- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00758615
Pilot Evaluation of a Walking School Bus Program
December 4, 2013 updated by: Jason Mendoza, Seattle Children's Hospital
Pilot and Feasibility Evaluation of a Walking School Bus Program Intervention for Elementary School Students
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
149
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I
Walking School Bus Intervention
|
Students are chaperoned to and from school by adults (study staff or parent volunteers) along set routes.
Other Names:
|
No Intervention: C
Usual school procedures for student transportation to school
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Method of student transportation to school
Time Frame: Immediately pre- and post-intervention
|
Immediately pre- and post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: Immediately pre- and post-intervention
|
Physical activity objectively measured by accelerometers.
|
Immediately pre- and post-intervention
|
Pedestrian crosswalk behavior
Time Frame: Immediately pre- and post-intervention
|
Immediately pre- and post-intervention
|
|
Parents' psychosocial constructs related to allowing their child to walk to school
Time Frame: Immediately pre- and post-intervention
|
Immediately pre- and post-intervention
|
|
Child's self-efficacy for walking to school
Time Frame: Immediately pre- and post-intervention
|
Immediately pre- and post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason A Mendoza, MD, MPH, Seattle Children's Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 22, 2008
First Submitted That Met QC Criteria
September 23, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Estimate)
December 6, 2013
Last Update Submitted That Met QC Criteria
December 4, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21CA133418-01 (U.S. NIH Grant/Contract)
- 163773
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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