Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000450819
Ethics application status
Approved
Date submitted
18/04/2012
Date registered
20/04/2012
Date last updated
16/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
ManUp UWS: Internet-based physical activity intervention for middle-aged male university employees
Scientific title
Comparing the ManUp UWS internet-based physical activity intervention for middle-aged male university employees, with a control group receiving only generic printed material on physical activity and health.
Secondary ID [1] 280355 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 286319 0
Condition category
Condition code
Public Health 286559 286559 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the ManUp UWS intervention group will be invited to partake in a 12-week online physical activity intervention where they will be able to set physical activity challenges, interact with other study participants, and track their progress using online tracking tools. Participants in the intervention group will have full-time access to the online intervention for the duration of the 12-week program where they will be able to utilise the ManUp UWS website and tools at their discretion (as much or as little as they like).

Participants will be required to wear an accelerometer to measure physical activity and sedentary time (for one week each time) at three time points (week zero - baseline, week 12 – end of formal intervention, and week 24 – follow-up).

Participants in the intervention group will receive email prompts to use the online intervention and generic printed materials on physical activity and health at four time points (week zero, week three, week six and week nine).
Intervention code [1] 284720 0
Lifestyle
Intervention code [2] 284740 0
Behaviour
Comparator / control treatment
Participants in the control group will receive only generic printed materials on physical activity and health at four time points (week zero, week three, week six and week nine). The generic printed materials will be used at the participants’ discretion.

Participants will be required to wear an accelerometer to measure physical activity and sedentary time (for one week each time) at three time points (week zero – baseline, week 12 – end of formal intervention, and week 24 – follow-up).
Control group
Active

Outcomes
Primary outcome [1] 286993 0
Primary Outcome 1: physical activity, objectively measured using accelerometer.
Timepoint [1] 286993 0
Timepoint: at baseline and at 12, and 24 weeks after intervention commencement.
Secondary outcome [1] 297159 0
Secondary Outcome 1: sedentary time, objectively measured using accelerometer.
Timepoint [1] 297159 0
Timepoint: at baseline and at 12, and 24 weeks after intervention commencement.
Secondary outcome [2] 297160 0
Secondary Outcome 2: body mass index (BMI), using height and weight measurements taken by a trained research assistant.
Timepoint [2] 297160 0
Timepoint: at baseline and at 12, and 24 weeks after intervention commencement
Secondary outcome [3] 297161 0
Secondary Outcome 3: waist circumference, measured by a trained research assistant.
Timepoint [3] 297161 0
Timepoint: at baseline and at 12, and 24 weeks after intervention commencement
Secondary outcome [4] 297162 0
Secondary Outcome 4: blood pressure, measured using a digital blood pressure monitor by a trained research assistant.
Timepoint [4] 297162 0
Timepoint: at baseline and at 12, and 24 weeks after intervention commencement.
Secondary outcome [5] 297163 0
Secondary Outcome 5: health-related quality of life, measured using the SF-12.
Timepoint [5] 297163 0
Timepoint: at baseline and at 12, and 24 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Participants meeting the following criteria will be deemed eligible to join the study:

Male

Aged between 35 and 64 years

Employed as an ongoing or fixed-term member of staff at the University of Western Sydney

Not meeting current National physical activity guidelines of 150 minutes of moderate-vigorous physical activity per week

Have regular access to the internet

Not have a condition where physical activity is contraindicated

Have completed a pre-exercise screening assessment and have a low or moderate risk for exercise related complications, or if high risk have approval from medical professional to participate in exercise. (http://sma.org.au/wp-content/uploads/2009/05/new_pre_screening.pdf)

Participants will be deemed healthy volunteers by completing the pre-exercise screening assessment.
Minimum age
35 Years
Maximum age
64 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are:

Female

Younger than 35 years or older than 64 years

Exceeding current National physical activity guidelines of 150 minutes of moderate-vigorous physical activity per week

Without regular access to the internet

Experiencing a condition where physical activity is contraindicated

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/05/2012
Actual
30/07/2012
Date of last participant enrolment
Anticipated
30/11/2012
Actual
11/12/2012
Date of last data collection
Anticipated
4/06/2013
Actual
4/06/2013
Sample size
Target
120
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285132 0
University
Name [1] 285132 0
University of Western Sydney
Country [1] 285132 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797. Penrith NSW 2751.
Country
Australia
Secondary sponsor category [1] 283996 0
None
Name [1] 283996 0
Address [1] 283996 0
Country [1] 283996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287148 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 287148 0
Ethics committee country [1] 287148 0
Australia
Date submitted for ethics approval [1] 287148 0
Approval date [1] 287148 0
12/10/2011
Ethics approval number [1] 287148 0
H9339

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

Contacts
Principal investigator
Name 34087 0
Dr Emma George
Address 34087 0
Western Sydney University
Locked bag 1797
Penrith NSW 2751
Country 34087 0
Australia
Phone 34087 0
+61247360052
Fax 34087 0
Email 34087 0
[email protected]
Contact person for public queries
Name 17334 0
Dr Emma George
Address 17334 0
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751
Country 17334 0
Australia
Phone 17334 0
+61 2 4736 0052
Fax 17334 0
Email 17334 0
[email protected]
Contact person for scientific queries
Name 8262 0
Emma George
Address 8262 0
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751
Country 8262 0
Australia
Phone 8262 0
+61 2 4736 0052
Fax 8262 0
Email 8262 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.