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

August 2, 2016 updated by: Ida Høgstedt Danquah, University of Southern Denmark

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

337

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1353
        • National Institute of Public Health - University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced total time spend sitting at work
Time Frame: 1 month
Method of measurement: ActiGraph, average daily sitting time during work hours.
1 month
Reduced number of prolonged siting periods (>30 min)
Time Frame: 1 month
Method of measurement: ActiGraph, number of periods sitting >30 min.
1 month
Increased number of breaks from sitting time
Time Frame: 1 month
Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced musculoskeletal problems
Time Frame: 1 month
Method of measurement: Questionnaire
1 month
Waist circumference
Time Frame: 3 month
Method of measurement: Waist circumference measurement
3 month
Body fat percentage
Time Frame: 3 months
Method of measurement: Body fat % is measured using a segmental body composition analyser
3 months
Reduced total time spend sitting at work
Time Frame: 3 months
Method of measurement: ActiGraph, average daily sitting time during work hours
3 months
Reduced number of prolonged siting periods (>30 min)
Time Frame: 3 months
Method of measurement: ActiGraph, number of periods sitting >30 min
3 months
Increased number of breaks from sitting time
Time Frame: 3 months
Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

TRYG Foundation

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 61110-2071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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