Psychosocial Supports for Walking to School Paired With a Walking School Bus
Phase: NA
Conditions: Health Behavior
Sponsor: Children's Mercy Hospital Kansas City

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PROTOCOL TITLE: 
Walking to school at Banneker Elementary 
PRINCIPAL INVESTIGATOR: 
Jordan Carlson, PhD 
Center for Children’s Healthy Lifestyles and Nutrition 
816-234-9240 
jacarlson@cmh.edu 
VERSION NUMBER/DATE: 
V3 9/24/19 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
8/27/19 
Updates to include Phase 2 details 
N 
3 
9/24/19 
Updates eligibility and screening 
N 
4 
11/1/19 
Updates to inclusion/exclusion criteria 
N 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives ................................................................................................................ 4 
3.0 
Background .............................................................................................................. 4 
4.0 
Study Endpoints ....................................................................................................... 4 
5.0 
Study Intervention/Investigational Agent ................................................................ 4 
6.0 
Procedures Involved................................................................................................. 5 
7.0 
Data and Specimen Banking .................................................................................... 6 
8.0 
Genetic Analysis Information .................................................................................. 6 
9.0 
Sharing of Results with Subjects ............................................................................. 6 
10.0 Study Timelines ....................................................................................................... 6 
11.0 Inclusion and Exclusion Criteria .............................................................................. 6 
12.0 Vulnerable Populations ............................................................................................ 7 
13.0 Local Number of Subjects ....................................................................................... 7 
14.0 Screening and Recruitment Methods ....................................................................... 7 
15.0 Reimbursement, Payment and Tangible Property provided to subjects .................. 8 
16.0 Withdrawal of Subjects ............................................................................................ 8 
17.0 Risks to Subjects ...................................................................................................... 9 
18.0 Potential Benefits to Subjects .................................................................................. 9 
19.0 Investigator Assessment of Risk/Benefits Ratio. ..................................................... 9 
20.0 Data Management and Confidentiality .................................................................. 10 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 10 
22.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 10 
23.0 Compensation for Research-Related Injury ........................................................... 11 
24.0 Economic Burden to Subjects ................................................................................ 11 
25.0 Permission/Assent/Consent Process ...................................................................... 11 
26.0 Process to Document Permission/Assent/Consent................................................. 12 
27.0 Setting .................................................................................................................... 12 
28.0 Resources Available............................................................................................... 12 
29.0 Multi-Site Research ............................................................................................... 13 
30.0 International Research ........................................................................................... 13 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Walking to school at Banneker Elementary 
Study Design 
Phase 1: cross-sectional survey 
Phase 2: behavioral Intervention 
Primary Objective 
Phase 1: to identify students and families interested in 
walking to/from school 
Phase 2: to provide support to students and families 
interested in walking to/from school 
Secondary 
Objective(s) 
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Phase 2 involves a behavioral intervention involving health 
coaching delivered over the phone and through email 
messaging. 
IND/IDE #  
N/A 
Study Population 
Children enrolled at Benjamin Banneker School and their 
parent(s) 
Sample Size 
Phase 1: the survey will be sent home with all students 
enrolled at Banneker; estimated response is 600 parents 
Phase 2: 30 parent/child dyads 
Study Duration for 
Individual 
Participants 
Phase 1: one survey that takes approximately 10 minutes to 
complete 
Phase 2: approximately 6 weeks 
Study Specific 
Abbreviations/ 
Definitions  
 
 
 

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2.0 
Objectives 
 
Phase 1: to identify students and families interested in walking to/from school. 
Phase 2: to provide support to students and families interested in walking to/from school, 
and determine acceptability and appropriateness of the supports. 
 
3.0 
Background 
 
Increasing rates of walking to school can lead to improvements in children’s overall 
physical activity and health. Yet, few children walk to school. Walking school bus 
programs, often included in Safe Routes to School efforts, provide children an 
opportunity to walk to school in a group accompanied by an adult. This improves safety 
and support for walking to school. Our community partner, BikeWalkKC, provides 
walking school bus programming at some local schools in the Kansas City area. 
However, it is difficult to engage students and families to join these walking school buses 
and walk to school in general.  
 
