Evaluation of a Walking School Bus Program

Obesity Clinical Trial

Official title:

Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626807
• Other study ID #: 1R01CA163146-01A1
• Status: Completed
• Phase: N/A
• First received: June 21, 2012
• Last updated: April 24, 2017
• Start date: December 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 838
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Physical Activity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

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	Weekly rate of children's active commuting to school		5-6 months
Secondary	Moderate-to-vigorous physical activity		5-6 months
Secondary	Body mass index z-score		5-6 months

External Links

•   Walking School Bus Guidelines