Condition category
Not Applicable
Date applied
20/12/2017
Date assigned
24/01/2018
Last edited
02/08/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People whose job primarily involves desk-based work spend a large proportion of their day sitting down at work and many of these individuals also sit a lot when they are at home. High levels of sitting have been linked to diseases such as type 2 diabetes, heart disease, and some cancers. This makes office workers an ‘at-risk’ group and who should be targeted for lifestyle intervention. An intervention has been developed called SMArT Work & Life that is designed to reduce the time that office workers spend sitting both inside and outside of work, emphasising a ‘whole-of-day’ preventive approach. Previous interventions have only focused on sitting at work. The SMArT Work & Life intervention involves multiple strategies to encourage a reduction in sitting time both in and out of the workplace, including strategies at the organisational level (e.g., provision for standing meetings, competitions), environmental level (e.g., relocating waste bins, printers) and group/individual level (education, goal setting, progress sessions, technology to track and provide feedback on their own sitting time). Workplace champions within local councils will deliver some of these strategies. This intervention will be delivered with and without the provision of a height adjustable workstation (allows the user to either stand or sit to work). This is important because although previous studies have achieved substantial reductions in workplace sitting, there are cost implications associated with these workstations so it is also important to also evaluate the impact of the intervention without this resource. The aim of this study is to test how effective the SMArT Work & Life intervention is, with and without a height-adjustable workstation.

Who can participate?
Office workers at local councils in Leicester and Manchester (UK)

What does the study involve?
Participating office groups are randomly allocated to one of three groups. One third of the office groups receive the intervention and a height-adjustable workstation, one third receive the intervention without a height-adjustable workstation, and one third act as a comparison group (carry on as normal). The research team measure how much office workers sit during the day (inside and outside of work) using a physical activity device worn on the thigh for 7 days. This monitor also provides an accurate measure of daily steps taken, time standing, and time being active. A number of measures of health are also taken, including weight, body fat, waist circumference, blood pressure, and a finger prick blood sample to analyse levels of blood sugar and cholesterol. Participants are asked to answer some questions about their health and work. These measurements are taken from all participants before the intervention begins and again at 3, 12 and 24 months after the first set of measurements. No interventions targeting sitting have followed participants over this length of time before. This will show whether participants maintain any behaviour change over the long term. The research team also talk to a number of office workers and workplace champions throughout the intervention delivery period about their experiences of the various strategies. The research team also test whether the intervention, with and without a height-adjustable desk, is value for money.

What are the possible benefits and risks of participating?
Benefits of taking part in this study include receiving feedback on health following a health assessment, receiving a £10 voucher for each assessment completed, and participants receiving intervention may experience health benefits and feel better. The research team are promoting regular posture change and not prolonged time in any one behaviour as this may lead to discomfort such as sore feet and lower back pain.

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

When is the study starting and how long is it expected to run for?
January 2018 to March 2021

Who is funding the study?
NIHR Public Health Research Programme (UK)

Who is the main contact?
Dr Charlotte Edwardson
ce95@le.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Edwardson

ORCID ID

http://orcid.org/0000-0001-6485-9330

Contact details

Diabetes Research Centre
University of Leicester
Leicester General Hospital
Leicester
LE54PW
United Kingdom
+44 (0)116 258 8577
ce95@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PHR 16/41/04

Study information

Scientific title

A three arm cluster randomised controlled trial to test the effectiveness and cost-effectiveness of the SMArT Work & Life intervention for reducing daily sitting time in office workers

Acronym

SMArT Work & Life

Study hypothesis

This study aims to determine the long term effectiveness and cost-effectiveness of the multi-component SMArT Work & Life intervention (when provided with and without a height-adjustable desk) for reducing daily sitting time in office workers compared with no intervention. If both interventions are shown to be effective, a secondary aim will be to determine if one intervention is more effective than the other.