The purpose of this study is to test the acceptability and appropriateness of a novel 
behavioral coaching intervention for increasing the number of students who participate in 
a walking school bus or walk to school through other means. This study will be 
conducted at one local school, Banneker Elementary School in KCPS, where 
BikeWalkKC is providing a walking school bus in the fall of 2019. The walking school 
bus and BikeWalkKC’s involvement is not part of the research study. The research 
activities, which are being conducted by our team at CMH, involve a cross-sectional 
survey of all students in the school (Phase 1), and a behavioral coaching intervention to 
up to 30 students, aimed to transition them from driving to school to walking (either with 
the walking school bus or through other means).  
 
  
4.0 
Study Endpoints 
4.1 Completion of Phase 1, then Phase 2 if selected. 
4.2 No primary safety Endpoint. 
 
5.0 
Study Intervention/Investigational Agent 
5.1 
Description: behavioral intervention only. See below: 
Intervention  
In general, Phase 2 will involve a behavioral coaching intervention. This will include 
handouts, text messages via Redcap and Outlook (see Jaylene Weigel’s letter of support 
and the Texting Protocol in IRB submission), phone/skype calls, and email message 
communications with families (students and parent(s)) for delivering motivational 
content. The content will be theoretically based and cover skills building, goal setting, 
and problem solving. 
 

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6.0 
Procedures Involved 
6.1 
 
Overview and study design  
Phase 1 is a cross-sectional survey. 
Phase 2 is a single group intervention design with purposeful selection of participants.  
 
6.2 
 
Study measures 
Phase 1. The survey asks about current mode of transportation to school, barriers to 
walking to school, and interest in walking to school through various means. They survey 
also asks for the student’s name, home address, parent email, and parent phone number. 
The survey is included in this IRB application. It was designed specifically for this study 
and some items were adapted from the National Safe Routes to School Center’s parent 
survey.  
 
Phase 2. At the end of the intervention, a survey will be administered to families (student 
and parent(s)) to assess their acceptability and preferences around the intervention 
content, and its appropriateness.  
  
 
6.3 Describe: 
• 
Source surveys, slides with scripts (these will include 
PowerPoint slides that are turned into videos by doing a 
voiceover and accessible from a study website), parent 
handouts, and module protocols will be uploaded to myIRB. 
• 
Materials will be accessible here 
(www.ciparesearchteam.org/walk-to-school) and the URLs 
will be sent to participants each week via text/email: 
• Module 1: https://www.ciparesearchteam.org/mod1 
• Module 2: https://www.ciparesearchteam.org/mod2 
• Module 3-5: 
https://www.ciparesearchteam.org/mod35 
• Nonwalker Module 3: 
https://www.ciparesearchteam.org/mod3 
• Nonwalker Module 4: 
https://www.ciparesearchteam.org/mod4 
• Nonwalker Module 5: 
https://www.ciparesearchteam.org/mod5 
 
6.4 Data collected during the study includes: Student name, address, and 
parent phone number and email address. This information will be 
collected via the Phase 1 School Travel Survey to determine 

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eligibility of families for Phase 2 or via response to a recruitment 
flier (if not already obtained from the screener survey).  
6.5 Once Phase 2 is complete, no long term follow-up will be 
completed. 
6.6 N/A – no biologic or radiation review 
 
7.0 
Data and Specimen Banking 
7.1 N/A not using biorepository 
 
8.0 
Genetic Analysis Information 
8.1 N/A no genetic analysis 
 
 
9.0 
Sharing of Results with Subjects 
9.1 N/A results will not be shared with participants 
 
10.0 Study Timelines 
10.1 Describe: For Phase 1, the survey will be administered at the 
beginning of the school year (approximately during the week of Aug 
12, 2019). Within 3-8 weeks of the survey administration, a select 
group of families will be contacted to offer them the intervention 
(Phase 2). The intervention (Phase 2) will last approximately 6 
weeks. 
 
11.0 Inclusion and Exclusion Criteria 
11.1 Describe the criteria that define who will be included or excluded in 
your final study sample. 
 
Inclusion Criteria 
• Phase 1: Parents of children enrolled at Benjamin Banneker school 
• Phase 2: Parents/child dyads who completed the Phase 1 survey OR 
respond to recruitment attempts and express interest in walking to school. 
Included parent/child dyads will be: 
o Those who do not participate in LINC program both before and after 
school 4+ days per week (child); 
o Those who live within the school boundary and south of Meyer Blvd (i.e., 
close enough to an existing walking school bus route) or are willing to 
drop off and/or pick up the child at a place along an existing walking 
school bus route (i.e., remote drop off).  

