VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
Phase: NA
Conditions: Obesity, Overweight
Sponsor: University of Iowa

 
 
 
 
VA MapTrek- Yr 2 
 
IRB #: 201901762 
 
 
 
Study 
Procedures 
 
Approval Date: 2/15/2019 
 
 
 

 
 
 
 

 
 
Table of Contents 
Section 1.0- Project Overview...................................................................................................................... 1 
Section 1.1 Background Information .................................................................................................... 1 
Section 1.2 Research Questions ........................................................................................................... 2 
Section 1.3 Project Outline................................................................................................................... 2 
Section 2.0- Participant Enrollment Procedures........................................................................................... 5 
Section 2.1 Consort Flow Diagram Data ............................................................................................. 5 
Section 2.2 Arrival at the Clinic ............................................................................................................ 5 
Section 2.3 Epic Pre-Screening ............................................................................................................. 5 
Section 2.4 In-Person Screening ........................................................................................................... 5 
Section 2.5 Consenting Procedures ...................................................................................................... 6 
Section 2.6 Randomization Procedures ................................................................................................ 7 
Section 2.7 Control Group Instructions .............................................................................................. 7 
Section 2.8 Intervention Group Instructions ........................................................................................ 8 
Section 2.9 Data Entry Procedures .................................................................................................... 10 
Section 2.10 Storing the Files.............................................................................................................. 10 
Section 3.0- Follow-Up Procedures ............................................................... Error! Bookmark not defined. 
Section 3.1 Submitting Payments ........................................................................................................ 10 
Appendices .................................................................................................................................................. 11 
Appendix A ......................................................................................................................................... 13 
Appendix B .......................................................................................................................................... 15 
Appendix C ......................................................................................................................................... 17 
Appendix D ......................................................................................................................................... 26 
Appendix E .......................................................................................................................................... 32 
Appendix F .......................................................................................................................................... 34 
Appendix G ......................................................................................................................................... 36 
Appendix H ............................................................................................ Error! Bookmark not defined. 
Appendix I .............................................................................................. Error! Bookmark not defined. 
Appendix J .............................................................................................. Error! Bookmark not defined. 

 
 
 
 

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Section 1.0- Project Overview 
 
 
 
VA MapTrek is a mobile-phone-based web application that allows participants to take a virtual 
walk in interesting locations around the world while tracking their progress against the progress of 
other veterans on an interactive map. Steps are counted using a commercially-available triaxial 
accelerometer (e.g., Fitbit), and users see their progress overlaid on Google Maps. Our objective is to 
report activity levels to veterans, thereby encouraging them to walk more. Once participants know how 
to text and use Google maps, no additional training is needed. VA MapTrek does not require a special 
app, so there are no logins or passwords to remember. Simply registering one's Fitbit and mobile phone 
at an initial enrollment meeting suffices.  
 
  
Section 1.1 Background Information 
 
Nearly one-third of all veterans are obese, and an additional 44% are overweight. Obesity is a 
known risk factor for hypertension, coronary artery disease, type two diabetes, and multiple forms of 
cancer, all common medical problems affecting US veterans. Among veterans who are obese, 75% 
report the desire to lose weight, but 59% of these individuals are either inactive or irregularly active. 
Even moderate amounts of physical activity, e.g., 30 minutes of walking per day, can facilitate weight loss 
in overweight and obese individuals. Increased time walking is also associated with increased quality of 
life in all domains, including decreased depressive symptoms in older men. The prevalence of obesity and 
associated medical problems in veterans using VA services highlights the need for new interventions to 
help increase physical activity, specifically walking, among US veterans.  
 
