Reminder to complete survey, with $25 
compensation 
End of week 24 
Thank you for participating, time & effort was/is 
important 
 
Dummy email accounts: 
Every participant will be assigned a dummy email account to use to login to the Fitbit account. 
The dummy emails will be made by research study staff and will be Gmail, Hotmail and/or other 
commercial email services. The research staff will create the Fitbit account using the dummy 
email which will have a different password then the dummy email. Research staff will track the 
accounts in a separate excel file. The applicable Fitbit login information will be housed in the 
Access database. The Fitbit account will be disconnected from the Fitbit device and deleted at 
week 24 or when the participant withdraws, whichever comes first. The dummy account contains 
no PII.  
Fitbits: 
For this study we will be using the Fitbit Inspire 2 ($80). We have received 150 Fitbit Inspire 2.   
Fitbits were deemed consumable for this study by the Assistant Chief Supply Chain Officer, 
Steven Peterson. Therefore, if a participant screens into the study they will be eligible to keep the 
Fitbit. There will be no Fitbit (an Alphabet) company contact with the research team and no data 
will be shared. This means that Fitbits will not be returned from participants unless participants 
withdraw from the study. If a participant withdraws or far exceeds the allowable step count during 
the baseline week, we will gladly accept any Fitbits the participants would like to return.   
The Fitbit Inspire 2 can track numerous measures. We will instruct the participants to: 
• 
not sync the Fitbit with any other feature on their phone 
• 
not use any of the options within the application   
Prior to distribution of the Fitbit, research coordinators will login to the dummy Fitbit account and 
disable all options aside from the daily step count. It is possible that participants would be able to 
login to the dummy account and enable these settings, but we will encourage them not to. If they 
do, there is minimal risk of accidental exposure of these data by the study team because the 
study team will not pull these data from the participants Fitbit account. 
Data 
Fitbit Statement/Description 
What we are doing about it.  
Premium 
Trial 
Inspire 2 unlocks a free 1-year trial for new 
Premium users, complete with personalized 
insights, guided programs, advanced sleep 
tools, health metrics and more. 
 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. Once they have completed 
their time in the study and logged out of 
the dummy account, they can make 
whatever decisions they choose.  
24/7 Heart 
Rate 
24/7 heart rate helps you maximize your 
exercise sessions, see heart rate zones, track 
sleep stages and better estimate calorie burn. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data.  

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Resting 
Heart Rate 
Wear Inspire 2 all day and night to record your 
resting heart rate and track your heart rate 
trends over time. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Breathing 
Rate 
With Fitbit Premium, automatically measure 
your breathing rate while you sleep to help 
you understand your wellness and learn if 
there are signs of significant changes. View 
your nightly average and trends over time in 
the Health Metrics dashboard.*** 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. 
We will not pull this data. 
Heart Rate 
Variability 
With Fitbit Premium, track heart rate 
variability (HRV)—the variation of time 
between each heartbeat— to see if your body 
is showing potential signs of stress, illness or 
fatigue. View your nightly average and trends 
over time in the Health Metrics dashboard. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Guided 
Breathing 
Sessions  
Inspire 2 helps you find moments of calm 
throughout your day with personalized guided 
breathing sessions based on your heart rate. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Menstrual 
Health 
Tracking 
Understand your body on a deeper level by 
using your tracker with the Fitbit app to follow 
your cycle, record symptoms and more. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Food 
Logging  
Make the most of the Fitbit app by logging 
your meals and comparing calories eaten to 
calories burned as you go for your goals. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Active Zone 
Minutes 
Active Zone Minutes help you make every 
minute count during workouts by buzzing your 
wrist when you enter your personalized target 
heart rate zone. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
All Day 
Activity 
Every part of your day impacts your goals, so 
Inspire 2 tracks all-day steps, distance and 
calories burned. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will only pull daily step count.  
Heart Rate 
Zones 
Inspire 2 personalizes your real-time stats 
based on your age and resting heart rate to 
show whether you’re in fat burn, cardio or 
peak zone. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Cardio 
Fitness 
Level 
Check your Cardio Fitness Score in the Fitbit 
app to see how fit you are, and get tips on 
how to improve it. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Swimproof 
& Swim 
Tracking 
Inspire 2 is swimproof, so you can wear it in 
the shower, pool and beyond. Plus, it 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  

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automatically tracks how long you’ve been 
swimming.** 
We will not pull this data. 
Real-Time 
Pace & 
Distance 
Connect Inspire 2 to your phone’s GPS to see 
real-time pace and distance on your wrist 
during walks, jogs, hikes and bike rides. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Workout 
Intensity 
Map- In 
App Only  
After outdoor exercise, check your workout 
intensity map in the Fitbit app to see your 
heart rate zones throughout your route and 
learn where you put in the most effort. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. 
We will not pull this data. 
20+ 
Exercise 
Modes+Sm
artTrack 
Choose from 20+ exercise modes to get real-
time stats during your workouts—or let 
SmartTrack™ automatically recognize and 
record your exercises. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
All-Day 
Calorie 
Burn 
Check Inspire 2 or the Fitbit app to see how 
many calories you’ve burned throughout the 
day so you can keep your nutrition on track. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Reminders 
to Move 
Get friendly reminders that encourage you to 
stretch your legs and take 250 steps every 
hour—and get recognition when you hit that 
250! 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Sleep 
Stages 
See how much light, deep and REM sleep you 
get, and get tips in the app that can help 
improve sleep quality. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Sleep Score 
Sleep Score is a quick, easy way to see how 
well you slept, watch your trends over time & 
celebrate your progress when you wake more 
energized. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Silent 
Alarms 
Make mornings more peaceful. Set a silent 
alarm in the Fitbit app and Inspire 2 will wake 
you up with a quiet vibration on your wrist. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily.  
We will not pull this data. 
Sleep 
Mode 
Before you turn in for the night, turn on sleep 
mode to disable screen wake and notifications 
so light and vibrations from your tracker don’t 
interrupt your sleep. 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. 
We will not pull this data. 
Personal 
setting 
Name, address, time zone, sleep sensitivity,  
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. 
We will not pull this data. 
Privacy 
(this is under the settings feature): study staff 
will lock all personal info, statistics and graphs 
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. 
We will not pull this data. 

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Manage 
your Fitbit 
Data 
If a participant logs into this feature they can 
delete data                
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. 
We will not pull this data. 
Notification
s 
We will enable all mobile notifications except 
auto-recognizing exercises, low battery  
We are asking the participant to not do 
anything in the app except sync their 
Fitbit daily. 
We will not pull this data. 
 
