Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000514404
Ethics application status
Approved
Date submitted
16/04/2016
Date registered
21/04/2016
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity levels in Sydney Local Health District (SLHD) allied health professionals.
Scientific title
Physical activity levels of allied health professionals working within the Sydney Local Health District (SLHD).
Secondary ID [1] 288992 0
None
Universal Trial Number (UTN)
U1111-1181-8964
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 298397 0
Condition category
Condition code
Public Health 298496 298496 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
7
Target follow-up type
Days
Description of intervention(s) / exposure
This is an observational study in allied health professionals so there is no intervention. The participants' levels of physical activity will be monitored for seven days using a physical activity monitor (ActiGraph GT1M) which will be worn during waking hours.


Intervention code [1] 294479 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297986 0
Number of steps per day measured using an activity monitor (Actigraph (GT1M) which the participant will wear for a 7 day period.
Timepoint [1] 297986 0
End of the 7 day wear of the activity monitor.
Primary outcome [2] 298047 0
Amount of time in moderate to vigorous physical activity during work time and non-work time. Moderate-to-vigorous physical activity is defined as 3 metabolic equivalents (METS) or more.
Timepoint [2] 298047 0
End of the 7 day wear of the activity monitor.
Secondary outcome [1] 322838 0
Physical activity levels measured by the Active Australia Questionnaire

Timepoint [1] 322838 0
This questionnaire will be administered to participants at the initial assessment prior to the 7 day wear of the activity monitor.
Secondary outcome [2] 323006 0
Physical activity levels measured by the International Physical Activity Questionnaire (IPAQ)
Timepoint [2] 323006 0
This questionnaire will be administered to participants at the initial assessment prior to the 7 day wear of the activity monitor.
Secondary outcome [3] 323007 0
Physical activity levels measured by theOccupational Sitting and Physical Activity questionnaire (OSPAQ)
Timepoint [3] 323007 0
This questionnaire will be administered to participants at the initial assessment prior to the 7 day wear of the activity monitor.

Eligibility
Key inclusion criteria
Allied health professionals (aged 20 - 70 years including physiotherapists, speech pathologists, occupational therapists, psychologists, dietitians, pharmacists, radiographers, social workers, podiatrists, and orthotists) employed in the Sydney Local Health District (SLHD) (i.e. Royal Prince Alfred Hospital, Concord Repatriation General Hospital, Balmain hospital, Canterbury hospital) and who are working within their usual professional capacity will be invited to participate in this study. They will be eligible for study inclusion if they are working within their usual professional capacity during the data collection period (7 days).
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria – those employees who are unable to perform their usual work duties over the course of the study period.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be expressed as means and standard deviations. Independent groups t-tests will be performed to compare allied health groups/disciplines. Significance will be set a p<0.05 with a power at 0.80.
Comparisons will also be made between physical activity levels achieved by the allied health professionals and the Australian physical activity guidelines .
For the sample size, if there is truly no difference in average step count per day between the allied health professionals and the recommended guideline of 10,000 steps/day, 112 participants are required to be 80% sure that the lower limit of a one-sided 95% confidence interval will be above the non-inferiority limit of 1000 steps per day (Tudor-locke et al, 2001)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2016
Actual
25/04/2016
Date of last participant enrolment
Anticipated
27/05/2019
Actual
12/12/2017
Date of last data collection
Anticipated
Actual
19/12/2017
Sample size
Target
129
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5613 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 5614 0
Balmain Hospital - Balmain
Recruitment hospital [3] 5615 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 5616 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 13059 0
2050 - Camperdown
Recruitment postcode(s) [2] 13060 0
2041 - Balmain
Recruitment postcode(s) [3] 13061 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [4] 13062 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 293353 0
Hospital
Name [1] 293353 0
Royal Prince Alfred Hospital
Country [1] 293353 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital / Sydney Local Health District
Address
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 292179 0
University
Name [1] 292179 0
University of Sydney
Address [1] 292179 0
The University of Sydney
NSW 2006
Country [1] 292179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294821 0
Research Ethics and Governance Office SLHD
Ethics committee address [1] 294821 0
Ethics committee country [1] 294821 0
Australia
Date submitted for ethics approval [1] 294821 0
18/11/2015
Approval date [1] 294821 0
15/02/2016
Ethics approval number [1] 294821 0
X15-0435 & HREC/15/RPAH/580

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

Contacts
Principal investigator
Name 65142 0
Prof Jennifer Alison
Address 65142 0
Faculty of Health Sciences University of Sydney
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 65142 0
Australia
Phone 65142 0
+61 414 300 416
Fax 65142 0
+612 9351 9601
Email 65142 0
[email protected]
Contact person for public queries
Name 65143 0
Jennifer Alison
Address 65143 0
Faculty of Health Sciences University of Sydney
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 65143 0
Australia
Phone 65143 0
+61 414 300 416
Fax 65143 0
+612 9351 9601
Email 65143 0
[email protected]
Contact person for scientific queries
Name 65144 0
Jennifer Alison
Address 65144 0
Faculty of Health Sciences University of Sydney
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 65144 0
Australia
Phone 65144 0
+61 414 300 416
Fax 65144 0
+612 9351 9601
Email 65144 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.