Sedentary LifestyleBPS2NCT02951624
The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors
A study testing Breaker, Prolonger and Intermediate in people with Sedentary Lifestyle and Overweight and Obesity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The primary aim of this study is to investigate the acute effect of the frequency and duration of breaks in sitting time on the metabolic risk factor profile. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Overweight and Obesity, Metabolic Disease
- What is being tested?
- Breaker, Prolonger and Intermediate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to 15 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, age 20-50 years, waist-to-height ratio ≥ 0.5 and/or waist circumference ≥ 102 cm.
Who cannot join
- Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz \& Reibold 1990), contraindications to increased levels of physical activity.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Physical Activity Research, Copenhagen University Hospital
Copenhagen, 2100
About this study
The primary aim of this study is to investigate the acute effect of the frequency and duration of breaks in sitting time on the metabolic risk factor profile.
Read the detailed description
Fifteen (n=15) sedentary adult overweight males will be included in the study. All participants will undergo the four interventions in a randomized cross-over design. Wash out between intervention will be minimum four days.
Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.), with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand or walk to go to the toilet.
Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low intensity walking.
Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low intensity walking
Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low intensity walking
All interventions will be matched for total physical activity as well as sitting. Thus, we aim for the active interventions to be iso-caloric.
- Being tested
- Control, Breaker, Prolonger, Intermediate
- Keywords
- Exercise, Breaking prolonged sitting, physical activity
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Metabolic Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Control intervention
BreakerBehavioural
Short breaks of physical activity
ProlongerBehavioural
longer breaks of physical activity
IntermediateBehavioural
Intermediate breaks of physical activity
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Participants will spend 8 hours sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.) Participants will only be allowed to stand or walk to go to the toilet. Receives: Behavioral: Control |
| Breaker | Experimental | Participants will spend a total of 7 hours and 12 min sedentary and a total of 48 min breaking sitting time with LPA. Sedentary time will be done in bouts of 18 min with 2 min of light walking. Receives: Behavioral: Breaker |
| Intermediate | Experimental | Total duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 54 min with 6 min of LPA between each bout. Receives: Behavioral: Intermediate |
| Prolonger | Experimental | Total duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 108 min with 12 min of LPA between each bout. Receives: Behavioral: Prolonger |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC post prandial glucose concentration
Measured: 6 hours
Secondary outcomes (10)
AUC post prandial insulin concentration
Measured: 6 hours
AUC post prandial c-peptide concentration
Measured: 6 hours
AUC post prandial triglyceride concentration
Measured: 6 hours
AUC post prandial total cholesterol concentration
Measured: 6 hours
AUC post prandial ldl concentration
Measured: 6 hours
AUC post prandial hdl concentration
Measured: 6 hours
AUC post prandial glucagon concentration
Measured: 6 hours
Mean 24 hour glucose concentration
Measured: 24 hours
Variation in 24 hour glucose concentration
Measured: 24 hours
Maximum in 24 hour glucose concentration
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Ried-Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mathias Ried, PhD, Principal investigator, Group leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951624
- Sponsor's protocol ID
- 53476
- Acronym
- BPS2
- Status last verified
- Dec 2018
- First submitted
- 30 Oct 2016
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data may be available after publication (fully anonymized) by contact the PI
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02951624
- Acronym / sponsor ID
- BPS2 / 53476
- Keywords
- Exercise, Breaking prolonged sitting, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to investigate the acute effect of the frequency and duration of breaks in sitting time on the metabolic risk factor profile.
Detailed description
Fifteen (n=15) sedentary adult overweight males will be included in the study. All participants will undergo the four interventions in a randomized cross-over design. Wash out between intervention will be minimum four days.
Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.), with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand or walk to go to the toilet.
Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low intensity walking.
Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low intensity walking
Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low intensity walking
All interventions will be matched for total physical activity as well as sitting. Thus, we aim for the active interventions to be iso-caloric.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: ControlParticipants will spend 8 hours sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.) Participants will only be allowed to stand or walk to go to the toilet. |
| Breaker | Experimental | Behavioral: BreakerParticipants will spend a total of 7 hours and 12 min sedentary and a total of 48 min breaking sitting time with LPA. Sedentary time will be done in bouts of 18 min with 2 min of light walking. |
| Intermediate | Experimental | Behavioral: IntermediateTotal duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 54 min with 6 min of LPA between each bout. |
| Prolonger | Experimental | Behavioral: ProlongerTotal duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 108 min with 12 min of LPA between each bout. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males, age 20-50 years, waist-to-height ratio ≥ 0.5 and/or waist circumference ≥ 102 cm.
Key exclusion criteria (1 listed)
- Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz \& Reibold 1990), contraindications to increased levels of physical activity.
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 |
|---|---|---|
| ControlControl intervention | Behavioural | Control |
| BreakerShort breaks of physical activity | Behavioural | Breaker |
| Prolongerlonger breaks of physical activity | Behavioural | Prolonger |
| IntermediateIntermediate breaks of physical activity | Behavioural | Intermediate |
Primary outcome
AUC post prandial glucose concentration
Time frame: 6 hours
10 secondary outcomes
AUC post prandial insulin concentration
Time frame: 6 hours
AUC post prandial c-peptide concentration
Time frame: 6 hours
AUC post prandial triglyceride concentration
Time frame: 6 hours
AUC post prandial total cholesterol concentration
Time frame: 6 hours
AUC post prandial ldl concentration
Time frame: 6 hours
AUC post prandial hdl concentration
Time frame: 6 hours
AUC post prandial glucagon concentration
Time frame: 6 hours
Mean 24 hour glucose concentration
Time frame: 24 hours
Variation in 24 hour glucose concentration
Time frame: 24 hours
Maximum in 24 hour glucose concentration
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Individual participant dataSharing planned: Undecided. Data may be available after publication (fully anonymized) by contact the PI
Related trials for Sedentary Lifestyle
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
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.
Mathias Ried, PhD principal investigator
Group leader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breaker, Prolonger and Intermediate in people with Sedentary Lifestyle and Overweight and Obesity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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 14 Dec 2018. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC post prandial glucose concentration (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2018.