5.0 
Study Procedures 
5.1 Study Design 
This is a factorial design study. Aim 1 is the largest and most involved portion of the study. Aim 1 
is to conduct a 24 factorial designed screening-phase trial of incentives for increasing average 
steps per day by 15% a week over 12 weeks among physically inactive Veterans. Recruitment is 
expected to occur at a rate of 10-20 participants per month. There will be overlap between the 
aims of the study. Aim 2 is to conduct a cost analyses and qualitative interviews. The qualitative 
interviews occur after the participant has reached the week 24 mark of the study. Aim 3 is to 
convene an expert panel to choose components for the next phases of the MOST trial. This aim 
will occur at the very end of the study period, expected in study year 4, FY23. All participants will 
be invited to participate in the rewards research repository, #00982. An updated Visio diagram of 
the study flowchart is included with this submission.  
 
To make the study as Veteran centric and successful as possible, we are soliciting feedback 
from a group of Veterans recruited from the repository, #00982. Participants will participate on a 
Cisco WebEx meeting prior to the start of enrollment. They will be compensated $50 for their 
participation. Research staff will ask for their input on increasing physical activity, incentives, 
motivation and messaging. At the conclusion of the study we will schedule a follow-up WebEx 
meeting to share the results and experiences based off of their input and feedback.  
 
All participants are randomized into the following categories, or factors: financial or non-financial, 
mixed lottery or loss incentive, pre-commitment postcard or not, request for advice or not. There 
should be 32 participants in each group.  
Table 2. Factorial design of the proposed screening phase trial 
 
 
Cash incentive 
Non-financial 
incentive 
Total  
subjects 
 
Mixed 
Lottery 
Loss  
Incentive 
Mixed 
Lottery 
Loss  
Incentive 
 
Request for advice- Yes 
 
 
 
 
 
Pre-commitment- Yes 
8 
8 
8 
8 
32 
Pre-commitment- No 
8 
8 
8 
8 
32 
No request for advice- No  
 
 
 
 
 
Pre-commitment- Yes 
8 
8 
8 
8 
32 
Pre-commitment- No 
8 
8 
8 
8 
32 
Total subjects 
32 
32 
32 
32 
128 
 

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Participants will either earn cash or points for achieving walking goals. How they will receive the 
cash or points is dependent on which factor mixed lottery or loss incentive they are randomized 
to. Each subject will choose a number between 0 and 99 when they are enrolled in the study. For 
each day of the trial, a random digit will be drawn from 0 to 99. The patient will win a small 
reward worth $7 (or points) if the first- or second-digits match (an 18% probability), and a $75 (or 
points) reward if both digits match (1% probability). This has a weekly expected value of $14.20. 
For the loss framed incentive, at the beginning of each week a subject is awarded $14 or 14 
points. Each day the subject fails to meet her goal step count the subject loses $2 or points. The 
prizes are attached in appendix 31. The prizes were reviewed by participants in Exercise 
Collaborative meeting and prizes were adjusted accordingly.  
 
Subjects randomized to the pre-commitment postcard arm will be asked at to fill out 3 postcards 
(appendix 2) that complete the sentence “I will meet my walking goals because…”. Participants 
will return the postcards in a prepaid envelope if randomized to this group. We will collect the 
postcards and mail them in sealed envelopes to the subjects at weeks 13, 17, and 21. Subjects 
in the no-pre-commitment arm will not complete this task and will not receive the postcards. 
Factor four is the request for advice or not. At the start of habit maintenance period in week 13, a 
letter from Dr. Susan Raffa, the VHA National Program Director for Weight Management, will be 
mailed to half of the subjects (appendix 3); other subjects will receive no letter. The letter will 
thank the Veteran for participating in the study and ask for their advice. An enclosed form 
(Appendix 4) will contain 2 boxes large enough for a few hand-written sentences in response to 
the following questions: “What is your best advice for Veterans who are trying to increase their 
physical activity?” and “What is your best advice for Veterans who are trying to stay active?” A 
return envelope will be enclosed. 
 
There are the sixteen different possibilities for randomization: 
1. Financial Reward, mixed lottery, pre-commitment postcard reminders, request physical 
activity advice 
2. Financial Reward, mixed lottery, pre-commitment postcard reminders, no request 
physical activity advice 
3. Financial Reward, mixed lottery, no pre-commitment postcard reminders, no request 
physical activity advice 
4. Financial Reward, mixed lottery, no pre-commitment postcard reminders, request 
physical activity advice 
 
5. Financial Reward, loss incentive, pre-commitment postcard reminders, request physical 
activity advice 
6. Financial Reward, loss incentive, pre-commitment postcard reminders, no request 
physical activity advice 
7. Financial Reward, loss incentive, no pre-commitment postcard reminders, no request 
physical activity advice 
8. Financial Reward, loss incentive, no pre-commitment postcard reminders, request 
physical activity advice 
 
9. Non-financial reward, mixed lottery, pre-commitment postcard reminders, request 
physical activity advice 
10. Non-financial reward, mixed lottery, pre-commitment postcard reminders, no request 
physical activity advice 
11. Non-financial reward, mixed lottery, no pre-commitment postcard reminders, no request 
physical activity advice 

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12. Non-financial reward, mixed lottery, no pre-commitment postcard reminders, request 
physical activity advice 
 
13. Non-financial reward, loss incentive, pre-commitment postcard reminders, request 
physical activity advice 
14. Non-financial reward, loss incentive, pre-commitment postcard reminders, no request 
physical activity advice 
15. Non-financial reward, loss incentive, no pre-commitment postcard reminders, no request 
physical activity advice 
16. Non-financial reward, loss incentive, no pre-commitment postcard reminders, request 
physical activity advice 
 
The complete description of each group is detailed in Appendix 49.  
Study Population: Current VA Puget Sound Health Care System Veterans that meet the following 
criteria. Populations targeted for recruitment include male, female, outpatients.  
The inclusion and exclusion criteria are outlined in section 5.4 below.  
Special populations of employees, students, economically and/or educationally disadvantaged 
persons, illiterate/limited or no English proficiency individuals will also be included as long as 
they meet the above criteria. Employees/students, economically and/or educationally 
disadvantaged persons, illiterate/limited or no English proficiency will be included in this 
research. All participants in this study are Veterans who will meet the inclusion criteria. We are 
leaving these vulnerable groups in because any benefit from participating is greater than any 
possible risk. 
We are not excluding employees/students, economically/educationally disadvantaged and 
illiterate, limited or no English language proficiency. We will only be recruiting Veterans. We do 
not believe that being an employee, student or being economically or educationally 
disadvantaged would have any impact on an individual’s ability to participate. Everything will be 
done remote, so an employee or student would not need to share their enrollment status with 
anyone. If the study visits cannot be completed remotely, we will make accommodations to 
complete the study in person following current guidance for in person visits. We expect this to be 
extremely rare. We are screening for homelessness or housing instability and will only exclude if 
the participant cannot receive mail or charge their electronics. We do not have a method of 
screening for someone being economical or educationally disadvantaged.  
 
