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Trial record 1 of 1 for:    NCT01996176
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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
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
Ida Høgstedt Danquah, University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date August 3, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2013)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Reduced total time spend sitting at work [ Time Frame: 1 month ]
    Method of measurement: ActiGraph, average daily sitting time during work hours. Expectation: Sitting time reduced by 1 hour pr. day.
  • Reduced number of prolonged siting periods (>30 min) [ Time Frame: 1 month ]
    Method of measurement: ActiGraph, number of periods sitting >30 min. Expectation: Number of prolonged periods reduced by 1 pr. day.
  • Increased number of breaks from sitting time [ Time Frame: 1 month ]
    Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking Expectation: Number of breaks increased by 3 pr. day
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Reduced musculoskeletal problems [ Time Frame: 1 month ]
    Method of measurement: Questionnaire Expectation : 20 % of participants report a reduction of musculoskeletal pain.
  • Waist circumference [ Time Frame: 3 month ]
    Method of measurement: Waist circumference measurement Expectation : A reduction in waist circumference of 1 cm
  • Body fat percentage [ Time Frame: 3 months ]
    Method of measurement: Body fat % is measured using a segmental body composition analyser Expectation : A reduction of 0.5 % in bodyfat
  • Reduced total time spend sitting at work [ Time Frame: 3 months ]
    Method of measurement: ActiGraph, average daily sitting time during work hours Expectation: Sitting time reduced by 1 hour pr. day.
  • Reduced number of prolonged siting periods (>30 min) [ Time Frame: 3 months ]
    Method of measurement: ActiGraph, number of periods sitting >30 min Expectation: Number of prolonged periods reduced by 1 pr. day.
  • Increased number of breaks from sitting time [ Time Frame: 3 months ]
    Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking Expectation: Number of breaks increased by 3 pr. day
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Take a Stand! - an Intervention to Reduce Occupational Sitting Time
Official Title  ICMJE Take a Stand ! - a Cluster Randomized Controlled Intervention Study at Four Office-based Workplaces Aiming to Reduce Occupational Sitting Time
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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sedentary Lifestyle
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention group
    Intervention group
    Intervention: Behavioral: Intervention group
  • Placebo Comparator: Intervention control
    Control group
    Intervention: Behavioral: Control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2014)
337
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
400
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01996176
Other Study ID Numbers  ICMJE 61110-2071
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ida Høgstedt Danquah, University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE TRYG Foundation
Investigators  ICMJE
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
PRS Account University of Southern Denmark
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP