Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000725167
Ethics application status
Approved
Date submitted
6/05/2019
Date registered
14/05/2019
Date last updated
24/02/2022
Date data sharing statement initially provided
14/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
GoodForm: An intervention to enhance body image and prevent doping and supplement use in adolescent boys
Scientific title
Goodform: A cluster randomised-controlled trial of an educational program to enhance body esteem, reduce attitudes toward doping in sport, and reduce intentions to use supplements and steroids for boys aged 14-15.
Secondary ID [1] 296979 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body image 310943 0
Appearance and Performance Enhancing Substance use 310944 0
Condition category
Condition code
Public Health 309608 309608 0 0
Health promotion/education
Mental Health 309609 309609 0 0
Eating disorders
Mental Health 309610 309610 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
OVERVIEW
Goodform is a 1 hr x four weekly sessions educational program for boys aged 14-15 aimed at improving body image, reducing positive attitudes towards doping in sport, and reducing intentions to use appearance and performance enhancing substances (APES). The program is based on two highly successful existing programs; ATLAS (Goldberg et al., 1996) and The Body Project (Stice et al., 2000), and uses a dissonance-based approach and a social norms approach to achieve outcomes.

The intervention will be delivered by Health and Physical Education (HPE) teachers of boys in year 9, during weekly face to face HPE classes at participants' schools. All teachers will receive a facilitator workbook (specifically designed for this program) with structured activities and explanations for how to deliver the program. Attendance of participants will be monitored using attendance sheets each lesson. Adherence to session content will be monitored using a self-report checklist completed by the teacher following each lesson.

The intervention will take place over the course of four HPE classes. Each lesson will cover a set of structured activities. Session 1 introduces cultural ideals around appearance, and helps boys learn to challenge these ideals. Session 2 introduces supplements and steroids, and helps boys learn about the social, financial, and health risks of these substances. Session 3 is structured around critiquing the use of APES and developing strategies to argue against using them. Session 4 takes an advocacy-based approach, with boys presenting a campaign against one of four types of APES, and identifying ways they can advocate against APES in their everyday lives.

Sessions 2-4 take a Jigsaw approach to learning. The classroom will be split up into four groups, with each group learning about a different APES in each activity, so that eventually all boys have learned about each substance.

MATERIALS
Facilitator workbook - teachers all receive a facilitator workbook (designed specifically for this study) that explains the theoretical basis and evidence for the program's activities, and how to facilitate all activities. The workbook can be accessed by emailing the researchers.

Student workbook - students receive a student workbook (designed specifically for this study), in which the majority of activities are completed. The workbook contains 10 worksheets, completed throughout the four intervention sessions. The workbook can be accessed by emailing the researchers.

Digital cultural ideal tool - Found at http://goodform.org.au/ - this tool introduces boys to the cultural ideal in session 1.

Videos - Five videos have been developed for Goodform. Four focus on the risks of using APES, and are used for boys to learn about these substances. Links are below:
https://www.youtube.com/watch?v=8ZgbmgsRi7s
https://www.youtube.com/watch?v=eYZle8EyotE
https://www.youtube.com/watch?v=B-r7U8Fw7jY
https://www.youtube.com/watch?v=ZaQmCKnhQtA
One was developed to highlight the social and emotional risks of using APES, and is accompanied by in-class discussion around help-seeking for body image and APES use. Link here: https://www.youtube.com/watch?v=fyCG_4IO-UU
Intervention code [1] 313254 0
Behaviour
Intervention code [2] 313255 0
Lifestyle
Intervention code [3] 313256 0
Prevention
Comparator / control treatment
Participants in the control group will receive the intervention after completing the follow-up questionnaire at 2 months.
Control group
Active

Outcomes
Primary outcome [1] 318569 0
Intentions to use APES - measured by Intentions to Use Steroids (McKinnon et al., 2001).
- self-report questionnaire.
Timepoint [1] 318569 0
Post-test (i.e., 4 weeks after baseline).
Primary outcome [2] 318570 0
Attitudes towards APES - measured by Outcome Expectations for Steroid Use (Parent & Moradi, 2011) self-report questionnaire.
Timepoint [2] 318570 0
Post-test (i.e., 4 weeks after baseline)
Primary outcome [3] 318571 0
Body esteem/body image, measured by:
- Sociocultural Attitudes Towards Appearance Questionnaire 4-R (Schaefer, Harriger, Heinberg, Soderberg, & Kevin Thompson, 2017) - self report questionnaire.
Timepoint [3] 318571 0
Post-test (i.e., 4 weeks after baseline).
Secondary outcome [1] 365399 0
Body talk - measured by Male Body Talk Scale (Sladek, Engeln, & Miller, 2014) - self-report questionnaire.
Timepoint [1] 365399 0
Post-test (i.e., 4 weeks after baseline).
Secondary outcome [2] 365400 0
Social norms around using supplements and steroids - measured using adaptation of the Peer Norms Scale, (Ling et al., 2015) - self-report questionnaire.
Timepoint [2] 365400 0
Post-test (i.e., 4 weeks after baseline)
Secondary outcome [3] 365401 0
Teacher outcomes - (composite measure) evaluations of the quality, student engagement, and appropriateness of the program. Measured by self-report questionnaire specifically designed for this study..
Timepoint [3] 365401 0
Post-test (i.e., 4 weeks after baseline).
Secondary outcome [4] 370352 0
- Male Body Attitudes Scale (Ryan, Morrison, Roddy, & McCutcheon, 2011) - self-report questionnaire.
Timepoint [4] 370352 0
Post-test (i.e., 4 weeks after baseline). Please note - this is actually a primary outcome.

