Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001125415
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/09/2025
Date registered
Help: Date registered
15/10/2025
Date last updated
Help: Date last updated
29/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of Butterfly Body Bright in Victorian primary schools: A whole-school program to support body image
Scientific title
An evaluation of Butterfly Body Bright in Victorian primary schools: A whole-school program to support body image
Additional trial identifiers [1] 315462 0
MRFF Grant ID 2035802
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Body image 339025 0
Condition category
Condition code
Mental Health 335312 335312 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Butterfly Body Bright (BBB) (www.butterflybodybright.org.au) is a strength-based, evidence-informed universal prevention program which aims to promote healthy attitudes and behaviours towards the body, eating, and physical activity in children and build a positive body image environment. The program targets key risk/protective factors, mapped across six BRIGHT themes; BRAVE against appearance teasing, RESILIENT to unhelpful media messaging, INCLUSIVE of all bodies, GRATEFUL through body appreciation, HAPPY from joyful physical activity, and THOUGHTFUL relationships with eating. BBB addresses both the child and the environments around them via four key elements: 17 expert-endorsed school culture guidelines, staff training (4h online), staff and family resources (e.g., posters, tipsheets, early identification toolkit), and >50 lesson plans across all Year levels (foundation-Year 6). It is a requirement that staff who deliver lesson content have completed the online Body Bright Staff Training. The intervention is available online through a learning management system (LMS) and is thus accessible to schools at any time (post baseline survey for intervention schools, at the end of the research for control schools).

The mode of delivery used on the LMS includes downloadable/printable curriculum aligned-lesson plans – including interactive activities, short videos, slide decks etc. Staff training is delivered through online, educational videos. Family resources are delivered through PDFs and videos through home–school communication (e.g., newsletters).
Schools asked to deliver the program over a single intervention term. To ensure a real-world understanding of BBB’s implementation, no strict rules are provided to schools about how many lessons to deliver or how long to spend per week using the program
Teachers access LMS online and present materials within the classroom (e.g., presentation slides, print outs). Students do not require logins – activities are teacher-led in-class.
Intervention engagement/adherence will be collected through LMS analytics, BBB Lead delivery logs each week and implementation survey post-intervention, and teacher surveys.

Importantly, the intervention will be administered in all participating schools. Consent will only be sought for the survey assessments.
Intervention code [1] 332082 0
Prevention
Description of the comparator or control
Waitlist control.
Schools continue usual practice; full BBB access after study completion for 12-months
Control group
Active

Outcomes
Primary outcome [1] 342892 0
Student body appreciation
Timepoint [1] 342892 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Primary outcome [2] 342893 0
Student body dissatisfaction
Timepoint [2] 342893 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Primary outcome [3] 342895 0
Student eating disorder risk
Timepoint [3] 342895 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [1] 452576 0
Student appearance conversations with friends
Timepoint [1] 452576 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [2] 452606 0
Student life engagement
Timepoint [2] 452606 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [3] 452607 0
Student internalisation of appearance ideals
Timepoint [3] 452607 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [4] 452608 0
Student appearance comparisons
Timepoint [4] 452608 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [5] 452609 0
Staff knowledge around body image
Timepoint [5] 452609 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [6] 452610 0
Parent behaviours around body image
Timepoint [6] 452610 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [7] 452611 0
Student body functionality appreciation
Timepoint [7] 452611 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [8] 452612 0
Student help-seeking attitudes
Timepoint [8] 452612 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [9] 452613 0
Student media literacy
Timepoint [9] 452613 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [10] 452614 0
Student confidence to deal with teasing
Timepoint [10] 452614 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [11] 452615 0
Student inclusivity
Timepoint [11] 452615 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [12] 452616 0
Student joyful movement
Timepoint [12] 452616 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [13] 452617 0
Student intuitive eating
Timepoint [13] 452617 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [14] 452957 0
Parent knowledge around body image
Timepoint [14] 452957 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [15] 468687 0
Parent body dissatisfaction
Timepoint [15] 468687 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [16] 468688 0
Parent overvaluation of shape and weight
Timepoint [16] 468688 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [17] 468689 0
Staff body dissatisfaction
Timepoint [17] 468689 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [18] 468690 0
Staff overvaluation of shape and weight
Timepoint [18] 468690 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [19] 468691 0
Student appearance-based teasing
Timepoint [19] 468691 0
Baseline, post-intervention (~10 weeks), 3-month follow-up
Secondary outcome [20] 468692 0
Implementation of Butterfly Body Bright
Timepoint [20] 468692 0
Post-intervention (~10 weeks) and 3-month follow-up

Eligibility
Key inclusion criteria
Schools: Primary schools in Victoria.

Students: Year 5–6 (approx. 10–12 years) in participating schools with parental consent and student assent

Parents/guardians: Adults (18+) who are parents of Year 5–6 students

School staff: Staff working at participating schools are eligible to participate in the surveys and/or interviews. This includes teaching and non-teaching staff involved in, or with knowledge of, the implementation of Butterfly Body Bright within the school.

School community members: Relevant members of the participating school community may participate in the workshops. This may include school leadership, wellbeing staff, teachers, other school staff, parents/guardians and other individuals involved in supporting the implementation of Butterfly Body Bright within the school community.
Minimum age
9 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Schools: Schools that have previously implemented the Butterfly Body Bright program are not eligible to participate in the trial.

