Location-based Smartphone Technology to Guide College Students Healthy Choices Phase II
Phase: NA
Conditions: Overweight and Obesity, Health Behavior, Sleep Deprivation
Sponsor: Klein Buendel, Inc.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Location-based Smartphone Technology to Guide College Students Healthy Choices (Healthy Detours) 
Protocol 
NCT02996864 
8/16/2016 
 
 

Overview 
The Heathy Detours app will be tested in a 12-week randomized controlled trial (RCT) with 300 college 
students at Louisiana State University (LSU) during the Fall 2016 and Spring 2017 semesters. RCT 
enrollment will be split between these two semesters, with approximately 150 students enrolling during 
each 12-week period. Students will be randomized to either the Healthy Detours app or to an active 
control condition app. 
 
USDA’s SuperTracker was originally proposed to serve as the control app for the research project. 
However, only the SuperTracker web page is currently functioning, thereby eliminating it as an 
appropriate control condition for the Healthy Detours app. 
 
The research team agreed on the following criteria for the control app: 
• 
Must be publically available at no cost to the user 
• 
Must be compatible with both Android and iPhone platforms 
• 
Must come from a reputable source 
• 
Must not be an app specifically designed for weight loss; weight monitoring apps may be 
included 
 
Based on these criteria, Calorie Counter by FatSecret was selected as the RCT control condition app. 
Recruitment 
RCT participants will be recruited from the student population at LSU.  Recruitment methods will include 
but are not limited to:  flyers posted on campus and at businesses in the immediate area; social media 
posts; email and newsletter announcements by various departments and student organizations; online 
announcements through myLSU and SONA; recruitment tables set up at various campus events before 
and during the semester; recruitment presentations during classes and events; and by classified ads 
posted on Craigslist and the LSU newspaper, The Reveille.   
 
Potential participants will be directed to an online baseline screening questionnaire to determine 
eligibility.  They will also schedule their enrollment visit through this site.   
Preliminary Enrollment 
A standardized enrollment procedure will be utilized for the RCT (Appendix A). From the recruitment 
materials, students will be directed to the baseline screener questionnaire (Appendix B) that is to be 
created by KB production staff. Students attempting to enroll in the study through PBRC will be directed 
to the enrollment website by sending a website link to the students’ email. 
Eligibility to participate in the RCT will be determined through the information provided by the student 
in the enrollment website. Students that are considered “screen fails” will be thanked and encouraged 
to participate in other research activities.  

Students that meet eligibility criteria will be directed to the online consent form (Appendix C). Here, 
students will be asked to read the consent information and indicate that they understand and agree to 
the terms of the study. Students unwilling to provide consent will be thanked for their interest and 
encouraged to participate in future research projects.  
Note:   This is considered an informal consent; a formal consent will be provided at the baseline 
enrollment meeting. The purpose of this informal consenting is to ensure that students are 
aware of the parameters of their participation prior to the baseline enrollment meeting to 
prevent attrition.  
Students meeting eligibility requirements and providing online consent will be prompted to schedule a 
time for the baseline enrollment session (Appendix D). They will be provided a list of times that PBRC 
will be holding mass enrollments, and will indicate which of those sessions they are available to attend. 
Participants will also be prompted to schedule their 12-week follow-up visit at this time. 
If a student is unavailable to attend one of these mass enrollment/follow-up sessions, they will be 
contacted by PBRC to arrange a one-on-one enrollment meeting.  
Note: These one-on-one enrollment sessions are tentative and dependent on how quickly 
participants are being recruited. If recruitment fills quickly, only those with mass enrollment 
availability will participate in the study. 
Participants will be assigned C-Numbers once they have registered for an enrollment meeting. The C-
Numbers for RCT participants are assigned numerically beginning with C00-03-0201 and going up to 
C00-03-1000. 
Upon completing the online enrollment process, participants will automatically receive an email 
confirmation for their enrollment and exit interview dates. Participants will receive an email reminder 
three days and one day prior to these meetings (Appendix E).  
As a backup to the scheduler programming, KB and PBRC will also receive these email confirmations and 
reminders through their project-specific email accounts: healthydetours@kleinbundel.com and 
healthydetours@pbrc.com.  
Baseline Enrollment Meeting 
Based on their provided availability, participants will attend a baseline enrollment meeting on LSU 
campus. The following protocol will be employed at the baseline enrollment meetings: 
1. Study Orientation: PBRC staff will provide an overview of the study and allow an opportunity for 
participants to ask questions 
2. Written Consent, Identity Confirmation & W-9: Participants will be asked to provide written 
consent indicating they understand the terms of the study. Participants will confirm their 
identity during this step by showing PBRC staff their LSU ID, and they will be asked to complete a 
W-9 form.   

