Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000171718
Ethics application status
Approved
Date submitted
29/01/2013
Date registered
12/02/2013
Date last updated
12/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy eating behaviours in male gym users
Scientific title
The body image program: targeting self-esteem and body image in male gym users between the ages of 18 and 65 years
Secondary ID [1] 281861 0
Nil Known
Universal Trial Number (UTN)
U1111-1138-5606
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Behaviours 288233 0
Body Image - increase body image 288234 0
Self Esteem - increase in self-esteem 288235 0
Condition category
Condition code
Mental Health 288594 288594 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered as a small group seminar by a provisionally registered psychologist under the supervision of a registered psychologist. The intervention will take place at Bond University and will run for approximently 4 hours for one day. The intervention will focus on educating male gym users about ideal body image and healthy eating behaviours.
Intervention code [1] 286422 0
Behaviour
Comparator / control treatment
The control group will not recieve intervention. The control group will be taken from a sample of participants who have completed a questionnaire booklet.
Control group
Active

Outcomes
Primary outcome [1] 288745 0
Increase Self esteem - The Rosenberg Self Esteem Scale (RSES; Rosenberg, 1965)
Timepoint [1] 288745 0
Baseline at 2 week follow-up after treatment
Primary outcome [2] 288846 0
Increase Body Image - Body Image Avoidance Questionnaire (BIAQ; Rosen, Srebnik, Saltzberg & Wendt, 1991).
Timepoint [2] 288846 0
Baseline at 2 week follow-up after treatment
Secondary outcome [1] 300891 0
Body Weight - calibrated digital scales
Timepoint [1] 300891 0
Baseline and 2 week follow-up
Secondary outcome [2] 301128 0
Number of sessions at gym per week - participants will complete a demographic questionnaire
Timepoint [2] 301128 0
Baseline at 2 week follow-up after treatment
Secondary outcome [3] 301129 0
Average time at gym for each session - participants will complete a demographic questionnaire
Timepoint [3] 301129 0
Baseline at 2 week follow-up after treatment

Eligibility
Key inclusion criteria
Gym users
male
between ages of 18 and 65 years
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under the age of 18 years of age
Female
non-gym users

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
independent samples t-test and/or ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2013
Actual
Date of last participant enrolment
Anticipated
27/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286640 0
University
Name [1] 286640 0
Bond University
Country [1] 286640 0
Australia
Primary sponsor type
University
Name
Bond University
Address
University Drive, (Off Cottesloe Drive) Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 285423 0
None
Name [1] 285423 0
Address [1] 285423 0
Country [1] 285423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288717 0
Bond University Ethics Comittee
Ethics committee address [1] 288717 0
Ethics committee country [1] 288717 0
Australia
Date submitted for ethics approval [1] 288717 0
11/10/2012
Approval date [1] 288717 0
29/11/2012
Ethics approval number [1] 288717 0
RO1569

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

Contacts
Principal investigator
Name 37446 0
Dr Peta Stapleton
Address 37446 0
Bond University
16 University Drive, Robina
QLD 4226
Country 37446 0
Australia
Phone 37446 0
+61 7 55952 515
Fax 37446 0
Email 37446 0
[email protected]
Contact person for public queries
Name 37447 0
Timothy McIntyre
Address 37447 0
Bond University
16 University Drive, Robina
QLD 4226
Country 37447 0
Australia
Phone 37447 0
+61425882242
Fax 37447 0
Email 37447 0
[email protected]
Contact person for scientific queries
Name 37448 0
Peta Stapleton
Address 37448 0
Bond University
16 University Drive, Robina
QLD 4226
Country 37448 0
Australia
Phone 37448 0
+61 7 55952 515
Fax 37448 0
Email 37448 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.