We are not doing any screening for a participant being illiterate or having limited or no English 
proficiency. We are only recruiting Veterans. If English is a Veteran’s second or third language, 
we think they will be fully able to participate. We are also not screening for literacy because that 
is highly subjective, and we do not believe will impact someone’s ability to understand the study. 
If a potential participant does not respond to our letter, a research coordinator will call them. 
Every aspect of the study will be explained in a variety of modalities including written (in the 
enrollment packet) and verbally. Participants and potential participants are free to not enroll or 
withdraw from the study at any time. We are including these groups because after study team 
conversations we do not believe this research study exposes these groups to any additional risk. 
The goal of this study is to increase participants’ daily step counts in inactive persons. Increasing 
step count is a free and relatively easy health behavior that has a positive impact on all 
individuals regardless of socioeconomic status, educational attainment, or language.  
 

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All potential study participants will go through the study screening (CDW, medical record screen 
and phone screening). All participants will have ample time to ask any questions and go over all 
study procedures. Potential participants and enrolled participants are free to discuss the study 
with whomever they chose to make an informed choice about deciding to participate.  
 
The health intervention itself poses no undue risks. Walking is the safest form of physical activity. 
The risk of minor injury is 0.2 per 1,000 hours of walking. These risks include falls, dehydration, 
blisters, glycemic control, angina, and worsening of breathing and blood pressure changes. The 
risks of remaining sedentary out-weigh the risks of adverse events associated with walking. The 
Physical Activity Guideline Committee 2018 report states that “adding a small and comfortable 
amount of walking, such as 5 to 15 minutes 2 to 3 times per week, to one’s usual daily activities 
has a low risk of musculoskeletal injury and no known risk of sudden severe cardiac events.” We 
put in place three safeguards in this study.  
1) First, we screen Veterans for an ability to walk 20 minutes without problems (self-report). 
2) Second, we ask if the potential participant thinks they will benefit from walking more.  
3) Third, we make Veteran-specific step goals based on baseline step counts. Each week 
Veterans will be incentivized for increasing step counts per day by 15% over the previous 
week’s daily average. For a person with 2,000 steps/day at baseline, this represents an 
additional 300 steps, or roughly 3 minutes of walking per day. The maximum number of 
steps any participant will be asked to walk is 7,000 steps per day. If the participant 
reaches the maximum number of steps per day prior to the end goal at week 12, they will 
still be eligible for all prizes depending on what group they are in until they reach the 
maintenance phase at week 12. Once they hit 7,000 steps they will have a goal of 7,000 
steps per day until the end of the study. No participants will ever have a goal of >7,000 
steps per day.  
There will be minimal risks to the participants responding to the study questionnaires (screening 
and surveys). The screening (appendix 5), surveys (appendix 6), including health history 
questionnaires, could potentially induce stress secondary to invasion of privacy. Although 
unlikely, some respondents may find some questions intrusive or offensive. Participants are free 
to skip any questions they do not wish to answer. Participants will be given a schedule of surveys 
and will be free to withdraw from the study at any time without penalty or loss of any incentives 
they have already earned.  
All medical centers are required to track the amounts paid to patients during a year. If the 
amount is $600 or more, the institution is required by the Internal Revenue Service (IRS) to issue 
a form 1099MISC to the participant and send a copy to the IRS. This is reported as 
"miscellaneous" income to the IRS. This amount could have the potential to change Veterans’ 
eligibility for social services in the coming tax year.  
The maximum that could be earned by a participant in the loss-framed incentives group is $318, 
assuming the patient achieves all step goals, completes both follow-up surveys, and completes 
the study interview. There is no way to calculate a maximum for the lottery incentives group, but 
we anticipate that the average maximum will not differ significantly from the loss framed rewards 
group. The IRS operates on a calendar year cycle. Veteran remittance will be tracked closely by 
study staff.  Veterans will be notified of the $600 threshold through the informed consent process 
(appendix 7) and study overview document (appendix 8) provided and discussed at enrollment.  

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Participants in the incentive lottery will earn points towards items. Participants in the incentive 
loss-framed group will aim to not lose points. All points will be available to redeem at week 12 or 
if the participant chooses to withdraw early. Most incentives were selected by the pre-trial focus 
group participants. Most items follow a theme of walking or spending time outdoors. To date 
items include: trekking poles, national park walking guide, binoculars, picnic blanket, etc. 
5.2 Recruitment Methods 
Veteran Exercise Collaborative:  
Prior to recruitment to the MOST trial, we will convene a focus group of Veterans enrolled in the 
rewards data repository, MIRB #00982, to get their feedback on the specifics of the trial. We are 
requesting a waiver of documentation of informed consent, waiver of HIPAA authorization and 
information statement for the exercise collaborative participants (appendix 9). The enrollment 
goal for the exercise collaborative is 10 participants. To reach this goal we will mail 30 letters 
(appendix 10) and postcards with prepaid return postage (appendix 11). Coordinators and study 
staff are on the approved study staff list for the repository and for this study. An approved 
repository modification outlining the physical activity exercise collaborative will be approved prior 
to any exercise collaborative activities. Once the study is fully approved coordinators will mail 
participants enrolled in the repository letters with pre-addressed postcards to indicate if they are 
interested in participating on an exercise collaborative. If we have not received a return postcard 
within two weeks of mailing research coordinators will call repository participants up to two times.  
 
Participants will enroll with an information statement under a waiver of documentation of 
informed consent and a Waiver of HIPAA Authorization. Participants will be given an information 
statement (appendix 9). Participants will be sent the information for the meeting in the mail 
(appendix 13) and also sent a text or email message from the email account  with the meeting 
information. The meeting will occur through an online meeting platform. Exercise collaborative 
participants will be compensated $50 for each of the two meetings they attend. Research 
coordinators will fill out the VA subject payment form and submit the payment through the 
approved VA Puget Sound research & development payment process. Due to the study  
payment, we will collect or access all exercise collaborative members social security number. 
Exercise collaborative participants will receive a thank you card in the mail (appendix 14).  
 
Main Study: 
The target enrollment is 128 participants, but we anticipate that some patients who enroll will not 
be able to install the Fitbit app and will need to disenroll before being assigned to a treatment 
group. Once the Fitbit is set-up, participants will complete a 2-week trial period to establish a 
baseline average daily step count. We will follow procedures used in previous trials (Patel 2016 a 
and b) to establish this baseline: 
• 
The first week of data will be disregarded because the novelty of the device makes a 
participant walk more than usual.  
• 
Average steps over the second week will be used as a baseline provided than at least 
four days of step counts are recorded by the device in that week—i.e, the participants 
remembers to wear the device on at least four days in week two.  
• 
If fewer than four days of steps are recorded, we will call the participant to encourage 
them to wear the device, and we will follow them for another week or until four days of 
step counts are recorded over a 7-day period. 
• 
If a participant screens into the study, we will call them to inform them. We will clarify 
what their chosen day of the week is to reset their goals. If their 2-week assessment 
period ends on a Tuesday, and their chosen day of the week is Monday, then their week 
1 goal (and potential rewards) wouldn’t start until the following Monday.  

