Stay Active Physical Activity Program for Teachers, Students, and Families
Phase: NA
Conditions: Healthy Lifestyle, Sedentary Behavior
Sponsor: Children's Mercy Hospital Kansas City

SHORT TITLE: Stay Active 
 
Page 1 of 17 
Version 1.4 dated 7.13.18 
PROTOCOL TITLE: 
Stay Active 
PRINCIPAL INVESTIGATOR: 
Jordan Carlson 
Weight Management 
816-234-9240 
jacarlson@cmh.edu 
VERSION NUMBER/DATE: 
V4 / 9.17.2020 
 
REVISION HISTORY 
 
This Revision History table is provided for the benefit of study team version 
control.  If this table will not be useful to your team, you do not need to include it. 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
8.31.2020 
Updated sample size information to include 
parents and teachers (Section 1.0) 
 
Updated to include weekly teacher survey 
information, post-study interview, and pre-
study training options (Section 5.2) 
 
Updated for clarity on additional support 
resources being sent to families and family 
survey information (Section 5.3) 
 
Updated to match previous updates as well as 
information on opt-out detail, how the Garmin 
devices will be given to participants (Section 
6.1) 
 
Updated to include who will receive weekly 
text messages and how data might be shared 
with PE teachers (Section 9.1) 
 
Updated to include corrected sample 
information (Section 13.2) 
 
 

SHORT TITLE: Stay Active 
 
Page 2 of 17 
Version 1.4 dated 7.13.18 
Updated to include study information letter 
(Section 14.2) 
 
Updated to include Garmin device value 
(Section15.2) 
 
Updated to include withdrawal information 
(Section15.4) 
 
Updated data management practices for 
participant surveys (Section 20.5) 
 
Updated to include P/A/C information for non-
English speakers and teachers (Section 25.1) 
 
Updated to clarify who can provide consent to 
participate for children (Section 25.2) 
2 
9.7.2020 
Updated to include Stay Active Information 
Letter (Section 6.1 and 14.1) 
Updated Multi-Site Research to include 
KUMC and UMKC information (Section 29.0) 
 
3 
9.17.2020 
Update that all parents of students with a 
Garmin will receive text reminders regarding 
wear of device (Section 5.3) 
 
Clarification update for students who opt out of 
CBPA portion of the study (Section 6.1) 
 
Updated to clarify no recording of physical 
activity sessions will occur and video 
conferencing will be set up by the classroom 
teacher (Section 6.1) 
 
Updated to include recruitment of classrooms 
are determined by the school/district (Section 
14.1) 
 
 
 
 
 
 
 
 
 
 
 
 

SHORT TITLE: Stay Active 
 
Page 3 of 17 
Version 1.4 dated 7.13.18 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives ................................................................................................................ 5 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Endpoints ....................................................................................................... 5 
5.0 
Study Intervention/Investigational Agent ................................................................ 5 
6.0 
Procedures Involved................................................................................................. 7 
7.0 
Data and Specimen Banking .................................................................................... 7 
8.0 
Genetic Analysis Information ................................. Error! Bookmark not defined. 
9.0 
Sharing of Results with Subjects ............................ Error! Bookmark not defined. 
10.0 Study Timelines ....................................................................................................... 9 
11.0 Inclusion and Exclusion Criteria .............................................................................. 9 
12.0 Vulnerable Populations .......................................................................................... 10 
13.0 Local Number of Subjects ..................................................................................... 10 
14.0 Screening and Recruitment Methods ..................................................................... 10 
15.0 Reimbursement, Payment and Tangible Property provided to subjects ................ 11 
16.0 Withdrawal of Subjects .......................................................................................... 12 
17.0 Risks to Subjects .................................................................................................... 12 
18.0 Potential Benefits to Subjects ................................................................................ 12 
19.0 Investigator Assessment of Risk/Benefits Ratio. ................................................... 13 
20.0 Data Management and Confidentiality .................................................................. 13 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 14 
22.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 14 
23.0 Compensation for Research-Related Injury ........................................................... 15 
24.0 Economic Burden to Subjects ................................................................................ 15 
25.0 Permission/Assent/Consent Process ...................................................................... 15 
26.0 Process to Document Permission/Assent/Consent................................................. 16 
27.0 Setting .................................................................................................................... 16 
28.0 Resources Available............................................................................................... 16 
29.0 Multi-Site Research ............................................................................................... 17 
30.0 International Research ........................................................................................... 17 
 
