Take a Stand! - an Intervention to Reduce Occupational Sitting Time
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|ClinicalTrials.gov Identifier: NCT01996176|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : August 3, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Sedentary Lifestyle||Behavioral: Intervention group Behavioral: Control group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||337 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Take a Stand ! - a Cluster Randomized Controlled Intervention Study at Four Office-based Workplaces Aiming to Reduce Occupational Sitting Time|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Intervention group
Behavioral: Intervention group
The intervention consists of four components, which as described below:
Placebo Comparator: Intervention control
Behavioral: Control group
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.
- 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
- Reduced musculoskeletal problems [ Time Frame: 1 month ]Method of measurement: Questionnaire
- Waist circumference [ Time Frame: 3 month ]Method of measurement: Waist circumference measurement
- Body fat percentage [ Time Frame: 3 months ]Method of measurement: Body fat % is measured using a segmental body composition analyser
- Reduced total time spend sitting at work [ Time Frame: 3 months ]Method of measurement: ActiGraph, average daily sitting time during work hours
- Reduced number of prolonged siting periods (>30 min) [ Time Frame: 3 months ]Method of measurement: ActiGraph, number of periods sitting >30 min
- Increased number of breaks from sitting time [ Time Frame: 3 months ]Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996176
|National Institute of Public Health - University of Southern Denmark|
|Copenhagen, Denmark, 1353|
|Study Director:||Janne S Tolstrup, MD, PhD||National Institute of Public Helath - University of Southern Denmark|
|Study Chair:||Morten Grønbæk, MD PhD||Centre for Intervention Research in HEalth Promotion and Disease Prevention|