Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living
Phase: NA
Conditions: Sedentary Behavior
Sponsor: University of Iowa

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Residential MapTrek 
This title should include, where possible, information on the participants, condition being evaluated, and 
intervention(s) studied. 
Protocol Number: 201904816 
National Clinical Trial (NCT) Identified Number: NCT04041869 
Principal Investigator: Lucas Carr, PhD 
Sponsor:  
"Sponsor" indicates an institution, foundation, or individual who takes responsibility for and initiates a 
clinical investigation; often times this is the university with which the Principal Investigator is affiliated. 
Grant Title: Institute for Clinical and Translational Science Pilot Program 
Grant Number: UL1TR002537 
Funded by: NCATS 
Version Number: v.1.007 
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All versions should have a version number and a date. Use an international date format (e.g.,YYYY-MM-
DD [2017-12-21] or write out the month (e.g., 21 December 2017). 
For the initial submission of a protocol to the IRB, indicate "Not applicable; this is the first version of the 
protocol." in the table below. For any subsequent amendment being submitted to the IRB, add details of 
the specific changes that are being implemented in the amendment. Please note that Section 10.4 is a 
high-level summary of all formal protocol versions/amendments. 
 
 
Summary of Changes from Previous Version: 
Affected 
Section(s)
Summary of Revisions Made  
Rationale  
   
   
   
   
   
   
 
 
Table of Contents 
 Table of Contents - Please right-click and choose 'Update Field'. 
 
 

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STATEMENT OF COMPLIANCE 
Provide a statement that the trial will be conducted in compliance with the protocol, International 
Council on Harmonisation Good Clinical Practice (ICH GCP) and applicable state, local and federal 
regulatory requirements. Each engaged institution must have a current Federal-Wide Assurance (FWA) 
issued by the Office for Human Research Protections (OHRP) and must provide this protocol and the 
associated informed consent documents and recruitment materials for review and approval by an 
appropriate Institutional Review Board (IRB) or Ethics Committee (EC) registered with OHRP. Any 
amendments to the protocol or consent materials must also be approved before implementation. Select 
one of the two statements below. If the study is an intramural NIH study, use the second statement 
below: 
1. The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following: 
o 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
OR 
2. The trial will be conducted in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and 
the [specify NIH Institute or Center (IC) [ Terms and Conditions of Award. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from the funding agency and documented approval from the 
Institutional Review Board (IRB), and the Investigational New Drug (IND) or Investigational 
Device Exemption (IDE) sponsor, if applicable, except where necessary to eliminate an 
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study 
have completed Human Subjects Protection and ICH GCP Training. 
For either option above, the following paragraph would be included: 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
INVESTIGATOR'S SIGNATURE 
Principal Investigator or Clinical Site Investigator: 

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Signed: 
Lucas J. Carr 
Date: 
8/28/19 
Name*:  
Lucas J. Carr 
Title*:  
Associate Professor 
 
 
Investigator Contact Information: 
Affiliation*: University of Iowa 
Address:  
225 South Grand Avenue, Field House E130 
Telephone:  319-353-5432 
Email:  
lucas-carr@uiowa.edu 
 
For multi-site studies, the protocol should be signed by the clinical site investigator who is responsible  
for the day to day study implementation at his/her specific clinical site:  
Signed: 
  
Date: 
  
Name:  
  
Title:  
  
Affiliation:   
 
 

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title:
 Residential MapTrek 
Grant Number:
 UL1TR002537 
Study Description: 
The overarching goal of our project is to develop an inexpensive 
and scalable tool to increase volume of physical activity in our 
target population, older adults living in a residential facility. 
MapTrek is a web-based application that allows participants to 
take a virtual walk in interesting locations around the world 
while tracking their progress against the progress of other older 
adults living in a retirement community. Steps are counted using 
a commercially available accelerometer (e.g., Fitbit), and 
participants see their progress overlaid on Google Maps. The 
overarching goal of our project is to develop an inexpensive and 
scalable tool to increase volume of physical activity in our 
target population, older adults living in a residential facility.  
 
All participants will be provided with a Fitbit activity monitor 
and instructed to wear it 24 hours/day (except for 
bathing/swimming time) on their wrist for 12 weeks. 
Participants will participate in four team based walking races, 
each two weeks long. Participants will view their team progress 
on TV monitors placed in various locations at the Oaknoll 
facility. The monitors will present aggregated team data and 
will not report any individual data that could link back to the 
individual participant.  
 
