MenNCT03781453
POWERPLAY Phase 2: Development and Evaluation in Male-dominated Workplaces
A study testing POWERPLAY in people with Men and Health Behavior, run by Joan Bottorff at 3 sites in Canada.
Trial summary
With funding from the Alberta Ministry of Labour (Grant #095244772), a program called POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be evaluated in workplaces in Alberta. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Men, Health Behavior, Mental Health Wellness 1
- What is being tested?
- POWERPLAY
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 498 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Apr 2019to 7 Feb 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men employed in participating workplaces, full-time or part-time, in any position within the organizations.
Who cannot join
- Although females may participate in the POWERPLAY program and surveys, they will not be included in the evaluation.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Shell Canada Ltd (Scotford Site)
Ft Saskatchewan, Alberta, T8L 4A4
PeroxyChem
Prince George, British Columbia, V2N 2S6
Roper Ventures
Rocky Mountain House, Alberta, T4C 1B2
About this study
Official title: POWERPLAY: Building Employee Health and Safety Through Prevention in Male-dominated Workplaces
With funding from the Alberta Ministry of Labour (Grant #095244772), a program called POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be evaluated in workplaces in Alberta.
Read the detailed description
In year 1, this project includes two main research components: 1. A pragmatic (real world) study will be conducted employing a quasi-experimental (not a randomized controlled trial), before and after design to evaluate the effectiveness of the POWERPLAY program. 2. An integrated set of research activities (systematic review, sleep behaviors and consultation groups) will be used to provide the basis for developing recommendations for promoting sleep health in male-dominated workplaces, and inform the development and testing of a POWERPLAY sleep health module (REST-UP) in Year 2.
- Being tested
- POWERPLAY
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWERPLAYBehavioural
Employees from participating worksites will be invited to completed surveys prior to and following implementation of a workplace wellness program (called "POWERPLAY")
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate to Vigorous Physical Activity
Minutes of Moderate to Vigorous physical activity will be assessed using self-report at baseline and follow-up using the Godin Leisure-Time Exercise Questionnaire (Godin \& Shephard, 1985). The Godin Leisure-Time Exercise Questionnaire contains three self-report questions that assess both the average frequency and duration (in minutes) of mild, moderate, and vigorous activities during free time over a typical week. Frequency and minutes are multiplied to obtain minutes per week (range from 0 and up). Weekly moderate and vigorous activity minutes will be summed and compared from baseline to follow-up, with higher scores indicating more activity. In addition, a cutoff of 150 minutes in 7 days will be used to classify participants as meeting or not meeting Canadian guidelines for physical activity at baseline and follow-up.
Measured: 4 months
Mental Wellness
Mental well-being will be assessed using the well validated Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) (Haver, Akerjordet, Caputi, Furunes, \& Magee, 2015; Tennant et al., 2007) at baseline and follow-up. Participants respond to 7-items (e.g., "I've been feeling optimistic about the future") on a 5-point Likert scale ranging from none of the time (1) to all of the time (5), with higher scores reflecting greater mental well-being. The SWEMWBS is scored by summing the score for each of the seven items (possible range 7-35).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Apr 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Quasi-experimental, pre-post study design
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joan Bottorff
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Athabasca University, University of Alberta, Newcastle University, University of Melboune, University of Technology, Sydney
- Responsible party
- Sponsor-investigator, Joan Bottorff, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781453
- Sponsor's protocol ID
- 095244772
- Status last verified
- Apr 2020
- First submitted
- 18 Dec 2018
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POWERPLAY: Building Employee Health and Safety Through Prevention in Male-dominated Workplaces
- ClinicalTrials.gov ID
- NCT03781453
- Acronym / sponsor ID
- 095244772
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Joan BottorffUniversity, hospital or other
- Collaborators
- University of British Columbia, Athabasca University, University of Alberta, Newcastle University, University of Melboune, University of Technology, Sydney
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With funding from the Alberta Ministry of Labour (Grant #095244772), a program called POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be evaluated in workplaces in Alberta.
Detailed description
In year 1, this project includes two main research components: 1. A pragmatic (real world) study will be conducted employing a quasi-experimental (not a randomized controlled trial), before and after design to evaluate the effectiveness of the POWERPLAY program. 2. An integrated set of research activities (systematic review, sleep behaviors and consultation groups) will be used to provide the basis for developing recommendations for promoting sleep health in male-dominated workplaces, and inform the development and testing of a POWERPLAY sleep health module (REST-UP) in Year 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Quasi-experimental, pre-post study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men employed in participating workplaces, full-time or part-time, in any position within the organizations.
Key exclusion criteria (1 listed)
- Although females may participate in the POWERPLAY program and surveys, they will not be included in the evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POWERPLAYEmployees from participating worksites will be invited to completed surveys prior to and following implementation of a workplace wellness program (called "POWERPLAY") | Behavioural | – |
Primary outcome
Moderate to Vigorous Physical Activity
Time frame: 4 months
Minutes of Moderate to Vigorous physical activity will be assessed using self-report at baseline and follow-up using the Godin Leisure-Time Exercise Questionnaire (Godin \& Shephard, 1985). The Godin Leisure-Time Exercise Questionnaire contains three self-report questions that assess both the average frequency and duration (in minutes) of mild, moderate, and vigorous activities during free time over a typical week. Frequency and minutes are multiplied to obtain minutes per week (range from 0 and up). Weekly moderate and vigorous activity minutes will be summed and compared from baseline to follow-up, with higher scores indicating more activity. In addition, a cutoff of 150 minutes in 7 days will be used to classify participants as meeting or not meeting Canadian guidelines for physical activity at baseline and follow-up.
Mental Wellness
Time frame: 4 months
Mental well-being will be assessed using the well validated Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) (Haver, Akerjordet, Caputi, Furunes, \& Magee, 2015; Tennant et al., 2007) at baseline and follow-up. Participants respond to 7-items (e.g., "I've been feeling optimistic about the future") on a 5-point Likert scale ranging from none of the time (1) to all of the time (5), with higher scores reflecting greater mental well-being. The SWEMWBS is scored by summing the score for each of the seven items (possible range 7-35).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- POWERPLAY program websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWERPLAY in people with Men and Health Behavior, run by Joan Bottorff at 3 sites in Canada.
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 1 inclusion and 1 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Moderate to Vigorous Physical Activity (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2020.