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Exclusion Criteria 
• Children not enrolled at Benjamin Banneker school 
• Those who participate in LINC program both before and after school 4+ 
days per week (child); 
• Those who do not live within the school boundary and south of Meyer Blvd 
(i.e., close enough to an existing walking school bus route) or are not 
willing to drop off and/or pick up the child at a place along an existing 
walking school bus route (i.e., remote drop off).  
 
11.2 We will exclude each of the following special populations: (You 
may not include members of the following populations as subjects in 
your research unless you indicate this in your inclusion criteria.) 
• 
Adults unable to consent  
• 
Prisoners  
• 
Wards of the state 
• 
Pregnant women may be included, but only in such capacity as 
parents of other children enrolled at Benjamin Banneker school  
 
12.0 Vulnerable Populations 
12.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
• HRP-416 Checklist has been reviewed. 
 
13.0 Local Number of Subjects 
13.1 Phase 1: anticipated that 600 parents will respond to the survey 
Phase 2: up to 30 parent/child dyads 
13.2 N/A 
13.3 N/A 
 
14.0 Screening and Recruitment Methods 
14.1 Phase 1: The survey will be sent home with all students. Banneker 
staff will give the survey to each student to take home.  
Phase 2: We will purposefully select survey respondents based on 
their survey responses to reach out to via various means to offer the 
intervention (Phase 2). If the desired enrollment numbers are not 
reached using this approach, recruitment fliers will be send home 

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with students living within walking distance of the school. We will 
try to target those living close to the school but it is likely that some 
students living further away will receive the flier.  
We did not receive very many returned screeners. Thus, we are 
going to recruit more broadly as described above. We will screen 
those who respond to the recruitment flier to determine their 
eligibility. These eligibility questions were asked in the Phase 1 
screener survey, but need to use the Phase 2 phone script as a 
screener because we won’t have Phase 1 data on everyone who we 
send the recruitment flier to. 
14.2 
The participants will come from Banneker elementary school. 
14.3 Phase 1 will include all students at Banneker. Phase 2 will involve a 
select group of students selected based on their survey responses. A 
Letter of Support from the school is included in this IRB application.  
14.4 No identifiers will be collected prior to p/a/c by the CMH study 
team. 
14.5 For Phase 2, study staff will contact a select subset of survey 
respondents up to three times to offer the intervention, and share the 
flier with other families (including those who did not respond to the 
screener) until up to 30 dyads agree to receive the intervention. First, 
a recruitment letter will be sent in the mail and email. Next, we will 
call the parent on the phone and go over the details of the study and 
screening (if interested). At this time, the parent and child will either 
agree to participate or decline. The intervention will start the Sunday 
after enrollment.  
 
15.0 Reimbursement, Payment and Tangible Property provided to 
subjects 
 
15.1 N/A – no reimbursement 
 
15.2 Phase 1: No incentive. Phase 2: $50 for responding to at least 80% of the 
daily tracking text messages and another $50 for completing a close-out 
interview. 
 
15.3 N/A – no tangible property 
 
 
 
16.0 Withdrawal of Subjects 
16.1 Withdrawal of participants is not anticipated for any one reason. 
16.2 N/A 

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16.3 When a participant decides to withdraw data obtained up to the time 
of withdrawal will be kept. 
 
17.0 Risks to Subjects 
17.1 The main risk of this study is a loss of confidentiality. 
17.2 The risks involved in this study are minimal. 
17.3 Walking to school may have some unforeseeable risks but the 
decision to walk to school is ultimately up to the dyads. 
BikeWalkKC is working with the school to minimize dangers 
potentially associated with walking and our assessment of risks is 
that they are minimal and do not outweigh the benefits of walking to 
school. 
17.4 N/A no risk to embryo or fetus 
17.5 Parents and dyads may also experience a small risk of loss of 
confidentiality. 
 
18.0 Potential Benefits to Subjects 
18.1 Participants may experience greater levels of physical activity, lower 
adiposity, as well as greater cognitive and academic performance 
associated with walking to school. 
18.2 N/A 
 
