Trial Review

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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.
Scientific title
Piloting a single-session intervention to enhance help-seeking in young adults aged 18-25 at risk of disordered eating.
Secondary ID [1] 314424 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disordered eating 337448 0
Condition category
Condition code
Mental Health 333820 333820 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 331038 0
Behaviour
Intervention code [2] 331039 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 341453 0
Feasibility of the SSI
Timepoint [1] 341453 0
Immediately post-intervention
Primary outcome [2] 341700 0
Feasibility of the SSI
Timepoint [2] 341700 0
Immediately following the intervention
Secondary outcome [1] 447550 0
Help-seeking engagement
Timepoint [1] 447550 0
Immediately post-intervention
Secondary outcome [2] 447551 0
Body Image Flexibility
Timepoint [2] 447551 0
Immediately prior to the intervention and immediately post-intervention
Secondary outcome [3] 447556 0
Denial/illness insight
Timepoint [3] 447556 0
Immediately prior to the intervention and immediately post-intervention
Secondary outcome [4] 448290 0
Mood
Timepoint [4] 448290 0
Immediately prior to the intervention and immediately post-intervention

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)
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently receiving professional help (i.e., from a qualified practitioner such as psychologist, psychiatrist, GP, dietician) for eating concerns.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 randomisation process
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/05/2025
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
30
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318951 0
University
Name [1] 318951 0
Flinders University
Country [1] 318951 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 321419 0
None
Name [1] 321419 0
Address [1] 321419 0
Country [1] 321419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317563 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 317563 0
Ethics committee country [1] 317563 0
Australia
Date submitted for ethics approval [1] 317563 0
27/03/2025
Approval date [1] 317563 0
01/05/2025
Ethics approval number [1] 317563 0

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

Contacts
Principal investigator
Name 141434 0
Dr Marcela Radunz
Address 141434 0
Flinders Univeristy, 1 Sturt Road, Bedford Park SA 5042
Country 141434 0
Australia
Phone 141434 0
+61 08 8201 7821
Fax 141434 0
Email 141434 0
[email protected]
Contact person for public queries
Name 141435 0
Marcela Radunz
Address 141435 0
Flinders Univeristy, 1 Sturt Road, Bedford Park SA 5042
Country 141435 0
Australia
Phone 141435 0
+61 08 8201 7821
Fax 141435 0
Email 141435 0
[email protected]
Contact person for scientific queries
Name 141436 0
Marcela Radunz
Address 141436 0
Flinders Univeristy, 1 Sturt Road, Bedford Park SA 5042
Country 141436 0
Australia
Phone 141436 0
+61 08 8201 7821
Fax 141436 0
Email 141436 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



What supporting documents are/will be available?



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.