An Intervention Study to Assess the Role of the Built Env... | NCT01711138

Studies
An Intervention Study to Assess the Role of the Built Environment on Physical Activity and Active Transportation to School in Children and Youth

NCT01711138

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Dec 7, 2022Actual

Enrollment

573Actual

Phase

Not provided

Conditions

Physical Activity

Interventions

Not provided

Countries

Canada

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

Dec 2022

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

Oct 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 19, 2012

First Posted Date

Oct 22, 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

Dec 5, 2022

Last Update Posted Date

Dec 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Heather McKay, Principal Investigator, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Name	Class
City of Vancouver	UNKNOWN
Vancouver School Board	UNKNOWN
JW Sporta	UNKNOWN
City of Surrey

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to evaluate if changes to the built environment influence physical activity and active transport to school in children and youth.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

573Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention		Intervention group is geographically located near a built environment intervention (neighbourhood redevelopment).
Comparison		Comparison group is not exposed to the built environment intervention according to their geographic location.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objectively measured physical activity overall (minutes of moderate-to-vigorous physical activity per day)	Accelerometry (ActiGraph, FL, USA)	up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Objectively measured physical activity during commuting to and from school (minutes of moderate-to-vigorous physical activity during commuting)	Accelerometry (ActiGraph, FL, USA)	up to 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Student is in grade 4 - 10 at start of study (fall 2012), or grade 4 at any of the subsequent study years (2013-2015).
Student's parent(s) or guardian(s) provide(s) consent.

Exclusion Criteria:

Student is not in grade 4 - 10 at start of study (fall 2012).
Student's parent(s) or guardian(s) do(es) not provide consent.
Student cannot read or write in English.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Participants who attend school grades 4-10 at baseline (Fall 2012) will be invited to participate (intervention group). Participants (n-matched) who attend school grades 4-10 at baseline (Fall 2012) in a neighbouring catchment boundary will be invited to participate (comparison group).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heather A McKay, PhD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Vancouver	British Columbia		Canada