 
 

SHORT TITLE: Stay Active 
 
Page 4 of 17 
Version 1.4 dated 7.13.18 
1.0 
Study Summary 
 
Study Title 
Stay Active 
Study Design 
Experimental Intervention 
Primary Objective 
To compare the impact of two physical activity interventions 
on student’s physical activity. 
Secondary 
Objective(s) 
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Two arms:  
Arm 1: classroom based physical activity 
Arm 2: classroom based physical activity plus family support 
for physical activity. 
IND/IDE #  
 
Study Population 
Up to 15 classrooms from Kansas City area elementary 
schools. 
Sample Size 
Up to 250 Students, 250 parent(s)/guardian(s), and 15 
teachers 
Study Duration for 
Individual 
Participants 
1 semester (for about 4 months) 
Study Specific 
Abbreviations/ 
Definitions  
CBPA: classroom based physical activity 
 
 

SHORT TITLE: Stay Active 
 
Page 5 of 17 
Version 1.4 dated 7.13.18 
2.0 
Objectives 
2.1 The pilot study will create, implement, and evaluate a physical 
activity program in both the school and home setting during the 
COVID-19 pandemic.  
3.0 
Background 
3.1 COVID-19 has created numerous challenges to children’s ability to 
engage in healthy lifestyles. The need for physical distancing creates 
barriers to many types of physical activity children typically engage 
in. The school setting is an essential source of children’s physical 
activity and the recent move of school education from in-person to 
online eliminated over half of children’s daily physical activity. 
Since the COVID-19 pandemic is accelerating socioeconomic 
disparities, which have major implications for long term health, it is 
more important than ever to provide safe opportunities for children 
from low-income families to engage in active lifestyles. 
The 2020-2021 school year in the Kansas City area will create 
numerous challenges to teachers and other school personnel. 
Whether classes will be conducted online, in-person, or using a mix 
of the two approaches is still unknown, but all approaches will 
substantially limit opportunities for children to engage in healthy 
lifestyles. Schools will be forced to constantly adapt to new 
procedures that prevent the spread of infection. These challenges 
will make it even more difficult for elementary schools to support 
children’s health and physical activity. 
In addition to supporting health, the activities reenergize students 
and improve attention, learning, and positive behavior in the 
classroom. Teachers are trained and supported to deliver additional 
activities throughout the week, but our physical activity leaders 
minimize burden on the teachers as we acknowledge that teachers 
are in a particularly challenging situation due to the pandemic. 
 
4.0 
Study Endpoints 
4.1 The primary endpoints are daily step counts and daily physical 
activity minutes. 
4.2 The secondary endpoints are parent and teacher perceptions. 
5.0 
Study Intervention/Investigational Agent 
5.1 
This study will be conducted in in-school and out-of-school 
settings. 
5.2 Arm 1 (CBPA): 

SHORT TITLE: Stay Active 
 
Page 6 of 17 
Version 1.4 dated 7.13.18 
•  CBPA: Physical activity support is provided by integrating daily 
structured activities in the classroom delivered by physical activity 
leaders through a video conferencing platform in partnership with 
the classroom teacher. Activities last about 10 minutes or less and 
have the flexibility of being integrated with academic lessons or 
serving as a break from academics.  
The activities are simple and get kids moving in place. The 
activities will be delivered by a research staff member via video 
conferencing (using the schools preferred platform). A 
combination of live activities led by the research team and pre-
recorded videos will be used (see example below). If live videos do 
not work for the teacher, they will have the option to only use the 
pre-recorded videos or receive a list of resources to promote CBPA 
in their classrooms.  
Teachers will be asked to complete weekly a weekly REDCap 
survey to track the amount of CBPA they offered to their class 
outside of the time study staff provided physical activity support. 
Teachers will also be asked to complete one post-study survey and 
interview to provide their perceptions of the Stay Active program. 
 
