Is a multi-component intervention to reduce workplace sedentary behaviour acceptable and feasible to professional males?
| ISRCTN | ISRCTN11584275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11584275 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Study3 |
| Sponsor | Trinity College Dublin |
| Funder | Dean of the Faculty of Health Sciences, Trinity College Dublin |
- Submission date
- 07/10/2019
- Registration date
- 27/02/2020
- Last edited
- 28/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Methods: Male staff will be invited to take part. Primary outcomes are acceptability and feasibility and secondary outcomes include levels of sedentary behaviour, physical activity and work engagement.
Discussion: The findings are expected to inform the design of a future trial assessing the impact of an intervention using pedal machines and mHealth on short and longer-term occupational sedentary behaviour, work-related outcomes such as productivity and cost effectiveness.
Background and study aims
Prolonged sitting, an independent risk factor for increased death and disease, occurs mostly in the workplace. A recent study found that professional males have the longest workplace sitting times. Current evidence supports the use of multi-level interventions developed using participative approaches. This study aims to explore the acceptability and feasibility of a multi-level intervention to reduce workplace sitting.
Who can participate?
Males over 18 working in full-time sedentary and professional occupations
What does the study involve?
Two companies in Dublin, Ireland will take part in a cluster-randomised crossover pilot study, and office-based employees will be recruited. The components of the intervention target multiple levels of influence including organisational structures (via management consultation and recruitment), the physical work environment (via provision of an under-desk pedal machine), and individual determinants (via mHealth technology to support behaviour change techniques).
What are the possible benefits and risks of participating?
The benefits of the study are that the participants involved are contributing to the understanding of the acceptability and feasibility of an intervention to reduce sedentary behaviour in a workplace setting. People taking part will potentially reduce their daily sedentary behaviour and may thereby benefit from taking part in the study. There are minimal risks to taking part in this study.
Where is the study run from?
Public Health and Primary Care, Trinity College, Dublin
When is the study starting and how long is it expected to run for?
September 2019 to December 2019
Who is funding the study?
Dean of the Faculty of Health Sciences, Trinity College Dublin, Ireland
Who is the main contact?
Gail Nicolson
nicolsg@tcd.ie
Contact information
Scientific
Institute of Population Health
Tallaght Cross
Belgard Square West
Dublin
D24 DH74
Ireland
 ORCID ID |
0000-0002-5580-8635 |
|---|---|
| Phone | +353 1 8963739 |
| nicolsg@tcd.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised wait-list crossover design |
| Secondary study design | Randomised cross over trial |
| Participant information sheet | ISRCTN11584275_PIS_7Oct19.pdf |
| Scientific title | Pilot study to test the acceptability and feasibility of a theory-led multicomponent intervention to reduce sedentary behaviour in the workplace |
| Study objectives | A multicomponent theory-led intervention to reduce workplace sedenatry behaviour will be acceptable and feasible to professional males |
| Ethics approval(s) | Approved 18/09/2019, School of Medicine, Trinity College Dublin (Trinity College, 152-160 Pearse St, Dublin 2, Ireland; +353 1 896 1476; SOMREC@tcd.ie), ref: 20190702 |
| Health condition(s) or problem(s) studied | Reduction of risk factor sedenatry behaviour |
| Intervention | Two companies in Dublin, Ireland will take part in a cluster-randomised crossover pilot study, and office-based employees will be recruited and randomised to the control or the intervention arms. The components of the intervention target multiple levels of influence including organisational structures (via management consultation and recruitment), the physical work environment (via provision of an under-desk pedal machine), and individual determinants (via mHealth technology to support behaviour change techniques). The intervention comprises the provision of three components: 1. An under-desk pedal machine (DeskCycle2; 3D Innovations LLC., Greeley, CO, USA) 2. Garmin Forerunner 35 activity tracker 3. Access to a Garmin Connect application (app) and website (Garmin.com) The intervention will communicate the key message: “Cycle at work”. As highlighted from prior qualitative work determinants of goal-setting, self-monitoring, and social-comparison will be targeted using behaviour change techniques provided within the Garmin Connect app/website. Social-comparison, focusing on the masculine ideal and gender influences, such as individual or team-based competition will be used as a strategy in this study. This BCT will be targeted by the lead researcher creating a graph displaying each team’s participants’ weekly progress to enable social comparison. Participants will also be prompted to move every 60 minutes of accumulated sedentary behaviour using the move prompt on the Garmin Forerunner 35 wrist-worn device. Based on randomisation, either the first or fourth week will involve an active intervention to use an under-desk pedal machine to interrupt sedentary behaviour every hour and accumulate ≥30 minutes of light physical activity during the working day. There will be a washout period of one week between the intervention and control arms. In circumstances where a participant suffers any adverse outcome such as pain or discomfort while taking part in the study, they will be advised to immediately discontinue participation in the study. Randomisation Following baseline assessments, worksites will be randomised to either the intervention or control arms of the trial. Simple cluster randomisation will be determined by a statistician not associated with the project, who will use randomisation software to allocate each worksite to begin with either the intervention or control period. Allocation concealment Participants will not be advised of their group allocation until after baseline assessments have been made. The allocation concealment mechanism is important to reduce selection bias as it prevents foreknowledge of the period (control/intervention) in which participants are enrolling, which negatively affect recruitment. Blinding Due to the nature of the study, neither the participants nor research team will be blinded to group assignments. This lack of blinding introduces biases such as performance bias and outcome assessment bias. However, the use of objective and reliable measures of the secondary outcomes have been included in terms of measurement of the secondary outcomes which reduces the risks associated with a lack of blinding. Control arm Participants in the control arm will be informed that they have been randomised to a delayed intervention that will begin after three weeks, and will be asked to continue their normal workplace habits. All measures collected in the intervention group will be collected in the control arm. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The following outcomes will be assessed using a pen and paper questionnaire: |
| Key secondary outcome measure(s) |
Trial-related outcomes, assessed at baseline (before randomisation) and throughout the control and intervention periods: |
| Completion date | 20/12/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 30 |
| Total final enrolment | 22 |
| Key inclusion criteria | For participants 1. Male 2. Adult (i.e. 18 years and older) currently in full-time sedentary and professional occupation 3. Must be present for the duration of the study period 4. rPARQ will be used as a screening tool to ensure physical capability in the study. Individuals who answer no to all of the questions can be included in the study For worksites: 1. Professional company in the Dublin region with >5 male employees |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 18/09/2019 |
| Date of final enrolment | 11/10/2019 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D24 DH74
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/09/2021 | 09/09/2021 | Yes | No | |
| Protocol article | 10/11/2020 | 28/03/2023 | Yes | No | |
| Participant information sheet | 07/10/2019 | 27/02/2020 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 10/10/2019 | 27/02/2020 | No | No |
Additional files
- ISRCTN11584275_PIS_7Oct19.pdf
- uploaded 27/02/2020
- ISRCTN11584275_PROTOCOL_10Oct19.pdf
- uploaded 27/02/2020
Editorial Notes
28/03/2023: Publication reference added.
09/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
12/03/2020: Internal review.
27/02/2020: The following changes were made to the trial record:
1. The participant information sheet was uploaded as an additional file.
2. Uploaded protocol (not peer reviewed) as an additional file.
11/10/2019: Trial’s existence confirmed by Trinity College Dublin