 
The VA has taken steps to improve health through lifestyle changes, specifically through the 
MOVE! Weight Management Program and the Whole Health Clinic. While proving to be successful, 
these programs require attendance at a VA location and only last for a finite period of time. Upon 
program completion, there is an unmet need to provide continued engagement. Ideally, the solution 
would be to offer a program suitable for long-distance deployment, especially to veterans living in rural 
areas. This program should also scale to expand in a cost-effective manner to serve veterans in all areas 
without requiring significant additions of personnel or increasing workloads in existing VA staff.  
The goal of our study is to test the feasibility of using our new VA-specific version of MapTrek to 
incentivize veterans to engage in or maintain an active lifestyle.  
 
 
VA MapTrek, an m-health intervention developed by collaborators at the University of Iowa, is a 
mobile-phone-based web app that allows users to take a virtual walk in interesting locations around the 
world while tracking their progress against that of others like themselves on an interactive map. Steps 
are counted by a commercially-available Fitbit triaxial accelerometer, and users see their progress 
overlaid on Google Maps. The objective is to report activity levels in the virtual environment to 
veterans, thereby encouraging them to first, walk more every day, and second, maintain these new 
increased levels of physical activity. Communication occurs via SMS text messaging, a ubiquitous 
communication medium. Using familiar technologies makes VA MapTrek easy to use. It does not require 
additional apps, logins, or passwords to remember. Registering a Fitbit and mobile phone during one 
appointment at a VA clinic allows play for the entire study.  
 

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Section 1.2 Research Questions  
 
The purpose of the proposed project is to contribute to and improve upon the existing weight 
management and physical-activity-promoting programs available to veterans. Our specific objectives are 
to:  
 
 
1) Assess the effectiveness of VA MapTrek as a whole to increase steps per day in veterans 
 
compared to the control group.  
 
2) Assess the effectiveness of challenges within VA MapTrek to increase steps per day in 
 
veterans in the intervention group.  
 
3) Identify additional areas of development within the MapTrek program to improve its future 
 
efficacy among veterans. 
 
 
Section 1.3 Project Outline 
 
All consented participants will be provided with a Fitbit and instructed to wear it all day, every 
day for the next 9 weeks (The first few participants may require an additional week or two of wear as 
we will not begin the first MapTrek race until we have at least 5 participants enrolled in the study. They 
will be told this upon enrollment.). We expect the enrollment process to take anywhere from 15 to 45 
minutes, depending on group assignment and participant familiarity with using Fitbits.  
 
 
This, plus an exit survey (given via text message or phone, whichever the participant prefers), 
will be the extent of participation for the control group.  
 
 
Members of the intervention group will be instructed on how to use MapTrek, our virtual 
walking race, and will also be given an instruction packet to refer to later. Data collected during the first 
week from the Fitbit will be used to compute baseline activity level. This baseline data will be used to 
place participants into an appropriate initial race group. Participants are placed into groups with other 
individuals who are active at a similar level, so that groups will be competitive.  
 
 
Each virtual walking race will begin on Monday morning and end on Saturday night. Results of 
each race will be announced on Sundays. Depending on their performance each week, group assignment 
may change. Participants will compete in 8 week-long races over the course of the study.  
 
 
Participants will receive 2-4 text messages per day including a daily status report and a link to 
view the race. They will also periodically receive challenge messages. If a participant completes a 
challenge, they will be awarded bonus steps to help move them along the route quicker.  
 
 
To win a race, a participant must be furthest along on the route at 11:59 pm on Saturday. There 
is a leaderboard within MapTrek that helps participants determine their standing within each race. 
Participants are allowed to choose the screen name displayed on the leaderboard so that they may 
remain anonymous if desired.  
 
 
At baseline, we will collect the following data about all participants: first and last name, last 4 of 
social security number (for consent documentation and to look up records in CPRS), age, sex, race, 

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ethnicity, marital status, height, weight, body mass index, blood pressure, zip code, current medications, 
and comorbidities.  
 
 
At the end of the study (9 weeks), we will collect the following data about all participants: 
height, weight, body mass index, blood pressure, current medications, and comorbidities.  
 
