NCT01398059

Brief Summary

The purpose of this study is to determine whether acute bouts of sedentary behaviour (with or without breaks and/or structured physical activity) result in measurable changes in metabolic health in children and youth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

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

Study Start

First participant enrolled

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
7 years until next milestone

Results Posted

Study results publicly available

July 24, 2019

Completed
Last Updated

July 24, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

July 18, 2011

Results QC Date

April 23, 2018

Last Update Submit

May 22, 2019

Conditions

Keywords

Sedentary BehaviorCardiometabolic RiskPediatrics

Outcome Measures

Primary Outcomes (1)

  • Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)

    Insulin levels will be assessed multiple times throughout the day, and the resulting values will be used to calculate AUC.

    Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

Secondary Outcomes (4)

  • Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)

    Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

  • Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)

    Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

  • Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)

    Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

  • Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)

    Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

Study Arms (3)

Sedentary

EXPERIMENTAL

In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.

Other: Sedentary

Sedentary With Breaks

EXPERIMENTAL

In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.

Other: Sedentary With Breaks

Sedentary With Breaks and Physical Activity

EXPERIMENTAL

In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.

Other: Sedentary With Breaks and Physical Activity

Interventions

In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.

Sedentary

In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.

Sedentary With Breaks

In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.

Sedentary With Breaks and Physical Activity

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 10-14
  • Normal weight or obese

You may not qualify if:

  • Overweight
  • Overt diabetes or heart disease (or taking medications to treat this conditions)
  • Being unambulatory or otherwise unable to perform the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioural Metabolic Research Unit, University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (1)

  • Saunders TJ, Chaput JP, Goldfield GS, Colley RC, Kenny GP, Doucet E, Tremblay MS. Prolonged sitting and markers of cardiometabolic disease risk in children and youth: a randomized crossover study. Metabolism. 2013 Oct;62(10):1423-8. doi: 10.1016/j.metabol.2013.05.010. Epub 2013 Jun 15.

MeSH Terms

Conditions

Insulin ResistanceSedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Travis Saunders
Organization
University of Prince Edward Island

Study Officials

  • Mark S Tremblay, OhD

    Children's Hospital of Eastern Ontario Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Mark Tremblay, Director, Healthy Active Living and Obesity Research Group

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 24, 2019

Results First Posted

July 24, 2019

Record last verified: 2019-05

Locations