Feasibility Clinical Trial
Official title:
The Metabolic Effects of Breaks in Sedentary Time
NCT number | NCT01398059 |
Other study ID # | 11/01E |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | August 2012 |
Verified date | May 2019 |
Source | Children's Hospital of Eastern Ontario |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 14 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Behavioural Metabolic Research Unit, University of Ottawa | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Eastern Ontario | University of Ottawa |
Canada,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC) | 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 | |
Secondary | Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC) | 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 | |
Secondary | Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC) | 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 | |
Secondary | Change in Glucose Net Incremental Area-Under-The-Curve (iAUC) | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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