At the end of the 8 week active intervention, research team 
members will meet with participants at Oaknoll to administer an 
exit/process evaluation survey. The exit survey will ask about 
psychosocial predictors of physical activity as well as 
participants thoughts and opinions of the MapTrek game. This 
survey should take approximate 10-15 minutes to complete. We 
will then ask the participants to wear the Fitbit for four more 
weeks without playing MapTrek, which will act as a control 
condition since this is a single-arm study. 
Objectives*: 
Primary Objective: 1. To determine the efficacy of MapTrek 
for improving physical activity levels of 
older adults living in a residential facility. 
Secondary 
Objectives: 
1. To determine the efficacy of MapTrek for 
improving psychosocial outcomes(e.g., self-
efficacy, social support, outcome 

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expectations) among older adults living in a 
residential facility. 
2. To determine the acceptability of MapTrek 
among older adults living in a residential 
facility. 
Endpoints*: 
Primary Endpoint: 8-week active intervention (August 26, 
2019) 
Secondary 
Endpoints: 
4-week follow up (September 22, 2019) 
Study Population:
Adults (25-64 years) and older adults (65+ years) 
Phase* or Stage:
  
Description of Sites/Facilities 
Enrolling Participants: 
One retirement community  
Description of Study 
Intervention/Experimental 
Manipulation: 
All participants will then be provided with a Fitbit activity monitor 
and instructed to wear it 24 hours/day (except for bathing/swimming 
time) for the next 4 days. After 4 days of baseline data collection, our 
team will assign participants to one of three teams through 
randomization based on their baseline activity data. The three teams 
will be identified by three colors of wrist bands that hold the Fitbit 
monitor; black white and teal.  
  
After baseline data collection, the research team will hold a kick-off 
event for the participants. The research team will give a brief 
presentation describing the study again. Participants will be 
informed of their team by a research team member and will be 
provided a wrist band that corresponds to their team color (black, 
white or teal). At that point, participants will receive written 
instructions ("game rules") on how to play the MapTrek intervention 
(our virtual walking race platform).  
 
As part of the MapTrek game, participants will be asked to wear their 
Fitbit activity monitor every day for 12 weeks. For the first eight 
weeks, participants will participate in four team based walking races, 
each two weeks long. Participants will view their team progress on 
TV monitors placed in various locations at the Oaknoll facility. The 
Oaknoll leadership has given us approval to do this at their facility 
(see letter of support). The monitors will present aggregated team 
data and will not report any individual data that could link back to 
the individual participant. After the 8-week active intervention, we 
will take MapTrek away and will ask participants to wear the Fitbit 
for an additional 4 weeks. This will be done to determine the effects 
of MapTrek had on physical activity compared to a control where 
participants only wear the Fitbit.  
Study Duration*:
12 weeks 

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Participant Duration:
13 weeks  
 
 
1.2 SCHEMA 
Example #1 Flow diagram (e.g., single arm, pre-posttest intervention) 
  
  
  
  
 
 

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1.3 SCHEDULE OF ACTIVITIES 
 
 

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2 INTRODUCTION 
2.1 STUDY RATIONALE 
Older adults are a growing population, with projections to reach 83.7 million by 2050. 
Furthermore, older adults are the most sedentary and least physically active adult population. It is 
estimated that nearly 90% of older adults 65 years of age or older do not meet the recommended 
levels of physical activity. Evidence suggests great health benefits can be achieved for older 
adults who are the most sedentary, and that replacing sitting with even light intensity walking 
can be beneficial.  
 
 
2.2 BACKGROUND 
Older adults (aged 60 and older) are a growing population, with projections to reach 83.7 million 
by 2050, almost double the population in 2012 (Ortman, Velkoff, & Hogan, 2014).Increasing age 
is associated with declines in many physiological systems(Sakuma & Yamaguchi, 20112) and 
increased risk for several non-communicable chronic health conditions(World Health 
Organization, 2009). Older adults often experience declines in balance, loss of muscle mass, 
reductions in muscle strength and endurance, and decreased cognitive function(Piercy et al., 
2018; Sakuma & Yamaguchi, 2012; Salthouse, 2003; Warburton, Nicol, & Bredin, 2006) 
Collectively, these age-related declines can negatively impact older adult’s physical function and 
quality of life(Taylor, 2014).  
 
Physical activity is an important modifiable behavior demonstrated to reduce the risk for several 
age-related chronic diseases while improving physical function.(Piercy et al., 2018) Maintaining 
a physically active lifestyle is important for maintaining independence(Taylor, 2014), improving 
health-related quality of life(Choi, Lee, Lee, & Jung, 2017), and increasing performance in 
activities of daily (Dionigi, 2007; Piercy et al., 2018). Previous studies have demonstrated 
favorable financial impacts of physical activity-based wellness programs targeted to older 
adults.  
 