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If a participant walks <2,000 steps/day on average or >5,000 steps/day on average over their 7-
day baseline period, then they will not be eligible to participate in the full study. We expect a fair 
number of people to not walk within these step parameters. Consequently, we are planning to 
enroll up to 200 Veterans in the main study with the expectation that 72 will be disenrolled prior 
to treatment assignment. 
 
The consent and Fitbit set-up process will require patience and a lot of back and forth with the 
study team. The consent visit and Fitbit setup visits are two distinct visits that are necessary prior 
to starting the study. For this reason, we expect to do the CDW data pull for up to 5,000 records. 
We are requesting to pull up to 5,000 records which we believe is an appropriate figure based on 
our experience recruiting for MIRB #00928. Study coordinators will quickly screen the medical 
record to screen out participants that have one or more of the exclusion criteria. The screening is 
discussed in detail in section 5.4. From our experience in previous studies, we generally have 
been able to phone screen and potentially enroll 20% of all mail letters. We do not yet know how 
many potential participants will be interested in participating, how many will fail the phone screen 
and how many will stop participating during the baseline screening phase or the first week.  To 
ensure that we are adequately recruiting minority Veterans we will see what percentage of racial 
minorities screens positive in the CDW and CPRS screen. We will aim to routinely mail out at 
least that percentage (higher of the two) of letters to minority Veterans in each mailing.  
 
The CDW data pull will include VA Puget Sound Veterans between the ages of 50-69.25, and 
those who have a diagnosis of hypertension, depression, diabetes or a BMI between 25-40, have 
been seen in primary care or the womens clinic in the previous 2 years and email address. To 
assist in applying the exclusion criteria and creating the study database we will also pull birthday, 
SSN, PatientICN, medical record number, SID, ICD 9 or 10 codes for the exclusion criteria, blood 
pressure readings from the previous 24 months and diagnosis of diabetes. Veterans with a 
diagnosis of psychosis/mania, behavioral flag active suicidal or homicidal ideation will be 
excluded. We will also pull mailing address, phone number, height, weight, BMI, race/ethnicity, 
sex, gender and pronoun (if available). Prior to mailing the letters the CDW list will be further 
screened in the medical record.  
 
The medical record screen will be checked to confirm the individual is a Veteran, confirm their 
age, 50-69.25, and screen negative for: behavioral flag, active psychosis/mania, diagnosis of 
dementia/Alzheimer’s, suicidal or homicidal ideation, presently in the MOVE! Program or 
pregnant. If the potential participant has diabetes, we will screen their chart to see if they have a 
diabetic foot ulcer or peripheral neuropathy. Participants with either condition will be excluded. 
Participants in hospice or end of life care or who are/have been hospitalized in the past 3 months 
will be excluded. Veterans living in a nursing home, assisted living facility, or group home will be 
excluded. If data from the CDW data pull is missing or incomplete, we will validate the 
questionable measure from the medical record. Potentially eligible participants will be mailed a 
letter describing the study (Appendix 15) and either a self-addressed postcard (Appendix 11) or a 
QR code that directs them to a Qualtrics survey for them to indicate if they are interested or not 
(or both a postcard and a QR code). If patients do not opt-out, research staff may telephone 
patients and screen interested patients for eligibility. Potential participants will be asked a variety 
of questions to determine eligibility. The full screening questionnaire is included in this 
submission (Appendix 5). Alternately, the medical record screen may also be conducted after the 
mailings are sent, with screens only conducted for Veterans who reply with an “interested” 
response and/or for Veterans who do not respond. The option of conducting the screens after the 
mailings streamlines the process and allows study staff to prioritize those who are interested in 

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participating. Should a Veteran indicate interest and then “fail” the medical record screen, they 
will receive either a letter in the mail or a phone call to inform them. With this method it is likely 
that not all Veterans who receive recruitment letters will ultimately be contacted about their 
participation, though we will ensure all Veterans who explicitly indicate interest will be contacted. 
 
If someone is interested and passes the telephone screening, we will schedule a virtual 
enrollment visit (either phone, VA Video Connect or other approved video visit software such as 
WebEx, Teams, Zoom, etc.) Prior to the virtual visit, we will ask the participant if they are able 
and comfortable receiving the documents virtually. If they are, we will utilize Docusign to send 
the consent and HIPAA authorization electronically. Using Docusign, the participant will also get 
electronic copies of the documents once they have signed the documents. If they prefer hard 
copies, we will mail them an enrollment packet with two copies of all documents (Appendix 16).  
One copy they will keep for their records and the second they will return to us in the prepaid 
envelope. If the participant prefers, they will be able to use DocuSign to remotely sign the 
documents. We will also give them the option to sign the paper copies and email back a photo of 
their signature on the consent, and the last page of the HIPAA completely filled out.  
 
If a participant is apprehensive about completing the consent visit and/or Fitbit set up visit 
virtually, and current local conditions allow for an in person visit, we will offer the Veteran an in 
person visit for the consent and Fitbit set-up (as one visit) or the Fitbit set-up. Each visit will have 
the same compensation as the virtual visit ($25 each). For participants that complete both visits 
in person they will receive a link for the survey immediately following the visit. Participants must 
complete the survey by the end of the baseline period. Participants will not receive any additional 
compensation for completing the visit(s) in person and scheduling will be subject to local 
conditions and staff availability.  
 
The enrollment packet will include the informed consent, HIPAA authorization, study overview, 
vendorization form and a postage paid envelope. The participant will go over the packet with a 
research coordinator. The coordinator will walk the participant through the informed consent and 
answer any questions they have. Once all of the participant’s questions have been answered the 
participant will be instructed to return the signed copies through the pre-paid envelope or sign the 
electronic versions using DocuSign. Once the documents have been received by the research 
coordinator, the coordinator will immediately mail out the Fitbit packet. 
 
There are two variations to the process above. We have created a flyer (appendix 17) with basic 
information about this study. Flyers will be distributed to the primary care clinic clinicians, 
physical therapy, occupational therapy and rehab to provide to patients that may be interested in 
participating. Occasionally in previous studies we have had participants who want to tell their 
Veteran group, friends or family about the study. The same flyers will be used to give to them.  
 
If a Veteran receives a flyer, they will call the study line and go through the same process as the 
other Veterans. The only difference being that instead of a mailed letter as their first exposure to 
the study, their first exposure would be the study flyer. If an interested Veteran calls who was not 
in a CDW data pull, we will do a CPRS screen prior to doing the screen over the phone with 
them. This will be done under a waiver of informed consent for recruitment. For this specific 
population we will screen the medical record for the information that is normally gained through 
the CDW data pull and Medical record screen, as described above. Once we have the results of 
the medical record screening, we will call the Veteran back. If they are ineligible, we will tell 
them, if they seem to be eligible, we will continue with the phone screen. All steps with this group 
will be the same as participants in the CDW data pull.  
 

