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Completed

NCT Number: NCT01398059

The Metabolic Effects of Breaks in Sedentary Time

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.

Completed

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Key information

Conditions

Feasibility Behavior Eating Glucose Glucose Metabolism Disorders Hyperinsulinism Insulin Insulin Resistance Lipids Metabolic Diseases Nutritional and Metabolic Diseases Sedentary Behavior

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behavioural Metabolic Research Unit, University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedentary

Other

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

Sedentary With Breaks

Other

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

Other

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.

Primary outcomes

  1. Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)

    Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

    Insulin levels will be assessed multiple times throughout the day, and the resulting values will be used to calculate AUC.

Secondary outcomes

  1. Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)

    Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

    Blood draws will be taken several times throughout the day, and the resulting values will be used to calculate AUC.

  2. Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)

    Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

    Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.

  3. Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)

    Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

    Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.

  4. Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)

    Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

    Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Collaborators

  • University of Ottawa

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2011
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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