Pilot and Feasibility Evaluation of a Walking School Bus Program Intervention for Elementary School Students
Pilot Evaluation of a Walking School Bus Program
Sponsors
Source
Seattle Children's Hospital
Oversight Info
Has Dmc
No
Brief Summary
Walking to school is one of the objectives for children and adolescents in Healthy People
2010 and in previous studies was associated with higher levels of overall physical activity,
which has been shown to decrease obesity. Therefore, more children walking to school should
result in increased physical activity and presumably reduce obesity. However, increasing
child pedestrian activity could increase the risk of child pedestrian injuries. Walking with
an adult who provides instruction in pedestrian skills and monitors the child's actual
behavior may be the most important component of a successful intervention. Walking with an
adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB)
addresses safety concerns by providing a period of physical activity supervised by several
responsible adults and teaching opportunities around pedestrian safety skills on the way to
and from school. Children may join the WSB at various points along the set route. Despite the
growing popularity of WSB programs in the United States, randomized, controlled-studies are
lacking that examine the impact on children's safety, physical activity, and health. We seek
to help fill this gap in the literature by piloting a WSB program in elementary schools in
the Houston Independent School District to test feasibility. We hypothesize that a WSB
program will: (1) increase the number of students walking to school and decrease the number
of students driven to school by car, (2) increase students' pedestrian safety behaviors (3)
increase students' physical activity, and (4) decrease students' excess weight gain.
Overall Status
Completed
Start Date
2008-09-01
Completion Date
2009-06-01
Primary Completion Date
2009-06-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Method of student transportation to school |
Immediately pre- and post-intervention |
Secondary Outcome
Measure |
Time Frame |
|
Physical activity |
Immediately pre- and post-intervention |
|
Pedestrian crosswalk behavior |
Immediately pre- and post-intervention |
|
Parents' psychosocial constructs related to allowing their child to walk to school |
Immediately pre- and post-intervention |
|
Child's self-efficacy for walking to school |
Immediately pre- and post-intervention |
Enrollment
149
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
Description
Students are chaperoned to and from school by adults (study staff or parent volunteers) along set routes.
Arm Group Label
I
Other Name
Safe Routes to School
Eligibility
Criteria
Inclusion Criteria:
- 4th grade student at a study school in the Houston Independent School District
- Must be physically able to walk to and from school
Exclusion Criteria:
- Any condition that would prevent the student from walking to or from school
Gender
All
Minimum Age
8 Years
Maximum Age
12 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Jason A Mendoza, MD, MPH |
Principal Investigator |
Seattle Children's Research Institute |
Location
Facility |
|
Baylor College of Medicine Houston Texas 77030 United States |
Location Countries
Country
United States
Verification Date
2013-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Seattle Children's Hospital
Investigator Full Name
Jason Mendoza
Investigator Title
Associate Professor of Pediatrics
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
163773
Number Of Arms
2
Arm Group
Arm Group Label
I
Arm Group Type
Experimental
Description
Walking School Bus Intervention
Arm Group Label
C
Arm Group Type
No Intervention
Description
Usual school procedures for student transportation to school
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Study First Submitted
September 22, 2008
Study First Submitted Qc
September 23, 2008
Study First Posted
September 25, 2008
Last Update Submitted
December 4, 2013
Last Update Submitted Qc
December 4, 2013
Last Update Posted
December 6, 2013
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.