Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000607279
Ethics application status
Approved
Date submitted
21/07/2009
Date registered
21/07/2009
Date last updated
21/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breast support education improves bra knowledge and bra wearing behaviour in young female athletes: a randomised trial
Scientific title
Education Intervention to improve the breast support of female adolescents during physical activity with the outcomes of bra knowledge and bra wearing behaviour.
Secondary ID [1] 935 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast support during physical activity 237307 0
Condition category
Condition code
Public Health 239630 239630 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Educational booklet and multifaceted intervention to encourage reading of the booklet.
The booklet, “Sports Bra Fitness” was designed to educate female athletes on the components of a well-fitted, well-designed and supportive bra appropriate to their athletic pursuits. It was intended primarily to guide the reader in selecting and fitting the next bra they purchased
The booklet was given to each of the experimental group participants after the baseline measurement. It contained targeted key messages and photos of high-profile academy athletes and coaches to act as role models. Focus group were used its it development. All testing was performed by the same assessor, a sports physiotherapist during either physical training or competition, where reminders were given to read the booklet. Testing at baseline, 1-month and 4-months involved the completion of a custom-designed 50-question self-administered survey sought information on different bra designs, bras component parts, bra sizing, as well as questions related to correct and incorrect bra fit and bra wearing habits. Responses included multiple choice options, true/false and short answer questions. An "I do not know?" response was offered for every question and face validity tests were conducted through focus groups. Testing at baseline and 4-months also involved a physical bra fit and level of breast support test by the one assessor. This was performed in a chnage room taking approximately 5 minutes.
The Bra Fit Assessment test evaluated the fit of six bra components: the front band, posterior band, side band, cups, straps and underwire. If one or more of these six components were rated a fail grade in fit, and the straps or the band could not be adjusted by the assessor to achieve correct fit, an overall fail grade was awarded.

The Level of Breast Support test was ranked a pass or fail grade, taking into consideration the design and lifespan of the bra relative to the participant's breast size and level of physical activity. The participants were also asked to rate their exercise-induced breast discomfort when wearing this bra during their sport, using a visual analogue scale (VAS, 1-10 cm).

Reminders were also given during a phone call to confirm attendance at the final testing session. The relationship formed with the physiotherapist throughout the duration of the trial assisted to remove the possible barrier of embarrassment when discussing the potentially sensitive issue of breast support and bra fit.
Intervention code [1] 236983 0
Lifestyle
Intervention code [2] 236984 0
Behaviour
Comparator / control treatment
Control group underwent the exact same tests at baseline, 1 month and 4 months as per the experimental group but with no education given
Control group
Active

Outcomes
Primary outcome [1] 238414 0
Knowledge of bra fit and breast support.
A custom-designed 50-question self-administered survey sought information on different bra designs, bras component parts, bra sizing, as well as questions related to correct and incorrect bra fit and bra wearing habits. Responses included multiple choice options, true/false and short answer questions. An "I do not know?" response was offered for every question and face validity tests were conducted through focus groups
Timepoint [1] 238414 0
1 and 4 months after baseline
Secondary outcome [1] 244893 0
Physical bra fit and level of breast support test.
The Bra Fit Assessment test evaluated the fit of six bra components: the front band, posterior band, side band, cups, straps and underwire. If one or more of these six components were rated a fail grade in fit, and the straps or the band could not be adjusted by the assessor to achieve correct fit, an overall fail grade was awarded.

The Level of Breast Support test was ranked a pass or fail grade, taking into consideration the design and lifespan of the bra relative to the participant's breast size and level of physical activity. The participants were also asked to rate their exercise-induced breast discomfort when wearing this bra during their sport, using a visual analogue scale (VAS, 1-10 cm).
Timepoint [1] 244893 0
baseline and 4 months after baseline

Eligibility
Key inclusion criteria
adolescent female
netball or hockey player from regional academy of sport
Minimum age
14 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Allocation was not concealed.
The four academies were numbered 1 - 4 and then these numbers were allocated to a control or experimental group by a computer based program
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Seven regional academies of sport were contacted by phone requesting the involvement of their female hockey and netball squads in the study. Four responded postitively, 2 declined and 1 was excluded as they had just received bra fit education from a bra manufacturer.
The 4 academies were then randomised into a control or experimental group by a simple randomisation using a randomization table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
115
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1964 0
2340
Recruitment postcode(s) [2] 1965 0
2350
Recruitment postcode(s) [3] 1966 0
2580
Recruitment postcode(s) [4] 1967 0
2560
Recruitment postcode(s) [5] 1968 0
2500
Recruitment postcode(s) [6] 1969 0
2533
Recruitment postcode(s) [7] 1970 0
2575
Recruitment postcode(s) [8] 1971 0
2444
Recruitment postcode(s) [9] 1972 0
2480
Recruitment postcode(s) [10] 1973 0
2478

Funding & Sponsors
Funding source category [1] 237365 0
Charities/Societies/Foundations
Name [1] 237365 0
IMB Community Foundation
Country [1] 237365 0
Australia
Funding source category [2] 237367 0
Government body
Name [2] 237367 0
NSW Sporting Injury Committee
Country [2] 237367 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
IMB Community Foundation
Address
PO Box 2077
Wollongong NSW 2500
Head Office Address
253-259 Crown Street
Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 236860 0
Government body
Name [1] 236860 0
NSW Sporting Injury Committee
Address [1] 236860 0
4/92 - 100A Donnison St
Gosford, New South Wales 2250
Country [1] 236860 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239492 0
UNIVERSITY OF WOLLONGONG/ILLAWARRA AREA HEALTH SERVICE HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 239492 0
Ethics committee country [1] 239492 0
Australia
Date submitted for ethics approval [1] 239492 0
21/11/2006
Approval date [1] 239492 0
31/01/2007
Ethics approval number [1] 239492 0
HE06/169

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

Contacts
Principal investigator
Name 29935 0
Address 29935 0
Country 29935 0
Phone 29935 0
Fax 29935 0
Email 29935 0
Contact person for public queries
Name 13182 0
Deirdre McGhee
Address 13182 0
School of Health Sciences
Faculty Health and Behavioural Sciences
University of Wollongong
Northfields Ave
Wollongong
Country 13182 0
Australia
Phone 13182 0
+61 2 42 214980
Fax 13182 0
+61 2 42 215945
Email 13182 0
[email protected]
Contact person for scientific queries
Name 4110 0
Deirdre McGhee
Address 4110 0
School of Health Sciences
Faculty Health and Behavioural Sciences
University of Wollongong
Northfields Ave
Wollongong
Country 4110 0
Australia
Phone 4110 0
+61 2 42 214980
Fax 4110 0
+61 2 42 215945
Email 4110 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.