Study staff will provide an optional training session for teacher to 
walk through the importance of CBPA, as well as accessing the 
resources that will be provided to them. This training will be 
accessible through live videoconference or a PowerPoint 
presentation sent via email. 
 
 
5.3 Arm 2 (CBPA plus family): 

SHORT TITLE: Stay Active 
 
Page 7 of 17 
Version 1.4 dated 7.13.18 
• CBPA component will be identical to above. 
• Family Component: A newsletter, with supporting handouts and 
resources for the family to use, will be sent to parents or guardians 
once every two weeks over the semester and posted on the study 
website. The newsletters include physical activity information 
related to safety/protection, skills building, motivation, 
overcoming barriers, and goal setting and monitoring. The 
handouts include optional worksheets and physical activity 
tracking sheets to support families. As part of the program, 
children also receive a Garmin wearable physical activity monitor. 
Parents or guardians will receive text messages with behavior 
change messages based on the Garmin data. Text messages also 
contain links to website materials. Parents/Guardians of students 
who receive a Garmin will receive text reminders about wearing 
the device if no steps or minutes of physical activity are being 
detected. 
Texts will be sent out using the Twilio platform. 
Participants (both parent and child) will be asked to complete two 
surveys during the study. Surveys ask questions related to general 
demographics, household physical activity habits, and COVID-19 
related questions. The first survey has been submitted in the 
SmartForm (Baseline Survey_Version_0.02), the second survey 
will be submitted later as an amendment, as it is still being 
developed. 
 
6.0 
Procedures Involved 
 
6.1 Data Collection Procedures 
• Describe the method for identifying candidates for the study 
o School Recruitment: We will work with district contacts to identify 
schools and classrooms to participate. School staff will be provided an 
informational letter about the study. 
o Participant Recruitment: A recruitment flyer will be sent to families 
via their classroom teacher.  
• Describe the procedure for obtaining data 
o Teachers will receive weekly emails containing a brief REDCap 
survey to complete.  
o Teachers will complete a post intervention survey (we will submit this 
later as an IRB amendment, as it is still being developed). 

SHORT TITLE: Stay Active 
 
Page 8 of 17 
Version 1.4 dated 7.13.18 
o Teachers will complete a post intervention interview (we will submit 
this later as an IRB amendment, as it is still being developed). 
o If the teacher withdraws from the study, their class will no longer be 
able to participate in the Arm #1 of the study. 
o Parents or guardians will complete a pre- and- post intervention survey, 
with the options of on paper or over RedCap. The post intervention 
survey will be submitted later as an IRB amendment, as it is still being 
developed.  
o Students in both arms will be asked to wear Garmin physical activity 
devices to provide physical activity information throughout the 
intervention. The Garmin is worn like a wristwatch. The device is small 
and non-intrusive. The Garmin device is a consumer wearable that will 
automatically detect and track activity such as walking, running, and 
cycling.  
o Study staff will set up the Garmin account with an email address 
provided by the parent and a generic password. This information will be 
shared in the Participant Garmin Instructions sent in the mail along with 
the Garmin device. Study staff will not input any personal information, 
aside from the provided email address, while creating the Garmin 
account.  
o Students can participate in the CBPA portion of the study without 
opting in to wearing the Garmin device. This participant will not be 
consented or assented but will still receive the classroom physical 
activity lessons via their classroom. 
o Students who neither opt out or opt in to the study will be allowed to 
participate in the CBPA portion of the study. No personal information 
or data will be collected from these students. 
o Any potential participant that opts out of the CBPA portion of the 
study will be told that they can watch, engage in a separate activity, or 
leave the session temporarily. 
o No data aside from that which is already being collected via the 
Garmin devices will be collected from the physical activity sessions. 
o Two-way video conferencing will be used to deliver physical activity 
study, but sessions will not be recorded by study staff. Study staff is 
will be joining an existing video meeting set up by the school 
(meetings that are already being used by the school). Staff will not set 
up the meeting platforms for the physical activity sessions. 
 

