Risk Reduction BehaviorNCT02007681
What is in Fact the Contribution of Reducing Time Spent in Sedentary Behaviors on Daily Energy Expenditure? A Doubly Labeled Water Study
A study testing Reduction of sedentary time by breaking it with low intensity physical activity in people with Risk Reduction Behavior, run by Technical University of Lisbon at 1 site in Portugal.
Trial summary
The main purposes of this randomized cross-over trial are to test if a 3h/day reduction of time spent in sedentary behaviour (SB) through breaking up hourly and shifting it for standing and walking behaviours would substantially increase total (TEE) and PA energy expenditure (PAEE) compared to a week of habitual… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior
- What is being tested?
- Reduction of sedentary time by breaking it with low intensity physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2013to Nov 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants were required to be sedentary, between 18-65 years old, have a BMI above 25.0 kg/m2 and physical inactive (not meeting the MVPA recommendations and not exceed 6000 steps/day). In addition subjects had to be free of any major disease with a general healthy status warranted.
Who cannot join
- Taking any medication or dietary supplements that may interfere with body composition or energy expenditure regulation, performing more than 5000 steps/day and meeting actual MVPA recommendations
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Exercise and Health Laboratory, Faculty of Human Kinetics, University of Lisboa
Cruz Quebrada, Lisbon District, 1495
About this study
Official title: The Effects of Shifting Sedentary Behaviors to Light Activities on Energy Expenditure: A Randomized Controlled Trial in Sedentary Adults
The main purposes of this randomized cross-over trial are to test if a 3h/day reduction of time spent in sedentary behaviour (SB) through breaking up hourly and shifting it for standing and walking behaviours would substantially increase total (TEE) and PA energy expenditure (PAEE) compared to a week of habitual prolonged SB, in male and female overweight/obese inactive (which do not attained MVPA recommendations) and sedentary desk workers. Specifically using an experiment design our main aims are: a) to determine the impact of reducing SB on TEE and PAEE; b) to analyse the independent effects of interrupting SB through breaks and the overall reduction in SB on TEE and PAEE; c) To analyse the determinants for the overall reduction in SB; d) If the changes occurred in TEE and PAEE were dependent on specific covariates.
Read the detailed description
There is enough information about exercise physiology to support the well-documented public health guidelines promoting at least 150 minutes of moderate-to vigorous physical activity (MVPA)(1). However there is an emergence of inactivity physiology studies. If we divide a day into periods of MVPA, light intensity PA (LIPA), sedentary behavior and sleep we observe a large proportion of the time taken up by time spent sitting, such as TV viewing, car driving and computer use. In fact, evidence exists that excessive time spent in sedentary behavior (SB) is a health risk that is not mitigated by performing half an hour of MVPA per day (2, 3). Life expectancy at birth may increase by ~2y if SB is reduced to <3h/day (4) whereas prospective associations exist between SB with mortality and morbidity (2, 3). Short term experimental studies indicate that physical inactivity affects energy balance and is considered conducive to weight gain (5, 6). A decrease in PA has a considerable ability to decrease total energy expenditure (TEE) without any compensatory changes in energy intake, which generate a positive energy balance. The extent to which reducing and breaking up SB over sustained periods of time considerably increases TEE has never been investigated under free-living conditions.
Our hypothesis are that, a daily 3h reduction of SB during 1-week, either by increasing the number of breaks and by shifting SB to low intensity physical activity (LIPA), mainly through standing and walking activities, would substantially increase physical activity energy expenditure (PAEE) in male and female overweight/obese inactive computer desk workers compared to 1-week of usual prolonged SB. Prior to intervention, number of steps/day and PA were assessed through the use of a pedometer and accelerometer to respectively identify the habitual daily steps and to assure participants are inactive (<30 min/day of MVPA and ~ 5000 steps/day). Eligible participants were enrolled in a crossover experiment with two conditions performed in a random order: intervention (3h-reduction in SB) and control (habitual SB), both under free-living conditions. Each condition last for 1 week and participants were instructed to keep the same eating patterns while wearing an accelerometer, pedometer, a combined accelerometer and heart rate device, and an inclinometer (activpal). Doubly labeled water (DLW) was administered in both conditions to assess TEE, indirect calorimetry was employed to measure resting energy expenditure (REE), and PAEE subtracted from the sum of REE and thermogenic effect of food (assumed as 10% of TEE). Body composition was assessed at baseline and in the last day of the intervention week with DXA and participants wore the devices 24 hours a day during the two weeks and did the food records in three days in each week. In practice, at the workplace, our intervention to reduce SB include a software that hourly alert the participants to break up SB for approximately 7 minutes through adopting walking behaviors (~30-60 minutes/day) while during transportation, home/domestic, and leisure time contexts, an individual goal for number of steps/day was set based on an expected step cadence for ambulatory activities (~90-120 minutes/day). Also a number of strategies to break up SB were transmitted to the participants in the several contexts for accomplishing their goals.
