The Metabolic Effects of Breaks in Sedentary Time

• Sponsor: Children's Hospital of Eastern Ontario (Other)
• Overall Status: Completed
• CT.gov ID: NCT01398059
• Collaborator: University of Ottawa (Other)
• Enrollment: 19
• Location: 1
• Arms: 3
• Duration (Months): 13
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Actual Enrollment: 19 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: Jul 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 14 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Behavioural Metabolic Research Unit, University of Ottawa	Ottawa	Ontario	Canada	K1N 6N5

Sponsors and Collaborators

• Children's Hospital of Eastern Ontario
• University of Ottawa

Investigators

• Principal Investigator: Mark S Tremblay, OhD, Children's Hospital of Eastern Ontario Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: 11/01E
• First Posted: Jul 20, 2011
• Last Update Posted: Jul 24, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mark Tremblay, Dr Mark Tremblay, Director, Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario: Sedentary Behavior; Cardiometabolic Risk; Pediatrics

Study Results

Participant Flow

Arm/Group Title	Sed, Sed With Breaks, Sed With Breaks and PA	Sed, Sed With Breaks and PA, Sed With Breaks	Sed With Breaks, Sed With Breaks and PA, Sed	Sed With Breaks, Sed, Sed With Breaks and PA	Sed With Breaks and PA, Sed, Sed With Breaks	Sed With Breaks and PA, Sed With Breaks, Sed
Arm/Group Description	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	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	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	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	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	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
Period Title: Overall Study
STARTED	4	3	4	2	4	2
COMPLETED	4	3	4	2	4	2
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All participants experienced all 3 conditions, in random order.
Overall Participants	19
Age (Count of Participants)
<=18 years	19 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	12 (1)
Sex: Female, Male (Count of Participants)
Female	8 42.1%
Male	11 57.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
Canada	19 100%
Body Mass Index calculated using height and weight (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	18 (4)
Waist circumference measured in cm (Centimetres) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimetres]	64 (12)
Pubertal stage measured by self-reported Tanner stage (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2 (1)
Baseline PA level by Actical Accelerometer (minutes/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes/day]	64 (27)
Baseline Sedentary Behaviour by Actical Accelerometer (minutes/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes/day]	507 (56)
Insulin (pmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/L]	39 (24)
Glucose (pmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/L]	5 (0)
LDL-Cholesterol (pmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/L]	2 (1)
HDL-Cholesterol (pmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/L]	1 (1)
Triglycerides (pmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/L]	1 (0)

Outcome Measures

1. Primary Outcome

Title	Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)
Description	Insulin levels will be assessed multiple times throughout the day, and the resulting values will be used to calculate AUC.
Time Frame	Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedentary	Sedentary With Breaks	Sedentary With Breaks and Physical Activity
Arm/Group Description	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.	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.	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.
Measure Participants	19	19	19
Mean (Standard Deviation) [pmol/L/min]	80559.3 (66380.3)	78707.3 (83074.5)	64270.8 (42272.4)

2. Secondary Outcome

Title	Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)
Description	Blood draws will be taken several times throughout the day, and the resulting values will be used to calculate AUC.
Time Frame	Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedentary	Sedentary With Breaks	Sedentary With Breaks and Physical Activity
Arm/Group Description	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.	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.	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.
Measure Participants	19	19	19
Mean (Standard Deviation) [mmol/L/min]	99.8 (114.4)	101.5 (69.0)	65.2 (66.4)

3. Secondary Outcome

Title	Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)
Description	Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.
Time Frame	Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedentary	Sedentary With Breaks	Sedentary With Breaks and Physical Activity
Arm/Group Description	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.	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.	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.
Measure Participants	19	19	19
Mean (Standard Deviation) [mmol/L/min]	-38.7 (39.9)	-32.2 (40.2)	-52.3 (41.4)

4. Secondary Outcome

Title	Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)
Description	Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.
Time Frame	Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedentary	Sedentary With Breaks	Sedentary With Breaks and Physical Activity
Arm/Group Description	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.	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.	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.
Measure Participants	19	19	19
Mean (Standard Deviation) [mmol/L/min]	-62.9 (67.2)	-50.0 (28.9)	-76.5 (51.4)

5. Secondary Outcome

Title	Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)
Description	Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.
Time Frame	Baseline, 1.5, 3, 4.5, 6, and 7.5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedentary	Sedentary With Breaks	Sedentary With Breaks and Physical Activity
Arm/Group Description	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.	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.	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.
Measure Participants	19	19	19
Mean (Standard Deviation) [mmol/L/min]	185.3 (171.7)	163.2 (148.8)	248.0 (220.4)

Adverse Events

Time Frame	1 day
Arm/Group Title	Sedentary		Sedentary With Breaks		Sedentary With Breaks and Physical Activity
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Sedentary		Sedentary With Breaks		Sedentary With Breaks and Physical Activity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/19 (0%)
Serious Adverse Events
	Sedentary		Sedentary With Breaks		Sedentary With Breaks and Physical Activity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Sedentary		Sedentary With Breaks		Sedentary With Breaks and Physical Activity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.