Clinical trial NCT01398059: The Metabolic Effects of Breaks in Sedentary Time
Official title: The Metabolic Effects of Breaks in Sedentary Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility
Insulin
Glucose
Lipids
Eating
Keywords: Sedentary Behavior
Cardiometabolic Risk
Pediatrics
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2011-07-20
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)
timeFrame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Secondary outcomes:
measure: Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)
timeFrame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
measure: Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)
timeFrame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
measure: Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)
timeFrame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
measure: Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)
timeFrame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Behavioural Metabolic Research Unit, University of Ottawa
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario Research Institute
name: Mark S Tremblay, OhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.