Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000110684
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
9/08/2005
Date last updated
9/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Worksite intervention effects on psychological and physical health: A randomised controlled trial
Scientific title
A randomised controlled trial study to evaluate the effects of exercise plus health education on psychological and physical health outcomes in healthy sedentary employees from a single worksite
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive, anxious, and stress symptoms, 195 0
Self-rated sleep quality 196 0
Quality-of-life outcomes, 197 0
Physical health 198 0
Condition category
Condition code
Mental Health 219 219 0 0
Depression
Mental Health 220 220 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 24 week randomised controlled trial of exercise plus dietary behavioral intervention inlcuding sleep hygiene.
Intervention code [1] 122 0
Treatment: Other
Comparator / control treatment
Waitlist controls
Control group
Historical

Outcomes
Primary outcome [1] 265 0
Depression
Timepoint [1] 265 0
Measured at pre-test (baseline) and post-test (24 weeks)
Primary outcome [2] 266 0
Anxiety
Timepoint [2] 266 0
Measured at pre-test (baseline) and post-test (24 weeks)
Primary outcome [3] 267 0
Stress Scales (DASS)
Timepoint [3] 267 0
Measured at pre-test (baseline) and post-test (24 weeks)
Primary outcome [4] 268 0
Quality-of-Life (SF-36 Health Status Survey)
Timepoint [4] 268 0
Measured at pre-test (baseline) and post-test (24 weeks)
Secondary outcome [1] 591 0
Waist circumference
Timepoint [1] 591 0
Secondary outcome [2] 592 0
Body mass
Timepoint [2] 592 0
Secondary outcome [3] 593 0
Body mass index
Timepoint [3] 593 0
Secondary outcome [4] 594 0
Predicted maximal aerobic capacity (predicted VO2max), (note that the number 2 should be subscripted).
Timepoint [4] 594 0

Eligibility
Key inclusion criteria
Healthy sedentary employees, able to produce a medical clearance to exercise, and willingness to be randomised to treatment or waitlist groups.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to commit to intervention, and medical conditions severly limiting regular exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nonconcealed randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised to permuted blocks stratified by gender and by psychological symptom category
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Waitlist control
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 278 0
Name [1] 278 0
Country [1] 278 0
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 213 0
Commercial sector/Industry
Name [1] 213 0
StarCity casino
Address [1] 213 0
Country [1] 213 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36311 0
Address 36311 0
Country 36311 0
Phone 36311 0
Fax 36311 0
Email 36311 0
Contact person for public queries
Name 9311 0
Evan Atlantis
Address 9311 0
School of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9311 0
Australia
Phone 9311 0
+61 2 93519277
Fax 9311 0
+61 2 93519204
Email 9311 0
[email protected]
Contact person for scientific queries
Name 239 0
Evan Atlantis
Address 239 0
School of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 239 0
Australia
Phone 239 0
+61 2 93519277
Fax 239 0
+61 2 93519204
Email 239 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.