The Metabolic Effects of Breaks in Sedentary Time

Feasibility Clinical Trial

Official title:

The Metabolic Effects of Breaks in Sedentary Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398059
• Other study ID #: 11/01E
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Eating
• Feasibility
• Glucose
• Insulin
• Lipids

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