Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000682347
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
12/05/2017
Date last updated
24/07/2020
Date data sharing statement initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation trial of the BeUpstanding Champion Toolkit in desk-based workers: evaluation of uptake, implementation, effectiveness, and costs.
Scientific title
National implementation trial of an evidence-informed workplace sitting reduction intervention in desk-based workers: evaluation of uptake, implementation, effectiveness and costs.
Secondary ID [1] 291828 0
None
Universal Trial Number (UTN)
U1111-1196-1886
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 303072 0
Poor mental health 303073 0
Musculoskeletal Disorders 303074 0
Condition category
Condition code
Cardiovascular 302529 302529 0 0
Normal development and function of the cardiovascular system
Mental Health 302530 302530 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 302531 302531 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the BeUpstanding program. This 3-month program is designed to support workplaces to sit less through raising awareness, building culture, and creating a supportive environment. The intervention is designed to be run by a workplace champion (a workplace champion can be any staff member but it is recommended that they have the ability to talk to general staff and management). Via the boarding page of the BeUpstanding website, a staff member who has decided to be a workplace champion can sign up to the free online BeUpstanding Champion Toolkit. (There is no selection criteria to become a workplace champion).

Once signed up, workplace champions are guided step-by-step through program delivery and evaluation via the online BeUpstanding Champion Toolkit. There are five steps (Step 1: Gaining support from management; Step 2: Needs assessment; Step 3: Preparing for the program; Step 4: Putting the program into practice and 5: Evaluation) that are self-paced. Although it is recommended that the workplace champion complete the five steps over a 3 month period. Each of the steps have accompanying multi-media resources including tips sheets, information videos, email guides and templates and posters.

The intervention is designed to be tailored to each work team, with work teams deciding on the strategies that they will implement as a team to stand up, sit less, and move more. Example strategies include moving bins/printers to a central location and holding regular walking and standing meetings.
Intervention code [1] 297940 0
Behaviour
Intervention code [2] 297941 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301948 0
Adoption: number of work teams registered. Data for the adoption outcomes will be collected at the Registration point via the registration survey (no. of work teams), and the champion survey (characteristics) via the online website. These surveys have been developed for this study.
Timepoint [1] 301948 0
Length of the intervention trial (~2.5 years)
Primary outcome [2] 301949 0
Effectiveness: self-reported workplace sitting time via the online staff survey that collects sitting time per day at work over the past week. We are using a validated tool the Occupational Sitting & Physical Activity Questionnaire (OSPAQ) as part of the staff survey to collect this outcome. (Clark BK et al. Validity of self-reported measures of workplace sitting time and breaks in sitting time.Med Sci Sports Exerc. 2011 Oct;43(10):1907-12).
Timepoint [2] 301949 0
The primary timepoint is the end of the program. Data for the effectiveness outcomes will be collected at baseline, at the end of the program, and at 9 months post the program.
Primary outcome [3] 301950 0
Implementation: completion of Toolkit steps/ components collected via implementation checks and website analytics (ie. website analytics will allow tracking of downloads of resources and page views of each of the steps).
Timepoint [3] 301950 0
End of program
Secondary outcome [1] 334335 0
Characteristics of participating work teams and champions will be collected via the registration survey and champion profile survey. Workplace characteristics collected include: size, location, sector (i.e. blue or white collar). Workplace champion characteristics collected include: age, sex, job role, time at employer, previous experience in health promotion programs. The registration survey and champion profile survey have been designed for this study.
Timepoint [1] 334335 0
Baseline
Secondary outcome [2] 334336 0
Barriers and enablers to implementation will be collected from champions via qualitative interviews and online surveys during the program, at the end of the program, and 9 months following the program.. Focus groups in a sub-sample of staff will be used to understand the processes and outcomes associated with the program.
Timepoint [2] 334336 0
During the program, end of program, 9 months post end of program.
Secondary outcome [3] 334337 0
Activity promoting policies and practices collected via the Workplace Audit tool to be completed by workplace champions
Timepoint [3] 334337 0
Baseline, end of program, 9 months post end of program
Secondary outcome [4] 334338 0
Workplace time spent in other activities including standing, walking and heavy labour per day over the past week collected via the online staff survey. We are using a validated tool the Occupational Sitting & Physical Activity Questionnaire (OSPAQ) as part of the staff survey to collect this outcome. Information on prolonged sitting and breaks in sitting time, activity preferences, and physical activity (walking, moderate and vigorous intensity activity) will also be collected via the online staff survey.
Timepoint [4] 334338 0
Baseline, end of program, 9 months post end of program
Secondary outcome [5] 334339 0
Perceived barriers and enablers for staff to sit less and move more will be collected via the online staff survey and qualitative focus groups with staff. Questions have been designed for this study.
Timepoint [5] 334339 0
Baseline, end of program, 9 months post end of program
Secondary outcome [6] 334340 0
Perceived organisational norms regarding sitting less and moving more will be collected via the staff survey. Questions have been designed for this study.
Timepoint [6] 334340 0
Baseline, end of program, 9 months post end of program
Secondary outcome [7] 334341 0
Work performance indicators (productivity, engagement, satisfaction) will be collected via the online staff survey.
Timepoint [7] 334341 0
Baseline, end of program, 9 months post end of program
Secondary outcome [8] 334342 0
Perceived health status: Musculoskeletal symptoms in the last week will be measured using 3-items to assess the level of discomfort in (1) upper back, neck, shoulders, elbows, wrists or hands; (2) lower back; and, (3) hips, thighs, buttocks, knees, ankles or feet. Each item will be assessed on an 11-point scale, from 0 (no discomfort at all) to 10 (severe discomfort). Present rating of physical and mental health will be each asked on by a single item question.. Participants will also be asked to rate the extent in the last week at work that they felt stressed, alert, energetic, and creative.
Timepoint [8] 334342 0
Baseline, end of program, 9 months post end of program
Secondary outcome [9] 334658 0
Costs - an economic evaluation will be undertaken from a societal perspective, but with the major focus on a workplace perspective (covering both costs and benefits to employers and employees). The primary economic analysis will comprise analysis of costs, outcomes, and the relationship between costs and outcomes. Included costs will relate to workplace recruitment (promotion events, social media, newsletters, etc.) and intervention delivery (such as the staff information and brainstorming workshop, posters, conduct of toolkit components, champion time, meetings of staff wellbeing committees, maintenance of website, etc.). Data on the strategies adopted by individual work teams (including estimated costs) will be collected via the workplace audit at three and 12 months. All resources will be valued in Australian dollars for the 2019 reference year. The economic outcomes for the implementation study will be presented as total costs, average costs per work team, and per work team of different size. Analysis of who incurs the associated costs (government, employers, individual employees, research team) will be undertaken to assess intervention affordability and sustainability.
Timepoint [9] 334658 0
3 years
Secondary outcome [10] 368265 0
Reach: measured through the number of staff identified by the champion as being in the work team; the number (%) participating in staff surveys; and characteristics of staff taking part in the evaluation
Timepoint [10] 368265 0
End of program
Secondary outcome [11] 368266 0
Use of activity promoting strategies: Participants will be provided with a menu of common strategies that have been used to promote standing up, sitting less and moving more in the desk-based environment inclusive of those promoted in the BeUpstanding resources
Timepoint [11] 368266 0
Baseline, end of program, 9 months after end of program
Secondary outcome [12] 368267 0
Program satisfaction and feedback: Feedback on the BeUpstanding program will be sought from both champions and staff via quantitative (fixed-option questions) and qualitative (open ended questions; qualitative interviews).
Timepoint [12] 368267 0
End of program