Ethics approval

College of Life Sciences University of Leicester, 23/01/2018, ref: 14372-ce95-diabetesresearchcentre

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

General chronic disease prevention

Intervention

Clusters (different office spaces) will be randomised to receive one of the following conditions:
1. The multi-component SMArT Work & Life intervention with a height-adjustable workstation (intervention group 1)
2. The multi-component SMArT Work & Life intervention without a height-adjustable workstation (intervention group 2)
3. Usual practice (control condition)

The SMArT Work & Life intervention is a multicomponent intervention promoting positive changes in sitting (at work and in leisure time) and movement in office workers. The intervention includes organisation (manager buy in, workshop for managers), environmental (small scale restructuring in the office and at home, display of posters/reminders at work and at home) and individual (action planning, goal setting, free apps and prompts) and group (education workshops, regular coaching, competitions (colleagues and family) based components.

The research team will measure how much office workers sit during the day (inside and outside of work) using a physical activity device worn on the thigh for 7 days. This monitor also provides an accurate measure of daily steps taken, time standing, and time being active. We will also take a number of measures of health including weight, body fat, waist circumference, blood pressure, and take a finger prick blood sample to analyse levels of blood sugar and cholesterol. Participants will be asked to complete some questions about their health and work. These measurements will be taken from all participants before the intervention begins, and again at 3, 12 and 24 months after the first set of measurements. No interventions targeting sitting have followed participants over this length of time before. This will allow the research team to assess whether participants maintain any behaviour change over the long term. They will also talk to a number of office workers and workplace champions throughout the intervention delivery period about their experiences of the various strategies. The research team will also test whether our intervention, with and without a height-adjustable desk, is value for money.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Current primary outcome measures as of 02/08/2018:
Objectively measured daily sitting time, measured using activPAL at 24 months

Previous primary outcome measures:
Objectively measured sitting time, measured using activPAL at baseline, 3, 12 and 24 months

Secondary outcome measures

Current secondary outcome measures as of 02/08/2018:
1. Objectively measured sitting during work hours at 3, 12 and 24 months and daily sitting at 3 and 12 months
2. Objectively measured prolonged sitting time (daily and during work hours) at 3, 12 and 24 months
3. Objectively measured standing and movement (daily and during work hours), measured using activPAL and Axivity at baseline, 3, 12 and 24 months
4. Self-reported sitting, assessed using an adapted version of the Occupational Sitting and Physical Activity Questionnaire (Chau et al 2012) and an adapted version of the past day recall of sedentary time (PAST) questionnaire (Clarke et al 2015) at baseline, 3, 12 and 24 months
5. Adiposity (BMI, percent body fat [measured with body composition scales], waist circumference), blood pressure and blood markers [HbA1c, fasting glucose, cholesterol, triglycerides measured with finger prick blood samples]), measured at baseline, 3, 12 and 24 months
6. Fatigue (Fatigue Scale, Chalder 1993), stress (Perceived Stress Scale, Cohen et al 1983), anxiety and depression (Hospital Anxiety and Depression Scale (HADS), Zigmond et al, 1983), wellbeing (WHO-5 scale, Bech 1998), emotion (Positive and Negative Affect Schedule), work engagement (Utretcht Work Engagement Scale (UWES) Schaufeli et al, 2002), job performance (single-item 7-point likert scale, Bond et al 2001) and satisfaction (single-item 7-point likert scale, Nagy, 2002),occupational fatigue (Need for Recovery Scale), musculoskeletal issues (Standardised Nordic Questionnaire), presenteeism (Work Limitations Questionnaire, Lerner et al, 2001), work load and relations (Health and Safety Executive Management Standards Indicator Tool), sickness absence (self-reported and organisation records), and quality of life (EQ5D-5L, Herdman et al 2011), measured at baseline, 3, 12 and 24 months
7. Self-reported sleep (Pittsburgh Sleep Quality Index (PSQI), Buysse et al 1989) and objectively measured sleep (Axivity), measured at baseline, 3, 12 and 24 months
8. Social norms, cohesion and support for sitting less:
8.1. Social norms measured using eight items (e.g., 'My workplace is committed to supporting staff choices to stand or move more at work’) on a 5-point Likert (Dunstan et al 2013) measured at baseline, 3, 12 and 24 months
8.2. Social cohesion measured using the ‘social community’ sub-scale of the Copenhagen Psychosocial Questionnaire-II (CPS2) (Kristensen, 2001) measured at baseline, 3, 12 and 24 months
8.3. Support, measured using questions on support from the organisation, manager, colleagues and family for sitting less and moving more often will be adapted from Brackenridge et al 2016 measured at baseline, 3, 12 and 24 months
9. Self-reported health resource use (for cost-effectiveness analysis), measured at baseline, 3, 12 and 24 months
10. Process evaluation: attendance at workshops and coaching (workplace champion logs), opinions of, and engagement with different intervention components (questionnaires and focus groups), intervention fidelity and receipt (workshop and coaching observations), barriers and facilitators focus groups). These measures are ongoing throughout the study

