Clinical trial NCT01996176: Take a Stand! - an Intervention to Reduce Occupational Sitting Time
Official title: Take a Stand ! - a Cluster Randomized Controlled Intervention Study at Four Office-based Workplaces Aiming to Reduce Occupational Sitting Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Sedentary Lifestyle
Sedentary work
Office workers
Work
Workplace intervention
Sitting time
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2013-11-27
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Reduced total time spend sitting at work
timeFrame: 1 month
measure: Reduced number of prolonged siting periods (>30 min)
timeFrame: 1 month
measure: Increased number of breaks from sitting time
timeFrame: 1 month
Secondary outcomes:
measure: Reduced musculoskeletal problems
timeFrame: 1 month
measure: Waist circumference
timeFrame: 3 month
measure: Body fat percentage
timeFrame: 3 months
measure: Reduced total time spend sitting at work
timeFrame: 3 months
measure: Reduced number of prolonged siting periods (>30 min)
timeFrame: 3 months
measure: Increased number of breaks from sitting time
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public Health - University of Southern Denmark
Study officials:
affiliation: National Institute of Public Helath - University of Southern Denmark
name: Janne S Tolstrup, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centre for Intervention Research in HEalth Promotion and Disease Prevention
name: Morten Grønbæk, MD PhD
role: STUDY_CHAIR
References:
citation: Danquah IH, Kloster S, Holtermann A, Aadahl M, Bauman A, Ersboll 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. 2017 Feb 1;46(1):128-140. doi: 10.1093/ije/dyw009.
citation: Danquah IH, Kloster S, Tolstrup JS. "Oh-oh, the others are standing up... I better do the same". Mixed-method evaluation of the implementation process of 'Take a Stand!' - a cluster randomized controlled trial of a multicomponent intervention to reduce sitting time among office workers. BMC Public Health. 2020 Aug 8;20(1):1209. doi: 10.1186/s12889-020-09226-y.
citation: Danquah IH, Tolstrup JS. Does It Work for Everyone? The Effect of the Take a Stand! Sitting-Intervention in Subgroups Defined by Socio-Demographic, Health-Related, Work-Related, and Psychosocial Factors. J Occup Environ Med. 2020 Jan;62(1):30-36. doi: 10.1097/JOM.0000000000001737.
citation: Danquah IH, Pedersen ESL, Petersen CB, Aadahl M, Holtermann A, Tolstrup JS. Estimated impact of replacing sitting with standing at work on indicators of body composition: Cross-sectional and longitudinal findings using isotemporal substitution analysis on data from the Take a Stand! study. PLoS One. 2018 Jun 13;13(6):e0198000. doi: 10.1371/journal.pone.0198000. eCollection 2018.
citation: Danquah IH, Kloster S, Holtermann A, Aadahl M, Tolstrup JS. Effects on musculoskeletal pain from "Take a Stand!" - a cluster-randomized controlled trial reducing sitting time among office workers. Scand J Work Environ Health. 2017 Jul 1;43(4):350-357. doi: 10.5271/sjweh.3639. Epub 2017 Apr 3.
citation: Pedersen ES, Danquah IH, Petersen CB, Tolstrup JS. Intra-individual variability in day-to-day and month-to-month measurements of physical activity and sedentary behaviour at work and in leisure-time among Danish adults. BMC Public Health. 2016 Dec 3;16(1):1222. doi: 10.1186/s12889-016-3890-3.