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To be compensated participants must be vendorized with VA Puget Sound Health Care System 
or agree to accept remittance in the form of electronic gift cards. Study staff will assist 
participants with this process. Participants can complete the vendorization process online, in 
person via the agent cashier or send/email their completed vendor form to the study staff. If a 
participant chooses to not be vendorized or cannot complete the form, the only other option to be 
compensated is electronic gift cards. All study compensation will be via direct deposit.  
The payments for the enrollment visit, surveys and interview payments will be processed the 
same week the participant earns them. Participants will earn $25 for completing the enrollment 
visit (Consent visit), Fitbit set-up visit, baseline survey, week 12 survey, week 24 survey and 
interview (if selected). For completing the basic study procedures, visits and surveys, participants 
will earn up to a total of $150 if they complete all activities. These payments will be sent out as 
they are earned. All participants will be paid via direct deposit or electronic gift card. We have 
tentatively added in the process to vendorize Veterans at the beginning of the study. With the 
extensive payment issues experienced in prior studies we do not want to further delay any 
participants receiving payment. We are also adding in statements throughout the participant 
documents that we cannot guarantee they will be paid. While this is less then ideal, the research 
study staff has no method to ensure the Veteran is paid at all, appropriately or timely.   
 
The financial rewards from the lottery and the loss-framed groups will be received as one 
payment. Research coordinators will process all their earnings after week 12. We are doing this 
to minimize confusion about receiving the correct amount of money. At week 12, participants will 
know exactly how much money they have earned. 
5.3 Informed Consent Procedures 
 
Veteran Exercise Collaborative (pre-trial focus group):  
Exercise Collaborative:  
Veterans enrolled in the rewards data repository, MIRB #00982, will be approached and asked of 
their interest in participating in a focus group about exercise. We are requesting a waiver of 
documentation of informed consent and waiver of HIPAA authorization (appendix 9) for the 
exercise collaborative participants. Coordinators and study staff are on the approved study staff 
list for the repository and for this study. Once the study is fully approved to begin, coordinators 
will mail participants enrolled in the repository letters with pre-addressed postcards to indicate if 
they are interested in participating on an exercise collaborative (Appendix 10).  If we have not 
received a return postcard within two weeks of mailing, research coordinators will call repository 
participants. Participants will be told how the exercise collaborative will be virtual, what we will 
discuss, time commitment and compensation ($50). If the participant is interested, they will be 
mailed a hard copy of the information statement and meeting invitation information (url and 
passcode, Appendix 13). Coordinators will explain that the board will meet virtually, so 
participants will need to be able to participate in an online meeting. This will be done by emailing 
a meeting link to a webex or zoom meeting link to the participant’s email. The link will come from 
a group email account to be set up. (This meeting occurred on August 11, 2021.) 
 
Prior to the start of the exercise collaborative, coordinators will moderate the individuals joining 
the call to ensure the appropriate individuals are participating. At the beginning the exercise 
collaborative we will give an overview of the study and what we are trying to accomplish 
(Appendix 18).   
 
Main Study: 

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We are requesting a waiver of informed consent and HIPAA Authorization for recruitment 
purposes and a written informed consent once a participant agrees and enrolls in the study 
(Appendix 19). We will offer paper informed consent, electronic DocuSign, and a photo of the last 
page of the consent and HIPAA authorization.  
 
Participants from the CDW data pulls and the medical record screen will be sent a recruitment 
letter and response postcard and/or QR code that links to a Qualtrics survey to indicate interest 
or to opt out.  
 
The QR code, which can be scanned by their mobile phone’s camera, will open a hyperlink to a 
fully anonymous Qualtrics survey where participants can enter their Study ID and indicate if they 
are interested or not. 
 
If someone is interested and passes the telephone screening (appendix 5 & 12), we will schedule 
a virtual enrollment visit. Prior to the virtual visit, we will mail them an enrollment packet with two 
copies of all documents or send electronic copies through Docusign. For the paper copies, one 
copy they will keep for their records and the second they will return to us in the prepaid envelope. 
The enrollment packet will include the informed consent form, HIPAA authorization, study 
overview and a postage paid envelope.  The participant will have the option to complete the 
forms via DocuSign (electronic signature), or by signing the consent and completing the last 
page of the HIPAA authorization, taking a photo of their signatures and emailing it to the study 
email account. 
 
If the participant completes the documents electronically, we will immediately send out the 
survey through Qualtrics.  
 
If the participant completes paper copies, the survey will be sent through Qualtrics immediately 
upon the staff receiving the copies.  
 
The coordinators will set up an enrollment visit approximately 1-2 weeks after the mailing of the 
enrollment packet/electronically signing the consent & HIPAA depending on the current speed of 
the mail handled by the United States Postal Service. The visit will follow the format in appendix 
8. The format for the visit will either be telephone, VA Video Connect, Teams, WebEx, or Zoom, 
depending on whatever the Veteran prefers.  
 
When the documents have been returned, the coordinator will immediately mail out the Fitbit 
packet and submit to VA Finance the request to mail the participant the $25 payment for 
completing the enrollment or provide an electronic giftcard. Each time the participant is paid they 
receive  direct deposit. The participant will then speak with a research coordinator once they 
receive the Fitbit and will be instructed on how to set up the Fitbit up with their device (appendix 
21). All participants will need to download the Fitbit app. Instructions provided to the participants 
and are included with this submission. Participants will be encouraged to open the application 
daily to sync their Fitbit with the app.  
 
Consent staff: 
The study staff obtaining consent will be trained to provide adequate time and opportunity for the 
participant to consider all options, respond to the participant's questions, ensure that the 
participant has comprehended this information, obtain the participant's voluntary agreement to 
participate, and continue to provide information as the participant or situation evolves. We will 
ensure there is opportunity for the researcher and the participant to exchange information and 

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ask questions. If a potential participant is unsure about participating, we will encourage them to 
think about it, discuss with people they trust, and we will set a time to follow-up with them. 
Potential Issues:  
We are not excluding employees/students, economically/educationally disadvantaged and 
illiterate, limited or no English language proficiency. We will only be recruiting Veterans. We do 
not believe that being an employee, student or being economically or educationally 
disadvantaged would have any impact on an individual’s ability to participate. Everything will be 
done remote, so an employee or student would not need to share their enrollment status with 
anyone. If the study visits cannot be completed remotely, we will make accommodations to 
complete the study in person following current guidance for in person visits. We expect this to be 
extremely rare. We do not have a method of screening for someone being economical or 
educational disadvantaged.  
 