Eligibility
Key inclusion criteria
Based on data reported by the champion as part of the online registration process, eligible work teams will be those with: a minimum of five staff; job roles or tasks that predominantly involve desk-based work; and, a staff member willing to perform the duties of a workplace champion. For large organisations, including those located across numerous sites, multiple work teams from the one organisation will be eligible to participate. Once eligibility is confirmed, a unique password will be allocated to allow the champion access to the BeUpstanding Champion Toolkit and associated resources, and enable data to be identified by work team. All employees within a participating work team will be invited by the champion to participate in the program and its evaluation.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No workplace champion.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
1/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
896
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296327 0
Government body
Name [1] 296327 0
The University of Queensland
Country [1] 296327 0
Australia
Funding source category [2] 302252 0
Government body
Name [2] 302252 0
National Health and Medical Research Council of Australia
Country [2] 302252 0
Australia
Primary sponsor type
Individual
Name
Genevieve Healy - The University of Queensland
Address
School of Public Health
The University of Queensland
Herston Rd, Herston
Queensland, Australia, 4006
Country
Australia
Secondary sponsor category [1] 295255 0
None
Name [1] 295255 0
Address [1] 295255 0
Country [1] 295255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297557 0
University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 297557 0
Ethics committee country [1] 297557 0
Australia
Date submitted for ethics approval [1] 297557 0
Approval date [1] 297557 0
09/01/2017
Ethics approval number [1] 297557 0
2016001743

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74430 0
A/Prof Genevieve N. Healy
Address 74430 0
School of Public Health
The University of Queensland
Herston Rd, Herston
Brisbane, Queensland, 4006
Country 74430 0
Australia
Phone 74430 0
+61-7-3365 5528
Fax 74430 0
Email 74430 0
[email protected]
Contact person for public queries
Name 74431 0
Genevieve N. Healy
Address 74431 0
School of Public Health
The University of Queensland
Herston Rd, Herston
Brisbane, Queensland, 4006
Country 74431 0
Australia
Phone 74431 0
+61-7-3365 5528
Fax 74431 0
Email 74431 0
[email protected]
Contact person for scientific queries
Name 74432 0
Genevieve N. Healy
Address 74432 0
School of Public Health
The University of Queensland
Herston Rd, Herston
Brisbane, Queensland, 4006
Country 74432 0
Australia
Phone 74432 0
+61-7-3365 5528
Fax 74432 0
Email 74432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of ethical consent.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSupporting workers to sit less and move more through the web-based beupstanding program: Protocol for a single-arm, repeated measures implementation study.2020https://dx.doi.org/10.2196/15756
N.B. These documents automatically identified may not have been verified by the study sponsor.