SHORT TITLE: Stay Active 
 
Page 9 of 17 
Version 1.4 dated 7.13.18 
• No personal information will be recorded in the recruitment phase prior to 
a participant enrolling in the study.  
• Garmin devices, device set up and participant information, along with a 
hardcopy of surveys if requested by the participant will be sent to the 
provided mailing address of the participant. Mailing address is collected 
during the consent process and will be stored securely in REDCap. 
 
7.0 
Data and Specimen Banking 
7.1 N/A.  
8.0 
Genetic Analysis Information 
8.1 N/A 
 
9.0 
Sharing of Results with Subjects 
9.1 Parents or Guardians of students in Arm #2 will receive weekly text 
messages with updates on the students overall physical activity and 
previous weeks step count. Step and minutes of physical activity 
information from the Garmin data may also be shared with the PE 
teachers. Information will be aggregate and will not contain any 
identifiers. 
10.0 Study Timelines 
 
 
Aug 
2020 
Sep 
2020 
Oct 
2020 
Nov 
2020 
Dec
2020 
Jan 
2020 
Feb 
2020 
Mar 
2020 
Recruit participants 
 
 
 
 
 
 
 
 
Collect data 
 
 
 
 
 
 
 
 
Conduct intervention 
 
 
 
 
 
 
 
 
Analyses 
 
 
 
 
 
 
 
 
Publication and presentation  
 
 
 
 
 
 
 
 
11.0 Inclusion and Exclusion Criteria 
11.1  
Inclusion Criteria 
• Classrooms 
o Teacher of a 4th or 5th grade class in the Kansas City area. 
o English speaking only 
• Students 

SHORT TITLE: Stay Active 
 
Page 10 of 17 
Version 1.4 dated 7.13.18 
o Any student in the selected classrooms 
o A parent or guardian of the student that has a smartphone 
o English speaking only 
Exclusion Criteria 
• Does not meet the required criteria above. 
11.2 Indicate specifically whether you will include or exclude each of the 
following special populations:  
• 
Adults unable to consent- EXCLUDE 
• 
Individuals who are not yet adults (infants, children, teenagers) 
- INCLUDE 
• 
Pregnant women – we will not be screening for pregnancy so 
there is potential that pregnant women will be participating. 
• 
Prisoners – EXCLUDE 
• 
Wards of the state - EXCLUDE 
12.0 Vulnerable Populations 
12.1 
Children: P/A will be obtained from participants under the age of 18 and 
their parent/LAR. Research staff involved in the P/A process will review the 
HRP-416 CHECKLIST – Children to ensure sufficient information is provided 
during the P/A appointment with the child and their parent/LAR. 
 
13.0 Local Number of Subjects 
13.1 Up to 15 Kansas City school teachers and classrooms. 
13.2 Up to 250 students (4th and 5th graders), 250 parent(s)/guardian(s), 
and 15 teachers 
14.0 Screening and Recruitment Methods 
14.1 Classrooms 
• We will work with district contacts to identify schools and 
classrooms to participate. 
• A study information letter will be sent out via multiple modes of 
communication to schools and teachers.  
• Study staff will communicate with the leader in the district who has 
authority to approve the project. The leader then identifies the classrooms 
and relays what classrooms have been selected to study staff. 
14.2 Participants 
• A recruitment flyer will be sent out via multiple modes of 
communication to all families of 4th and 5th grade students in 