At the workplace, daily breaks were automatically generated and registered through the software. Daily adherence in breaking up SB was supervised using phone calls during the day as well as compliance with the individual steps/day goal, self-registered in a diary at the end of the day. During the control week, supervision was performed to assure that participants remained inactive with a similar SB and number of steps/day, as observed at baseline.
During the trial, a 3-day food intake record was collected and analyzed at each condition. We anticipate that by using objective measures of transitions from sitting to standing and stepping, we will provide important methodological information, as sedentary time comprises a large proportion of waking hours and small changes may go undetected using self-report SB. A unique aspect of the present study is the utilization of state of-the-art technologies to investigate differences in daily EE and activity patterns in overweight/obese individuals.
The results of this project may have remarkable public health relevance. Most of the population weight gain in the past could have been avoided if a negative energy balance of 100 Kcal/day was achieved. We expect that our findings reveal a meaningful difference in energy expenditure by breaking up SB. We anticipated a public health message emphasizing "standing and walking more" as a simple approach to prevent weight gain and the rise of obesity in developed countries. This project may also contribute to disclose innovative energy balance -based methodologies for designing long-term intervention studies examining the effect of breaking up sedentary time on health-related parameters.
- Conditions
- Risk Reduction Behavior
- Being tested
- Reduction of sedentary time by breaking it with low intensity physical activity
- Keywords
- Sedentary Behavior; Breaks; Workplace; Energy Expenditure; Physical activity; doubly labeled water
- Medical subject headings
- Risk Reduction Behavior, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of sedentary time by breaking it with low intensity physical activityBehavioural
Also called LIPA, breaks
One 5-10 minute break per hour during the work day using a software that alert the participant, and perform 6000 steps above the baseline number of steps/day (previously evaluated), by adopting several domain specific strategies, during 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle change | Experimental | One 5-10 minute break per hour during the work day using a software that alert the participant, and perform 6000 steps above the baseline number of steps/day (previously evaluated), by adopting several domain specific strategies, during 7 days. Receives: Behavioral: Reduction of sedentary time by breaking it with low intensity physical activity |
| Control | No intervention | Regular free week with no changes performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from control week and intervention week in total energy expenditure (TEE)
The TEE was estimated by the doubly labeled water technique
Measured: week 1 and week 2
Resting energy expenditure (REE)
REE was measured by indirect calorimetry
Measured: Baseline (day 0)
Change from control week and intervention week in physical activity energy expenditure (PAEE)
PAEE was calculated as the difference between TEE and the sum of the REE and the thermogenic effect of food (assumed to be 10% of TEE)
Measured: week 1 and week 2
Change from control week and intervention week in daily time spent in sedentary (SB)
PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart)
Measured: week 1 and week 2
Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities
PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart)
Measured: week 1 and week 2
Change from control week and intervention week in number of breaks in sedentary time (BST)
PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart), and an inclinometer (activpal)
Measured: week 1 and week 2
Change from control week and intervention week in time spent sitting (TSS)
An inclinometer (activpal)
Measured: week 1 and week 2
Change from control week and intervention week in time spent standing (TSst)
An inclinometer (activpal)
Measured: week 1 and week 2
Change from control week and intervention week in time spent walking (TSW)
An inclinometer (activpal)
Measured: week 1 and week 2
Change from control week and intervention week in number of steps
Steps were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart), an inclinometer (activpal) and a pedometer.
Measured: week 1 and week 2
Secondary outcomes (1)
Change from baseline and intervention week in body composition
Body composition was assessed by DXA
Measured: Baseline (day 0) and final day of intervention week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Risk Reduction BehaviorStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Analiza M Silva, PhD, Technical University of Lisbon
- Investigators
- Analiza M Silva, PhD, Principal investigator, Faculty of Human Kinetics, University of Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007681
- Sponsor's protocol ID
- CEFMH || Parecer 14/2013
- Status last verified
- Dec 2013
- First submitted
- 26 Nov 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Judice PB, Teixeira L, Silva AM, Sardinha LB. Accuracy of Actigraph inclinometer to classify free-living postures and motion in adults with overweight and obesity. J Sports Sci. 2019 Aug;37(15):1708-1716. doi: 10.1080/02640414.2019.1586281. Epub 2019 Mar 7.
PubMed 30843462Judice PB, Hamilton MT, Sardinha LB, Silva AM. Randomized controlled pilot of an intervention to reduce and break-up overweight/obese adults' overall sitting-time. Trials. 2015 Nov 2;16:490. doi: 10.1186/s13063-015-1015-4.