 
At the end of the study (9 weeks), we will also contact participants via text message or phone 
call (based on their preference at baseline) to complete an exit survey. We anticipate this survey taking 
approximately 10 minutes to complete. We will attempt to contact all participants up to 3 times to 
complete the exit survey. If they cannot be reached, they will be considered lost to follow up.   
 
 

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Section 2.0- Participant Enrollment Procedures 
Section 2.1 Consort Flow Diagram Data 
 
Prior to enrolling any participants, we need to begin tracking the number of people who are 
eligible for our study, how many we contact, how many enroll, etc.  To do this, make sure that you are 
filling out a Screening Survey in REDCap for anyone that is considered for enrollment in the study.   
Section 2.2 Arrival at the Clinic 
 
TBD 
Section 2.3 Screening 
 
Prior to enrolling participants, eligibility must be assessed.  This may be done by asking the 
person or by screening CPRS first and then finishing the remaining questions with the potential 
participant.  Everyone should be screened for: 
 
 
1) Comfort speaking and reading in English (must be yes) 
 
 
2) Age (must be 18-100 years) 
 
 
2) Smartphone with text messaging and internet capabilities (must be yes) 
 
 
3) Current Fitbit account (doesn’t matter) 
 
 
4) Male or Female (doesn’t matter) 
 
5) Current height (in inches) (You must indicate the date the height was 
measured/reported.  If they are self-reporting it, put today’s date; if it is from CPRS, 
indicate the date it was logged in CPRS) 
 
6) Current weight (in pounds) (You must indicate the date the weight was 
measured/reported.  If they are self-reporting it, put today’s date; if it is from CPRS, 
indicate the date it was logged in CPRS) 
 
7) BMI (REDCap will calculate, must be ≥ 25) 
 
8) Text message or phone call exit survey preference (doesn’t matter) 
 
9) Record if the height/weight were self-reported or from CPRS 
 
10) Determine if the potential participant is eligible 
 
11) Indicate if they were randomized to the intervention group or control group 
 
12) Include any relevant notes that we may need to know later 
 
 
Section 2.4 Approaching the Patient 
 
If you believe a patient is eligible for the study based on their CPRS data and discussions with 
the medical staff, approach the patient to see if they are interested in learning more and to finish any 
screening questions.  You should only approach patients upon approval from the medical staff so that 
you don’t disrupt clinic flow.  Here is an example script (feel free to say in your own words as long as 
the major points are covered): 
 
 
“We are conducting a study with eligible participants to see if our map-based race will encourage 
Veterans to take more steps per day.  We will randomize the participants to 2 different groups, a control group 
and an intervention group.  The control group will receive a Fitbit, which is a small device that is worn on your 
wrist that measures your movements, to wear for approximately 9 weeks.  At the end of the 9 weeks, they will 
complete an exit survey via phone call or online. 

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The intervention group will also be given a Fitbit and asked to wear it for approximately 9 weeks, but 
they will also be enrolled in a map-based race.  You will be notified about your progress in the race via text 
message and you may also receive challenges where you can earn extra steps in the race. At the end of the 9 
weeks, they will also complete an exit survey that asks about their experiences with the study.   
 
 
Is this something that you’d like to learn more about or might be interested in participating in?”    
 
 
If the person indicates that they’d like to learn more about the study or want to participate, be 
sure to complete any remaining fields on the Screening Survey (Appendix A).    
 
 
 
 
If any of these criteria are not met, the person is ineligible for the study.  Please explain the 
reason for their ineligibility and thank them for their time.   
 
 
If all criteria are met, you should continue on with the informed consent procedures in a room 
that is approved by the medical staff to avoid disrupting the clinic flow.  
Section 2.5 Consenting Procedures   
 
If the person is deemed eligible for the study and is still interested in participating, provide them 
with a copy of the Information Sheet for Research Subjects (Appendix B), the Informed Consent 
document (Appendix C), and the VA brochure about participating in research studies (not pictured)  to 
follow along with while you explain the study.  They may take these home with them for their records 
in case they need to refer to them at a later date.   
 