SHORT TITLE: Stay Active 
 
Page 11 of 17 
Version 1.4 dated 7.13.18 
classrooms of selected teachers that are participating. The 
recruitment flyer will be sent by the teacher.  
• The recruitment flyer will describe the CBPA as all students in the 
classroom (even those who do not wear the Garmin device) will be 
able to participate in the CBPA if desired. The recruitment flyer 
will explain that such students/families can opt out of receiving the 
CBPA by contacting the study team or their teacher. These 
students will not complete any study assessments.  
• The recruitment flyer will also describe the Garmin assessment portion of 
the study and the potential family content that half of the classrooms will 
be randomized. To enroll in the Garmin portion of the study participants 
will need to opt in by contacting the study team. Thus, these are the study 
participants who will be consented/assented and measured/assessed.  
 
• Research staff will respond via email or telephone to inquiries generated 
by the recruitment email and flyer. The research team will go over the 
details of the study with potential participants over the phone or email. If a 
potential participant says they want to enroll in the study after receiving 
the study information, having any questions answered by the research 
team member, and being confirmed as eligible, the parent and child will be 
consented and assented over the phone. E-consent will then officially take 
place over the phone and REDCap. The participant will receive a copy of 
the P/A/C form and participant instructions by e-mail or in the mail.  
 
14.3 
We will have access to parent names, email addresses, and phone numbers 
prior to obtaining permission/assent. We are requesting a waiver of HIPAA 
authorization for recruitment purposes only. We will not retain any data from 
potential participants who do not enroll in the study. 
 
15.0 Reimbursement, Payment and Tangible Property provided to 
subjects 
 
15.1 
Classroom teachers who complete the post intervention assessments will 
receive a Greenphire ClinCard in the amount of $50.  
15.2 
Participants will receive up to $50 for participating. The cash card will be 
issued at the end of the fall semester. $25 will be given to participants who wear 
the Garmin device the first week of the study. Another $25 will be given to 
participants who wear the device the last week of the study and complete the final 
survey, which is completed by the parent and child. In addition to the cash card, 
the participant will be able to keep the Garmin device at the end of the program, 
which is valued at $80.  
 

SHORT TITLE: Stay Active 
 
Page 12 of 17 
Version 1.4 dated 7.13.18 
15.3 
The research team will collect the required information (e.g. address and 
date of birth) for issuing compensation after P/A/C has been obtained during the 
P/A/C appointment. This information will be immediately entered into Greenphire 
by the research team and then shredded to protect confidentiality. Payment will be 
issued to the participant when they complete the study and complete the final 
survey. 
 
15.4 
If the participant chooses to withdraw at any point during the study, they 
will not be asked to return the Garmin device. They will be compensated for each 
portion of the study they complete.  
 
16.0 Withdrawal of Subjects 
16.1 Participants will be informed that they may withdraw from the study 
at any time by contacting a member of the research team.  
 
16.2 Data collected from subjects prior to withdrawal will be retained for 
analysis. At the time subjects withdraw, no additional data will be 
collected from the subject. 
 
17.0 Risks to Subjects 
17.1 
Classroom: 
• The primary risk, albeit minimal, is the risk of loss of 
confidentiality. The use of video conferencing could result in a 
potential loss of privacy, but study staff will be using the schools 
video conferencing system to minimize this risk. 
17.2 
Participants: 
• The risk to the child’s comfort, albeit minimal, is the wearing of 
the device daily on their wrists. 
• There is a risk to the participant of loss of privacy due to the 
Garmin being a consumer device that uploads data to Garmin 
servers. 
• There is a slight risk of loss of privacy due to the use of Twilio as 
the text messaging platform. 
• There is a slight risk of burden to the parents or guardians due to 
the text messaging frequency. 
18.0 Potential Benefits to Subjects 
18.1 Participants will benefit from resources and opportunities provided 
on how to be physically active during the COVID-19 pandemic. 
18.2 Participants may experience health and developmental benefits from 
increasing their physical activity. 

