Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000770460
Ethics application status
Approved
Date submitted
10/06/2025
Date registered
21/07/2025
Date last updated
21/07/2025
Date data sharing statement initially provided
21/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Piloting a Co-Designed Digital Body Image Intervention for Young Australian Women
Scientific title
Piloting a Co-Designed Digital Body Image Intervention for Young Australian Women
Secondary ID [1] 314622 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body appreciation 337760 0
Sociocultural appearance pressures towards appearance 337761 0
Relative body dissatisfaction or satisfaction 337762 0
Health confidence 337763 0
Condition category
Condition code
Mental Health 334094 334094 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
School of Self-Acceptance is a web-based intervention comprised of six modules. The modules include components of psychoeducation, media and health literacy, and body acceptance, with a range of cognitive-behavioural and mindfulness activities. The website was co-designed by women with lived experience of body dissatisfaction and relevant mental health experts through interviews, focus groups, and a feedback survey. The website is designed for individuals to work through independently without guidance from a facilitator and is intended to be completed individually. In our RCT the participants will be given two weeks to work through the six modules, each taking approximately 30 minutes to complete, and due to the digital nature, they can be completed at a time and place of their choosing. The intervention is not designed to be tailored; however, individuals will likely gravitate more to activities that align with their interests. Participant self-reporting will determine adherence, e.g., "do you believe you read, watched, and understood the provided information?" with responses Yes/No/Maybe and text options for additional context.
Intervention code [1] 331248 0
Prevention
Comparator / control treatment
We are utilising a wait-list control, whereby participants who are randomly allocated to the control group will wait to receive the treatment until after the trial has been completed.
Control group
Active

Outcomes
Primary outcome [1] 341753 0
Body appreciation
Timepoint [1] 341753 0
Baseline, after completing the intervention (i.e., two weeks after baseline), and one month following completion of the intervention
Primary outcome [2] 341754 0
Sociocultural appearance pressures
Timepoint [2] 341754 0
Baseline, after completing the intervention (i.e., two weeks after baseline), and one month following completion of the intervention
Primary outcome [3] 341755 0
Relative body dissatisfaction or satisfaction
Timepoint [3] 341755 0
Baseline, after completing the intervention (i.e., two weeks after baseline), and one month following completion of the intervention
Secondary outcome [1] 448596 0
Health confidence
Timepoint [1] 448596 0
Baseline, after completing the intervention (i.e., two weeks after baseline), and one month following completion of the intervention
Secondary outcome [2] 448597 0
System Usability
Timepoint [2] 448597 0
Baseline, after completing the intervention (i.e., two weeks after baseline), and one month following completion of the intervention
Secondary outcome [3] 448598 0
Feedback to implement improvements
Timepoint [3] 448598 0
Post-intervention will be two weeks following collection of baseline data
Secondary outcome [4] 448599 0
Likelihood to recommend
Timepoint [4] 448599 0
Post-intervention will be two weeks following collection of baseline data
Secondary outcome [5] 448600 0
Feasibility from attrition
Timepoint [5] 448600 0
It will be calculated by the number of participant survey responses collected at pre-intervention time one (i.e., baseline data), compared to post-intervention time two (i.e., two weeks following baseline data collection).

Eligibility
Key inclusion criteria
Participants must
a) identify as women
b) be aged 18 to 35
c) be living in Australia
d) have body dissatisfaction and no eating disorder diagnosis as of the past five years
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they
a) do not identify as women
b) are aged under 18 years or over 35 years
c) do not live in Australia
d) do not experience body dissatisfaction
e) have been diagnosed with an eating disorder in the past five years

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)
Given the digital nature of this study, the allocation of participants into the treatment and control group will be at random and facilitated by Qualtrics software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be completed by computer software (i.e. Qualtrics inbuilt computerised 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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2025
Date of last participant enrolment
Anticipated
15/09/2025
Actual
Date of last data collection
Anticipated
28/10/2025
Actual
Sample size
Target
38
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319182 0
Government body
Name [1] 319182 0
Australian Government Department of Education - Research Training Program Scholarship for Lauren Conboy completing PhD studies at University of South Australia
Country [1] 319182 0
Australia
Primary sponsor type
Individual
Name
Lauren Conboy - University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 321649 0
None
Name [1] 321649 0
Address [1] 321649 0
Country [1] 321649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317766 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 317766 0
Ethics committee country [1] 317766 0
Australia
Date submitted for ethics approval [1] 317766 0
16/05/2025
Approval date [1] 317766 0
26/05/2025
Ethics approval number [1] 317766 0

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

Contacts
Principal investigator
Name 142070 0
Miss Lauren Conboy
Address 142070 0
University of South Australia, 38 Saint Bernards Road, Magill, 5072, South Australia
Country 142070 0
Australia
Phone 142070 0
+61 883023387
Fax 142070 0
Email 142070 0
[email protected]
Contact person for public queries
Name 142071 0
Lauren Conboy
Address 142071 0
University of South Australia, 38 Saint Bernards Road, Magill, 5072, South Australia
Country 142071 0
Australia
Phone 142071 0
+61 883023387
Fax 142071 0
Email 142071 0
[email protected]
Contact person for scientific queries
Name 142072 0
Lauren Conboy
Address 142072 0
University of South Australia, 38 Saint Bernards Road, Magill, 5072, South Australia
Country 142072 0
Australia
Phone 142072 0
+61 883023387
Fax 142072 0
Email 142072 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Future journal publication or its supplementary materials

Are there extra considerations when requesting access to individual participant data?
No


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.