We are not doing any screening for a participant being illiterate having limited or no English 
proficiency. We are only recruiting Veterans. If English is a Veteran’s second or third language, 
we think they will be fully able to participate. We are also not screening for literacy because that 
is highly subjective, and we do not believe will impact someone’s ability to understand the study. 
If a potential participant does not respond to our letter, a research coordinator will call them. 
Every aspect of the study will be explained in a variety of modalities including written (in the 
enrollment packet), verbally and interactive with an open question and answer dialog between 
the coordinator and participant. 
Individuals that exhibit threatening, violent or otherwise troubling or inappropriate behavior during 
the screening phone call or consent visit will be excluded from this study. In previous research 
studies we had individuals that met all inclusion criteria but exhibited troubling behavior or made 
highly inappropriate comments towards study staff even after being asked to cease the 
behaviors. Study staff are not trained in all skills necessary to successfully interact with all 
individuals. We fully understand this is subjective, and we will do everything we can to avoid 
doing this. After reviewing uncomfortable interactions in previous studies, we are unaware of a 
screening method to avoid and screen these participants out. We are including this language, so 
the participant can have the best experience and to protect study staff.  
5.4 Inclusion/Exclusion Criteria 
Potential participants will be screened through a CDW data pull, medical records screen and 
phone screen.  
Inclusion:  
• 
Age 50-70. This age range is being focused on because the benefits of physical activity 
have the greatest benefit and individuals in this age range are more likely to have one of 
the conditions we are focusing on. The CDW data pull will include Veterans up to age 
69.25, so as not to include Veterans who are about to turn 70. 
• 
Diagnosis of hypertension, depression, diabetes or a BMI between 25-40. These 
conditions are highly prevalent in physically inactive populations and are amenable to 
change through greater physical activity. We will collect self-reported physical activity 
information, followed by asking participants if they think they would benefit from increased 
walking. Participants will also be asked if they are able to walk for 20 minutes without 
pain.  

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• 
Use of and/or own a smart phone. This is necessary to both sync the Fitbit and to receive 
the daily texts or emails  
• 
Ability to receive mail. 
• 
Ability to walk for 20 minutes without pain  
• 
Has had a primary care or women’s clinic visit in the past 2 years 
 
Exclusion: 
• 
Not a Veteran of the U.S. Armed Services: We only want to recruit Veterans. We are 
aware there are non-Veterans that have VA medical records, therefore only Veterans will 
be recruited. 
• 
Currently in the MOVE! Program. We do not want to enroll participants that are in the 
MOVE group because group dynamics may be adversely impacted particularly if a 
participant is receiving incentives.   
• 
Blind: participants will need to be able to read the value on their fitbit and the text 
messages/emails.  
• 
Highly physical active according to self-report.  
• 
Inability to walk 20 minutes without pain (self-report). 
• 
Diabetic foot condition (ulcer or peripheral neuropathy): We do not want to encourage any 
activities or increases in activity that could cause harm.   
• 
Dementia/Alzheimer’s/cognitive impairment: Potential participants need to fully able to 
understand the study and what they are voluntarily choosing to participate in.   
• 
Metastatic cancer, end-stage renal disease, hospice, palliative care, heart failure, 
undergoing chemotherapy, radiation or hemodialysis, have had or are on the list for an 
organ transplant: We do not want to recruit anyone that is battling a potentially life-
threatening condition.  
• 
Implanted cardiovascular device such as defibrillator or ventricular device 
• 
Active psychosis/mania/behavioral flag: We are not able to accommodate potential 
participants with these conditions or behaviors.  
• 
Pregnant women: We are excluding pregnant women because it is highly unlikely, we will 
have a 50-year-old plus, inactive female Veteran interested in participating in this study.  
• 
Homeless or housing insecure:  We will only exclude individuals experiencing 
homelessness or housing insecurity if they do not have a way to get mail or charge 
electronic devices.  
• 
Has a paid caregiver that provides >50% of daily living activities, lives in a nursing home, 
assisted living facility or group home: Someone that has a caregiver for >50% of daily 
living activities is likely either medically complex or ill. We understand that many medical 
conditions and interpersonal relationships can be strained with additional tasks and 
activities. We do not want this study to interfere with caretaking or this relationship.   
Individuals that exhibit threatening, violent or otherwise troubling or inappropriate 
behavior during the screening phone call or consent visit will be excluded from this study.  
• 
Presently own a Fitbit, have the Fitbit application and not interested or willing to login to 
the dummy account, and use the study provided Fitbit.  
 
5.5 Study Evaluations 
Phone Screening: 
Interested participants will complete a telephone screen with a research coordinator. Potential 
participants will be asked a variety of screening questions to determine eligibility. The phone 

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screening questions are included as an appendix 5. The screening includes the above 
inclusion/exclusion criteria and also includes questions about current physical activity and 
movement, the walking ability assessment and the six-item screener to determine if the 
participant has any cognitive impairment. The participant screening responses will be recorded 
directly into the study database located within the study folder on the J:drive (J:\MOTIVATE 
Walking (MIRB#01930) ).  
2 Week Trial Period:  
After the subject has enrolled and has set up the Fitbit they will start a 2-week trial period. 
The participant will be instructed to wear the Fitbit Inspire the study team provided for 
them daily for two weeks and walk/move as they normally would. To sync the data the 
participant will need to open the application on their smart phone in close proximity to 
their Fitbit. The participant’s step data is stored within their Fitbit accounts that will be 
accessed by the study team. The study team will record their available step-count data 
from the two-week trial period and use the procedures described above to establish a 
baseline average daily step count. .  Research staff will only review the participant step 
data from days 7-13 for eligibility. Participants will not be aware of the dates we are 
reviewing for study inclusion. 
If a participant walked less than 2,000/steps/day or more than 5,000 steps/day they will 
not be eligible for the study. Research study staff will call the participant and inform them 
if they are in the study or not. If there are fewer then 4 days of data reported days 7-13, 
we will extend the baseline window up to 2 weeks until 4 days of data can be established.  
If a participant is not eligible, they will still be compensated for all study activities up to 
that point (consent visit, Fitbit visit and baseline survey). At this time participants will be 
able to keep their Fitbit.  
The participants week 1 start date will start on their selected day of the week. If their 
baseline assessment period ends on a Monday and the participants chosen day of the 
week starts on a Saturday, then their week 1 wouldn’t start until the following Saturday.  
This will be the same process regardless of the randomized group.  
  
Data Syncing: 
To sync the data on most phones, the participant will need to open the application on 
their smart phone in close proximity to their Fitbit. The participant’s step data is stored 
within their Fitbit accounts that will be accessed by the study team. The study team will 
record the participant’s baseline step-count data in a study created Access database. 
Research staff will review the participant step data from days 0-7 to ensure it is being 
captured.   
Surveys: 
The participants will need to complete a baseline survey (appendix 6) and follow-up 
surveys at weeks 12 and 24. The participants will be emailed/texted a link to complete the 
survey through Qualtrics. The participant will need to complete the baseline survey before 
finding out what group they are in. Under very rare circumstances if the participant is 
unable to complete the survey through Qualtrics we will offer the participant the 
opportunity to complete the survey over the phone with a research coordinator or 
completing a paper survey. Due to mailing issues, we will strongly encourage the phone 
survey option.  The participant will receive the Qualtrics link after they have been 
consented and before the Fitbit visit. If the participant still has not completed the survey 

