The Metabolic Effects of Breaks in Sedentary Time
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ClinicalTrials.gov Identifier: NCT01398059 |
Recruitment Status
:
Completed
First Posted
: July 20, 2011
Last Update Posted
: September 25, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Feasibility Insulin Glucose Lipids Eating | Other: Sedentary Other: Sedentary With Breaks Other: Sedentary With Breaks and Physical Activity | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Metabolic Effects of Breaks in Sedentary Time |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
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Experimental: Sedentary
In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
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Other: Sedentary
In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
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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.
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Other: 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.
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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.
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Other: 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.
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- Change in Insulin Area-Under-The-Curve (AUC) [ Time Frame: Change in insulin AUC between "sedentary", "sedentary with breaks", and "sedentary with breaks and physical activity" conditions ]Blood draws will occur at 8:00, 9:30, 11:00, 12:30, 14:00 and 15:30 during each condition. Insulin levels will be assessed during each of these blood draws, and the resulting values will be used to calculate AUC.
- Change in Triglyceride Area-Under-The-Curve (AUC) [ Time Frame: Change in triglyceride AUC between "sedentary", "sedentary with breaks", and "sedentary with breaks and physical activity" conditions ]Blood draws will occur at 8:00, 9:30, 11:00, 12:30, 14:00 and 15:30 during each condition. Triglyceride levels will be assessed during each of these blood draws, and the resulting values will be used to calculate AUC.
- Change in HDL-Cholesterol (HDL-C) Area-Under-The-Curve (AUC) [ Time Frame: Change in HDL-C AUC between "sedentary", "sedentary with breaks", and "sedentary with breaks and physical activity" conditions ]Blood draws will occur at 8:00, 9:30, 11:00, 12:30, 14:00 and 15:30 during each condition. HDL-C levels will be assessed during each of these blood draws, and the resulting values will be used to calculate AUC.
- Change in LDL-Cholesterol (LDL-C) Area-Under-The-Curve (AUC) [ Time Frame: Change in LDL-C AUC between "sedentary", "sedentary with breaks", and "sedentary with breaks and physical activity" conditions ]Blood draws will occur at 8:00, 9:30, 11:00, 12:30, 14:00 and 15:30 during each condition. LDL-C levels will be assessed during each of these blood draws, and the resulting values will be used to calculate AUC.
- Change in Glucose Area-Under-The-Curve (AUC) [ Time Frame: Change in glucose AUC between "sedentary", "sedentary with breaks", and "sedentary with breaks and physical activity" conditions ]Blood draws will occur at 8:00, 9:30, 11:00, 12:30, 14:00 and 15:30 during each condition. Glucose levels will be assessed during each of these blood draws, and the resulting values will be used to calculate AUC.
- Caloric Intake [ Time Frame: The 24 hours immediately following each session. ]Food intake will be assessed using a buffet meal at 16:00 during each experimental condition, and participants will use a food diary to record all food intake up to 17:00 the following day.
- Physical Activity [ Time Frame: 24 hours following each condition. ]Participants will wear accelerometers which will assess total physical activity and sedentary behavior from the end of each study condition until 5pm the following day.
- Change in Hunger and Appetite Between the Three Conditions [ Time Frame: Change in Hunger and Appetite Scores between "sedentary", "sedentary with breaks", and "sedentary with breaks and physical activity" conditions ]Hunger and appetite scores will be assessed at 8:05, 16:00 and 17:00 during each study condition using visual analog scales. These scores will be used to calculate the satiety quotient of meals during the condition as well as hunger and appetite area-under-the-curve for each study condition.

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Ages Eligible for Study: | 10 Years to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398059
Canada, Ontario | |
Behavioural Metabolic Research Unit, University of Ottawa | |
Ottawa, Ontario, Canada, K1N 6N5 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mark Tremblay, Dr Mark Tremblay, Director, Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario |
ClinicalTrials.gov Identifier: | NCT01398059 History of Changes |
Other Study ID Numbers: |
11/01E |
First Posted: | July 20, 2011 Key Record Dates |
Last Update Posted: | September 25, 2012 |
Last Verified: | September 2012 |
Keywords provided by Mark Tremblay, Children's Hospital of Eastern Ontario:
Sedentary Behavior Cardiometabolic Risk Pediatrics |