SHORT TITLE: Stay Active 
 
Page 13 of 17 
Version 1.4 dated 7.13.18 
19.0 Investigator Assessment of Risk/Benefits Ratio: (IRB makes the 
final determination) Based upon your response in Sections 17.0 and 18.0, 
please provide your assessment of risk and benefits in below table. 
 
Select as applicable: 
Pediatric Risk Category: 
X 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
 
Category 2 
Research involving greater than minimal risk but 
presenting the prospect of direct benefit to the 
individual 
subjects. (45 CFR §46.405 and 21 CFR §50.52) 
 
Category 3 
Research involving greater than minimal risk and no 
prospect of direct benefit to individual subjects, but 
likely to yield generalizable knowledge about the 
subject's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
 
Category 4 
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable: 
Adult Risk Category: 
X 
Not Greater than Minimal Risk 
 
Greater than Minimal Risk 
 
20.0 Data Management and Confidentiality 
20.1 Measures 
• Primary measure(s): Daily minutes of physical activity and step 
count 
• Secondary measure(s): parent and teacher perceptions 
20.2 General Design Issues 
• Pre-post between group comparison 
20.3 Sample size determination 
• Based on availability of resources 
20.4 Data Analyses 
• Mixed effects models will account for nesting of time within 
participants and participants within classrooms. Changes in PA 
from pre to post will be compared between the intervention 
groups.  
20.5 
Secure Storage of Data 
• Garmin data will be obtained through the Garmin API. It will 
show each student’s daily minutes of physical activity and step 
counts when participants were wearing the device. Participant 
also have access to this information through their Garmin 
Connect account. As part of the consent/assent process study 
staff will describe that information from the devices will be 

SHORT TITLE: Stay Active 
 
Page 14 of 17 
Version 1.4 dated 7.13.18 
collected through the Garmin API and that Garmin will have 
access to this information. 
Garmin data are stored on Garmin servers and will be accessed 
by the research team via the Garmin web apps on CMH secure 
computers. Study staff will not provide Garmin access to 
participant names or any other PHI that would make a participant 
readily identifiable. Reports will be aggregated across the 
participants so no participant will be identifiable, and no 
identifiable data will be published or presented. 
Online surveys will be managed in REDCap. 
To protect the security of responses on hardcopy surveys, 
participants will complete a confidential survey that includes a 
participant identification number on the form. The participant 
ID#, rather than name, will be recorded on hardcopy surveys. A 
master list containing the names and associated IDs will be kept 
securely in REDCap. No one except the study team members 
will have access to this master list. Names and descriptions of 
participants will not be published or reported. All data will be 
stored without identifiers, and only participant number. Survey 
data are entered on Children’s Mercy computers and will be 
stored in REDCap. Research team members are trained to not 
divulge participants' information in anyway.  
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
21.1 Describe: 
• 
N/A – the study is minimal risk. 
22.0 Provisions to Protect the Privacy Interests of Subjects 
22.1 
Secure Storage of Data (repeated) 
Garmin data will be obtained through the Garmin API. It will show 
each student’s daily minutes of physical activity and step counts 
when participants were wearing the device. Participant also have 
access to this information through their Garmin Connect account. 
As part of the consent/assent process study staff will describe that 
information from the devices will be collected through the Garmin 
API and that Garmin will have access to this information. 
Garmin data are stored on Garmin servers and will be accessed by 
the research team via the Garmin web apps on CMH secure 
computers. Study staff will not provide Garmin access to 
participant names or any other PHI that would make a participant 
readily identifiable. Reports will be aggregated across the 
participants so no participant will be identifiable, and no 
identifiable data will be published or presented. 

