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Trial registered on ANZCTR
Registration number
ACTRN12625000572460
Ethics application status
Approved
Date submitted
15/05/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Online single-session interventions to encourage young adults at risk of disordered eating to seek help.
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Scientific title
Piloting a single-session intervention to enhance help-seeking in young adults aged 18-25 at risk of disordered eating.
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Secondary ID [1]
314424
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Disordered eating
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Condition category
Condition code
Mental Health
333820
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0
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Eating disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
30 minute help-seeking single session intervention (SSI). The SSI will be administered online via the Qualtrics survey software. This SSI follows a "learn" and "do" section. The “learn” section of help-seeking SSI provides psychoeducation on negative body image and its consequences, and psychoeducation on the societal pressure to confirm to certain body or appearance standards and the costs associated with pursuing these ideals. The “do” section incorporates activities that encourage participants to identify the benefits of change, fears of change, and responses to fears. Strategies used to monitor adherence to the intervention include a timer on each page (participant must look at page for 10 seconds before they can click proceed) and forced responses (participant must answer questions within the SSI to proceed).
There will be five levels of help-seeking resources provided to all participants immediately following their allocated SSI. Engagement will be measured with number of clicks on each resource. If participants do not engage with the level, the task will end, and they will immediately move onto the post-intervention questionnaires. Level 1 will gauge initial interest/awareness by asking participants if they would like to learn about supports available for body image and eating concerns. Level 2 will measure passive engagement by providing a fact sheet with an overview of supports available for eating concerns and body image help. Level 3 will assess moderate engagement, which involves downloading a PDF with helpful self-guided strategies for overcoming negative body image or eating concerns. Level 4 will determine high engagement by asking participants if they would like to learn about support services available on campus for negative body image and eating concerns. Level 5, strong intent to seek help, will provide participants with the option to actively seek help, such as receiving information on how to book an appointment with Flinders University student counselling, downloading a self-referral form for the Flinders University Services for Eating Disorders (FUSED), ringing Butterfly Helpline, or accessing CCI resources.
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Intervention code [1]
331038
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Behaviour
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Intervention code [2]
331039
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Prevention
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Comparator / control treatment
30 minute behavioural activation single session intervention. The SSI will be administered online via the Qualtrics survey software. This intervention follows a "learn" and "do" section. The “learn” section demonstrates that mood can be manipulated through a behavioural experiment and provides psychoeducation on behavioural activation. The “do” section involves goal setting focused on 1) activities to do alone to improve mood, 2) big picture goals (choose 1 of several areas [study/work, friends, sport/hobby, being active, family]) and specific smaller goals for chosen area, and 3) activities to enjoy indoors, outdoors, or anywhere. Roadblock thoughts are also explained, and goals are set to help overcome them. Strategies used to monitor adherence to the intervention include a timer on each page (participant must look at page for 10 seconds before they can click proceed) and forced responses (participant must answer questions within the SSI to proceed).
