ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1181-8964

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Physical inactivity

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Number of steps per day measured using an activity monitor (Actigraph (GT1M) which the participant will wear for a 7 day period.

Timepoint [1]

End of the 7 day wear of the activity monitor.

Primary outcome [2]

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]

End of the 7 day wear of the activity monitor.

Secondary outcome [1]

Physical activity levels measured by the Active Australia Questionnaire

Timepoint [1]

This questionnaire will be administered to participants at the initial assessment prior to the 7 day wear of the activity monitor.

Secondary outcome [2]

Physical activity levels measured by the International Physical Activity Questionnaire (IPAQ)

Timepoint [2]

This questionnaire will be administered to participants at the initial assessment prior to the 7 day wear of the activity monitor.

Secondary outcome [3]

Physical activity levels measured by theOccupational Sitting and Physical Activity questionnaire (OSPAQ)

Timepoint [3]

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]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Balmain Hospital - Balmain

Recruitment hospital [3]

Concord Repatriation Hospital - Concord

Recruitment hospital [4]

Canterbury Hospital - Campsie

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2041 - Balmain

Recruitment postcode(s) [3]

2139 - Concord Repatriation Hospital

Recruitment postcode(s) [4]

2194 - Campsie

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital

Address [1]

Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050

Country [1]

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]

University

Name [1]

University of Sydney

Address [1]

The University of Sydney
NSW 2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics and Governance Office SLHD

Ethics committee address [1]

Research Ethics and Governance Office 
Royal Prince Alfred Hospital 
Missenden Rd
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/11/2015

Approval date [1]

15/02/2016

Ethics approval number [1]

X15-0435 & HREC/15/RPAH/580

Summary

Brief summary

Physical inactivity has been linked to increases in morbidity and mortality, with major implications for the general health. Participation in sufficient physical activity levels throughout the day is associated with significant health benefits.  The study aims to evaluate the physical activity levels of allied health staff working in Sydney Local Health District (SLHD) to determine the contribution of workplace to daily physical activity levels.
Specifically, the aims of the study are to:
1.	Quantify the number of steps taken and the amount of moderate to vigorous physical activity of allied health professionals during work time and outside work time. 
2.	Determine how the physical activity levels of allied health professionals employed within the SLHD compare to recommended physical activity levels for Australian adults.
3.	Investigate how physical activity levels vary between allied health professionals working in different allied health disciplines.
This study will be an observational cross sectional study.  A recruitment flyer will be distributed to all allied health departments (physiotherapy, speech pathology, occupational therapy, psychology, nutrition and dietetics, pharmacy, radiography, and social work, podiatry, orthotics) across the SLHD (Royal Prince Alfred hospital, Concord hospital, Balmain Hospital and Canterbury Hospital). 
Interested participants will be given a participant information sheet and will be required to sign a consent form.
Inclusion Criteria - Allied health professionals (aged 20 - 70 years) employed in the SLHD and who are working within their usual professional capacity during the data collection period (7 days).
Exclusion criteria – Allied health professionals who are unable to perform their usual work duties over the seven day study period.
Methods
Allied health professionals who agree to participate in this study will have the following baseline measurements collected:
-	Demographic information - age, gender, occupational classification, work department.
-	Basic anthropometric measurements - weight, height, body mass index (BMI), 
-	Administration of validated physical activity questionnaires:  Activity Australia Questionnaire,  International Physical Activity Questionnaire (IPAQ),  Occupational Sitting and Physical Activity Questionnaire (OSPAQ).
Participants will then be fitted with a physical activity monitor (uniaxial Actigraph GT1M accelerometer) and asked to wear for 7 days. Participants will also be asked to keep an activity diary.
Physical activity data will be analysed and presented as means and standard deviations of daily step count and amount of moderate-to-vigorous physical activity. Physical activity during work time will be compared with physical activity outside work time. Physical activity levels will be compared with recommended guidelines for Australian adults.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Jennifer Alison

Address

Faculty of Health Sciences University of Sydney
University of Sydney
PO Box 170
Lidcombe NSW 1825

Country

Australia

Phone

+61 414 300 416

Fax

+612 9351 9601

jennifer.alison@sydney.edu.au

Contact person for public queries

Name

Jennifer Alison

Address

Faculty of Health Sciences University of Sydney
University of Sydney
PO Box 170
Lidcombe NSW 1825

Country

Australia

Phone

+61 414 300 416

Fax

+612 9351 9601

jennifer.alison@sydney.edu.au

Contact person for scientific queries

Name

Jennifer Alison

Address

Faculty of Health Sciences University of Sydney
University of Sydney
PO Box 170
Lidcombe NSW 1825

Country

Australia

Phone

+61 414 300 416

Fax

+612 9351 9601

jennifer.alison@sydney.edu.au

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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