The Metabolic Effects of Breaks in Sedentary Time

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398059

Enrollment

Registered

2011-07-20

Start date

2011-07-31

Completion date

2012-08-31

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating, Feasibility, Glucose, Insulin, Lipids

Keywords

Sedentary Behavior, Cardiometabolic Risk, Pediatrics

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.

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.

Interventions

OTHERSedentary

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

OTHERSedentary With Breaks

OTHERSedentary 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 14 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.

Countries

Canada

Participant flow

Participants by arm

Arm	Count
All Study Participants All participants experienced all 3 conditions, in random order.	19
Total	19

Baseline characteristics

Characteristic	All Study Participants	—
Age, Categorical <=18 years	19 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	0 Participants	—
Age, Continuous	12 Years STANDARD_DEVIATION 1	—
Baseline PA level by Actical Accelerometer	64 minutes/day STANDARD_DEVIATION 27	—
Baseline Sedentary Behaviour by Actical Accelerometer	507 minutes/day STANDARD_DEVIATION 56	—
Body Mass Index calculated using height and weight	18 kg/m^2 STANDARD_DEVIATION 4	—
Glucose	5 pmol/L STANDARD_DEVIATION 0	—
HDL-Cholesterol	1 pmol/L STANDARD_DEVIATION 1	—
Insulin	39 pmol/L STANDARD_DEVIATION 24	—
LDL-Cholesterol	2 pmol/L STANDARD_DEVIATION 1	—
Pubertal stage measured by self-reported Tanner stage	2 units on a scale STANDARD_DEVIATION 1	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Canada	19 Participants	—
Sex: Female, Male Female	8 Participants	—
Sex: Female, Male Male	11 Participants	—
Triglycerides	1 pmol/L STANDARD_DEVIATION 0	—
Waist circumference measured in cm	64 Centimetres STANDARD_DEVIATION 12	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 19	0 / 19
other Total, other adverse events	0 / 19	0 / 19	0 / 19
serious Total, serious adverse events	0 / 19	0 / 19	0 / 19

Outcome results

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.