Sedentary LifestyleNCT01996176
Take a Stand! - an Intervention to Reduce Occupational Sitting Time
A study testing Intervention group in people with Sedentary Lifestyle, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of the study is to test an intervention aiming to reduce sitting time during work hours among office workers. Expectations according to outcome measures: Sitting time reduced by 1 hour pr. day (primary). Number of prolonged periods reduced by 1 pr. day (primary). Number of breaks increased by 3 pr. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Workplaces should be:
- Office-based with sedentary workers
- Able to include four sections of about equal size (about 25 people) and which could be separated to minimize spill-over effects (e.g. four different addresses, buildings or floors).
- Have a management willing to collaborate about the project by participating at meetings and at kick-off.
- Should have at least some financial resources to make structural changes at the work place.
- Individuals should be:
Show all 12Show fewer
- Adults >18 years
- Sedentary office-based work-
- Understanding of Danish
- Without sickness or disabilities affecting their ability to stand or walk
- Not pregnant
- Working more than 4 days a week (>30 h)
Who cannot join
- Not providing signed informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Institute of Public Health - University of Southern Denmark
Copenhagen, 1353
About this study
Official title: Take a Stand ! - a Cluster Randomized Controlled Intervention Study at Four Office-based Workplaces Aiming to Reduce Occupational Sitting Time
The purpose of the study is to test an intervention aiming to reduce sitting time during work hours among office workers.
Expectations according to outcome measures: Sitting time reduced by 1 hour pr. day (primary). Number of prolonged periods reduced by 1 pr. day (primary). Number of breaks increased by 3 pr. day (primary). 20 % of participants report a reduction of musculoskeletal pain (secondary). A reduction in waist circumference of 1 cm (secondary). A reduction of 0.5 % in bodyfat (secondary).
Read the detailed description
Background and aim: Sedentary behaviour has substantial impact on wellbeing and health, e.g. on the risk of cardiovascular disease and premature death. These associations seem to apply as well to people who carry out the recommended 30 minutes of physical activity per day. However, studies indicate that the harmful effects can be reduced through breaking prolonged periods of sitting by intervals of standing or walking.
In total 46 % of Danes are working in occupations which are primarily sedentary and the workplace is thus a relevant setting to intervene against sedentary behaviour.
The aim of the study is to test an intervention towards sitting time among office workers. The intervention will target both total sitting time, breaks from sitting and prolonged periods of sitting.
Design: Cluster-randomized control study led at four different workplaces in Denmark and Greenland. Each workplace should consist of four independent sections (clusters) of about 25 people. Those four sections are randomized to intervention or control. A cluster design is used because the intervention will target the workplace setting as a whole, thus individuals within the same office has to be randomized to the same arm of the intervention.
Participants: 400 adults with sedentary office-based work. Subjects should understand Danish and be without disabilities or diseases affecting their ability to stand or walk.
Intervention: Participating clusters are randomized to
- Intervention: The intervention consists of four parts: Information, local adaptions, structural changes and individual support.
- Control: The control group will receive the intervention after the last follow-up (about 3 months later).
Methods: Data on sedentary behaviour is collected objectively using ActiGraph. Waist circumference and body fat percentage is measured. Questionnaire data will be collected on background variables, physical activity level, workplace conditions and well-being.
Data will be collected at baseline, and after 1 and 3 months.
Analysis will be carried out following the intention-to-treat principle comparing the intervention and control group. We will use several outcomes and include baseline values as a covariate (ANCOVA). In addition we will use multilevel models to account for the hierarchical structure of data (workplace, cluster and participant).
Process evaluation will be conducted by the use of qualitative interviews and questionnaire data and concern both adoptions, implementation and sustainability of the intervention.
- Conditions
- Sedentary Lifestyle
- Being tested
- Intervention group, Control group
- Keywords
- Sedentary Lifestyle, Sedentary work, Office workers, Work, Workplace intervention, Sitting time
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
The intervention consists of four components, which as described below:
- Information about sedentary behaviour and health: Delivered at the kick-off workshop, in a leaflet and the project website.