Older adults are the most sedentary and least physically active adult population. Older adults 
spend an average of 9.4 hours per day engaged in sedentary behavior(Harvey, Chastin, & 
Skelton, 2014). The Physical Activity Guidelines for Americans recommend older adults to 
achieve a minimum of 150 minutes of moderate-to vigorous (MVPA), multicomponent physical 
activity per week which includes balance training, aerobic and muscle strengthening 
activities(Piercy et al., 2018). Moreover, older adult who cannot meet the guidelines are 
encouraged to do any amount of physical activity, to move more and sit less, in order to gain 
some health benefits(Piercy et al., 2018). However, it is estimated that nearly 90% of older adults 
65 years of age or older do not meet the recommended levels of physical activity.(Shepherd, 
2011) Evidence suggests great health benefits can be achieved for older adults who are the most 

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sedentary, and that replacing sitting with even light intensity walking can be beneficial.(Piercy et 
al., 2018)  
 
Retirement communities and residential living facilities can be important settings to consider 
when delivering physical activity interventions to older adults. Evidence suggests that older 
adults living in these facilities may have an increased number of chronic diseases, are frailer, 
more inactive, and perform worse on physical function tests. (Kang, White, Hayes, & Snow, 
2016; Mihalko & Wickley, 2003; Wert, Talkowski, Brach, & VanSwearingen, 2010) Retirement 
communities and residential living facilities can be an important setting to consider when 
delivering physical activity interventions to older adults.  
 
Rosenberg et al. (2012) found that facility-dwelling older adults found a walking intervention to 
be feasible and effective for improving participants’ daily steps, cognitive function. 
neighborhood barriers (i.e., hills, crime, traffic, unsafe crossing, or lack of places to walk) and 
satisfactions with walking opportunities (i.e., satisfaction with walking and exercise 
opportunities at their site, local area, and access to safe walking routes). However, a major 
limitation from this study was that participants used a pedometer to self-report their daily 
physical activity. With improvements in technology and the increasing use of wearable activity 
monitors, researchers can increase the quality of reliability of these study designs. 
 
 
2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
The physical risks include possible fatigue, and/or injury from participating in physical activity. 
There is a potential of loss of confidentiality of data. The intervention will promote engagement 
in low to moderate intensity physical activity which poses a low risk for injury. 
2.3.2 KNOWN POTENTIAL BENEFITS 
There is no guarantee of a direct benefit from participating in this study. However, participants may 
improve their health and might feel better. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
We will screen participants carefully and exclude if they do not meet health related eligibility 
criteria. For the intervention risks, all participants will be informed about the potential risks of 
increasing their physical activity. However, the physical activity recommended will be of light-
moderate intensity which the Physical Activity Guidelines for Americans recommend for all 
older adults. They will also be instructed to follow simple guidelines when doing physical 
activity. If something hurts, they should stop and only resume if it feels better. If they feel sick, 
they should seek medical attention. To minimize the risk of loss of confidentiality of data, we 
will take several steps including de-identifying and ID coding all electronic data, storing 

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electronic data on a password protected warehouse accessible only to the PI and the investigative 
team, and storing paper copies of data and informed consents under lock and key in the PI's 
office/laboratory 
 
 

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
1. To determine the 
efficacy of MapTrek 
for improving 
physical activity 
levels of older adults 
living in a residential 
facility. 
 Assessments made at 
baseline, 8 weeks and 
12 weeks.  
 We will determine 
whether the intervention 
was effective at 8 weeks 
and whether participants 
maintained outcomes at 
12 weeks.  
  
Secondary 
1. To determine the 
efficacy of MapTrek for 
improving psychosocial 
outcomes(e.g., self-
efficacy, social support, 
outcome expectations) 
among older adults 
living in a residential 
facility. 
  
2. To determine the 
acceptability of 
MapTrek among older 
adults living in a 
residential facility.  
 Assessments made at 
baseline, 8 weeks and 
12 weeks.  
 
 
 
 
 
 
 
We will assess 
acceptability at 8 
weeks.   
 We will determine 
whether the intervention 
was effective at 8 weeks 
and whether participants 
maintained outcomes at 
12 weeks. 
 
 
 
 
Participants will have 
just finished the 
intervention at 8 weeks. 
  
Tertiary/Exploratory

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
This intervention is a single arm, pre-post test pilot study.  
 