First, explain the Information Sheet for Research Subjects (Appendix B).  You do not need to 
read it word-for-word, but you should cover all major points on the document.  The first 3 bullets 
cover reasons that they may not want to participate in the study, while the last bullet is a reason that 
they may want to.  Give them time to read the document and answer any questions that they may have. 
 
If they are still interested in the study, move on to the Informed Consent (Appendix C). Again, 
you do not need to read it word-for-word to the participant, but you should cover all sections, give 
them time to read it, and answer any questions that they may have.   
 
Note: Be sure to get the correct spelling of the Participant’s first and last name on the top of 
the first page of the Informed Consent as well as their date of birth and last 4 of the SS # on the bottom 
of the first page.  You will need to transfer this information throughout the rest of the document after 
the patient leaves (see your example paperwork).  
 
Note: Page 4 of the Informed Consent (Appendix C) has a place for the participant to initial 
Yes or No about us using their data in the future.  One of these options must be initialed (not checked) 
by the participant.  Answering No to this question does not prevent them from participating in the 
study.   
 
Once the consent document has been discussed make sure that any remaining questions are 
answered.  If the person still wants to participate, have them print, sign, and date our copy of the 

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informed consent document.  Then, you will SIGN AND DATE the document as the person who 
obtained consent (this is very easy to forget). 
 
Finally, be sure to give them the VA brochure (not pictured) about being a research participant 
and answer any questions about this document that they may have.  
Section 2.6 Randomization Procedures 
 
To determine which group the participant will be placed into, grab one folder from each pile 
(Intervention and Control) and let the participant choose one.  If the folder contains the MapTrek 
instruction packet (Appendix D), they are in the intervention group.  If the folder contains the fake 
paperwork, they are in the control group.   
 
Be sure to note the group assignment in the Screening Survey and mark the survey as complete. 
Section 2.7 Control Group Instructions 
 
  If the participant was assigned to the control group, the following tasks need to be completed 
before they leave the appointment:   
 
1) Give the participant the Fitbit®.  Instruct them on how to keep it charged and help them put 
it on for the first time.  
 
2) Help the participant create a Fitbit® account by having them download the Fitbit® app from 
their app store and follow these steps:   
 
 
1) Make sure their phone’s Bluetooth is turned on.   
 
 
2) Once the app is downloaded, open the app and click ‘Join Fitbit’. 
 
 
3) Choose ‘Charge 3’ as the Fitbit Tracker. 
 
 
4) Click ‘Set Up Your Fitbit Charge 3’ 
 
 
5) Click ‘Let’s Go’ 
 
 
6) Have them scroll up or down to their current height.  Click ‘Next’. 
 
 
7) Select their gender by clicking on the appropriate picture.  Click ‘Next’. 
 
 
8) Have them scroll left or right to their current weight.  Click ‘Next’. 
 
 
9) Have them scroll left and right to input their birth date.  Click ‘Next’. 
 
10) Have them enter their Full Name, Email Address, and Password.  They will need to 
agree to the Terms of Service and Privacy Policy by clicking the check mark.  Let them 
choose if they would like to receive news and promotions from the company.  
 
 
11) Click ‘Next’ to get past the Terms of Service and Privacy Policy screen. 
 
 
12) Let them Meet their Charge 3 by clicking ‘Next’ through the tutorial page. 
 
 
13) You may need to plug the Charge 3 in to complete set up.  
 
 
14) Make sure the Charge 3 is awake and close to the phone so that they can sync. 
 
 
15) Once it syncs, it will ask for the 4-digit number of the Fitbit screen. 
 
 
16) Click ‘Next’ and ‘Done’ to get through some tutorial information. 
 
17) They will then be logged into the Fitbit app.  They may have a warning that email 
verification is required. They can do this at a later time. 
 
