Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000271303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
2/02/2026
Date registered
Help: Date registered
4/03/2026
Date last updated
Help: Date last updated
4/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/03/2026
Date results provided
Help: Date results provided
4/03/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
A digital intervention targeting eating disorder symptoms in cisgender sexual minority men
Scientific title
Effectiveness of a digital intervention targeting eating disorders symptoms in cisgender sexual minority men
Additional trial identifiers [1] 316327 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Eating disorders 340387 0
Condition category
Condition code
Mental Health 336593 336593 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
SEED is a 10-week app-based intervention that includes text, audio, and visual content incorporating (i) cognitive behavioural techniques (including dissonance techniques) to challenge disordered eating thought patterns and encourage healthy lifestyle choices to supplant eating disorder (ED) behaviours; (ii) psycho-education about healthy eating and exercise habits and dangers of EDs; (iii) media literacy development to reduce social media influence on ED symptoms; and (iv) acceptance and mindfulness relaxation to disrupt the influence of negative mood on binge eating. In total, there are 8 modules of content, each taking about 1-2 hours per week to complete.


Overview of app modules:
1. Values and Motivations: Introduction to values, identifying values, and building motivation to change in accordance with values.
2. Regulated Eating: Psychoeducation on regular eating, compensatory behaviours, strategies to help with regular eating.
3. Mood Management: Identifying, challenging, and balancing negative thoughts
4. Diet Rules and Exercise: Identifying beliefs about dieting, challenging unhelpful beliefs, and generating positive attitudes about exercise
5. Overvaluation: Psychoeducation on overvaluation of appearance, societal influences on appearance values, and challenging these societal messages about appearance and diet
6. Body Checking & Appearance Comparisons: Body checking, appearance comparisons, the role of social media in facilitating body checking & appearance comparisons.
7. Emotion Regulation: Linking emotions to eating and appearance, learning emotion regulation techniques, distress tolerance.
8. Maintaining Progress: Identifying and managing relapses, generating a relapse plan.

This study comprised three phases.

PHASE 1:
In Phase 1, participants completed a (i) screening survey to assess their eligibility for an interview, (ii) a phone interview to confirm eating disorder diagnosis symptoms/diagnosis (including prodromal cases), and (iii) a baseline self-report survey to examine key study outcomes.

The screening survey allowed us to screen potential participants as eligible or ineligible to participate. Participants were eligible if they had engaged in dieting and expressed concern about their physical appearance in the past 6 months, and were not at risk of suicide.

Eligible participants were invited to complete a the Eating Disorder Interview (administered by a provisional or registered psychologist) over the phone or via video conference call (e.g., Zoom), lasting approximately 30-45 minutes. Participants confirmed as having a prodromal or clinical eating disorder were enrolled in the trial whilst participants without an eating disorder, or with an ineligible eating disorder diagnosis, were given access to the intervention content but were not enrolled in the trial.

At the end of the clinical interview, participants were randomised to one of three arms using Qualtrics in-built randomisation function:
1. Personalised intervention arm: in this condition, participants were able to complete the 10-week program flexibly (i.e., in any order), and were provided personalised content recommendations based on their self-reported eating disorder symptoms (e.g., those who had high scores on binge eating were recommended to first complete the 'Regulated Eating' and 'Mood Management' modules, before moving onto other modules). These personalised content recommendations were emailed to participants by the research team following their clinical interview, and participants were instructed to not start using the app before receiving these recommendations.
2. Default intervention arm: in this condition, participants completed SEED in a sequential order (Modules 1 to 8), and were not provided personalised content recommendations.
3. Waitlist Control: in this condition, participants were given access to the default version of the app at the 10-week follow up.

Eligible participants completed a survey containing baseline measures after the EDE interview. The baseline survey includes measures of key study outcomes, including over-valuation, exercise, appearance comparisons, social media literacy, and quality of life.

PHASE 2:
Eligible participants from Phase 1 completed the 10-week intervention (except for waitlist control participants, who are given access to the app at the start of Phase 3). The intervention - named SEED - was developed for this study, incorporating evidence-based strategies for treating eating disorders (e.g., Cognitive Behavioural Therapy). While using the app, participants were asked to provide text responses to questions and activities, such as stating their values and goals.

While the SEED app was set up to record adherence to the intervention (e.g., app login data, number of content modules completed), a technical error meant that this data could not be accessed.

