- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626807
Evaluation of a Walking School Bus Program
Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial
Just two generations ago, walking or bicycling to school was the norm for a substantial number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13% in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic, which is at record high levels in the US and affects low-income and ethnic minority children the most. This project will test "the walking school bus" (WSB) program, in which children walk to and from school with adults, and its impact on low-income, ethnic minority children's walking to school, physical activity, and risk for obesity. Ultimately, this line of research has the potential to provide a low-cost, easy to disseminate program to reduce risk of obesity and cancer for at-risk children.
The investigators Specific Aims among 3rd-5th grade children include:
SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a cluster randomized controlled trial to assess the efficacy of a WSB program on children's walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and analyze data on individual-, school-, and macro-level influences on changes to children's walking to school resulting from the WSB program
The Primary Hypotheses to be tested, in comparison to control children, include:
H1) The WSB program will increase children's walking to school over a school-year.
H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between the WSB and changes to children's walking to school.
H1b) Walkability, safety, and acculturation will moderate changes to children's walking to school.
H2) The WSB program will increase children's physical activity and decrease BMI z-scores over a school-year.
H3) The WSB program will increase school-level pedestrian safety behaviors over a school-year.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98145-5005
- Seattle Children's Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- physically capable of walking to and from school
- live within 1-mile of school or parents agree to regularly drop off children within 1-mile of school
- attend a study school and enrolled in 3rd, 4th, or 5th grade
Exclusion Criteria:
- another child from the same household is enrolled in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
|
|
|
Experimental: Walking school bus
|
Children will have the option of walking to and/or from school with study staff who are trained in Safe Routes to School methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weekly rate of children's active commuting to school
Time Frame: 5-6 months
|
5-6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Moderate-to-vigorous physical activity
Time Frame: 5-6 months
|
5-6 months
|
|
Body mass index z-score
Time Frame: 5-6 months
|
5-6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason A Mendoza, MD, MPH, Seattle Children's Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01CA163146-01A1 (U.S. NIH Grant/Contract)
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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