 
18) Show them that steps, distance, calories, and minutes of exercise are tracked on the 
 
 
dashboard.  
    

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3) Enroll the participant in the Control Group Boomerang Study by visiting 
https://vinci.cs.uiowa.edu/meditext2 .  Even though they will not be using MapTrek, they need to be 
entered into the Boomerang Study so that we can obtain the data from their Fitbit®.    
o Log in using your username and password 
o Select VA FY19-20 Control from drop down menu 
o Click on the Green “Enroll Patient” button in the top right corner 
o Enter the participant’s phone number, click Next 
o Enter the Record ID for the participant from REDCap as the subject identifier (you do 
not need to enter an email address, Preferred Language should be kept as English for 
this study) 
o Select “Go to registration page” and click Submit 
o You will be taken to the Fitbit® screen and asked to provide the participant’s Fitbit login 
information.  Once they have entered their email and password, you need to select 
“Allow All” from the dropdown menu and click Allow.  Once this is completed, their 
Fitbit will be synced with Boomerang 
o Return to Boomerang, Click on the Patients tab, and select the Record ID for the 
patient you just enrolled 
o Click the Green “Add Subscription” button in the top right corner 
o Select “Fitbit Reminders” as the Protocol, “Today” as the start date, the Saturday date 
following the end of their 9 weeks of participation as the End Date, Frequency should be 
set to “1”, allow the participant to choose the times they will receive reminders to 
wear/sync their Fitbit, uncheck both “Send end message” and “Send end email to 
managers”, and click Submit 
o From the home screen in Boomerang, make sure the subscription worked by clicking 
the Patients tab, selecting the patient, and clicking on the Subscriptions tab.  Make sure 
the subscription is set up correctly 
 
 
4) Have the participant put the Fitbit® on now and instruct them to continue wearing it every 
day until the 9 weeks are finished (unless they are bathing, swimming, or sleeping).   
 
5) Remind them they will receive either a text message or a phone call to complete the exit 
survey at the end of the study. 
Once these tasks have been completed, the participant is free to leave. 
Section 2.8 Intervention Group Instructions 
 
  If the participant was assigned to the intervention group, the following tasks need to be 
completed before they leave the appointment:   
 
1) Give the participant the Fitbit®.  
 
2) Help the participant create a Fitbit® account by having them download the Fitbit® app from 
their app store and follow these steps:   
 
 
1) Make sure their phone’s Bluetooth is turned on.   
 
 
2) Once the app is downloaded, open the app and click ‘Join Fitbit’. 

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3) Choose ‘Charge 3’ as the Fitbit Tracker. 
 
 
4) Click ‘Set Up Your Fitbit Charge 3’ 
 
 
5) Click ‘Let’s Go’ 
 
 
6) Have them scroll up or down to their current height.  Click ‘Next’. 
 
 
7) Select their gender by clicking on the appropriate picture.  Click ‘Next’. 
 
 
8) Have them scroll left or right to their current weight.  Click ‘Next’. 
 
 
9) Have them scroll left and right to input their birth date.  Click ‘Next’. 
 
10) Have them enter their Full Name, Email Address, and Password.  They will need to 
agree to the Terms of Service and Privacy Policy by clicking the check mark.  Let them 
choose if they would like to receive news and promotions from the company.  
 
 
11) Click ‘Next’ to get past the Terms of Service and Privacy Policy screen. 
 
 
12) Let them Meet their Charge 3 by clicking ‘Next’ through the tutorial page. 
 
 
13) You may need to plug the Charge 3 in to complete set up.  
 
 
14) Make sure the Charge 3 is awake and close to the phone so that they can sync. 
 
 
15) Once it syncs, it will ask for the 4-digit number of the Fitbit screen. 
 
 
16) Click ‘Next’ and ‘Done’ to get through some tutorial information. 
 
17) They will then be logged into the Fitbit app.  They may have a warning that email 
verification is required. They can do this at a later time. 
 
