Clinical trial NCT01626807: Evaluation of a Walking School Bus Program
Official title: Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Physical Activity
Keywords: Safe Routes to School
Walking School Bus
Cluster Randomized Controlled Trial
Physical Activity
Obesity
Overweight
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 838
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Weekly rate of children's active commuting to school
timeFrame: 5-6 months
Secondary outcomes:
measure: Moderate-to-vigorous physical activity
timeFrame: 5-6 months
measure: Body mass index z-score
timeFrame: 5-6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Jason A Mendoza, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: