Evaluation of a Walking School Bus Program | NCT01626807

Studies
Evaluation of a Walking School Bus Program

NCT01626807

Sponsor

Seattle Children's Hospital

Status

Completed

Last Update Posted

Apr 25, 2017Actual

Enrollment

838Actual

Phase

Not Applicable

Conditions

Obesity
Physical Activity

Interventions

Walking School Bus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Aug 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jun 21, 2012

First Submission Date that Met QC Criteria

Jun 22, 2012

First Posted Date

Jun 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2017

Last Update Posted Date

Apr 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jason Mendoza, Associate Professor of Pediatrics, Seattle Children's HospitalPrincipal Investigator

Lead Sponsor

Seattle Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

838Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Walking school bus	Experimental		Behavioral: Walking School Bus
Usual care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Walking School Bus	Behavioral	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weekly rate of children's active commuting to school		5-6 months

Secondary Outcomes

Measure	Description	Time Frame
Moderate-to-vigorous physical activity		5-6 months
Body mass index z-score		5-6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason A Mendoza, MD, MPH	Seattle Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seattle Children's Research Institute		Seattle	Washington	98145-5005	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38730407	Derived	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.

ID	Term
D009765	Obesity
D009043	Motor Activity
D050177	Overweight

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight