Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000742976
Ethics application status
Approved
Date submitted
13/07/2011
Date registered
15/07/2011
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Stand Up Victoria: a trial to determine whether environmental modification and behavioural counselling can lead to reductions in workplace sitting time in office workers
Scientific title
In office workers, does environmental modification combined with behavioural counselling, compared to no change, lead to reductions in workplace sitting time.
Secondary ID [1] 262625 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged workplace sedentary (sitting) time 261348 0
Condition category
Condition code
Public Health 259507 259507 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention lasts for 3 months and consists of four distinct components: (1) an initial Unit Representatives Consultation involving a broad range of Unit Representatives. This consultation will include an explanation of the role of organisational, environmental, and individual factors in determining occupational sitting time. Furthermore, unit representatives will be asked to workshop appropriate strategies to reduce sitting time at their workplace; (2) a whole-of-workplace Information Session. The session will (a) outline recent research findings on the health consequences of too much sitting, (b) provide a summary of what emerged in the Unit Representatives Consultation and (c) provide summary feedback of sedentary and activity time generated from the baseline assessment; (3) Environmental Modification involving installation of sit-to-stand workstations for individual participants. The sit-stand workstation allows the employee to easily alternate their working posture between sitting and standing; and (4) Support for Behavioural Change which includes (a) an initial one-on-one individual consultation with project staff (i.e. health promotion and allied health professionals) trained in motivational interviewing techniques and (b) four telephone support calls over 3 months in support of initiation and maintenance of sedentary behaviour change.
Intervention code [1] 264200 0
Behaviour
Intervention code [2] 264202 0
Treatment: Other
Intervention code [3] 264203 0
Prevention
Comparator / control treatment
Participants within the control workplaces will be advised that the aims of the study are to examine the patterns of physical activity and sedentary time in office workers, and how these may be associated with cardio-metabolic and anthropometric markers. The control group will receive the same assessments as the intervention group at the same time-points.
Control group
Active

Outcomes
Primary outcome [1] 262312 0
A 30 minutes/day reduction in objectively-assessed (using physical activity monitors) workplace sedentary time
Timepoint [1] 262312 0
baseline, 3 months, 9 months
Primary outcome [2] 269211 0
An increase of 5 breaks/day in workplace sedentary time, objectively measured using physical activity monitors
Timepoint [2] 269211 0
baseline, 3 months, 9 months
Secondary outcome [1] 273507 0
Objectively measured non-workplace sedentary time and physical activity time. Sitting time and physical activity levels will be measured using an ActiGraph accelerometer (instensity of activity) and an activPAL inclinometer (posture)
Timepoint [1] 273507 0
baseline, 3 months, 9 months
Secondary outcome [2] 273508 0
Examine the effect of the intervention on cardiometabolic markers of health and disease including:
1) body composition inclusing waist circumference, BMI, and percent fat mass using bioimpedance analysis
2) fasting blood levels of glucose, insulin and lipids analysed by an accredited pathology laboratory
3) blood pressure will be measured by an Omron automatic blood pressure monitor
Timepoint [2] 273508 0
baseline, 3 months, 9 months
Secondary outcome [3] 279130 0
Explore workplace and individual-level mediators (how did the intervention work?) and moderators (for whom did it work?) of change using a specially formulated questionnaire
Timepoint [3] 279130 0
baseline, 3 months, 9 months

Eligibility
Key inclusion criteria
Working at least 0.6 FTE; Aged 18-65 years; Speaking English; Having designated access to a telephone, internet and desk within the workplace
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Being pregnant; Being non-ambulatory and/or have a planned absence from work for > 2 weeks or a planned relocation to another worksite during the 3-month intervention period.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This trial involves cluster randomisation of whole workplaces to the Intervention or Control arms, rather than individual partcipants. Stratification will be based on workplace size (small: 20-50 employees, large: 51-70 employees) in order to obtain balanced numbers of sites and employees in the Intervention and the Control arms. Sites will be enrolled and then randomised until the required sample size is reached.

Allocation concealment is done via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2011
Actual
30/04/2012
Date of last participant enrolment
Anticipated
Actual
19/11/2013
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
320
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 264645 0
Government body
Name [1] 264645 0
National Health and Medical Research Council
Country [1] 264645 0
Australia
Funding source category [2] 267448 0
Government body
Name [2] 267448 0
VicHealth
Country [2] 267448 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 266503 0
None
Name [1] 266503 0
Address [1] 266503 0
Country [1] 266503 0
Other collaborator category [1] 252108 0
University
Name [1] 252108 0
University of Queensland
Address [1] 252108 0
Level 2
Public Health Building
School Of Population Health
University of Queensland
Herston Road
Herston
QLD 4006
Country [1] 252108 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290774 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 290774 0
Ethics committee country [1] 290774 0
Australia
Date submitted for ethics approval [1] 290774 0
24/02/2011
Approval date [1] 290774 0
06/04/2011
Ethics approval number [1] 290774 0

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

Contacts
Principal investigator
Name 32333 0
A/Prof David Dunstan
Address 32333 0
Baker IDI Heart and Diabetes Institute Level 4 99 Commerical Rd Melbourne, Victoria Australia 3004
Country 32333 0
Australia
Phone 32333 0
+61 3 8532 1873
Fax 32333 0
Email 32333 0
David.Dunstan@bakeridi.edu.au
Contact person for public queries
Name 15580 0
David Dunstan
Address 15580 0
Baker IDI Heart and Diabetes Institute
Level 4
99 Commerical Rd
Melbourne, Victoria
Australia 3004
Country 15580 0
Australia
Phone 15580 0
+61 3 8532 1873
Fax 15580 0
Email 15580 0
David.Dunstan@bakeridi.edu.au
Contact person for scientific queries
Name 6508 0
David Dunstan
Address 6508 0
Baker IDI Heart and Diabetes Institute
Level 4
99 Commerical Rd
Melbourne, Victoria
Australia 3004
Country 6508 0
Australia
Phone 6508 0
+61 3 8532 1873
Fax 6508 0
Email 6508 0
David.Dunstan@bakeridi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseOffice workers' objectively assessed total and prolonged sitting time: Individual-level correlates and worksite variations.2016https://dx.doi.org/10.1016/j.pmedr.2016.06.011
EmbaseReducing occupational sitting: Workers' perspectives on participation in a multi-component intervention.2017https://dx.doi.org/10.1186/s12966-017-0530-y
N.B. These documents automatically identified may not have been verified by the study sponsor.