FeasibilityNCT01398059
The Metabolic Effects of Breaks in Sedentary Time
A study testing Sedentary, Sedentary With Breaks and Sedentary With Breaks and Physical Activity in people with Feasibility and Insulin, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Feasibility, Insulin, Glucose
- What is being tested?
- Sedentary, Sedentary With Breaks and Sedentary With Breaks and Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 10-14
- Normal weight or obese
Who cannot join
- Overweight
- Overt diabetes or heart disease (or taking medications to treat this conditions)
- Being unambulatory or otherwise unable to perform the study protocol
Trial locations and contacts
1 site in 1 country.
Canada1 site
Behavioural Metabolic Research Unit, University of Ottawa
Ottawa, Ontario, K1N 6N5
About this study
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.
Read the 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.
- Conditions
- Feasibility, Insulin, Glucose, Lipids, Eating
- Being tested
- Sedentary, Sedentary With Breaks, Sedentary With Breaks and Physical Activity
- Keywords
- Sedentary Behavior, Cardiometabolic Risk, Pediatrics
- Medical subject headings
- Insulin Resistance, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedentaryOther
In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
Sedentary With BreaksOther
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 ActivityOther
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 group | Role | What they receive |
|---|---|---|
| Sedentary | Experimental | In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour. Receives: Other: Sedentary |
| 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. Receives: Other: Sedentary With Breaks |
| 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. Receives: Other: Sedentary With Breaks and Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Secondary outcomes (4)
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.
Measured: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeasibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Principal investigator, Mark Tremblay, Children's Hospital of Eastern Ontario
- Investigators
- Mark S Tremblay, OhD, Principal investigator, Children's Hospital of Eastern Ontario Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398059
- Sponsor's protocol ID
- 11/01E
- Status last verified
- May 2019
- First submitted
- 18 Jul 2011
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23773981
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of Breaks in Sedentary Time
- ClinicalTrials.gov ID
- NCT01398059
- Acronym / sponsor ID
- 11/01E
- Conditions
- Feasibility, Insulin, Glucose, Lipids, Eating
- Keywords
- Sedentary Behavior, Cardiometabolic Risk, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sedentary | Experimental | Other: SedentaryIn this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour. |
| Sedentary With Breaks | Experimental | Other: Sedentary With BreaksIn 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 | Experimental | Other: Sedentary With Breaks and Physical ActivityIn 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 10-14
- Normal weight or obese
Key exclusion criteria (3 listed)
- Overweight
- Overt diabetes or heart disease (or taking medications to treat this conditions)
- Being unambulatory or otherwise unable to perform the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SedentaryIn this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour. | Other | Sedentary |
| Sedentary With BreaksIn 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 |
| Sedentary With Breaks and Physical ActivityIn 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 |
Primary outcome
Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)
Time frame: 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.
4 secondary outcomes
Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)
Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)
Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)
Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)
Time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23773981Saunders 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Tremblay, OhD principal investigator
Children's Hospital of Eastern Ontario Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary, Sedentary With Breaks and Sedentary With Breaks and Physical Activity in people with Feasibility and Insulin, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Net Incremental Area-Under-The-Curve (iAUC) (time frame: Baseline, 1.5, 3, 4.5, 6, and 7.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.