Previous secondary outcome measures:
1. Objectively measured standing and movement, measured using activPAL and Axivity at baseline, 3, 12 and 24 months
2. Adiposity (BMI, percent body fat [measured with body composition scales], waist circumference), blood pressure and blood markers [HbA1c, cholesterol, triglycerides measured with finger prick blood samples]), measured at baseline, 3, 12 and 24 months
3. Fatigue (Fatigue Scale, Chalder 1993), stress (Perceived Stress Scale, Cohen et al 1983), anxiety and depression (Hospital Anxiety and Depression Scale (HADS), Zigmond et al, 1983), wellbeing (WHO-5 scale, Bech 1998), work engagement (Utretcht Work Engagement Scale (UWES) Schaufeli et al, 2002), job performance (single-item 7-point likert scale, Bond et al 2001) and satisfaction (single-item 7-point likert scale, Nagy, 2002), presenteeism (Work Limitations Questionnaire, Lerner et al, 2001), sickness absence (organisation records), and quality of life (EQ5D-5L, Herdman et al 2011), measured at baseline, 3, 12 and 24 months
4. Self-reported sleep (Pittsburgh Sleep Quality Index (PSQI), Buysse et al 1989) and objectively measured sleep (Axivity), measured at baseline, 3, 12 and 24 months
5. Self-reported health resource use (for cost-effectiveness analysis), measured at baseline, 3, 12 and 24 months
6. Process evaluation: attendance at workshops and coaching (workplace champion logs), opinions of, and engagement with different intervention components (questionnaires and focus groups), intervention fidelity and receipt (workshop and coaching observations), barriers and facilitators (focus groups). These measures are ongoing throughout the study

Overall trial start date

02/01/2018

Overall trial end date

01/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Office-based employees within the Councils in Leicester and Manchester
2. Spend the majority of their day sitting
3. They must also work for the council at least 3 days/week
4. Participant is willing and able to give informed consent to take part in the study
5. Able to walk without the use of an assistive device or requiring assistance form another person

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

660

Participant exclusion criteria

1. Currently pregnant
2. Currently using a height-adjustable workstation at their primary work location
3. Unable to communicate in English
4. Unable to provide written informed consent

Recruitment start date

01/04/2018

Recruitment end date

07/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetes Research Centre (University of Leicester)
LE5 4PW
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Research Governance Office
Fielding Johnson Building
Leicester
LE1 7RH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Public Health Research Programme

Alternative name(s)

NIHR Public Health Research Programme, PHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The full trial protocol will be published in 2018 in an open access journal. The main results paper will be published within one year of completing the trial.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/08/2018: The following changes were made to the trial record: 1. Ethics approval details added. 2. The primary and secondary outcome measures were updated. 3. The recruitment end date was changed from 31/07/2018 to 07/09/2018.