Trial Outcomes & Findings for The Metabolic Effects of Breaks in Sedentary Time (NCT NCT01398059)

NCT ID: NCT01398059

Last Updated: 2019-07-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
• Results posted on: 2019-07-24

Participant Flow

Participant milestones

Measure	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	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	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	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	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	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
Overall Study STARTED	4	3	4	2	4	2
Overall Study COMPLETED	4	3	4	2	4	2
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=19 Participants All participants experienced all 3 conditions, in random order.
Age, Categorical <=18 years	19 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=19 Participants
Age, Continuous	12 Years STANDARD_DEVIATION 1 • n=19 Participants
Sex: Female, Male Female	8 Participants n=19 Participants
Sex: Female, Male Male	11 Participants n=19 Participants
Region of Enrollment Canada	19 Participants n=19 Participants
Body Mass Index calculated using height and weight	18 kg/m^2 STANDARD_DEVIATION 4 • n=19 Participants
Waist circumference measured in cm	64 Centimetres STANDARD_DEVIATION 12 • n=19 Participants
Pubertal stage measured by self-reported Tanner stage	2 units on a scale STANDARD_DEVIATION 1 • n=19 Participants
Baseline PA level by Actical Accelerometer	64 minutes/day STANDARD_DEVIATION 27 • n=19 Participants
Baseline Sedentary Behaviour by Actical Accelerometer	507 minutes/day STANDARD_DEVIATION 56 • n=19 Participants
Insulin	39 pmol/L STANDARD_DEVIATION 24 • n=19 Participants
Glucose	5 pmol/L STANDARD_DEVIATION 0 • n=19 Participants
LDL-Cholesterol	2 pmol/L STANDARD_DEVIATION 1 • n=19 Participants
HDL-Cholesterol	1 pmol/L STANDARD_DEVIATION 1 • n=19 Participants
Triglycerides	1 pmol/L STANDARD_DEVIATION 0 • n=19 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Sedentary n=19 Participants 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.	Sedentary With Breaks n=19 Participants 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.	Sedentary With Breaks and Physical Activity n=19 Participants 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.
Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)	80559.3 pmol/L/min Standard Deviation 66380.3	78707.3 pmol/L/min Standard Deviation 83074.5	64270.8 pmol/L/min Standard Deviation 42272.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sedentary n=19 Participants 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.	Sedentary With Breaks n=19 Participants 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.	Sedentary With Breaks and Physical Activity n=19 Participants 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.
Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)	99.8 mmol/L/min Standard Deviation 114.4	101.5 mmol/L/min Standard Deviation 69.0	65.2 mmol/L/min Standard Deviation 66.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sedentary n=19 Participants 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.	Sedentary With Breaks n=19 Participants 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.	Sedentary With Breaks and Physical Activity n=19 Participants 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.
Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)	-38.7 mmol/L/min Standard Deviation 39.9	-32.2 mmol/L/min Standard Deviation 40.2	-52.3 mmol/L/min Standard Deviation 41.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sedentary n=19 Participants 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.	Sedentary With Breaks n=19 Participants 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.	Sedentary With Breaks and Physical Activity n=19 Participants 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.
Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)	-62.9 mmol/L/min Standard Deviation 67.2	-50.0 mmol/L/min Standard Deviation 28.9	-76.5 mmol/L/min Standard Deviation 51.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sedentary n=19 Participants 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.	Sedentary With Breaks n=19 Participants 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.	Sedentary With Breaks and Physical Activity n=19 Participants 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.
Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)	185.3 mmol/L/min Standard Deviation 171.7	163.2 mmol/L/min Standard Deviation 148.8	248.0 mmol/L/min Standard Deviation 220.4

Adverse Events

Sedentary

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sedentary With Breaks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sedentary With Breaks and Physical Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Travis Saunders

University of Prince Edward Island

Phone: 902-566-0641

Email: trsaunders@upei.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place