 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Little physical activity research has been done within retirement communities, even though this is an 
optimal environment to deliver multilevel interventions (Jancey et al., 2017). Limitations with studies 
done in retirement communities include using a self-report measure of physical activity (Gallagher, 
Clarke, & Carr, 2016). Furthermore, studies were either not grounded in behavior change theory 
(Thompson, Kuhle, Koepp, McCrady-Spitzer, & Levine, 2014), or participants were not able to monitor 
their physical activity each day, receiving real-time feedback (Kerr et al., 2018). Similarly, there have 
been few mHealth physical activity interventions conducted with older adults. Of these studies, 
limitations include not clarifying if behavior change theory was used to drive the intervention design 
(Jonkman et al., 2018), and self-report measure of physical activity were used (Kim & Glanz, 2013; 
Muller, Khoo, & Morris, 2016). Finally, to our knowledge little research has been done on gamification of 
wearable activity monitors (Gremaud et al., 2018), specifically among older adults living in retirement 
communities. 
  
Our team has developed a mHealth intervention called MapTrek (Gremaud et al., 2018). MapTrek is a 
mobile-phone based walking game, grounded in behavioral theory that places participants into virtual 
walking races for the purpose of encouraging more daily physical activity throughout the day. MapTrek 
was designed to be fun, engaging and interactive.  In a recent trial, we found MapTrek to be feasible and 
efficacious at increasing physical activity among healthy sedentary office workers (Gremaud et al., 
2018). Participants were randomized to a MapTrek intervention or a Fitbit control group. Participants in 
the MapTrek group took an average of 1,455 more steps/day than the control group. At the start of the 
intervention, MapTrek participants immediately increased their steps by 2,183 steps/day beyond the 
control group. After the intervention started, both groups started to decrease their average steps/day 
back to baseline values. The MapTrek group decayed significantly faster at 44.8 steps/day compared to 
the control group at 24.3 steps/day. Conversely, 70.9% of participants reported MapTrek increased their 
perceived level of support to be physically active, 77.7% felt motivated to be more active, 70.2% 
reported MapTrek was a fun, and 93.1% of participants reported MapTrek was easy to play (Gremaud et 
al., 2018). While these outcomes suggest MapTrek was effective for middle-aged adults in the 
community, we have not yet tested this approach among older adults.  We believe MapTrek could be 
adapted for use and effective for increasing physical activity levels of older adults living in retirement 
communities. With the large and growing number of inactive older adults in the U.S., it is crucial that we 
identify effective and scalable approaches for promoting physical activity among older adults. 

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Translation of interventions to a population level has been slow and inconsistent. Significant effects on 
health can be made through widespread adoption and dissemination of interventions (Gonzales, 
Handley, Ackerman, & O'Sullivan P, 2012) 
 
 
4.3 JUSTIFICATION FOR INTERVENTION 
Older adults are a growing population, with projections to reach 83.7 million by 2050. Furthermore, 
older adults are the most sedentary and least physically active adult population. It is estimated that 
nearly 90% of older adults 65 years of age or older do not meet the recommended levels of physical 
activity. Evidence suggests great health benefits can be achieved for older adults who are the most 
sedentary, and that replacing sitting with even light intensity walking can be beneficial.  
 
The overarching goal of our project is to develop an inexpensive and scalable tool to increase volume of 
physical activity in our target population, older adults living in a residential facility. MapTrek is a web-
based application that allows participants to take a virtual walk in interesting locations around the world 
while tracking their progress against the progress of other older adults living in a retirement community. 
Steps are counted using a commercially available accelerometer (e.g., Fitbit), and participants see their 
progress overlaid on Google Maps. The overarching goal of our project is to develop an inexpensive and 
scalable tool to increase volume of physical activity in our target population, older adults living in a 
residential facility.  
 
 
4.4 END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, the 8-week active intervention sessions, and the 4-week follow-up. 
  
The end of the study is defined as completion of the 4-week follow-up assessment. 
 
 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
Participants must have met the following inclusion criteria: 1) between the ages of 25 and 100; 2) do not 
have any physical or cognitive limitations that prevent them from walking comfortably; 3) have not 
participated in a study that uses MapTrek; 4) their doctor has not told them that is not safe to be 
physically active. 
 
 
5.2 EXCLUSION CRITERIA 
Exclusion criteria includes: 1) reporting any physical or cognitive limitations that prevent them from 
walking comfortably; 2) have participated in a MapTrek study before; 3) their doctor has told them it is 
not safe to be physically active; 4) there is any other reason why they shouldn’t be physically active.  
 
