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| Name | Class |
|---|---|
| University of Ottawa | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedentary | Experimental | In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour. |
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| Sedentary With Breaks | Experimental | 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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| Sedentary With Breaks and Physical Activity | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedentary | Other | In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Tremblay, OhD | Children's Hospital of Eastern Ontario Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioural Metabolic Research Unit, University of Ottawa | Ottawa | Ontario | K1N 6N5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23773981 | Result | 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.2013.05.010. Epub 2013 Jun 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sed, Sed With Breaks, Sed With Breaks and PA | In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week. Sedentary condition Sedentary with breaks condition Sedentary with breaks and physical activity condition |
| FG001 | Sed, Sed With Breaks and PA, Sed With Breaks | In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week. Sedentary condition Sedentary with breaks and physical activity condition Sedentary with breaks condition |
| FG002 | Sed With Breaks, Sed With Breaks and PA, Sed | In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week. Sedentary with breaks and physical activity condition Sedentary with breaks condition Sedentary condition |
| FG003 | Sed With Breaks, Sed, Sed With Breaks and PA | In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week. Sedentary with breaks condition Sedentary condition Sedentary with breaks and physical activity condition |
| FG004 | Sed With Breaks and PA, Sed, Sed With Breaks | In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week. Sedentary with breaks and physical activity condition Sedentary condition Sedentary with breaks condition |
| FG005 | Sed With Breaks and PA, Sed With Breaks, Sed | In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week. Sedentary with breaks and physical activity condition Sedentary with breaks condition Sedentary condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants experienced all 3 conditions, in random order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | pmol/L/min | Baseline, 1.5, 3, 4.5, 6, and 7.5 hours |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedentary | In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour. Sedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Travis Saunders | University of Prince Edward Island | 902-566-0641 | trsaunders@upei.ca |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
|
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 |
| 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 |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index calculated using height and weight | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference measured in cm | Mean | Standard Deviation | Centimetres |
|
| Pubertal stage measured by self-reported Tanner stage | Tanner stages are a scale of physical development in children, adolescents and adults. The scale ranges from 1 (pre-pubescent child) to 5 (adult), and defines physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitals, testicular volume and development of pubic hair. | Mean | Standard Deviation | units on a scale |
|
| Baseline PA level by Actical Accelerometer | Mean | Standard Deviation | minutes/day |
|
| Baseline Sedentary Behaviour by Actical Accelerometer | Mean | Standard Deviation | minutes/day |
|
| Insulin | Mean | Standard Deviation | pmol/L |
|
| Glucose | Mean | Standard Deviation | pmol/L |
|
| LDL-Cholesterol | Mean | Standard Deviation | pmol/L |
|
| HDL-Cholesterol | Mean | Standard Deviation | pmol/L |
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| Triglycerides | Mean | Standard Deviation | pmol/L |
|
| OG002 | 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. 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | mmol/L/min | 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. | Posted | Mean | Standard Deviation | mmol/L/min | 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. | Posted | Mean | Standard Deviation | mmol/L/min | 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. | Posted | Mean | Standard Deviation | mmol/L/min | Baseline, 1.5, 3, 4.5, 6, and 7.5 hours |
|
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|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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: 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. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | 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. 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D001519 | Behavior |