AzTrials
AzTrials

Physical ActivityNCT02496507

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

A study testing Sit-stand workstation in people with Physical Activity, run by Liverpool John Moores University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Sit-stand workstation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2013to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • full-time member of staff
  • access to a work telephone and desktop computer with internet

Who cannot join

  • have a cardiovascular or metabolic disease
  • taking any medication
  • pregnant
  • planned absence > 1 week during the trial

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Liverpool John Moores University

    Liverpool, Merseyside, L3 2AT

Other trials in United Kingdom

About this study

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

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.

Read the 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%.
Being tested
Sit-stand workstation
Keywords
sitting, intervention, desks, workplace, cardiovascular, metabolic, qualitative, randomised controlled trial
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sit-stand workstationOther

    After 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.

Study groups in NCT02496507
Study groupRoleWhat they receive
InterventionExperimentalProvision of a sit-stand workstation for use at work.
Receives: Other: Sit-stand workstation
ControlNo interventionParticipants were asked to maintain their normal work practices and received no intervention. Participants were offered the opportunity to have a sit-stand workstation installed for 8 weeks after all data collection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in workplace sitting time at 4 and 8 weeks

    An ecological momentary assessment (EMA) diary assessed time spent sitting, standing, walking and in other activities during work hours over 5 days (Monday-Friday). At 15-minute intervals participants used a diary to record their main behaviour in response to the question: "What are you doing right now?" The options were sitting, standing, walking or other. If other was selected, participants were instructed to write the activity they were doing.

    Time spent in each behaviour per day was estimated by multiplying the frequency of recordings by 15. A diary day was considered valid if data entries were provided for ≥75% of time spent at work. Time spent in each behaviour was calculated for each valid day and means were calculated from valid days. To be retained for analyses, participants had to provide ≥2 valid days at each time point.

    Measured: Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks)

Secondary outcomes (15)
  1. Change from baseline in workplace standing time at 4 and 8 weeks

    An ecological momentary assessment (EMA) diary assessed time spent sitting, standing, walking and in other activities during work hours over 5 days (Monday-Friday). At 15-minute intervals participants used a diary to record their main behaviour in response to the question: "What are you doing right now?" The options were sitting, standing, walking or other. If other was selected, participants were instructed to write the activity they were doing.

    Time spent in each behaviour per day was estimated by multiplying the frequency of recordings by 15. A diary day was considered valid if data entries were provided for ≥75% of time spent at work. Time spent in each behaviour was calculated for each valid day and means were calculated from valid days. To be retained for analyses, participants had to provide ≥2 valid days at each time point.

    Measured: Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks)

  2. Change from baseline in workplace walking time at 4 and 8 weeks

    An ecological momentary assessment (EMA) diary assessed time spent sitting, standing, walking and in other activities during work hours over 5 days (Monday-Friday). At 15-minute intervals participants used a diary to record their main behaviour in response to the question: "What are you doing right now?" The options were sitting, standing, walking or other. If other was selected, participants were instructed to write the activity they were doing.

    Time spent in each behaviour per day was estimated by multiplying the frequency of recordings by 15. A diary day was considered valid if data entries were provided for ≥75% of time spent at work. Time spent in each behaviour was calculated for each valid day and means were calculated from valid days. To be retained for analyses, participants had to provide ≥2 valid days at each time point.

    Measured: Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks)

  3. Change from baseline in flow-mediated dilation (FMD) at 8 weeks

    A measure of endothelial dysfunction, which is an early and integral manifestation of atherosclerotic disease.

    Measured: Baseline (week 0), End-intervention (8 weeks)

  4. Change from baseline in carotid artery intima media thickness (cIMT) at 8 weeks

    An early subclinical marker of structural atherosclerosis.

    Measured: Baseline (week 0), End-intervention (8 weeks)

  5. Change from baseline in plasma glucose at 8 weeks

    Assessed via standard venepuncture technique

    Measured: Baseline (week 0), End-intervention (8 weeks)

  6. Change from baseline in triglycerides at 8 weeks

    Assessed via standard venepuncture technique

    Measured: Baseline (week 0), End-intervention (8 weeks)

  7. Change from baseline in total cholesterol at 8 weeks

    Assessed via standard venepuncture technique

    Measured: Baseline (week 0), End-intervention (8 weeks)

  8. Change from baseline in musculoskeletal discomfort or pain at the neck/shoulders at 8 weeks

    Assessed via an adapted questionnaire from a previous trial

    Measured: Baseline (week 0), End-intervention (8 weeks)

  9. Change from baseline in musculoskeletal discomfort or pain at the lower back at 8 weeks

    Assessed via an adapted questionnaire from a previous trial

    Measured: Baseline (week 0), End-intervention (8 weeks)

  10. Change from baseline in musculoskeletal discomfort or pain at the upper back at 8 weeks

    Assessed via an adapted questionnaire from a previous trial

    Measured: Baseline (week 0), End-intervention (8 weeks)

  11. Change from baseline in body mass index at 8 weeks

    Calculated from assessment of stature and body mass

    Measured: Baseline (week 0), End-intervention (8 weeks)

  12. Acceptability of the sit-stand workstation

    (Intervention arm only) Assessed via a 19-item five-point Likert scale (1 strongly disagree, 2 disagree, 3 neutral, 4 agree, 5 strongly disagree) adapted from a previous trial.

    Measured: End-intervention (8 weeks)

  13. Feasibility of the sit-stand workstation

    (Intervention arm only) Assessed via a 19-item five-point Likert scale (1 strongly disagree, 2 disagree, 3 neutral, 4 agree, 5 strongly disagree) adapted from a previous trial.

    Measured: End-intervention (8 weeks)

  14. Acceptability of the sit-stand workstation

    (Intervention arm only) Interviews

    Measured: End-intervention (8 weeks)

  15. Feasibility of the sit-stand workstation

    (Intervention arm only) Interviews

    Measured: End-intervention (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02496507
Sponsor's protocol ID
15-SPS-Graves1
Status last verified
Jul 2015
First submitted
8 Jul 2015
Last updated
14 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Batterham AM, Hopkins WG. Making meaningful inferences about magnitudes. Int J Sports Physiol Perform. 2006 Mar;1(1):50-7.

    PubMed 19114737
  • Hopkins WG, Marshall SW, Batterham AM, Hanin J. Progressive statistics for studies in sports medicine and exercise science. Med Sci Sports Exerc. 2009 Jan;41(1):3-13. doi: 10.1249/MSS.0b013e31818cb278.

    PubMed 19092709
  • E F Graves L, C Murphy R, Shepherd SO, Cabot J, Hopkins ND. Evaluation of sit-stand workstations in an office setting: a randomised controlled trial. BMC Public Health. 2015 Nov 19;15:1145. doi: 10.1186/s12889-015-2469-8.

    PubMed 26584856

Questions about this trial

What is this clinical trial studying?

A study testing Sit-stand workstation in people with Physical Activity, run by Liverpool John Moores University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in workplace sitting time at 4 and 8 weeks (time frame: Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02496507, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in