 
5.3 LIFESTYLE CONSIDERATIONS 
N/A 
 
 
5.4 SCREEN FAILURES 
Screen failures are defined as individuals who meet one or more of the exclusion criteria. Individuals 
who meet one or more of the exclusion criteria will not be able to be re-screen for participation in the 
intervention.  
 
 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
We anticipate screening 110 individuals including women, minorities, and participants across the 
lifespan, in order to reach the target enrollment size of 100. We anticipate enrolling 100 participants, 
50% female and 50% male. We anticipate accruing 75 older adults and 25 adults over 2-weeks.  
  

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At the Oaknoll off-site location, word about the study will be spread by word of mouth and 
advertisements. Advertisements will be displayed on TV monitors throughout Oaknoll. These materials 
will be distributed by the Activities Coordinator at Oaknoll. The research team members will spread 
information about the study through word of mouth. Interested participants will contact the Activities 
Coordinator to schedule a time and location for testing at Oaknoll. She will send out information about 
the study through Oaknoll's weekly news. If she receives any questions about the research beyond what 
is included in the brochures, ads, and posters, she will direct the person to contact a member of the 
research team. Once a participant shows interest in the study from seeing a poster advertisement or ad 
in the weekly news, she will schedule a time and location for testing at Oaknoll. The eligibly criteria will 
be listed in the ad, and all potential participants will be screened before the research team goes over the 
informed consent. Coercion and undue influence will be minimized by informing the subjects that 
participation in the study is completely voluntary and that they are free to quit the study at any time 
without penalty. 
  
All participants will receive a Fitbit activity monitor. For compensation, all participants will be allowed to 
keep the Fitbit activity monitor at the end of the study. Participants who participate in the focus groups 
will receive a $50 check for compensation.  
 
 

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6 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
We enrolled two different intervention groups, a group of older adults who live at Oaknoll and a group 
of Oaknoll employees. Enrolling a group of Oaknoll employees served two functions. First, it exposed the 
employees to MapTrek so that they can assist the residents with any technical problems or questions 
they may have during the course of the project period. Second, it fostered intergenerational 
engagement and generate excitement throughout the entire facility. Third, including employees was 
another avenue to increase social support for older adults, addressing the interpersonal level of the 
SEM. Physical activity interventions are likely to have greater effects when different levels are addressed 
at the same time. 
  
At enrollment, each participant was provided with a Fitbit, shown how to wear it, and consented to the 
research team accessing their Fitbit data. Participants were asked to complete a baseline survey which 
asked about demographic information, their self-efficacy for exercise, social support for exercise, 
outcome expectations for exercise, and social isolation. Total participation in this project lasted for 14 
weeks. The first two weeks were used to collected baseline data, where participants wore their Fitbit, 
but did not receive access to the MapTrek intervention. During the baseline period a kick-off event was 
held to answer participant’s questions, and to give participants their team colored wrist bands. 
Participants were placed into one of three teams, and stayed on these teams for the duration of the 
intervention. Three teams were used to help foster competition in the event that one team was walking 
significantly more or less steps than the others. 
After the two-week baseline period, participants received access to MapTrek and competed in four, two 
week-long races. Four two-week races were used so that teams had the opportunity to walk meaningful 
distances along each route (e.g., walking on the Grand Canyon Trail). The teams were assigned a new 
virtual walking route every two weeks. The team with the most steps at the end of two weeks were the 
winners. 
  
We made environmental change to Oaknoll. Participants were encouraged to walk by large TV monitors 
placed in three common areas throughout the facility. A small Raspberry Pi computer will be connected 
to each monitor. The Raspberry Pi is a credit-card sized computer that plugs into a computer monitor or 
TV to be used as a normal desktop. Two other Raspberry Pi devices were placed at convenient locations 
throughout Oaknoll. As participants walked by, their Fitbit data synced to the Raspberry Pi. The 
Raspberry Pi was used to sync the Fitbit so that (a) participants did not have to manually sync their Fitbit 
and (b) participants who did not have a computer or smartphone could still participate. Every two weeks 
during the intervention a new walking route was revealed. The teams will be competing against each 
other, and their total number of steps will be used to move their character on the map. The map routes 
were Seattle to San Diego (1,936 miles), through Arizona, Colorado, and Utah (2,194 miles), from New 
York through Key West to Pensacola, FL (2,422 miles), and from Vancouver to Minnesota down the 

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Mississippi River to New Orleans (2,540 mils). We made sure each route was long enough in case every 
team member walked ~5 miles/day. 
  