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by the Fitbit call, we will encourage the participant to complete the survey over the phone. 
If the participant completes the baseline survey through Qualtrics or over the phone, we 
will tell them what randomization group they are in and what that means for them. If the 
participant declines the survey over the phone, we will need their paper copy returned 
prior to starting the study. Once we receive the paper survey, we will call them to tell 
them what group they are in and their baseline week start date. They will be instructed to 
complete the mailed follow-up surveys as soon as possible during week 12 and 24 
(appendix 6). The surveys will be completed either through the Qualtrics link or over the 
phone. Surveys collected over the phone will be recorded either in Excel or the study 
Access database in the study folder on the J:drive. Once mailed surveys are returned 
study staff will manually enter survey responses into either the Excel file or the Access 
database. Another study coordinator will cross check recorded responses to the paper 
surveys to ensure accuracy.  
The survey is comprised of a variety of different measures that account for the secondary 
outcomes. The secondary outcomes are self-efficacy, intrinsic/extrinsic motivation and 
mental health.  
Self-efficacy: Measured using the Exercise Self-Efficacy Scale at baseline, week 12 and 
week 24 (McAuley E 1993). This measure has respondents indicate how confident they 
are they could exercise five times per week at moderate intensity for thirty minutes or 
more given various conditions. This scale ranges from 0 (not confident) to 10 (very 
confident). 
Intrinsic/extrinsic motivation: Measured using the Motivation for Physical Activity 
Measurement (MPAM) at baseline, week 12 and week 24 (Frederick CM 1993). This 
assessment measures the reasons and motivations for participating in physical activity. 
The assessment has the subject indicate why they exercise given various reasons and 
has the subject rate them on a scale 1 to 5. 1 indicates it is very true for me and 5 
indicates very untrue for me. 
Mental Health: Measured using the PHQ-8 depression scale at baseline, week 12 and 
week 24. The rating for this measure asks questions for how often during the past 2 
weeks participants bothered by various events. The rating goes from not at all (0 on the 
scale), several days (1), more than half the days (2), nearly every day (3). 
Additional measures that will be used include sociodemographics (from the VA survey of 
Health Experiences SHEP and Federal Reserve Board Survey of Household Economics 
and Decision Making), ENRICHD Social Support Instrument (ESSI), Perceived Stress 
Scale, PROMIS sleep disturbance short form ((PHO) and PROMIS Cooperative Group), 
Importance of Money Scale (IMS, Franzen and Mad), Loss Aversion (Gachter, Johnson 
and Herrmann), PROMIS Global Health Scale. These instruments are used to gather 
demographic data and how much social support and daily interaction the participant has 
with others. All of these assessments will be presented in the form of a cohesive survey, 
where responses are recorded based on a scale. Participants will select the response on 
the scale that most closely matches their life on the day they take the assessment.   
Participants will be able to skip any survey responses that they prefer not to answer. All 
of the surveys are included in in Appendix 6.  
Main Study, weeks 1-24: 
To participate, participants will be instructed to wear their Fitbits daily. Participants will need to 
open the Fitbit app on their phone and sync the Fitbit with the app on most phones. Participants 
will receive text message and/or emails with appropriate study updates. These updates will 

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include the new step goal for the next week, encouragement, reminders to sync the device with 
their phone, notification of non/financial incentives, lottery numbers, loss-framed results, 
reminders for surveys, transitioning into the maintenance phase, week 12-24 (appendix 22). All 
participants will select the day of the week when their new week starts. On the participants 
selected day, they will be given a new daily step goal for the next week.. The goal will be 15% 
more than the previous average weekly step count. If the participant is in a lottery group, they will 
participate in the lottery every day that they reach their new step goal. The text/email messages 
will be sent out the following day, i.e. “you won _______ in the lottery for your step count 
yesterday.” For participants in the loss-framed group, the participants will get their update on 
points or dollar amount based on the previous day’s steps.  
Syncing: 
Texts will encourage participants to sync their devices daily. If a participant fails to sync 
their Fitbit, they will continue to receive reminders to sync their Fitbit as soon as possible. 
Participants will receive text message reminders to sync their Fitbit or call us if they are 
having trouble. They will also get a reminder to charge their Fitbit if the charge drops 
below 15%. If a participant syncs sporadically, their step count will be adjusted to the 
most recent available data. In the absence of a full week of data, the average of the 
previous 7 days of data that was synced will be used.  
Once the participant syncs their device (anytime week 1-12), they will get a text messages 
updating them on:  
1) New daily step goal (the step goal will have been previously paused based on the 
most recent data we have. The next step goal will be based off whatever information 
is synced.)  
2) All rewards won to date. Once a participant syncs their Fitbit, they will be sent a 
message with their lottery winnings or loss-framed point/dollar amount value based of 
off what data was collected when the sync occurred.  
5.6 Data Analysis 
There are 16 combinations of factors, with 8 patients in each, for a modestly sized trial of 
128 patients. However, each factor has 64 patients per factor level: there are 64 people 
receiving financial and non-financial incentives for meeting PA goals, respectively, and 64 
patients receiving them in the form of a lottery and a loss-framed incentive. Every 
component is balanced with respect to the other components, which allows us to estimate 
the effects of all components with nearly the same power as if we had conducted 
independent trials of each component. 
We powered the analysis for a difference in steps between treatment groups at follow-up using a 
repeated measures design with 24 follow-up measures per person (weeks 1-24). We used data 
on the standard deviation in step count from the 2006 NHANES and applied the formula for a 
truncated normal distribution to estimate the standard deviation among subjects with <5,000 
steps at baseline. This yielded an estimated standard deviation of approximately 2,300. We 
assumed an intra-class correlation of 0.8 for the follow-up measures. We will enroll 128 patients, 
or 64 patients per treatment arm. This is similar in size to the treatment arms in studies described 
in Table 3 that compared active treatment groups (n=70). The slightly smaller sample size in the 
present study is justified by the higher type 1 error probability assumption. Loss to follow-up in 
the trials in Table 3 ranged from 4-7%. With 128 patients we will have 80% power to detect a 
difference as small as 375 steps per day with 10% loss to follow-up. We anticipate recruiting at 
least 10 participants per month.  
 

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All data will be collected by the VA research study team. The data collected during the first week, 
week 0, also referred to as the baseline week, will be used for all future step goals. The VA 
research team will monitor this period to ensure the participant is actually participating and 
syncing the data. If there is no data, the VA study team will call and encourage the participant to 
participate or help troubleshoot any issues.  
 
5.7 Withdrawal of Subjects 
2-week trial withdraw. If a participant fails to walk an average of 2,000 steps/day or exceeds 
5,000 steps per day, or cannot sync their Fitbit at the end of the trial period they will be 
withdrawn. The research staff will call them and thank them participating up to that point and 
inform them they are not eligible for the full study. The study Fitbit account will be closed, and the 
research study staff will delete their Fitbit account. 
 
Active withdraw. Any participant may at any time notify the Principal Investigator or research 
coordinator(s) that they no longer wish to participate in the study, and they will be considered 
withdrawn and will no longer participate in study procedures or activities. We will make every 
attempt to have a final (remote) study visit with the participant. During the final visit we will 
encourage the participant to complete the final survey, and we will deactivate their Fitbit account 
and stop the text/email messages. At this point in time, depending on the arm of the study the 
participant was randomized to, they will be told the total amount they can expect to receive in the 
mail, or they will be notified of the non-financial reward(s) they have earned. 
 