3. Online Surveys: Participants will complete four online surveys (Appendix G) using a study tablet 
4. Randomization: Participants will be randomized to a study condition 
5. App Download: Participants will download their respective app 
6. App Registration & Tutorial: Participants will be given a tutorial on how to use their study app 
and will be assisted in inputting personal information (class schedule, activity level, etc.) into the 
app 
7. Exit Interview Scheduling: Participants will schedule a 12-week follow-up meeting with 
researchers 
Step 1: Study Orientation 
PBRC staff will provide an overview of the study with a PowerPoint presentation. They will explain the 
purpose of the study, participant inclusion, study procedures, and participant compensation. 
Participants will be informed that they are expected to frequently use the app, and that their back end 
data will be tracked. Staff will notify participants that they will receive the 6-week interim survey link via 
email, and that they may receive app updates throughout the 12-week period. Participants will be 
instructed to download any app updates they may receive. 
Step 2: Written Consent & Identity Confirmation 
Following the study orientation, participants will be asked to review and sign the consent forms 
(Appendix F). PBRC staff should bring extra copies in case participants want to keep a copy of the form. 
When collecting the signed consent forms, PBRC staff should confirm the participants’ identities and LSU 
enrollment status by checking their student IDs. Only students whose identities and LSU statuses have 
been confirmed will be enrolled in the study.  
Participants will be required to complete a W-9 form in order for LSU to process their compensation. 
Participants must provide their Social Security Numbers (SSNs) on this form. 
Step 3: Online Surveys 
PBRC staff will hand out tablets for participants to complete the baseline surveys. Participants will first 
complete the KB-programmed baseline survey using the following link:  
https://www.questionpro.com/a/TakeSurvey?id=4781126 
After participants have finished the KB-programmed baseline survey, they will be instructed to take the 
ASA24 using the following link: https://asa24.nci.nih.gov/ 
PBRC staff will be required to enter the ASA24 username and password that is associated with the 
participant’s Subject ID and C-Number. The list of ASA24 usernames and passwords is included in 
Appendix H. See below for information on C-Numbers. 
 
 

Tablets 
The links for the online baseline survey, the ASA24, and the YouTube tutorial have been bookmarked on 
all six tablets provided to PBRC by KB. A majority of these tablets are password protected, and PBRC 
staff should be given the passwords to all of the tablets they will be using.  
 
For the Apple products (iPads), PBRC staff may be required to know the KB email account associated 
with the tablets. The login information provided below is universal for all KB Apple products. 
• 
Email address: = 
• 
Passcode: = 
Participant C-Numbers 
PBRC staff can access participant C-Numbers through the Admin Heathy Detours Study site.  
1. Visit www.healthydetoursstudy.com and click on the Admin link: 
2. Click on an individual within the schedule to view his/her C-Number 
Step 4: Randomization 
Participants should be instructed to notify PBRC staff once they have finished the ASA24. At this point, 
participants will be randomized to their study condition. The randomization link for each participant will 
be within the individual’s Healthy Detours Schedule Page. PBRC staff will click on this link to determine 
the participant’s study condition. 
Step 5: App Download 
Based on the randomization assignment, participants will download either the Healthy Detours app or 
Calorie Counter by FatSecret. There are four scenarios associated with this step, dependent on 
randomization assignment and participant phone type. 
Control Group – Android User  
1. From the Google Play store, search FatSecret, locate the Calorie Counter by FatSecret app, and 
install the app onto the participant’s phone. 
Control Group – iPhone User 
1. Locate the App Store on the participant’s phone by searching for it in the drag down bar 
2. Open the App Store and select “Search” in the bottom right corner 
 
3. Search for FatSecret, locate the app, and download it onto the participant’s phone 
 
 
 

Intervention Group – Android User 
1. Go to the phone’s settings. 
2. Go to Security (you may have to select “More” to get to Security) 
 
 
 

3. Find Unknown Sources and make sure it is checkedq 
4. Open the internet browser in the phone and type in: 
http://mdata.kleinbuendel.com/HeathyDetours/app/hdcurrent.apk 
 
 
 

5. The app will start to download. You will see a blinking arrow on the top left of the screen. When 
the arrow stops blinking, pull downward on the screen from the arrow. You will see the file 
name hdcurrent.apk. Select this file to open. 
 