- Local adaptation: Participants adapt the intervention to their personal and local environment setting individual and common goals. Local ambassadors are chosen and support from the management is emphasised.
- Structural changes: Facilities for standing meetings, both formal and informal. Routes for walking meetings should be defined.
- Individual support: At the kick-off workshop participants set individual goals. The individual can choose to receive e-mails and text messages (SMS)from the project. The individual receives a post-it block and a postcard to remind them of the project.
Control groupBehavioural
The control group receives the intervention after the last follow-up, the exact time will be settled together with each workplace in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group Receives: Behavioral: Intervention group |
| Intervention control | Placebo comparator | Control group Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced total time spend sitting at work
Method of measurement: ActiGraph, average daily sitting time during work hours.
Measured: 1 month
Reduced number of prolonged siting periods (>30 min)
Method of measurement: ActiGraph, number of periods sitting >30 min.
Measured: 1 month
Increased number of breaks from sitting time
Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking
Measured: 1 month
Secondary outcomes (6)
Reduced musculoskeletal problems
Method of measurement: Questionnaire
Measured: 1 month
Waist circumference
Method of measurement: Waist circumference measurement
Measured: 3 month
Body fat percentage
Method of measurement: Body fat % is measured using a segmental body composition analyser
Measured: 3 months
Reduced total time spend sitting at work
Method of measurement: ActiGraph, average daily sitting time during work hours
Measured: 3 months
Reduced number of prolonged siting periods (>30 min)
Method of measurement: ActiGraph, number of periods sitting >30 min
Measured: 3 months
Increased number of breaks from sitting time
Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Principal investigator, Ida Høgstedt Danquah, University of Southern Denmark
- Investigators
- Janne S Tolstrup, MD, PhD, Study director, National Institute of Public Helath - University of Southern DenmarkMorten Grønbæk, MD PhD, Study chair, Centre for Intervention Research in HEalth Promotion and Disease Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996176
- Sponsor's protocol ID
- 61110-2071
- Status last verified
- Aug 2016
- First submitted
- 21 Nov 2013
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Danquah IH, Kloster S, Holtermann A, Aadahl M, Bauman A, Ersboll AK, Tolstrup JS. Take a Stand!-a multi-component intervention aimed at reducing sitting time among office workers-a cluster randomized trial. Int J Epidemiol. 2017 Feb 1;46(1):128-140. doi: 10.1093/ije/dyw009.
PubMed 27094749Danquah IH, Kloster S, Tolstrup JS. "Oh-oh, the others are standing up... I better do the same". Mixed-method evaluation of the implementation process of 'Take a Stand!' - a cluster randomized controlled trial of a multicomponent intervention to reduce sitting time among office workers. BMC Public Health. 2020 Aug 8;20(1):1209. doi: 10.1186/s12889-020-09226-y.
PubMed 32770969Danquah IH, Tolstrup JS. Does It Work for Everyone? The Effect of the Take a Stand! Sitting-Intervention in Subgroups Defined by Socio-Demographic, Health-Related, Work-Related, and Psychosocial Factors. J Occup Environ Med. 2020 Jan;62(1):30-36. doi: 10.1097/JOM.0000000000001737.
PubMed 31626067Danquah IH, Pedersen ESL, Petersen CB, Aadahl M, Holtermann A, Tolstrup JS. Estimated impact of replacing sitting with standing at work on indicators of body composition: Cross-sectional and longitudinal findings using isotemporal substitution analysis on data from the Take a Stand! study. PLoS One. 2018 Jun 13;13(6):e0198000. doi: 10.1371/journal.pone.0198000. eCollection 2018.
PubMed 29897943Danquah IH, Kloster S, Holtermann A, Aadahl M, Tolstrup JS. Effects on musculoskeletal pain from "Take a Stand!" - a cluster-randomized controlled trial reducing sitting time among office workers. Scand J Work Environ Health. 2017 Jul 1;43(4):350-357. doi: 10.5271/sjweh.3639. Epub 2017 Apr 3.
