Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Take a Stand! - an Intervention to Reduce Occupational Sitting Time

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01996176
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
Ida Høgstedt Danquah, University of Southern Denmark

Brief 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. 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

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

  1. Intervention: The intervention consists of four parts: Information, local adaptions, structural changes and individual support.
  2. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Intervention group
Behavioral: Intervention group

The 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.

Placebo Comparator: Intervention control
Control group
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.




Primary Outcome Measures :
  1. Reduced total time spend sitting at work [ Time Frame: 1 month ]
    Method of measurement: ActiGraph, average daily sitting time during work hours.

  2. Reduced number of prolonged siting periods (>30 min) [ Time Frame: 1 month ]
    Method of measurement: ActiGraph, number of periods sitting >30 min.

  3. Increased number of breaks from sitting time [ Time Frame: 1 month ]
    Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking


Secondary Outcome Measures :
  1. Reduced musculoskeletal problems [ Time Frame: 1 month ]
    Method of measurement: Questionnaire

  2. Waist circumference [ Time Frame: 3 month ]
    Method of measurement: Waist circumference measurement

  3. Body fat percentage [ Time Frame: 3 months ]
    Method of measurement: Body fat % is measured using a segmental body composition analyser

  4. Reduced total time spend sitting at work [ Time Frame: 3 months ]
    Method of measurement: ActiGraph, average daily sitting time during work hours

  5. Reduced number of prolonged siting periods (>30 min) [ Time Frame: 3 months ]
    Method of measurement: ActiGraph, number of periods sitting >30 min

  6. Increased number of breaks from sitting time [ Time Frame: 3 months ]
    Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Individuals should be:

    • 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)

Exclusion Criteria:

  • Not providing signed informed consent.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
National Institute of Public Health - University of Southern Denmark
Copenhagen, Denmark, 1353
Sponsors and Collaborators
University of Southern Denmark
TRYG Foundation
Investigators
Layout table for investigator information
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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Ida Høgstedt Danquah, Research Assistant, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01996176    
Other Study ID Numbers: 61110-2071
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Keywords provided by Ida Høgstedt Danquah, University of Southern Denmark:
Sedentary Lifestyle
Sedentary work
Office workers
Work
Workplace intervention
Sitting time