6.  This pop-up page will appear, notifying users of the privacy agreement. Users must agree to this 
and Install. 
 
 
 
 

7. Once installed, you may open the app. 
 
Intervention Group – iPhone User 
1. Since KB programmers will know the randomization prior to the enrollment meeting, 
intervention group iPhone users will receive an email invite once they arrive to the meeting to 
beta test the Healthy Detours app. This will be sent to the email address linked to the 
participants’ iTunes account. Participants should be instructed to not look at their phones while 
they are providing consent and completing the online surveys. When ready to install the app, 
open the TestFlight email and select “Start Testing” 
 
 
 

2. You will be taken to this page and provided with a redemption code. This code should be written 
down for possible future use. If TestFlight has not already been installed, click on the blue link to 
download the program to the phone.  
 
 
3. You will be taken to the Apple Store. Select “Get” and then “Install.” Once the app has been 
installed, select “Open.” 
   
 
 

Accept TestFlight’s Terms of Service and Apple’s Privacy Policy and indicate that TestFlight can send the 
user notifications 
  
 
4. Healthy Detours should automatically appear in the user’s queue. Select “Install,” and then 
“Open.”  Once the app is open, allow Healthy Detours to access the participant’s location. After 
selecting “Allow”, you will be brought to the Registration Page. 
   
 
 
 
 

Step 6: App Registration & Tutorial 
Intervention App 
The Register page will appear when intervention participants open the Healthy Detours app for the first 
time. PBRC staff should assist these participants in entering the following information. 
1. User Name: Participants should enter their first and last name 
2. Email: Participants should enter the email address that has consistently been provided to PBRC 
staff. Notably, iPhone users should enter the email address that is associated with their iTunes 
account. 
3. Phone: Participants should enter their cell phone number 
4. C-Number: PBRC staff should enter the participant’s C-Number (see page 6). 
 
Need to add Class Schedule screenshots when they are made available 
After intervention participants have registered to Healthy Detours, PBRC staff should give them a tablet 
to watch the video tutorial: https://youtu.be/oi9mCUCTmMM  
The link to the YouTube video has been bookmarked on all KB tablets. This video is also available within 
the Learn to Detour feature of the app.  
Control App 
Participants randomized to the control group will be prompted to register for FatSecret when they open 
the app for the first time. PBRC staff may assist the participants in this registration process.   
1. Participants will open the app and select Start Now. They will first be asked to set a goal. 
Participants may choose whichever goal they want. 
  
2. Participants will input their gender, activity level, weight, height, and date of birth.  
   
 
3. Participants will sign up with an email address and a password for their account. Participants 
should be instructed to use the same email address on file with PBRC for this step. 
 
4. Participants will be brought to the home screen of the app. 
 
5. PBRC staff should give control participants the paper-based control tutorial (Appendix I) for 
their reference.  

Step 7: Exit Interview Scheduling 
Six-Week Assessment 
An invitation to complete the 6-week interim assessment will be sent to RCT participants via email. 
Participants who do not complete the surveys within 3 days of invitation will receive an email reminder. 
Posttest Assessment  
Participants will receive a reminder email approximately 1 week prior to their previously-scheduled 
posttest assessment. In addition to the four previously completed surveys, participants will complete 
the System Usability Scale and the Usage Rating Profile-Intervention (URPI) scale (Appendix J) at this 
meeting. The Healthy Detours app will be removed from the participants’ phones at this time. 
Participant Compensation 
Participants who complete the Posttest Assessment will be informed that their check for $200 will be 
requested from LSU Accounts Payable by study staff, and that LSU will mail their checks in 
approximately 4-6 weeks