NCT01626807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
838

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

June 21, 2012

Last Update Submit

April 24, 2017

Conditions

Keywords

Safe Routes to SchoolWalking School BusCluster Randomized Controlled TrialPhysical ActivityObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Weekly rate of children's active commuting to school

    5-6 months

Secondary Outcomes (2)

  • Moderate-to-vigorous physical activity

    5-6 months

  • Body mass index z-score

    5-6 months

Study Arms (2)

Walking school bus

EXPERIMENTAL
Behavioral: Walking School Bus

Usual care

NO INTERVENTION

Interventions

Children will have the option of walking to and/or from school with study staff who are trained in Safe Routes to School methods.

Walking school bus

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • another child from the same household is enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98145-5005, United States

Location

Related Publications (1)

  • Johnson AM, Zhou C, Haviland M, Mendoza JA. Evaluation of a walking school bus program: a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2024 May 10;21(1):55. doi: 10.1186/s12966-024-01602-w.

Related Links

MeSH Terms

Conditions

ObesityMotor ActivityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jason A Mendoza, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations