- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398059
The Metabolic Effects of Breaks in Sedentary Time
May 22, 2019 updated by: Mark Tremblay, Children's Hospital of Eastern Ontario
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
North American children spend the majority of their waking hours engaging in sedentary behavior (e.g.
sitting).
Research in adults and animal models suggests that even short bouts of uninterrupted siting may result in acute changes increases in cardiometabolic risk, although to date no studies have investigated this relationship in children and youth.
The purpose of this study is to assess the feasibility of a protocol which will expose participants aged 10-14 years to a full day of uninterrupted sitting, and to determine the impact of this protocol on markers of cardiometabolic risk (insulin, glucose, triglyceride, HDL-C and LDL-C) as well as subsequent food intake and physical activity.
The impact of uninterrupted sitting will be compared to the impact of interrupted sitting, with and without the inclusion of moderate physical activity.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1N 6N5
- Behavioural Metabolic Research Unit, University of Ottawa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 10-14
- Normal weight or obese
Exclusion Criteria:
- Overweight
- Overt diabetes or heart disease (or taking medications to treat this conditions)
- Being unambulatory or otherwise unable to perform the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sedentary
In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
|
In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
|
Experimental: 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.
|
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.
|
Experimental: Sedentary With Breaks and Physical Activity
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)
Time Frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)
Time Frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
Blood draws will be taken several 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
|
Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)
Time Frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.
|
Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)
Time Frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.
|
Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)
Time Frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.
|
Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark S Tremblay, OhD, Children's Hospital of Eastern Ontario Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
July 18, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimate)
July 20, 2011
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 11/01E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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