SHORT TITLE: Stay Active 
 
Page 15 of 17 
Version 1.4 dated 7.13.18 
23.0 Compensation for Research-Related Injury 
23.1 N/A 
24.0 Economic Burden to Subjects 
24.1 Time. 
25.0 Permission/Assent/Consent Process 
25.1 
Arm 1: The recruitment flier allows parents/students to opt out of 
the CBPA portion of the study and to opt in to the Garmin assessments 
and potentially receiving the family component of the intervention (if 
randomized to the second study arm). P/A/C for the family component 
would then follow the process for Arm 2.  
Non-English speakers will be able to call the study line to have the 
recruitment flyer read to them by an interpreter. A list of those who opt 
out of the CBPA portion of the study will be kept on secure CM servers 
for the duration of the study and will then be deleted.  
We will obtain permission/assent/consent for teachers but will not 
document permission/assent/consent in writing, and have developed a 
permission, assent and or consent scripts (e.g., Study Information Sheet) 
as applicable and uploaded them in myIRB in lieu of full 
permission/assent/consent forms. We have reviewed HRP-411 - 
CHECKLIST - Waiver of Written Documentation of Consent to ensure 
that we have provided sufficient information.  
25.2 
Arm 2: The study team will obtain permission/assent/consent via 
eConsent Lite on the potential participants smart device over the phone: 
• The p/a/c process will take place via telephone and will follow CM 
research policy (10.05 Telephone Process). 
• The potential participant will have a chance to ask questions and 
decide if they’d like to participate. 
• The Study team will be following CM research policies on 
informed permission/assent/consent. 
• Dr. Jordan Carlson’s research team, as well as the study 
coordinator or other research staff listed on the IRB may complete 
consent 
• Time devoted to consent will be will only consist of an eConsent 
conversation over the phone. 
• Participants and their families will be given plenty of time to 
consider participation (they can decline to participate during the 
consent phone call and request follow up) as well as ask any 
questions they have. 
• Study staff will explain each main section of the p/a/c form as well 
as provide a summary. Checking for understanding while going 
through the form and after. 

SHORT TITLE: Stay Active 
 
Page 16 of 17 
Version 1.4 dated 7.13.18 
Subjects who are not yet adults (infants, children, teenagers) 
• 
The study team will consider participants in the sample of 4th 
and 5th graders not yet adults. 
• 
One parent will provide permission, even if the other parent is 
alive, known, competent, reasonably available, and shares legal 
responsibility for the care and custody of the child. 
• 
Permission will only be obtained from individuals that are 
parents or legal guardians. 
Consent at 18 years of age, when minor subjects become adults 
N/A 
Non-English Speaking Subjects 
N/A 
Cognitively Impaired Adults 
N/A 
Adults Unable to Consent 
 
      N/A 
 
26.0 Process to Document Permission/Assent/Consent 
 
26.1 
The study team will be following CM Research Policy 10.04 Obtaining 
Permission/Assent/Consent.  
 
27.0 Setting 
27.1 
Research staff will receive a letter of support from schools or districts 
prior to enrolling classrooms. This letter will be provided to the IRB via 
modification and no study related activities will take place until the modification 
has been reviewed and approved. 
27.2 
Research will occur in both the school classroom setting as well as outside 
of the classroom.  
 
28.0 Resources Available 
28.1 
Our research team has the research training and equipment needed 
to conduct this study according to protocol. We anticipate being able to 
recruit participants through our existing partner networks and 

SHORT TITLE: Stay Active 
 
Page 17 of 17 
Version 1.4 dated 7.13.18 
organization. All research team members will review the protocol and be 
given instructions, as appropriate, for conducting the study. 
 
29.0 Multi-Site Research 
29.1 
Study-Wide Number of Subjects = up to 250 students, 250 
parents/guardians, and 15 classroom teachers. 
 
29.2   Investigators in the form of graduate and undergraduate research assistants 
from University of Kansas Medical Center (KUMC) and the University of 
Missouri- Kansas City (UMKC) will be involved in the study. These assistants 
will help gather and analyze data. 
 
30.0 International Research 
30.1.  
    N/A