PubMed 26525049Judice PB, Santos DA, Hamilton MT, Sardinha LB, Silva AM. Validity of GT3X and Actiheart to estimate sedentary time and breaks using ActivPAL as the reference in free-living conditions. Gait Posture. 2015 May;41(4):917-22. doi: 10.1016/j.gaitpost.2015.03.326. Epub 2015 Mar 30.
PubMed 25852024
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Shifting Sedentary Behaviors to Light Activities on Energy Expenditure: A Randomized Controlled Trial in Sedentary Adults
- ClinicalTrials.gov ID
- NCT02007681
- Acronym / sponsor ID
- CEFMH || Parecer 14/2013
- Conditions
- Risk Reduction Behavior
- Keywords
- Sedentary Behavior; Breaks; Workplace; Energy Expenditure; Physical activity; doubly labeled water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Technical University of LisbonUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Dec 2013 (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 main purposes of this randomized cross-over trial are to test if a 3h/day reduction of time spent in sedentary behaviour (SB) through breaking up hourly and shifting it for standing and walking behaviours would substantially increase total (TEE) and PA energy expenditure (PAEE) compared to a week of habitual prolonged SB, in male and female overweight/obese inactive (which do not attained MVPA recommendations) and sedentary desk workers. Specifically using an experiment design our main aims are: a) to determine the impact of reducing SB on TEE and PAEE; b) to analyse the independent effects of interrupting SB through breaks and the overall reduction in SB on TEE and PAEE; c) To analyse the determinants for the overall reduction in SB; d) If the changes occurred in TEE and PAEE were dependent on specific covariates.
Detailed description
There is enough information about exercise physiology to support the well-documented public health guidelines promoting at least 150 minutes of moderate-to vigorous physical activity (MVPA)(1). However there is an emergence of inactivity physiology studies. If we divide a day into periods of MVPA, light intensity PA (LIPA), sedentary behavior and sleep we observe a large proportion of the time taken up by time spent sitting, such as TV viewing, car driving and computer use. In fact, evidence exists that excessive time spent in sedentary behavior (SB) is a health risk that is not mitigated by performing half an hour of MVPA per day (2, 3). Life expectancy at birth may increase by ~2y if SB is reduced to <3h/day (4) whereas prospective associations exist between SB with mortality and morbidity (2, 3). Short term experimental studies indicate that physical inactivity affects energy balance and is considered conducive to weight gain (5, 6). A decrease in PA has a considerable ability to decrease total energy expenditure (TEE) without any compensatory changes in energy intake, which generate a positive energy balance. The extent to which reducing and breaking up SB over sustained periods of time considerably increases TEE has never been investigated under free-living conditions.
Our hypothesis are that, a daily 3h reduction of SB during 1-week, either by increasing the number of breaks and by shifting SB to low intensity physical activity (LIPA), mainly through standing and walking activities, would substantially increase physical activity energy expenditure (PAEE) in male and female overweight/obese inactive computer desk workers compared to 1-week of usual prolonged SB. Prior to intervention, number of steps/day and PA were assessed through the use of a pedometer and accelerometer to respectively identify the habitual daily steps and to assure participants are inactive (<30 min/day of MVPA and ~ 5000 steps/day). Eligible participants were enrolled in a crossover experiment with two conditions performed in a random order: intervention (3h-reduction in SB) and control (habitual SB), both under free-living conditions. Each condition last for 1 week and participants were instructed to keep the same eating patterns while wearing an accelerometer, pedometer, a combined accelerometer and heart rate device, and an inclinometer (activpal). Doubly labeled water (DLW) was administered in both conditions to assess TEE, indirect calorimetry was employed to measure resting energy expenditure (REE), and PAEE subtracted from the sum of REE and thermogenic effect of food (assumed as 10% of TEE). Body composition was assessed at baseline and in the last day of the intervention week with DXA and participants wore the devices 24 hours a day during the two weeks and did the food records in three days in each week. In practice, at the workplace, our intervention to reduce SB include a software that hourly alert the participants to break up SB for approximately 7 minutes through adopting walking behaviors (~30-60 minutes/day) while during transportation, home/domestic, and leisure time contexts, an individual goal for number of steps/day was set based on an expected step cadence for ambulatory activities (~90-120 minutes/day). Also a number of strategies to break up SB were transmitted to the participants in the several contexts for accomplishing their goals.
At the workplace, daily breaks were automatically generated and registered through the software. Daily adherence in breaking up SB was supervised using phone calls during the day as well as compliance with the individual steps/day goal, self-registered in a diary at the end of the day. During the control week, supervision was performed to assure that participants remained inactive with a similar SB and number of steps/day, as observed at baseline.
During the trial, a 3-day food intake record was collected and analyzed at each condition. We anticipate that by using objective measures of transitions from sitting to standing and stepping, we will provide important methodological information, as sedentary time comprises a large proportion of waking hours and small changes may go undetected using self-report SB. A unique aspect of the present study is the utilization of state of-the-art technologies to investigate differences in daily EE and activity patterns in overweight/obese individuals.
