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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01398059
Date of registration: 18/07/2011
Prospective Registration: No
Primary sponsor: Children's Hospital of Eastern Ontario
Public title: The Metabolic Effects of Breaks in Sedentary Time
Scientific title: The Metabolic Effects of Breaks in Sedentary Time
Date of first enrolment: July 2011
Target sample size: 19
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01398059
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Mark S Tremblay, OhD
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital of Eastern Ontario Research Institute
Key inclusion & exclusion criteria

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



Age minimum: 10 Years
Age maximum: 14 Years
Gender: All
Health Condition(s) or Problem(s) studied
Feasibility
Lipids
Eating
Glucose
Insulin
Intervention(s)
Other: Sedentary
Other: Sedentary With Breaks and Physical Activity
Other: Sedentary With Breaks
Primary Outcome(s)
Change in Insulin Net Incremental Area-Under-The-Curve (iAUC) [Time Frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours]
Secondary Outcome(s)
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]
Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC) [Time Frame: 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]
Change in Glucose Net Incremental Area-Under-The-Curve (iAUC) [Time Frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours]
Secondary ID(s)
11/01E
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Ottawa
Ethics review
Results
Results available: Yes
Date Posted: 24/07/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01398059
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