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)
Participating schools are automatically randomised 1:1 (intervention: waitlist control) via Qualtrics, concealing upcoming allocations. Randomisation is stratified by school size (<100 or =100), location (metro or regional/rural), and type (Government, independent or Catholic). Blinding of schools and intervention deliverers is not feasible, although personnel enrolling schools will not have access to the random allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated within Qualtrics; stratified by school size, sector, and location
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analyses for effectiveness evaluation: Analyses will be conducted on an intention-to-treat basis. To address objective #1, the intervention effect on child and environmental outcomes will be estimated using linear mixed models. The models will include study arm, time (T1, T2, T3), and time-by-study arm interaction as fixed effects, with the centred baseline value of each outcome included as a covariate. Multiple imputation may be used to handle missing data. Sensitivity analyses involving pattern mixture models will be conducted to evaluate robustness of findings to different assumptions about reasons for participant dropout.

Economic evaluation: To address objective #2, a cost-consequences analysis will be conducted to compare the costs and outcomes of the intervention and control groups. Standard Australian unit costs from published sources will be applied. Uncertainty will be explored using non-parametric bootstrapping to estimate confidence intervals around cost and outcome differences, and sensitivity analyses will assess the impact of key assumptions. The feasibility of modelling longer-term economic impacts, including potential reductions in future eating disorder incidence, will also be assessed. Such modelling will only be undertaken where sufficiently robust evidence is available to support extrapolation beyond the trial period.

Statistical analyses for implementation evaluation: To address objective #3, implementation outcomes will be analysed descriptively (i.e., frequencies and proportions) and qualitatively. Template thematic analysis will be used to analyse the interview data, using double coding.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
4/12/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
722
Accrual to date
264
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 320055 0
Government body
Name [1] 320055 0
Medical Research Future Fund (MRFF), Childhood Mental Health (ID 2035802) - administered by the Australian Government Department of Health, Disability and Ageing
Country [1] 320055 0
Australia
Primary sponsor type
University
Name
Deakin University (Australia)
Address
Country
Australia
Secondary sponsor category [1] 322603 0
None
Name [1] 322603 0
Address [1] 322603 0
Country [1] 322603 0
Other collaborator category [1] 283694 0
Charities/Societies/Foundations
Name [1] 283694 0
Butterfly Foundation
Address [1] 283694 0
Country [1] 283694 0
Australia
Other collaborator category [2] 283695 0
Other Collaborative groups
Name [2] 283695 0
National Eating Disorder Collaboation (NEDC)
Address [2] 283695 0
Country [2] 283695 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318599 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 318599 0
Ethics committee country [1] 318599 0
Australia
Date submitted for ethics approval [1] 318599 0
17/06/2025
Approval date [1] 318599 0
03/07/2025
Ethics approval number [1] 318599 0
2024/HE000745
Ethics committee name [2] 320615 0
Research in Schools and Early Childhood Settings (RISEC)
Ethics committee address [2] 320615 0
Ethics committee country [2] 320615 0
Australia
Date submitted for ethics approval [2] 320615 0
Approval date [2] 320615 0
15/10/2025
Ethics approval number [2] 320615 0
25-06-670
Ethics committee name [3] 321532 0
Melbourne Archdiocese Catholic Schools (MACS)
Ethics committee address [3] 321532 0
Ethics committee country [3] 321532 0
Australia
Date submitted for ethics approval [3] 321532 0
11/03/2026
Approval date [3] 321532 0
23/04/2026
Ethics approval number [3] 321532 0
1528
Ethics committee name [4] 321533 0
Diocese of Sale
Ethics committee address [4] 321533 0
Ethics committee country [4] 321533 0
Australia
Date submitted for ethics approval [4] 321533 0
14/05/2026
Approval date [4] 321533 0
01/06/2026
Ethics approval number [4] 321533 0
(none provided)
Ethics committee name [5] 321534 0
Diocese of Sandhurst
Ethics committee address [5] 321534 0
Ethics committee country [5] 321534 0
Australia
Date submitted for ethics approval [5] 321534 0
18/06/2026
Approval date [5] 321534 0
08/07/2026
Ethics approval number [5] 321534 0
(none provided)

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

Contacts
Principal investigator
Name 144670 0
Dr Hannah Jarman
Address 144670 0
School of Psychology, Deakin University Melbourne Burwood Campus, VIC 3125, Australia
Country 144670 0
Australia
Phone 144670 0
+61 392446430
Fax 144670 0
Email 144670 0
[email protected]
Contact person for public queries
Name 144671 0
Hannah Jarman
Address 144671 0
School of Psychology, Deakin University Melbourne Burwood Campus, VIC 3125, Australia
Country 144671 0
Australia
Phone 144671 0
+61 392446430
Fax 144671 0
Email 144671 0
[email protected]
Contact person for scientific queries
Name 144672 0
Hannah Jarman
Address 144672 0
School of Psychology, Deakin University Melbourne Burwood Campus, VIC 3125, Australia
Country 144672 0
Australia
Phone 144672 0
+61 392446430
Fax 144672 0
Email 144672 0
[email protected]

Data sharing statement
Will the study consider sharing 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.