Passive withdraw. If a participant stops syncing their device, we will encourage them to start 
syncing it again and we will be available for troubleshooting. If the participant does not sync their 
device but syncs it before the end of week 24, they will be given all rewards up to that date 
(reward period week 1-12). If they do not explicitly tell us that they want to withdraw we will keep 
them in the study. If a participant syncs their device after week 24, they will no longer be eligible 
for rewards because they have phased out of the study data collection timeframe. After 6 weeks 
from the Fitbit set-up visit, if the participant has not completed and returned the baseline survey, 
they will be considered withdrawn.  
 
Medical withdraw. At any point in time if a participant experiences a change in their health, is 
diagnosed with a new condition, gets medical advice to discontinue participation or feels that 
increasing their exercise is not in their best interest they can choose to withdraw. If a participant 
has medical questions about their involvement in the study, they can speak with the physician 
researcher and co-investigator. The physician researcher will review their chart and determine if 
there is anything that would contra-indicate further participation. Often participants mention their 
involvement in research to their medical care providers. If any of their medical care providers 
determine that participating is not beneficial, they may be withdrawn from the study. If this occurs 
the same withdrawal procedures will be followed for active withdraw. Participants will be 
compensated for all activities earned to the date of withdraw as outlined in the informed consent 
document.   
6.0 
Reporting 
Participant reports: If a participant reports an unanticipated problem, we will immediately report it 
to the Principal Investigator. If it is a serious event, we will immediately report it to the IRB. If it is 
regarding subject payment we will track the issues in our study payment folder on the J:drive and 

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correspond with the R&D payment staff accordingly. All protocol deviations will be immediately 
reported to the IRB using the report of problems form.  
7.0 
Privacy and Confidentiality 
We will use protected health information for recruitment, screening and payment purposes. 
Several steps will be taken to minimize the risk of invasion of privacy. Initial contact with 
prospective participants will be made via an introductory letter with a stamped post card allowing 
her/him to opt out of further contact by the study team, thus limiting risk for invasion of privacy. 
Several steps will be taken to ensure confidentiality and data protection throughout the rest of the 
study. All data gathered will be confidential. Data will be kept in offices at VA Puget Sound 
HSR&D with locked filing cabinets and password protected computers. The investigators, project 
coordinators and data analyst will be the only staff to have access to confidential records. Data 
collection, storage and management for this research project will adhere to all applicable VA 
policies, the VA Puget Sound Health Care System’s Automated Information Systems Security 
Policy, and the established Data Security Policy of the Seattle HSR&D. Access will be restricted 
to study investigators, the study data analyst, research coordinators and the HSR&D Center data 
manager. Protected health information will not be disclosed, copied, transmitted by email, or 
transmitted in total or in part to anyone not connected with the approved protocol and not 
approved by the VA (via a Data Use Agreement, if necessary) to access the identifiers.  
 
We will take stringent precautions to protect the confidentiality of subjects’ personal information, 
including PHI. Study data and PHI will comprise patient data, interview recordings and survey 
data. Data will be extracted, merged and matched on patient identifiers. We require patient 
identifiers to extract and merge previously collected data that will be housed in the study 
crosswalk.  
 
ID numbers rather than names will be used whenever possible. As part of the study, individuals 
will be reassured that information is to be kept confidential, no single individual will be identified 
by name and all data will be aggregated in published manuscripts and presentations. All data 
files will be maintained on password protected PCs and secured computer networks. Only 
aggregate data will be presented to external audiences. Individual identifiers will be deleted when 
they are no longer necessary for the project. Health care data will be stored on secure VA 
servers within the VA HSR&D COIN in Seattle. 
 
After all manuscripts are published (estimated December 2025), all human subject identifiable 
files and crosswalks will be destroyed in the manner approved by the VHA Records Control 
Schedule. Electronic media used to store identifiable data will be cleaned or destroyed in 
compliance with governing information security regulations.  
 
While we will make every effort to keep information confidential, no system for protecting 
confidentiality can be completely secure in this operational context. Individuals may choose to 
share with others the fact of their participation or opinions about the incentives, the survey, the 
interview or any other part of the study. We will not disclose participation in the study or 
responses to any questions to anyone outside our research team.  
 
Participants’ personal identifiable information (PII) and Protected Health Information (PHI) will not 
be share outside the study team. 

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8.0 
Communication Plan 
VA Puget Sound is the only VA site engaged in research. There are no other researchers 
at any other VA site. In the future we hope to work with a University of Washington PhD 
student. Should this happen, the protocol and study staff list will be updated.  
 
9.0      Information Security and Data Storage/Movement 
Data flow: Data pulled from CDW will be stored in the study folder on the J:drive in an Excel file, 
VINCI folder and SQL server, and HSR&D SQL server. The medical record screening will be 
done from this file. Participants that meet the inclusion criteria will then be placed in an Access 
database. Recruitment letters will be mailed, and the participants response or lack of response 
will be tracked within the Access database electronically. Participant consent will be collected in 
hard copies through the mail and filed in locked cabinets in the locked office.  
 
Once a participant has enrolled, their step data will be pulled from the Fitbit app by the research 
coordinators and saved in the J:drive folder. Participant survey responses and step counts will be 
collected by the research team.  Research staff will collect all data and save it daily in the study 
folder on the J:drive. Approved research staff will then run a program (likely Stata) to match the 
step data with a crosswalk of participant group, current week and email/text address and 
preference. Coordinators will then do a mail merge to match the correct message to the correct 
address (text/email) and send the messages from the study email account. A daily file with the 
internal study ID, step count and messages will be saved by date in the J:drive to be able to 
cross check for errors if needed.   
 
All qualitative interviews will be saved onto a VA issued recorder and saved immediately onto the 
J:drive study folder or recorded directly from Webex onto the J:drive study folder. Study 
interviewers will have an approved ATSI if using a portable recorder, authorization to transport 
data, so interviews can occur remotely or in one of the interview rooms. If using a recorder, once 
interviews are saved to the appropriate folder on the J:drive they will immediately be deleted 
from the recorders. 
 
The data will be retained throughout the research study period on the VA Puget Sound Health 
Care System (VAPSHCS) network server or OI&T managed archived back-up media. All files 
containing individually identifiable information (III) for this study will be deleted from the VA Puget 
Sound Health Care System (VAPSHCS) network server folder and/or database no later than six 
months prior to the closure of the study. Only de-identified data will be retained thereafter on the 
VAPSHCS network server.  
 
After all manuscripts are published (estimated December 2025), and assuming that the VA has 
approved the destruction of data, all human subject identifiable files and crosswalks will be 
destroyed. Electronic media used to store identifiable data will be cleaned or destroyed in 
compliance with governing information security regulations.  
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