Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2015
Date assigned
02/02/2015
Last edited
10/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Excessive sitting is bad for health. Modern society provides many opportunities to sit and we have engineered much physical activity out of our lives. Previous generations sat less because they engaged in less TV viewing, no computer use, less car travel, and less work-related sitting. Changing sitting time by providing an environment that makes sitting less likely and standing/moving easier could have significant health benefits. A good place to start this cultural shift is in the workplace because many jobs are desk-bound. The aim in this study is to assess the effectiveness of providing sit-stand desks that allow workers to stand or sit while working at a computer.

Who can participate?
NHS workforce, aged 18–70 years old

What does the study involve?
Self-contained buildings or blocks will be randomly assigned to the intervention or control arm. People in the intervention arm will receive height-adjustable sit-stand desks and behaviour-change techniques and strategies to help reduce sedentary behaviour. People in the control arm will not receive any of the behaviour-change intervention strategies nor the sit-stand desk. We will assess, after 3 months, 6 months and 12 months, whether the study reduced sitting time and improved employee health, job satisfaction and engagement, job performance, absenteeism, what worked well or not, and what can be done better in the future to sustain changes in behaviour.

What are the possible benefits and risks of participating?
Benefits not provided at time of registration. Risks not provided at time of registration.

Where is the study run from?
University Hospitals of Leicester NHS Trust (UK)

When is the study starting and how long is it expected to run for?
October 2014 to January 2018

Who is funding the study?
Department of Health (UK)

Who is the main contact?
Dr Ben Jackson
b.r.jackson@lboro.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Ben Jackson

ORCID ID

http://orcid.org/0000-0001-8888-4725

Contact details

School of Sport
Exercise and Health Sciences
Loughborough University
Loughborough
LE11 3PU
United Kingdom
+44 (0)1509 223087
b.r.jackson@lboro.ac.uk

Type

Scientific

Additional contact

Dr Fehmidah Munir

ORCID ID

Contact details

School of Sport
Exercise and Health Sciences
Loughborough University
Loughborough
LE11 3TU
United Kingdom
+44 (0)1509 228 228
f.munir@lboro.ac.uk

Type

Public

Additional contact

Dr Sophie O'Connell

ORCID ID

Contact details

Leicester Diabetes Centre
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 8571
sophie.oconnell@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of a behaviour-change intervention with sit-stand desks on NHS desk-based staff’s sitting time and associated factors (SMArT Work): a cluster randomised controlled trial

Acronym

SMArT

Study hypothesis

The provision of sit-to-stand workstations and supporting strategies aimed at promoting
reduced sitting will increase standing and movement over the long term (12 months) in office-based National Health Service (NHS) staff, reduce absenteeism, improve job performance, increase job satisfaction and work engagement, reduce occupational fatigue, improve musculoskeletal health, improve mood/affective states and improve quality of life.

Ethics approval

Ethics Approvals (Human Participants) Sub-Committee, Loughborough University (UK), 03/09/2014, Ref: SSEHS 1751

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Sedentary behaviour and associated conditions (e.g., musculoskeletal health)

Intervention

1. A cluster randomised controlled trial will be undertaken at three University Hospitals of Leicester (UK; Leicester General Hospital, Leicester Royal Infirmary and Glenfield General Hospital), with the unit of randomisation being at the level of each self-contained building or block.
2. The intervention arm will receive height-adjustable sit-stand desks and an array of behaviour-change techniques and strategies to help reduce sedentary behaviour (e.g., prompts, self-monitoring and education) identified using the Behaviour Change Wheel (Michie et al, 2011).
3. Control arm will not receive any of the behaviour-change intervention strategies nor the sit-stand desk; control sites will have limited opportunity to substantially increase their standing activity during working hours

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Long-term (12 months) changes: objectively measured sedentary behaviour at baseline, 3 months, 6 months, and 12 months using self-monitoring devices (including LumoBack, GeneActive and ActivPAL) worn by participants

Secondary outcome measures

1. Change in sedentary behaviour over the short term (3 months and 6 months) measured objectively
2. Absenteeism (using employment records)
3. Job performance
4. Job satisfaction
5. Work engagement
6. Occupational fatigue
7. Musculoskeletal health
8. Mood/affective states
9. Quality of life (self assessment)
10. Cognitive ability (using experimental measures such as the Hopkins Verbal Learning Test, the Digit-Symbol Subsitition Test, and Stroop Test)

Secondary outcomes will be measured at baseline, 3 months, 6 months, and 12 months after the intervention
using a range of validated psychometric measures (occupational fatigue, musculoskeletal health, mood/affective states and quality of life), self-report (job performance, job satisfaction and work engagement), employer records (absenteeism) and experimental cognitive tasks (cognitive ability).

Overall trial start date

22/10/2014

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Health professionals
2. Healthy volunteers
3. Age 18–70 years old
4. Able to speak and read English
5. Willing and able to give full informed consent for themselves
6. NHS-office based, predominantly sedentary staff employed by the University Hospitals of Leicester NHS Trust

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Exact cluster sizes are to be calculated after the first phase of the project (focus groups, intervention development). Assuming a standard deviation for sitting time of 60 minutes, an intraclass correlation of 0.05, and an average of 13 participants per office cluster (ranging from 3 to 50, based on clerical office data from our local partners) and informed by active discussion with potential sites within the University Hospitals of Leicester NHS Trust), we calculate that we need 14 units per study arm to detect a clinically relevant decrease in sitting time of 60 minutes with 90% power at the 5% significance level. Consistent with best practice, this sample size allows for 2 units to dropout of the study. At the individual level, allowing for a possible 25% dropout from those undertaking outcome measures during the study, we require 238 participants in total.

Participant exclusion criteria

1. Younger than 18 years old or older than 70 years old
2. Unable to give informed consent
3. NHS staff not predominantly in office-based jobs

Recruitment start date

01/02/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Trust
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

Loughborough University

Sponsor details

Epinal Way
Loughborough
LE11 3TU
United Kingdom
+44 (0)1509 222 222
ssehs-enquiries@lboro.ac.uk

Sponsor type

University/education

Website

www.lboro.ac.uk

Funders

Funder type

Government

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. We will likely publish our findings from the development phase of our study (focus groups to aid in the development of the intervention) at around month 12 of the study, whereas primary and secondary outcomes will be published at the end of the intervention phase.
2. We will also present our findings at academic conferences.

Intention to publish date

31/10/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26646026

Publication citations

Additional files

Editorial Notes