PubMed 28368549Pedersen ES, Danquah IH, Petersen CB, Tolstrup JS. Intra-individual variability in day-to-day and month-to-month measurements of physical activity and sedentary behaviour at work and in leisure-time among Danish adults. BMC Public Health. 2016 Dec 3;16(1):1222. doi: 10.1186/s12889-016-3890-3.
PubMed 27914468
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take a Stand ! - a Cluster Randomized Controlled Intervention Study at Four Office-based Workplaces Aiming to Reduce Occupational Sitting Time
- ClinicalTrials.gov ID
- NCT01996176
- Acronym / sponsor ID
- 61110-2071
- Conditions
- Sedentary Lifestyle
- Keywords
- Sedentary Lifestyle, Sedentary work, Office workers, Work, Workplace intervention, Sitting time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Nov 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 purpose of the study is to test an intervention aiming to reduce sitting time during work hours among office workers.
Expectations according to outcome measures: Sitting time reduced by 1 hour pr. day (primary). Number of prolonged periods reduced by 1 pr. day (primary). Number of breaks increased by 3 pr. day (primary). 20 % of participants report a reduction of musculoskeletal pain (secondary). A reduction in waist circumference of 1 cm (secondary). A reduction of 0.5 % in bodyfat (secondary).
Detailed description
Background and aim: Sedentary behaviour has substantial impact on wellbeing and health, e.g. on the risk of cardiovascular disease and premature death. These associations seem to apply as well to people who carry out the recommended 30 minutes of physical activity per day. However, studies indicate that the harmful effects can be reduced through breaking prolonged periods of sitting by intervals of standing or walking.
In total 46 % of Danes are working in occupations which are primarily sedentary and the workplace is thus a relevant setting to intervene against sedentary behaviour.
The aim of the study is to test an intervention towards sitting time among office workers. The intervention will target both total sitting time, breaks from sitting and prolonged periods of sitting.
Design: Cluster-randomized control study led at four different workplaces in Denmark and Greenland. Each workplace should consist of four independent sections (clusters) of about 25 people. Those four sections are randomized to intervention or control. A cluster design is used because the intervention will target the workplace setting as a whole, thus individuals within the same office has to be randomized to the same arm of the intervention.
Participants: 400 adults with sedentary office-based work. Subjects should understand Danish and be without disabilities or diseases affecting their ability to stand or walk.
Intervention: Participating clusters are randomized to
- Intervention: The intervention consists of four parts: Information, local adaptions, structural changes and individual support.
- Control: The control group will receive the intervention after the last follow-up (about 3 months later).
Methods: Data on sedentary behaviour is collected objectively using ActiGraph. Waist circumference and body fat percentage is measured. Questionnaire data will be collected on background variables, physical activity level, workplace conditions and well-being.
Data will be collected at baseline, and after 1 and 3 months.
Analysis will be carried out following the intention-to-treat principle comparing the intervention and control group. We will use several outcomes and include baseline values as a covariate (ANCOVA). In addition we will use multilevel models to account for the hierarchical structure of data (workplace, cluster and participant).
Process evaluation will be conducted by the use of qualitative interviews and questionnaire data and concern both adoptions, implementation and sustainability of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupIntervention group |
| Intervention control | Placebo comparator | Behavioral: Control groupControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Workplaces should be:
- Individuals should be:
Key exclusion criteria (1 listed)
- Not providing signed informed consent.
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 |
|---|---|---|
| Intervention groupThe intervention consists of four components, which as described below: 1. Information about sedentary behaviour and health: Delivered at the kick-off workshop, in a leaflet and the project website. 2. Local adaptation: Participants adapt the intervention to their personal and local environment setting individual and common goals. Local ambassadors are chosen and support from the management is emphasised. 3. Structural changes: Facilities for standing meetings, both formal and informal. Routes for walking meetings should be defined. 4. Individual support: At the kick-off workshop participants set individual goals. The individual can choose to receive e-mails and text messages (SMS)from the project. The individual receives a post-it block and a postcard to remind them of the project. | Behavioural | Intervention group |
| Control groupThe control group receives the intervention after the last follow-up, the exact time will be settled together with each workplace in the control group. | Behavioural | Intervention control |
Primary outcome
Reduced total time spend sitting at work
Time frame: 1 month
Method of measurement: ActiGraph, average daily sitting time during work hours.
