Evaluation of a Walking School Bus Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seattle Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Jason Mendoza, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01626807
First received: June 21, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Obesity
Physical Activity
Behavioral: Walking School Bus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Weekly rate of children's active commuting to school [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Moderate-to-vigorous physical activity [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
  • Body mass index z-score [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 770
Study Start Date: December 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Walking school bus 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.
No Intervention: Usual care

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626807

Contacts
Contact: Trina Colburn, PhD 206.884.8250 trina.colburn@seattlechildrens.org
Contact: Jason A Mendoza, MD, MPH 206.884.1261 jason.mendoza@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Research Institute Recruiting
Seattle, Washington, United States, 98145-5005
Contact: Trina Colburn, PhD    206-884-8250    trina.colburn@seattlechildrens.org   
Contact: Jason A Mendoza, MD, MPH    206.884.1261    jason.mendoza@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Jason A Mendoza, MD, MPH Seattle Children's Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Jason Mendoza, Associate Professor of Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01626807     History of Changes
Other Study ID Numbers: 1 R01 CA163146-01A1
Study First Received: June 21, 2012
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Safe Routes to School
Walking School Bus
Cluster Randomized Controlled Trial
Physical Activity
Obesity
Overweight

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014