Three TV monitors were placed in public areas which displayed the virtual walking map, google maps 
view of the walking route, team leaderboard, and daily news. The daily news displayed messages each 
day that were developed based on Social Cognitive Theory (Appendix H). These behavior-change 
techniques addressed specific barriers to physical activity that older adults face such as health concerns, 
motivation and beliefs, low self-efficacy, access difficulties, and social support. 
6.1.2 ADMINISTRATION AND/OR DOSING 
The TV monitors displaying MapTrek will stay on during the entire 8-week intervention. The daily news 
will be updated once per day at 7:00AM CST. 
 
 
6.2 FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
Fidelity of the delivery of the intervention will include checking the TV monitors periodically to make 
sure they are displaying the MapTrek intervention. 
 
 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
N/A- this is a non-randomized intervention 
 
 
6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
Intervention adherence will be monitored by participants syncing their Fitbit activity monitors.  
 
 
6.5 CONCOMITANT THERAPY 
  
6.5.1 RESCUE THERAPY 
N/A 

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7 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
When a subject discontinues from Residential MapTrek, the remaining study procedures will be 
completed as indicated by the study protocol. The data to be collected at the time of study intervention 
discontinuation will include the following: 
 
The reason(s) for discontinuing the participant from the intervention, and methods for determining the 
need to discontinue 
 
 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
  
An investigator may discontinue a participant from the study for the following reasons: 
 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives 
 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
 
Any event or medical condition or situation occurs such that continued collection of follow-up study data 
would not be in the best interest of the participant or might require an additional treatment that would 
confound the interpretation of the study 
 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation 
  
 
 
7.3 LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to return for [specify number of visits] 
scheduled visits and study staff are unable to contact the participant after at least 3 attempts. 
  
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 

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 
The site will attempt to contact the participant, reschedule the missed visit [specify time frame], counsel 
the participant on the importance of maintaining the assigned visit schedule and ascertain if the 
participant wishes to and/or should continue in the study 
 
Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the participant (where possible, 3 telephone calls and, if necessary, a certified letter 
to the participant’s last known mailing address or local equivalent methods). These contact attempts will 
be documented in the participant’s medical record or study file. 
 
Should the participant continue to be unreachable, he or she will be considered to have withdrawn from 
the study with a primary reason of lost to follow-up 
 
 

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Demographic characteristics. Participants self-reported their demographics at baseline by taking an 
online survey through Qualtrics, Inc. The survey was filled out interview-style with research team 
members on their computers during enrollment. Participants reported their age, gender, race and 
ethnicity, education level, income, marital status, length of stay at the retirement community, and 
height (in.) and weight (lb.). Body-mass index (BMI) will be calculated using the formula weight (lb.) / 
[height (in.)]2. 
  
Aim 1: Physical activity. At the beginning of the study, participants were given a Fitbit Zip activity 
monitor to wear on the wrist for 12 weeks. The Fitbit Zip was asked to be worn on the wrist because 
evidence suggests accelerometers worn on at the hip have lower wear-time compliance. The Fitbit Zip is 
a small (35.6 x 28.9 x 9.6 mm) commercially-available triaxial accelerometer-based physical activity 
monitor that estimates steps taken per day. The Fitbit (One or Zip) worn on the hip has been 
demonstrated as a valid and reliable measure of average steps/day among community dwelling older 
adults compared to the ActiGraph GT3X+ (ICC=0.94, 95% CI 0.88 to 0.97) (Paul et al., 2015). Through the 
Fitbit application programming interface, the research team will be able to access each participant’s 
physical activity data minute-by-minute each day the activity monitor is worn. Participants were 
instructed to wear the monitor during all waking hours (except time spent swimming or bathing) for 
thirteen consecutive weeks. 
  
Aim 2: Psychosocial outcomes. This will be measured with the Self-Efficacy for Exercise (SEE) scale, a 13-
item questionnaire designed to assess the participant’s self-efficacy related to their ability to continue 
exercising in the face of barriers 
  
Outcome expectations will be measured with the Outcome Expectations for Exercise (OEE) Scale. The 
OEE is a valid and reliable 9-item scale that assess the participant’s outcome expectations and benefits 
associated with exercise.  
  
Social isolation will be assessed with the Friendship Scale (FS). The FS is a 6-item scale that assesses six 
dimension contributing to social isolation. 
  