19.0 Investigator Assessment of Risk/Benefits Ratio: (IRB makes the 
final determination)  
 
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 

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Data Management and Confidentiality 
20.1 
 The data analyses will be descriptive, to summarize the results of the 
surveys. Qualitative data will also be collected and summarized as part of Phase 
2. 
20.2 This is a pilot study and the sample size was selected to provide a 
sufficient number of dyads who complete the intervention and post 
intervention survey on acceptability.  
20.3 All research staff will obtain the proper research training, 
authorization of access. Study data will be store using password 
protection, encryption, physical controls, and separation of 
identifiers and data [master list]) during storage, use, and 
transmission.   
20.4 This study will not obtain a certificate of confidentiality. 
20.5 Describe how data or specimens will be handled study-wide: 
• 
Study data will be stored per the Record Retention and 
Management Policy and the Record Retention Schedule 2015 
according to guidelines for NIH funded studies. 
• 
The CMH study team will have access to the data. 
 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
• 
N/A – no more than minimal risk 
 
22.0 Provisions to Protect the Privacy Interests of Subjects 
22.1 Participants will be given study ID numbers, all information 
collected for the study will be done using that ID, not their name or 
any other identifying information. The participant’s name will only 
be linked via a master list and on the permission/assent form. The 
initial study survey (Phase 1) will contain a verbal consent and some 
identifiers will be collected. 
22.2 Participants will be given ample time to decide whether or not they 
would like to participate in the study. They will be able to come back 
to the initial verbal consent after a time (Phase 1) and decide to 
complete it or not.  
22.3  The information accessed by the study team will come from the 
Phase 1 survey and responses to recruitment fliers. The information 
will be kept secure and not shared outside of the project team. The 
exception is that the information from the Phase 1 survey will be 

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shared with BikeWalkKC so that they can follow up with families 
interested in participating in the walking school bus that 
BikeWalkKC is providing. List all PHI to be accessed and/or 
recorded for this research study.  Identifiers includes: name, street 
address, telephone number, and email address.  
22.4 The HIPAA Authorization will be wrapped in with the 
permission/assent/consent form(s). 
 
23.0 Compensation for Research-Related Injury 
23.1 N/A 
23.2 N/A 
 
24.0 Economic Burden to Subjects 
24.1 No economic burden for subjects other than time investment. 
 
25.0 Permission/Assent/Consent Process 
25.1 Indicate whether you will you be obtaining 
permission/assent/consent, and if so describe: 
• 
The study staff requests an alteration of the permission/assent 
process, more specially to use a verbal permission/assent. They 
have reviewed the checklist for Waiver of Alteration of 
Consent process and have concluded that the study meets the 
criteria for number 1. 
• Since this survey collects minimally identifying 
information (name, address, phone number, and 
email) and the intervention is minimal (behavioral 
coaching) the study team is requesting an “opt out” 
permission/assent process where the participants 
indicate they do not wish to participate by not 
completing the form. 
• The recruitment/enrollment phone call for Phase 2 
includes a script that explains that participation is 
voluntary and that withdraw will not affect their 
relationship with the school or CMH. The script 
also covers the details/requirements of the study. 
This script has been uploaded with this amendment 
submission. 
 

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26.0 Process to Document Permission/Assent/Consent 
26.1 We will be requesting a waiver via 26.2.  
26.2 This research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of 
permission/assent/consent is normally required outside of the 
research context. The IRB will generally waive the requirement to 
obtain written documentation of permission/assent/consent. 
26.3 The study will obtain verbal permission/assent/consent, but not 
document permission/assent/consent in writing, therefore a 
permission, assent and or consent scripts (e.g., Study Information 
Sheet, in this case wrapped up in the study survey) will be developed 
and uploaded in myIRB in lieu of full permission/assent/consent 
forms.  
Review HRP-411 - CHECKLIST - Waiver of Written 
Documentation of Consent to ensure that you have provided 
sufficient information.  
 
27.0 Setting 
27.1 Describe the sites or locations where your research team will 
conduct the research. 
• 
The survey will be sent home with students. 
• 
The intervention will occur over the telephone/skype, text, and 
email. 
• 
For research conducted outside of the organization and its 
affiliates describe: 
• 
A letter of support has been obtained from the 
participating school. 
 
28.0 Resources Available 
28.1 Describe the resources available to conduct the research: For 
example, as appropriate: 
• 
Don Chisholm and the community have the appropriate 
resources (mainly meeting rooms and computers) to conduct 
the research. 
• 
N/A 
• 
All study staff will be trained on the protocol prior to study 
initiation and will undergo the proper research training. 
 

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29.0 Multi-Site Research – marked as collaborative in myIRB because 
Dr. Carlson works with GRAs from UMKC/KUMC 
29.1 
N/A 
29.2 
N/A 
29.3 
N/A 
29.4  N/A 
 
30.0 International Research 
29.1.  
N/A