Health BehaviorNCT02258438
Effect of Breaking up Prolonged Sitting on Metabolic Flexibility
A study testing Uninterrupted sitting, Sitting + 1 bout of activity and Sitting + microbursts of activity in people with Health Behavior, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise… Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Uninterrupted sitting, Sitting + 1 bout of activity and Sitting + microbursts of activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2014to Sep 2017
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight but weight stable (less than +/- 3kg over previous 6 months) male and female adults (n=24) will be recruited.
- age between 19-45 years old,
- a BMI of 27-33 kg/m2,
- inactive (≤ 1.5hr/wk of moderate-to-vigorous activity),
- sedentary (office employees who are spending more than 6hrs/day in sitting position) and
- English-speaking.
Who cannot join
- any history of renal, cardiovascular or hepatic diseases,
- type 1 or 2 diabetes,
- cancer,
- pregnancy,
- smoking,
- consumption of drugs or alcohol (>40g/d),
Show all 9Show fewer
- any medications known to interfere with lipid or energy metabolism,
- known physical activity contraindications, or major illness/physical problems (acute or chronic) that may limit their ability to perform the walking activities and
- menopause (defined as no menses in the prior 6 months). The use of birth pill control will be accepted. Women are asked to avoid pregnancy until completion of Condition C.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting. The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.
Read the detailed description
Although public-health recommendations to engage in moderate-to-vigorous physical activity (at least 30min, 5 days / week) have been widely promulgated by the government, most people are physically inactive. Sedentary behaviors, like time spent sitting, are associated with serious implications on metabolic health, indicating that even in individuals who regularly exercise a reduction in time spent sitting can confer health benefits. Encouraging recent evidence shows that walking breaks throughout the day are an effective strategy to offset the deleterious effects of prolonged uninterrupted sitting. Further data however are needed to better understand the effect of these microbursts of activity along the day. The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting. Plasma glucose, insulin, triglycerides and free fatty acids concentrations and the use of substrate (glucose, fat or protein) to provide energy to the body in response to meals consumption will be measured on day 3 of each of these three conditions. The investigators will furthermore assess the ability of the participants to perform the interventions on physical activity at the end of each day over the three days of intervention (2 days in free-living conditions and one day in a controlled environment). The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches like structured exercise.
- Conditions
- Health Behavior
- Being tested
- Uninterrupted sitting, Sitting + 1 bout of activity, Sitting + microbursts of activity
- Keywords
- Sedentary Behavior
- Medical subject headings
- Health Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uninterrupted sittingBehavioural
Subjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life. On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void.
Sitting + 1 bout of activityBehavioural
Subjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life. On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000.
Sitting + microbursts of activityBehavioural
Subjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life. On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min.
| Study group | Role | What they receive |
|---|---|---|
| Uninterrupted sitting | Experimental | Patient will refrain from any structured activity and reduce any daily life activity. The patient will spend 24 hours in the calorimeter room. During the 24 hours the patient will remain sedentary for the 24 hours but will be able to watch TV, computer work or read. Receives: Behavioral: Uninterrupted sitting |
| Sitting + 1 bout of activity | Experimental | The patient will be asked to perform the 45 minutes of moderate-exercise intervention in the morning once per day for two days in their daily life. This bout of exercise will be supervised by study staff on one of the treadmills On day 3 the patient will report at the Clinical and Translational Research Center (CTRC) of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, you will be asked to sit quietly in a chair, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity walking on a treadmill. Receives: Behavioral: Sitting + 1 bout of activity |
| Sitting + microbursts of activity | Experimental | The patient will be asked to refrain from any structured exercise running, swimming, lifting weights, yoga, dancing, etc.) for two days but to walk for the 5 minute intervention each hour between 1000 and 1800. On day 3, The patient will report at the CTRC of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, the patient will be asked to rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5 min moderate-intensity walking on a treadmill, which represents a total of 45 min. Receives: Behavioral: Sitting + microbursts of activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total substrate oxidation
Total fat oxidation during the test day will be determined using whole-room indirect calorimetry. O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described
Measured: 1 day
Postprandial plasma insulin and glucose response
Plasma glucose and insulin will be measured in fasting conditions and hourly during 12hrs following a standard meal consumption. The area under the curve will be calculated for both plasma glucose and insulin. This area will represent the postprandial response to a meal for both insulin and glucose.
Measured: 1 day
Dietary fat oxidation
Subjects will collect their own hourly breath sampling for 13CO2 by blowing through a straw into two 15ml Vacutainer after the investigators will have shown them the procedure. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with Isotopic Ratio Mass Spectrometer (IRMS).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study start8 Oct 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Bergouignan, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258438
- Sponsor's protocol ID
- 14-0429
- Other IDs
- UL1TR001082
- Status last verified
- Apr 2021
- First submitted
- 2 Oct 2014
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
De Jong NP, Rynders CA, Goldstrohm DA, Pan Z, Lange AH, Mendez C, Melanson EL, Bessesen DH, Bergouignan A. Effect of frequent interruptions of sedentary time on nutrient metabolism in sedentary overweight male and female adults. J Appl Physiol (1985). 2019 Apr 1;126(4):984-992. doi: 10.1152/japplphysiol.00632.2018. Epub 2019 Jan 10.
