Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000252617
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
10/03/2014
Date last updated
10/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of organisational support vs. organisational plus technology support for reducing prolonged sitting in the office workplace.
Scientific title
Comparison of organisational support vs. organisational plus technology support for reducing prolonged sitting in office workers.
Secondary ID [1] 284176 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged sitting time 291275 0
Condition category
Condition code
Public Health 291628 291628 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The organisational plus technology support intervention lasts for 12 weeks and consists of the following components: (1) A participant information session (30-45 mins) delivered by UQ research staff on the background of the study, and details of the assessment and participation process. (2) An electronic information booklet with details about: the study rationale (i.e. evidence on prolonged sitting and detrimental health outcomes) and purpose; general guidelines on optimal workplace activity; specific behaviour change strategies related to the key intervention messages; and, general information about the study procedure and timeline. (3) Fortnightly emails created with and distributed by the wellness manager to participants about the benefits of standing up, sitting less and moving more. (4) PLUS Technology support: participants will wear a LUMOback posture sensor device around their waist for 12 weeks. The LUMOback sensor (8.5mm thin) gently vibrates when the individual sits or stands in a poor posture (i.e. slouches). It tracks movements wirelessly and sends this information via Bluetooth connection to a mobile device, which provides real-time feedback, and long-term monitoring of sitting, standing, walking (including number of steps), and running behaviours, as well as sleep time.
Intervention code [1] 288874 0
Behaviour
Intervention code [2] 288875 0
Prevention
Intervention code [3] 288876 0
Treatment: Other
Comparator / control treatment
The organisational support only intervention consists of the same elements as above minus the wearing of the LUMOback (component 4).
Control group
Active

Outcomes
Primary outcome [1] 291580 0
Workplace sitting time - assessed objectively using an ActivPAL inclinometer
Timepoint [1] 291580 0
Baseline, 12 weeks, 12 months
Primary outcome [2] 291581 0
Daily sitting time - assessed objectively using an ActivPAL inclinometer
Timepoint [2] 291581 0
Baseline, 12 weeks, 12 months
Secondary outcome [1] 307112 0
Standing and moving time (a) at the workplace and (b) across the day - assessed objectively using an ActivPAL inclinometer
Timepoint [1] 307112 0
Baseline, 12 weeks, 12 months
Secondary outcome [2] 307113 0
Reliability and validity of the LUMOback - assessed throughout the 12 weeks using data collected from the LUMOback posture sensor device. Assessed at 12 weeks comparing data from the ActivPAL inclinometer and data from the LUMOback posture sensor device.
Timepoint [2] 307113 0
Ongoing throughout the 12 weeks
Secondary outcome [3] 307114 0
Predictors of change - assessed by self-report questionnaire, including individual and workplace level factors
Timepoint [3] 307114 0
Baseline, 12 weeks, 12 months

Eligibility
Key inclusion criteria
Office-based workers, working at least 0.6 full time equivalent and ambulatory (able to walk 10 metres)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, allergies to adhesive tape (Tegaderm or Hyperfix required for assessments), a planned absence from work for longer than two weeks during the study period, and employees who are already receiving a physical activity/environmental intervention (such as sit-to-stand desks)

In addition participants in the LUMOback device group will need access to a Bluetooth Low-Energy (BLE) compatible device such as an iPhone 4S or above or an Android device with Android version 4.3 or above

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)
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
Active, not recruiting
Date of first participant enrolment
Anticipated
17/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 288811 0
Charities/Societies/Foundations
Name [1] 288811 0
Heart Foundation Vanguard Grant
Country [1] 288811 0
Australia
Funding source category [2] 288812 0
Commercial sector/Industry
Name [2] 288812 0
Lend Lease
Country [2] 288812 0
Australia
Funding source category [3] 291168 0
Commercial sector/Industry
Name [3] 291168 0
Office Ergonomics Research Committee
Country [3] 291168 0
United States of America
Primary sponsor type
University
Name
Cancer Prevention Research Centre, The University of Queensland
Address
Cancer Prevention Research Centre,
Level 4, School of Population Health,
The University of Queensland,
Herston Rd, Herston Qld 4006
Country
Australia
Secondary sponsor category [1] 287506 0
None
Name [1] 287506 0
Address [1] 287506 0
Country [1] 287506 0
Other collaborator category [1] 277850 0
Other
Name [1] 277850 0
Baker IDI Heart and Diabetes Institute
Address [1] 277850 0
75 Commercial Rd
Melbourne VIC 3004
Country [1] 277850 0
Australia
Other collaborator category [2] 277851 0
University
Name [2] 277851 0
School of Physiotherapy and Exercise Science, Curtin University
Address [2] 277851 0
School of Physiotherapy and Exercise Science,
Building 408, Curtin University,
Kent Street, Bentley WA 6102
Country [2] 277851 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 46602 0
Dr Genevieve Healy
Address 46602 0
Cancer Prevention Research Centre
Level 4, School of Population Health,
The University of Queensland,
Herston Rd, Herston Qld 4006
Country 46602 0
Australia
Phone 46602 0
+61 7 3365 5039
Fax 46602 0
Email 46602 0
[email protected]
Contact person for public queries
Name 46603 0
Genevieve Healy
Address 46603 0
Cancer Prevention Research Centre
Level 4, School of Population Health,
The University of Queensland,
Herston Rd, Herston Qld 4006
Country 46603 0
Australia
Phone 46603 0
+61 7 3365 5039
Fax 46603 0
Email 46603 0
[email protected]
Contact person for scientific queries
Name 46604 0
Genevieve Healy
Address 46604 0
Cancer Prevention Research Centre
Level 4, School of Population Health,
The University of Queensland,
Herston Rd, Herston Qld 4006
Country 46604 0
Australia
Phone 46604 0
+61 7 3365 5039
Fax 46604 0
Email 46604 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://ijbnpa.biomedcentral.com/articles/10.1186/... [More Details]

Documents added automatically
No additional documents have been identified.