Aim 3: Satisfaction and adherence. To assess the acceptability of the intervention, we will measure 
participant adherence and satisfaction. Acceptability is important to assess because we want to be able 
to determine if older adults thought MapTrek was a fun game for increasing physical activity. 
Specifically, we will be able to determine which intervention features they thought were helpful. 
Adherence will be measured by examining the enrollment, completion, and compliance rates. 
Enrollment rate will be assessed by documenting the number of people who enroll in the study from the 
number of people living in the retirement community, and completion rate will be assessed by the 

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number of people who finish the study out of those who enrolled. Compliance rates will be assessed by 
examining the percentage of participants who are wearing and syncing their Fitbit over the course of the 
intervention. Process evaluations were administered to participants via phone or in-person during the 
first week after the active intervention. The process evaluation was used to assess the participant’s 
satisfaction with the game features. Participants were asked what they most liked about the game, what 
barriers prevented them from playing the game, and what improvements they would recommend. This 
information will be used when developing future intervention in which MapTrek is used to promote 
physical activity among an older adult population. Focus groups (6-8 participants) will be held the third 
week of the follow-up timepoint. 
 
 
8.2 SAFETY ASSESSMENTS 
N/A 
 
 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
Adverse event means any untoward medical occurrence associated with the use of the physical activity 
intervention in humans, whether or not considered intervention-related. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or 
sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient 
hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
  
8.3.3.1 SEVERITY OF EVENT 
All AEs will be assessed by the team medical director (Dr. Phil Polgreen, MD).   
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 

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All AEs will have their relationship to study participation assessed with a level of specificity appropriate 
to the study design. The medical director will determine whether the AE was related (reasonable 
possibility event was caused by participation) or unrelated (not reasonable possibility) to the 
participant's study participation.  
8.3.3.3 EXPECTEDNESS 
It is possible that participants could report musculoskeletal complications and/or cardiopulmonary 
complications that have been associated with vigorous bouts of physical activity. However, the 
intervention will not prescribe vigorous intensity activity, rather walking at a low to moderate intensity 
will be encouraged.  
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
Our team will continually be monitoring participant's progress in the study. Participants will be advised 
to contact our team by phone or email immediately if they experience an adverse event. Our team will 
be checking our email and voicemail daily.  
8.3.5 ADVERSE EVENT REPORTING 
Any adverse events reported to our team by participants will be reported to the Human Subjects Office 
within 10 working days by the principal investigator (Dr. Lucas Carr). We will follow the Human Subjects 
Office policy for reporting adverse events 
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
Any adverse events reported to our team by participants will be reported to the Human Subjects Office 
immediately by the principal investigator (Dr. Lucas Carr). We will follow the Human Subjects Office policy for 
reporting adverse events 
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
We will report any significant events that may impact their willingness to participate to participants as 
we learn of them.  
8.3.8 EVENTS OF SPECIAL INTEREST 
N/A 
8.3.9 REPORTING OF PREGNANCY 
Pregnancy is an exclusion criteria for this study. We will not be reporting pregnancy.  
 
 

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8.4 UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
8.4.2 UNANTICIPATED PROBLEMS REPORTING 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
 
 

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
 
Primary Efficacy Endpoint(s): We hypothesize that participants will increase their average steps/day from 
baseline to the initial adoption of the active intervention, there will be a significant difference in average 
steps/day from baseline to the last week of the active intervention, there will be a significant difference in 
average steps/day from baseline to the follow-up phase post-active intervention, participants will 
experience a decrease in average steps/day each day from the start of the 8-week intervention to the 
end. two to week eight. 
  
 
Secondary Efficacy Endpoint(s): We hypothesize participants will increase their feelings of social support, 
self-efficacy, and outcome expectations, and decrease their feeling of social isolation from baseline to 
post-active intervention. We hypothesize this will be an acceptable multilevel mHealth intervention 
among older adults living in a retirement community. 
  
 
 
9.2 SAMPLE SIZE DETERMINATION 
To achieve 80% power to detect a 1,750 step difference in step counts between the pre- and post-
intervention periods, with a standard deviation of 2,000 steps and a significance level of 0.05, we are 
required to enroll at least 42 participants. If we add an additional 25% for possible drop outs, we will 
need to enroll at least 50 participants into the older adult group.  
 
 
9.3 POPULATIONS FOR ANALYSES 
 
 
9.4 STATISTICAL ANALYSES 
  
9.4.1 GENERAL APPROACH 
To analyze descriptive statistics we will use frequencies, mean, and standard deviation.  

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9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
We will used mixed-effect models to Repeated measures ANOVA. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Student’s T Test will be used to test the mean scores for social support, self-efficacy, and outcome 
expectations, and social isolation from baseline to post-intervention. A simple linear regression will be 
used to examine the linear relationship between changes in psychosocial outcomes and changes in 
physical activity.  
  
