Obesity Clinical Trial
Official title:
Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial
Verified date | April 2017 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Children's Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital |
United States,
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 |
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