Reduced number of prolonged siting periods (>30 min)
Time frame: 1 month
Method of measurement: ActiGraph, number of periods sitting >30 min.
Increased number of breaks from sitting time
Time frame: 1 month
Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking
6 secondary outcomes
Reduced musculoskeletal problems
Time frame: 1 month
Waist circumference
Time frame: 3 month
Body fat percentage
Time frame: 3 months
Reduced total time spend sitting at work
Time frame: 3 months
Reduced number of prolonged siting periods (>30 min)
Time frame: 3 months
Increased number of breaks from sitting time
Time frame: 3 months
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 3 Aug 2016.
- Results publication: PubMed 27094749Danquah IH, Kloster S, Holtermann A, Aadahl M, Bauman A, Ersboll AK, Tolstrup JS. Take a Stand!-a multi-component intervention aimed at reducing sitting time among office workers-a cluster randomized trial. Int J Epidemiol. 2017 Feb 1;46(1):128-140. doi: 10.1093/ije/dyw009.
- Derived from this study: PubMed 32770969Danquah IH, Kloster S, Tolstrup JS. "Oh-oh, the others are standing up... I better do the same". Mixed-method evaluation of the implementation process of 'Take a Stand!' - a cluster randomized controlled trial of a multicomponent intervention to reduce sitting time among office workers. BMC Public Health. 2020 Aug 8;20(1):1209. doi: 10.1186/s12889-020-09226-y.
- Derived from this study: PubMed 31626067Danquah IH, Tolstrup JS. Does It Work for Everyone? The Effect of the Take a Stand! Sitting-Intervention in Subgroups Defined by Socio-Demographic, Health-Related, Work-Related, and Psychosocial Factors. J Occup Environ Med. 2020 Jan;62(1):30-36. doi: 10.1097/JOM.0000000000001737.
- Derived from this study: PubMed 29897943Danquah IH, Pedersen ESL, Petersen CB, Aadahl M, Holtermann A, Tolstrup JS. Estimated impact of replacing sitting with standing at work on indicators of body composition: Cross-sectional and longitudinal findings using isotemporal substitution analysis on data from the Take a Stand! study. PLoS One. 2018 Jun 13;13(6):e0198000. doi: 10.1371/journal.pone.0198000. eCollection 2018.
- Derived from this study: PubMed 28368549Danquah IH, Kloster S, Holtermann A, Aadahl M, Tolstrup JS. Effects on musculoskeletal pain from "Take a Stand!" - a cluster-randomized controlled trial reducing sitting time among office workers. Scand J Work Environ Health. 2017 Jul 1;43(4):350-357. doi: 10.5271/sjweh.3639. Epub 2017 Apr 3.
- Derived from this study: PubMed 27914468Pedersen ES, Danquah IH, Petersen CB, Tolstrup JS. Intra-individual variability in day-to-day and month-to-month measurements of physical activity and sedentary behaviour at work and in leisure-time among Danish adults. BMC Public Health. 2016 Dec 3;16(1):1222. doi: 10.1186/s12889-016-3890-3.
Related trials for Sedentary Lifestyle
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
Recruiting
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
Sedentary Behavior, Acute Exercise
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged
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.
Janne S Tolstrup, MD, PhD study director
National Institute of Public Helath - University of Southern Denmark
Morten Grønbæk, MD PhD study chair
Centre for Intervention Research in HEalth Promotion and Disease Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Sedentary Lifestyle, run by University of Southern Denmark 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 12 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 3 Aug 2016. 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. Some participants in this study may receive a placebo. 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?
Reduced total time spend sitting at work (time frame: 1 month). 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 NCT01996176, which also lists 6 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 3 Aug 2016.