Descriptive statistics (i.e., mean, SD, frequency) and qualitative analysis will be used to analyze 
acceptability outcomes from the process evaluation. 
  
  
  
9.4.4 SAFETY ANALYSES 
  
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Descriptive statistics (i.e., mean, SD, frequency) will be calculated for participant characteristic including 
age, sex, height, weight, and BMI, education, total annual household income, and length of residence at 
the retirement community.  
9.4.6 PLANNED INTERIM ANALYSES 
N/A 
9.4.7 SUB-GROUP ANALYSES 
  
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
  
9.4.9 EXPLORATORY ANALYSES 
  
 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
  
10.1.1 INFORMED CONSENT PROCESS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.  The following consent materials are submitted with this 
protocol: informed consent, waiver of informed consent. 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Informed consent documents will be provided to the participants.  
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
A research team member will review the consent document with participants before they sign it. 
Participants will indicate their consent by signing the consent document. Participants will be provided a 
copy of the signed consent form to keep for their records. Coercion and undue influence will be 
minimized by informing the subjects that participation in the study is completely voluntary and that they 
are free to quit the study at any time without penalty. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to [study participants, investigator, funding agency, the 
Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor and regulatory 
authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the IRB, and sponsor and will provide the reason(s) for the 
termination or suspension. Study participants will be contacted, as applicable, and be informed of 
changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Demonstration of efficacy that would warrant stopping 
 
Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination that the primary endpoint has been met 

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 
Determination of futility 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, sponsor, IRB, Food and Drug Administration (FDA), or other 
relevant regulatory or oversight bodies (OHRP, DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY 
 
Paper/hard copy records (hard copy surveys, questionnaires, case report forms, pictures, etc.) - Hard 
copies of informed consent documents will be stored in a secure cabinet located in a laboratory directed 
by the PI (Field House room E141). The lab is under lock and key and is only accessible to research staff. 
All participants will be given a unique study ID# which will be linked to collected data. When collecting 
data at Oaknoll, all documents will be stored in a temporary container in a research team member's 
possession and then transported to the storage location at the Field House. Databases that include ID 
numbers and collected data will be stored on a password protected and secure electronic warehouse 
accessible only to the principal investigator. All collected data will be destroyed 5 years following 
completion of data analysis. 
 
Electronic records (computer files, electronic databases, etc.) - All data will be collected through a UI 
Qualtrics account for screening and study data collection. Identifying information that we will collect from 
participants includes their Name, Address, and Phone Number. The storage of the MapTrek data will be 
on a password-protected, secure servers in Computer Science Dept. It will only be the participant's phone 
number and Fitbit data. Only members of the research team will have access to this information through a 
password protected electronic file on a UI protected server. All collected data will be coded and stored in 
a password protected electronic file on a UI protected server. These servers are password protected with 
access only to authorized staff. Folders within the server are also made available to only select staff and 
with password protection as needed for participant data. A separate list of names with ID#s will be stored 
in a separate password-protected file for repeated measures comparisons. During the informed consent, 
we will ask participants for permission to store their data for future use. Participants will be given the 
option (yes or no) to allow us to store their data. For participants who agree to us storing their data 
(selecting 'Yes'), we will store that data on our protected server for future analyses. If participants do not 
agree (select 'No'), we will not store their data and will destroy their electronic data within five years of 
completion of the study. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
  
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Medical Monitor or Independent Safety 
Monitor 

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10.1.6 SAFETY OVERSIGHT 
  
10.1.7 CLINICAL MONITORING 
  
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
  
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
  
10.1.9.2 STUDY RECORDS RETENTION 
  
10.1.10 PROTOCOL DEVIATIONS 
  
10.1.11 PUBLICATION AND DATA SHARING POLICY 
  
10.1.12 CONFLICT OF INTEREST POLICY 
  
 
 
10.2 ADDITIONAL CONSIDERATIONS 
 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
AE
Adverse Event
ANCOVA Analysis of Covariance
CFR
Code of Federal Regulations
CLIA
Clinical Laboratory Improvement Amendments
CMP
Clinical Monitoring Plan

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

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UP
Unanticipated Problem
US
United States
 
 
10.4 PROTOCOL AMENDMENT HISTORY 
Version
Date
Description of Change 
Brief Rationale
 
 

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11 REFERENCES