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

Sedentary Lifestyle Clinical Trial

Official title:

Take a Stand ! - a Cluster Randomized Controlled Intervention Study at Four Office-based Workplaces Aiming to Reduce Occupational Sitting Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996176
• Other study ID #: 61110-2071
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: August 2, 2016
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Intervention group
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 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.

Locations

Country	Name	City	State
Denmark	National Institute of Public Health - University of Southern Denmark	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	TRYG Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Danquah IH, Kloster S, Holtermann A, Aadahl M, Bauman A, Ersbøll 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. 2016 Apr 19. pii: dyw009. [Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced total time spend sitting at work	Method of measurement: ActiGraph, average daily sitting time during work hours.	1 month	No
Primary	Reduced number of prolonged siting periods (>30 min)	Method of measurement: ActiGraph, number of periods sitting >30 min.	1 month	No
Primary	Increased number of breaks from sitting time	Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking	1 month	No
Secondary	Reduced musculoskeletal problems	Method of measurement: Questionnaire	1 month	No
Secondary	Waist circumference	Method of measurement: Waist circumference measurement	3 month	No
Secondary	Body fat percentage	Method of measurement: Body fat % is measured using a segmental body composition analyser	3 months	No
Secondary	Reduced total time spend sitting at work	Method of measurement: ActiGraph, average daily sitting time during work hours	3 months	No
Secondary	Reduced number of prolonged siting periods (>30 min)	Method of measurement: ActiGraph, number of periods sitting >30 min	3 months	No
Secondary	Increased number of breaks from sitting time	Method of measurement: ActiGraph, number of postural shifts from sitting to standing/walking	3 months	No

External Links

•   Project web-page