Clinical Trials Directory

Trials / Completed

CompletedNCT02496507

A Mixed-methods Evaluation of Sit-stand Workstations in an Office Setting

A Mixed-methods Evaluation of Sit-stand Workstations in an Office Setting: a Randomised Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
Liverpool John Moores University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to investigate whether a device that allows office workers to sit or stand whilst working can reduce their sitting time at work and improve their health over 8 weeks.

Detailed description

Study design Treatment arms in this two-arm parallel-group randomised controlled trial (RCT) included a sit-stand workstation intervention group (each participant received a sit-stand workstation) and a control group (usual practice). Recruitment \- Organisation level Office workers from one organisation were targeted by the research team in August-September 2013. Consent was sought from 11 departmental managers for employee recruitment, installation of sit-stand workstations, study contact and laboratory visits during work time. Departments were located across four buildings with varying office layout (open-plan, individual offices or a combination). Employees within the targeted departments were predominantly administrative staff. \- Individual level Via an email from the research team, all employees in consenting departments received an overview of the study and participant information sheet, and were invited to a study information session (two sessions were organised per department). Employees were given 2 weeks to express interest. Interested employees were screened for eligibility using stated criteria by the research team via telephone. If inclusion criteria were met, written informed consent was obtained and baseline assessments scheduled. There was no racial or gender bias in the selection of participants. Group assignment and Intervention Following baseline assessments, participants were assigned by one member of the research team to a treatment arm using a randomised block design and random number table. Departments served as blocks and participants within departments were randomly assigned at the individual-level to an arm. Assignment of individual participants within each department alternated between arms (i.e. intervention, control, intervention, control…). Data collection At baseline, 4 weeks (mid-intervention) and 8 weeks (end-intervention), participants' office-based behaviours were assessed via ecological momentary assessment (EMA) diaries. At baseline and 8 weeks, participants attended University laboratories in the morning for individual assessments of other stated outcomes. Prior to laboratory visits, participants were required to fast for a minimum of 8 hours, avoid the consumption of alcohol for 12 hours, and avoid strenuous exercise for 24 hours. Sample size Allowing for small drop out, the study aimed to recruit 25 participants per arm, and retain 23 participants per arm. A sample size of 23 per arm was chosen a priori to achieve 90% power (alpha 5%; two-tailed) to detect a minimum difference of 60 minutes/8-hour workday between arms for workplace sitting time (primary outcome: expected SD of 60 minutes/day). Data collection for vascular and metabolic outcomes would provide effect size estimates for power calculations in subsequent trials. Statistical analyses * Data was analysed using the Statistical Package for the Social Sciences (SPSS) version 22 (IBM, New York, USA) with the alpha level set at p≤0.05. Intervention effects were compared at 4 weeks (sitting, standing and walking) and 8 weeks (all outcomes) from baseline using analysis of covariance (ANCOVA). The variable change score (4 or 8 weeks minus baseline) was the dependent variable, with intervention arm (control vs intervention) the independent variable. In all analyses, covariates were the baseline value for the variable to control for any imbalances at baseline. Anthropometric, sociodemographic, work-related and office-environment characteristics were tested as potential confounders for all outcomes. Confounders were entered as covariates if significant associations (p≤0.05) were observed with changes in an outcome and the effect on the mean difference between groups exceeded 20%. For changes in sitting, standing and walking time, baseline values of the other two behaviours were tested as potential confounders, though no effects on the mean difference between groups exceeded 20%. Adjusted change scores and 95% confidence intervals (CIs) for the difference in change between groups are presented unless stated otherwise. Acceptability and feasibility data are reported as medians and quartiles. * Missing data and Intention-to-treat analysis Due to participant withdrawal, lost EMA diaries or the inability to conduct assessments, data were missing for all outcomes. Accordingly, a per-protocol analysis was conducted and participants were excluded from analyses for outcomes they were missing data for. For workplace sitting, standing and walking, the per-protocol analysis was compared with an intention-to-treat analysis, as a sensitivity analysis. To treat missing data, the fully conditional imputation technique and ten imputation sets were used due to a low rate of missing data. Imputation was based on all 47 randomized participants. * Minimum important differences analysis Inferential statistics were ran using minimum clinically important difference principles, described elsewhere. Briefly, this approach makes inferences based on meaningful magnitudes and is recommended alongside hypothesis testing. A spreadsheet computed the quantitative and qualitative probability that the true effects were beneficial, trivial or harmful, after the outcome statistic, its p value, and the smallest/minimal important difference was entered. Minimum important differences for sitting and standing were 60 minutes/day, and for walking 10 minutes/day. Minimum important differences for other outcomes were determined through a distribution-based method as a Cohen's d (standardized difference between change scores between groups) of 0.2 between-subjects standard deviations (SDs). The SD of pooled baseline data was used to negate the possibility of individual differences from the intervention influencing the SD at 8 weeks. For each effect at 8 weeks, quantitative probabilities for benefit, trivial and harm, and qualitative descriptors are reported. Effects were interpreted as unclear if probabilities for benefit and harm were \>5%.

Conditions

Interventions

TypeNameDescription
OTHERSit-stand workstationAfter baseline, each participant had a sit-stand workstation installed on their existing workplace desk. A single or dual monitor WorkFit-A with Worksurface+ workstation was installed, dependent on the number of monitors. The monitor(s) and keyboard were housed on the workstation and the workstation could be quickly raised up and down by hand to enable seated or standing work. Participants were not prescribed an amount of time to use the station. Ergotron Ltd provided and installed the workstations and gave participants basic face-to-face training and ergonomic information on correct use. Participants received a web link to manufacturer ergonomic guidelines via an email from the research team. After end-intervention data collection, manufacturer staff uninstalled the workstations.

Timeline

Start date
2013-08-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2015-07-14
Last updated
2015-07-14

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02496507. Inclusion in this directory is not an endorsement.