PubMed 30629473
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breaking up Prolonged Sitting on Metabolic Flexibility
- ClinicalTrials.gov ID
- NCT02258438
- Acronym / sponsor ID
- 14-0429
- Conditions
- Health Behavior
- Keywords
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 8 Oct 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Oct 2014 (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 investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting. The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.
Detailed description
Although public-health recommendations to engage in moderate-to-vigorous physical activity (at least 30min, 5 days / week) have been widely promulgated by the government, most people are physically inactive. Sedentary behaviors, like time spent sitting, are associated with serious implications on metabolic health, indicating that even in individuals who regularly exercise a reduction in time spent sitting can confer health benefits. Encouraging recent evidence shows that walking breaks throughout the day are an effective strategy to offset the deleterious effects of prolonged uninterrupted sitting. Further data however are needed to better understand the effect of these microbursts of activity along the day. The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting. Plasma glucose, insulin, triglycerides and free fatty acids concentrations and the use of substrate (glucose, fat or protein) to provide energy to the body in response to meals consumption will be measured on day 3 of each of these three conditions. The investigators will furthermore assess the ability of the participants to perform the interventions on physical activity at the end of each day over the three days of intervention (2 days in free-living conditions and one day in a controlled environment). The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches like structured exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uninterrupted sitting | Experimental | Behavioral: Uninterrupted sittingPatient will refrain from any structured activity and reduce any daily life activity. The patient will spend 24 hours in the calorimeter room. During the 24 hours the patient will remain sedentary for the 24 hours but will be able to watch TV, computer work or read. |
| Sitting + 1 bout of activity | Experimental | Behavioral: Sitting + 1 bout of activityThe patient will be asked to perform the 45 minutes of moderate-exercise intervention in the morning once per day for two days in their daily life. This bout of exercise will be supervised by study staff on one of the treadmills On day 3 the patient will report at the Clinical and Translational Research Center (CTRC) of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, you will be asked to sit quietly in a chair, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity walking on a treadmill. |
| Sitting + microbursts of activity | Experimental | Behavioral: Sitting + microbursts of activityThe patient will be asked to refrain from any structured exercise running, swimming, lifting weights, yoga, dancing, etc.) for two days but to walk for the 5 minute intervention each hour between 1000 and 1800. On day 3, The patient will report at the CTRC of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, the patient will be asked to rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5 min moderate-intensity walking on a treadmill, which represents a total of 45 min. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- overweight but weight stable (less than +/- 3kg over previous 6 months) male and female adults (n=24) will be recruited.
- age between 19-45 years old,
- a BMI of 27-33 kg/m2,
- inactive (≤ 1.5hr/wk of moderate-to-vigorous activity),
- sedentary (office employees who are spending more than 6hrs/day in sitting position) and
Key exclusion criteria (9 listed)
- any history of renal, cardiovascular or hepatic diseases,
- type 1 or 2 diabetes,
- cancer,
- pregnancy,
- smoking,
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 |
|---|---|---|
| Uninterrupted sittingSubjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life. On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void. | Behavioural | Uninterrupted sitting |
| Sitting + 1 bout of activitySubjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life. On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000. | Behavioural | Sitting + 1 bout of activity |
| Sitting + microbursts of activitySubjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life. On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min. | Behavioural | Sitting + microbursts of activity |
Primary outcome
Total substrate oxidation
Time frame: 1 day
Total fat oxidation during the test day will be determined using whole-room indirect calorimetry. O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described
Postprandial plasma insulin and glucose response
Time frame: 1 day
Plasma glucose and insulin will be measured in fasting conditions and hourly during 12hrs following a standard meal consumption. The area under the curve will be calculated for both plasma glucose and insulin. This area will represent the postprandial response to a meal for both insulin and glucose.
Dietary fat oxidation
Time frame: 1 day
Subjects will collect their own hourly breath sampling for 13CO2 by blowing through a straw into two 15ml Vacutainer after the investigators will have shown them the procedure. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with Isotopic Ratio Mass Spectrometer (IRMS).
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 30 Apr 2021.
- Derived from this study: PubMed 30629473De Jong NP, Rynders CA, Goldstrohm DA, Pan Z, Lange AH, Mendez C, Melanson EL, Bessesen DH, Bergouignan A. Effect of frequent interruptions of sedentary time on nutrient metabolism in sedentary overweight male and female adults. J Appl Physiol (1985). 2019 Apr 1;126(4):984-992. doi: 10.1152/japplphysiol.00632.2018. Epub 2019 Jan 10.
- Individual participant dataSharing planned: No
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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.
Audrey Bergouignan, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uninterrupted sitting, Sitting + 1 bout of activity and Sitting + microbursts of activity in people with Health Behavior, run by University of Colorado, Denver at 1 site in United States.
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 6 inclusion and 9 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 30 Apr 2021. 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 United States. 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?
Total substrate oxidation (time frame: 1 day). The study lists 3 primary outcomes in all. 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 NCT02258438, 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 30 Apr 2021.