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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2019
Source Children's Hospital of Eastern Ontario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Behavioural Metabolic Research Unit, University of Ottawa Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Eastern Ontario University of Ottawa

Country where clinical trial is conducted

Canada, 

References & 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 — View Citation

Outcome

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
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