The results of this project may have remarkable public health relevance. Most of the population weight gain in the past could have been avoided if a negative energy balance of 100 Kcal/day was achieved. We expect that our findings reveal a meaningful difference in energy expenditure by breaking up SB. We anticipated a public health message emphasizing "standing and walking more" as a simple approach to prevent weight gain and the rise of obesity in developed countries. This project may also contribute to disclose innovative energy balance -based methodologies for designing long-term intervention studies examining the effect of breaking up sedentary time on health-related parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle change | Experimental | Behavioral: Reduction of sedentary time by breaking it with low intensity physical activityOne 5-10 minute break per hour during the work day using a software that alert the participant, and perform 6000 steps above the baseline number of steps/day (previously evaluated), by adopting several domain specific strategies, during 7 days. |
| Control | No intervention | –Regular free week with no changes performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were required to be sedentary, between 18-65 years old, have a BMI above 25.0 kg/m2 and physical inactive (not meeting the MVPA recommendations and not exceed 6000 steps/day). In addition subjects had to be free of any major disease with a general healthy status warranted.
Key exclusion criteria (1 listed)
- Taking any medication or dietary supplements that may interfere with body composition or energy expenditure regulation, performing more than 5000 steps/day and meeting actual MVPA recommendations
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 |
|---|---|---|
| Reduction of sedentary time by breaking it with low intensity physical activityAlso: LIPA, breaksOne 5-10 minute break per hour during the work day using a software that alert the participant, and perform 6000 steps above the baseline number of steps/day (previously evaluated), by adopting several domain specific strategies, during 7 days. | Behavioural | Lifestyle change |
Primary outcome
Change from control week and intervention week in total energy expenditure (TEE)
Time frame: week 1 and week 2
The TEE was estimated by the doubly labeled water technique
Resting energy expenditure (REE)
Time frame: Baseline (day 0)
REE was measured by indirect calorimetry
Change from control week and intervention week in physical activity energy expenditure (PAEE)
Time frame: week 1 and week 2
PAEE was calculated as the difference between TEE and the sum of the REE and the thermogenic effect of food (assumed to be 10% of TEE)
Change from control week and intervention week in daily time spent in sedentary (SB)
Time frame: week 1 and week 2
PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart)
Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities
Time frame: week 1 and week 2
PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart)
Change from control week and intervention week in number of breaks in sedentary time (BST)
Time frame: week 1 and week 2
PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart), and an inclinometer (activpal)
Change from control week and intervention week in time spent sitting (TSS)
Time frame: week 1 and week 2
An inclinometer (activpal)
Change from control week and intervention week in time spent standing (TSst)
Time frame: week 1 and week 2
An inclinometer (activpal)
Change from control week and intervention week in time spent walking (TSW)
Time frame: week 1 and week 2
An inclinometer (activpal)
Change from control week and intervention week in number of steps
Time frame: week 1 and week 2
Steps were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart), an inclinometer (activpal) and a pedometer.
1 secondary outcome
Change from baseline and intervention week in body composition
Time frame: Baseline (day 0) and final day of intervention week
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 11 Dec 2013.
- Derived from this study: PubMed 30843462Judice PB, Teixeira L, Silva AM, Sardinha LB. Accuracy of Actigraph inclinometer to classify free-living postures and motion in adults with overweight and obesity. J Sports Sci. 2019 Aug;37(15):1708-1716. doi: 10.1080/02640414.2019.1586281. Epub 2019 Mar 7.
- Derived from this study: PubMed 26525049Judice PB, Hamilton MT, Sardinha LB, Silva AM. Randomized controlled pilot of an intervention to reduce and break-up overweight/obese adults' overall sitting-time. Trials. 2015 Nov 2;16:490. doi: 10.1186/s13063-015-1015-4.
- Derived from this study: PubMed 25852024Judice PB, Santos DA, Hamilton MT, Sardinha LB, Silva AM. Validity of GT3X and Actiheart to estimate sedentary time and breaks using ActivPAL as the reference in free-living conditions. Gait Posture. 2015 May;41(4):917-22. doi: 10.1016/j.gaitpost.2015.03.326. Epub 2015 Mar 30.
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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.
Analiza M Silva, PhD principal investigator
Faculty of Human Kinetics, University of Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction of sedentary time by breaking it with low intensity physical activity in people with Risk Reduction Behavior, run by Technical University of Lisbon at 1 site in Portugal.
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 11 Dec 2013. 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 Portugal. 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?
Change from control week and intervention week in total energy expenditure (TEE) (time frame: week 1 and week 2). The study lists 10 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 NCT02007681, which also lists 3 linked publications.
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 11 Dec 2013.