Eligibility
Key inclusion criteria
SCHOOLS
Schools with year 9 boys and HPE classes are eligible to run the program.

PARTICIPANTS
Boys aged 14-15 (year 9) in HPE classes from participating schools are eligible to participate. HPE teachers of these boys are also eligible to participate.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/03/2019
Date of last participant enrolment
Anticipated
1/06/2019
Actual
14/06/2021
Date of last data collection
Anticipated
1/12/2019
Actual
30/08/2021
Sample size
Target
600
Accrual to date
Final
596
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 301552 0
Charities/Societies/Foundations
Name [1] 301552 0
World Anti-Doping Agency
Country [1] 301552 0
Canada
Primary sponsor type
Individual
Name
Dr Zali Yager
Address
Victoria University
Ballarat Rd
Footscray
VIC 3011
Country
Australia
Secondary sponsor category [1] 301253 0
None
Name [1] 301253 0
Address [1] 301253 0
Country [1] 301253 0
Other collaborator category [1] 280481 0
Individual
Name [1] 280481 0
Dr Sian Mclean
Address [1] 280481 0
Victoria University
Ballarat Rd
Footscray
VIC 3011
Country [1] 280481 0
Australia
Other collaborator category [2] 280482 0
Individual
Name [2] 280482 0
Dr Joanna Doley
Address [2] 280482 0
Victoria University
Ballarat Rd
Footscray
VIC 3011
Country [2] 280482 0
Australia
Other collaborator category [3] 280483 0
Individual
Name [3] 280483 0
Dr Scott Griffiths
Address [3] 280483 0
The University of Melbourne
Grattan Street,
Parkville
VIC 3010
Country [3] 280483 0
Australia
Other collaborator category [4] 280484 0
Individual
Name [4] 280484 0
Dr Linn Goldberg
Address [4] 280484 0
Oregon Health and Science University
3181 S.W. Sam Jackson Park Rd.
Portland
Oregon 97239-3098
Country [4] 280484 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302285 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 302285 0
Ethics committee country [1] 302285 0
Australia
Date submitted for ethics approval [1] 302285 0
13/07/2018
Approval date [1] 302285 0
09/11/2018
Ethics approval number [1] 302285 0
18-175

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

Contacts
Principal investigator
Name 89694 0
Dr Zali Yager
Address 89694 0
Victoria University
Ballarat Rd
Footscray
VIC 3011
Country 89694 0
Australia
Phone 89694 0
+61 0403011643
Fax 89694 0
Email 89694 0
[email protected]
Contact person for public queries
Name 89695 0
Zali Yager
Address 89695 0
Victoria University
Ballarat Rd
Footscray
VIC 3011
Country 89695 0
Australia
Phone 89695 0
+61 0403011643
Fax 89695 0
Email 89695 0
[email protected]
Contact person for scientific queries
Name 89696 0
Zali Yager
Address 89696 0
Victoria University
Ballarat Rd
Footscray
VIC 3011
Country 89696 0
Australia
Phone 89696 0
+61 0403011643
Fax 89696 0
Email 89696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants are under the age of 18, and to ensure their privacy and the privacy of the schools they attend we will not make our data available to the public.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
946Ethical approval    376659-(Uploaded-07-01-2019-15-33-49)-Study-related document.docx
947Informed consent form    Participant consent form 376659-(Uploaded-07-01-2019-15-34-25)-Study-related document.docx
948Informed consent form    Principal consent form 376659-(Uploaded-07-01-2019-15-34-55)-Study-related document.docx
949Informed consent form    Parent opt-out consent form 376659-(Uploaded-07-01-2019-15-35-22)-Study-related document.docx
950Informed consent form    Teacher consent form 376659-(Uploaded-07-01-2019-15-35-42)-Study-related document.docx
15198Study protocolhttps://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-8166-2  
15199Statistical analysis planhttps://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-8166-2  



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.