There will be five levels of help-seeking resources provided to all participants immediately following their allocated SSI. Engagement will be measured with number of clicks on each resource. If participants do not engage with the level, the task will end, and they will immediately move onto the post-intervention questionnaires. Level 1 will gauge initial interest/awareness by asking participants if they would like to learn about supports available for body image and eating concerns. Level 2 will measure passive engagement by providing a fact sheet with an overview of supports available for eating concerns and body image help. Level 3 will assess moderate engagement, which involves downloading a PDF with helpful self-guided strategies for overcoming negative body image or eating concerns. Level 4 will determine high engagement by asking participants if they would like to learn about support services available on campus for negative body image and eating concerns. Level 5, strong intent to seek help, will provide participants with the option to actively seek help, such as receiving information on how to book an appointment with Flinders University student counselling, downloading a self-referral form for the Flinders University Services for Eating Disorders (FUSED), ringing Butterfly Helpline, or accessing CCI resources.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility of the SSI
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Assessment method [1]
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Program Feedback Scale
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Timepoint [1]
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Immediately post-intervention
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Primary outcome [2]
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Feasibility of the SSI
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Assessment method [2]
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Self-Reported Percentage of Completion (completion of tasks within the SSI)
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Timepoint [2]
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Immediately following the intervention
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Secondary outcome [1]
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Help-seeking engagement
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Assessment method [1]
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Levels of help-seeking resource engagement accessed (as described in step 3)
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Timepoint [1]
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Immediately post-intervention
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Secondary outcome [2]
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Body Image Flexibility
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Assessment method [2]
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Body Image State Scales
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Timepoint [2]
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Immediately prior to the intervention and immediately post-intervention
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Secondary outcome [3]
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Denial/illness insight
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Assessment method [3]
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“Right now, I believe I currently have a problem with eating” (1 = strongly disagree; 5 = strongly agree)
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Timepoint [3]
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Immediately prior to the intervention and immediately post-intervention
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Secondary outcome [4]
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Mood
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Assessment method [4]
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International Positive and Negative Affect Schedule Short Form
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Timepoint [4]
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Immediately prior to the intervention and immediately post-intervention
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Eligibility
Key inclusion criteria
First Year Flinders University Psychology Students
Aged 18-25
Meet high risk on Weight Concerns Scale (i.e. scoring greater than or equal to 47)
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Minimum age
18
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Currently receiving professional help (i.e., from a qualified practitioner such as psychologist, psychiatrist, GP, dietician) for eating concerns.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer - participants will be randomised using the Qualtrics survey software to either the help-seeking SSI or the behavioural activation SSI.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 randomisation process
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Moderating variables of interest (measured at baseline):
Help-seeking intentions: General Help-Seeking Questionnaire
Past help-seeking behaviours: Actual Help Seeking Questionnaire
Depression: Patient Health Questionnaire-9
Anxiety: Generalised Anxiety Disorder-7
Eating behaviours: Eating Disorder Examination-Questionnaire 7
Linear mixed models moderation analyses will be used to examine the moderating impact of these variables on help-seeking engagement.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
9/05/2025
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Date of last participant enrolment
Anticipated
31/08/2025
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Actual
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Date of last data collection
Anticipated
31/08/2025
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Actual
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Sample size
Target
30
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Accrual to date
29
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Flinders University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
321419
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317563
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Flinders University Human Research Ethics Committee
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Ethics committee address [1]
317563
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https://staff-projects.flinders.edu.au/research-support/integrity/human-ethics
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Ethics committee country [1]
317563
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Australia
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Date submitted for ethics approval [1]
317563
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27/03/2025
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Approval date [1]
317563
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01/05/2025
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Ethics approval number [1]
317563
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Summary
Brief summary
This study is a pilot trial testing two brief online interventions for young adults (18-25 years) with high concerns about their weight and body shape. The goal is to see if these single-session interventions (SSIs) are feasible and acceptable, and to explore their effects on mental health and help-seeking attitudes. Participants, who are first-year psychology students at Flinders University, will be randomly assigned to one of two interventions: a help-seeking SSI or a behavioural activation SSI. The help-seeking SSI provides participants with a better understanding of what negative body image is and motivational strategies to promote help-seeking, whereas the behavioural activation SSI aims to improve mood by emphasising the importance of positive action. Participants will complete baseline measures, followed by their allocated single session intervention and post-treatment measures straight after.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Marcela Radunz
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Address
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Flinders Univeristy, 1 Sturt Road, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 08 8201 7821
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Marcela Radunz
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Address
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Flinders Univeristy, 1 Sturt Road, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 08 8201 7821
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Marcela Radunz
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Address
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Flinders Univeristy, 1 Sturt Road, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 08 8201 7821
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Fax
141436
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
file attached
Nguyen, Vanessa - Ethics Approval Letter 2025.pdf
Informed consent form
file attached
PIS and consent_FINAL_25.04.25.docx
Other
PDF of Qualtrics online survey, including all cons...
[
More Details
]
Qualtrics Survey_FINAL_09.05.25.docx
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.
Download to PDF