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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00758615
Other study ID # 1R21CA133418-01
Secondary ID 163773
Status Completed
Phase N/A
First received September 22, 2008
Last updated December 4, 2013
Start date September 2008
Est. completion date June 2009

Study information

Verified date December 2013
Source Seattle Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 12 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Walking School Bus
Students are chaperoned to and from school by adults (study staff or parent volunteers) along set routes.

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Method of student transportation to school Immediately pre- and post-intervention No
Secondary Physical activity Physical activity objectively measured by accelerometers. Immediately pre- and post-intervention No
Secondary Pedestrian crosswalk behavior Immediately pre- and post-intervention Yes
Secondary Parents' psychosocial constructs related to allowing their child to walk to school Immediately pre- and post-intervention No
Secondary Child's self-efficacy for walking to school Immediately pre- and post-intervention No
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