Effects of the Intensity and the Timing of the Physical A... | NCT02119208

Studies
Effects of the Intensity and the Timing of the Physical Activity in a Primary School

NCT02119208

Sponsor

Université de Montréal

Status

Unknown status

Last Update Posted

Apr 21, 2014Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Energy Intake

Interventions

Intensity and timing of exercise

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2014Estimated

Completion Date

May 2014Estimated

First Submitted Date

Feb 23, 2014

First Submission Date that Met QC Criteria

Apr 16, 2014

First Posted Date

Apr 21, 2014Estimated

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 16, 2014

Last Update Posted Date

Apr 21, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marie-Ève Mathieu, Assistant professor, Université de MontréalPrincipal Investigator

Lead Sponsor

Université de MontréalOTHER

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

In natural environment, the moderate-intensity break will allow a reduction of the caloric intake at the dinner more important than for the light-intensity break
In natural environment, the break taken juste before dinner will allow a reduction of the caloric intake at the diner more important than earlier in the day.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle counseling	Experimental		Behavioral: Intensity and timing of exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensity and timing of exercise	Behavioral		Lifestyle counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Caloric intake at the breakfast, lunch and diner (kj)		3 days per condition

Secondary Outcomes

Measure	Description	Time Frame
Anthropometric measures		At preliminary visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged of approximately 5 years old of a of a nursery class of the school Jacques-Barclay, St-Mathieu

Exclusion Criteria:

Present allergy of the foods in the lunch
having a handicap or a limitation that avoid walking, running or tkaing part of the physcial activity courses at the school.
Having a potential surgery
Having a metabolic disease or taking drugs that could have an impact on the results of the study
Be vegetarian
Having intestinal disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
École Jacques-Barclay		Saint-Mathieu	Quebec	J0L 2H0	Canada