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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
Sponsor:
Collaborator:
University of Ottawa
Information provided by (Responsible Party):
Mark Tremblay, Children's Hospital of Eastern Ontario

Study Description
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Brief 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.

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

Detailed 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.

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sedentary
In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
 Other: Sedentary
In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Canada, Ontario
Behavioural Metabolic Research Unit, University of Ottawa
Ottawa, Ontario, Canada, K1N 6N5
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
University of Ottawa
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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