 
18) Show them that steps, distance, calories, and minutes of exercise are tracked on the 
 
 
dashboard.  
   
 
3) Enroll the participant in MapTrek by visiting https://vinci.cs.uiowa.edu/maptrek2/admin/    
o Log in using your username and password 
o Basic Strategy: start at the bottom of the screen and work your way up 
o On the Home Screen, right click on the ‘Change’ next to Player Icons, choose ‘Open 
link in new tab’ 
o Using the 4 categories (animals, military, outdoors, other), help the participant choose 
an icon 
o Navigate back to MapTrek and click ‘Add’ next to ‘Players’  
o Have the participant choose a username (Note: inform them that this username will be 
visible by others, so they should make it something that is non-identifiable if they wish!) 
o Enter the participant’s phone number 
o Have the participant choose the earliest and latest times that they wish to receive text 
messages 
o Use the Notes field for any information you may want to remember about the person 
(that is not HIPAA sensitive) 
o Choose the requested icon from the dropdown menu 
o Click ‘Save’ 
o Click ‘Add’ next to League Participants 
o Choose the player from the dropdown menu 
o Choose the VA FY19-20 Intervention league from the dropdown 
o Make sure ‘Active’ is not selected  
o Click ‘Save’ 

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o Click on the words ‘User fitbits’ 
o Click on ‘Associate New User Fitbit’ in the top right corner 
o Choose the participant from the dropdown menu, click ‘Authentic with Fitbit’ 
o You will be taken to the Fitbit® screen and asked to provide the participant’s Fitbit login 
information.  Once they have entered their email and password, you need to select 
“Allow All” from the dropdown menu and click Allow.  Once this is completed, their 
Fitbit will be synced with MapTrek 
 
 
4) Give the participant the MapTrek Instruction Packet (Appendix D). Talk through each slide of 
the instructions and answer any questions that the participant has.   
  
5) Have the participant put the Fitbit® on now and instruct them to continue wearing it every 
day until the 9 weeks are finished (unless they are bathing, swimming, or sleeping).   
 
6) Remind them they will receive either a text message or a phone call to complete the exit 
survey at the end of the study. 
Once these tasks have been completed, the participant is free to leave. 
Section 2.9 Data Entry Procedures 
 
Once the participant has left, you need to complete 3 REDCap surveys- Baseline Participant Info 
(Appendix E), Baseline Medications (Appendix F), and Baseline Comorbidities (Appendix G).  The 
necessary information will come from your discussion with the participant and CPRS.   
Section 2.10 Storing the Files 
 
When you are done working in the clinic for the day, all of the participant informed consent 
forms/HIPAA authorization forms must be taken to the annex at UIHC to be stored in the locked 
cabinets.   
 
Note: Be sure you have your Authorization to Transport form with you before you transport 
any forms off of the VA campus! 
Section 2.11 Submitting Payments 
 
Once a participant has completed the exit survey, they need to be compensated.  Open the 
PaymentTemplate_MapTrekFitbitGame file using the following path:  rdss_lpolgree > MapTrek Pilot > 
FitbitGame > Payments.   
 
Create a new file by clicking “Save As” and re-naming the file using the following the date the 
payment was submitted to eVouchers (example: 01.29.2019.xlsx).   
 
Complete the spreadsheet by copying and pasting the participant’s information from the 
ParticipantInfo_MapTrekFitbitGame spreadsheet.  You can include multiple participants in this 
spreadsheet before submitting. 
 
Instructions on how to submit the payment are found in Payment Procedures file listed under  
rdss_lpolgree > MapTrek Pilot > FitbitGame > Payments. 
 

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Appendices 
 
 
 

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Appendix A 
 
 

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Appendix B 
 

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Appendix C 
 
 

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Appendix D  
 
 
 

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Appendix E 
 

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Appendix F 
 
 
 
 
 

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Appendix G