PHASE 3:
All participants completed the baseline survey and phone interview immediately post-intervention, and waitlist control participants were granted access to the app at this stage. All participants re-completed the baseline survey at 6- and 12-months post-intervention.
Intervention code [1] 332987 0
Behaviour
Description of the comparator or control
Waitlist control. Participants assigned to this group received the default (i.e., non-personalised) version of the SEED app at the 10-week follow up.
Control group
Active

Outcomes
Primary outcome [1] 344103 0
Eating disorder diagnosis (clinician-assessed)
Timepoint [1] 344103 0
At baseline and immediately post-intervention only
Primary outcome [2] 344104 0
Eating Disorder Symptoms (self-report)
Timepoint [2] 344104 0
At all timepoints: baseline, immediately post-intervention (primary timepoint), and at 6- and 12-months post-intervention.
Secondary outcome [1] 456767 0
Quality of life
Timepoint [1] 456767 0
Baseline, immediately post-intervention, and at 6- and 12-months post-intervention
Secondary outcome [2] 456768 0
Psychological flexibility
Timepoint [2] 456768 0
Baseline, immediately post-intervention, and at 6- and 12-months post-intervention
Secondary outcome [3] 456769 0
Internalisation of appearance ideals
Timepoint [3] 456769 0
Baseline, immediately post-intervention, and at 6- and 12-months post-intervention
Secondary outcome [4] 456770 0
Health economics: Out-of-pocket patient costs
Timepoint [4] 456770 0
Baseline, immediately post-intervention, and at 6- and 12-months post-intervention
Secondary outcome [5] 458467 0
Health economics: health service utilisation
Timepoint [5] 458467 0
Baseline, immediately post-intervention, and 6- and 12-months post-intervention
Secondary outcome [6] 458468 0
Government healthcare resource use
Timepoint [6] 458468 0
Baseline, immediately post-intervention, and 6- and 12-months post-intervention

Eligibility
Key inclusion criteria
The eligibility criteria for our trial were: (1) cis-gender men who are not exclusively heterosexual, (2) 18 years or older, (3) not at risk of suicide, (4) met criteria for a sub-clinical or clinical eating disorder diagnosis (exclusions: Atypical Anorexia Nervosa, Anorexia Nervosa, and Avoidant Restrictive Food Intake Disorder), and (5) not currently receiving treatment for eating or body image concerns.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria are subsumed in the inclusion criteria - i.e., does not meet criteria for clinical or sub-clinical eating disorder diagnosis; diagnosis of Atypical Anorexia Nervosa, Anorexia Nervosa, and Avoidant Restrictive Food Intake Disorder; currently receiving treatment for eating or body image concerns.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Used in-built randomization function in Qualtrics. As this was implemented once the participants completed the EDE interview, and automated by simple randomization through Qualtrics itself, the researchers were not aware of (and did not influence) what group eligible participants would be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization implemented via in-built function on Qualtrics (online survey program)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/02/2024
Date of last participant enrolment
Anticipated
Actual
3/10/2024
Date of last data collection
Anticipated
Actual
16/10/2025
Sample size
Target
300
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320928 0
Government body
Name [1] 320928 0
Million Minds Mental Health Research Mission grant from the National Health and Medical Research Council - (APP1179321)
Country [1] 320928 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 323625 0
None
Name [1] 323625 0
Address [1] 323625 0
Country [1] 323625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319467 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 319467 0
Ethics committee country [1] 319467 0
Australia
Date submitted for ethics approval [1] 319467 0
03/05/2024
Approval date [1] 319467 0
02/08/2024
Ethics approval number [1] 319467 0

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

Contacts
Principal investigator
Name 147418 0
A/Prof Scott Griffiths
Address 147418 0
The University of Melbourne, Grattan ST, Parkville, Victoria 3010, Australia
Country 147418 0
Australia
Phone 147418 0
+61 3 9035 3047
Fax 147418 0
Email 147418 0
[email protected]
Contact person for public queries
Name 147419 0
A/Prof Scott Griffiths
Address 147419 0
The University of Melbourne, Grattan St, Parkville, Victoria 3010, Australia
Country 147419 0
Australia
Phone 147419 0
+61 3 9035 3047
Fax 147419 0
Email 147419 0
[email protected]
Contact person for scientific queries
Name 147420 0
A/Prof Scott Griffiths
Address 147420 0
The University of Melbourne, Grattan St, Parkville, Victoria 3010, Australia
Country 147420 0
Australia
Phone 147420 0
+61 3 9035 3047
Fax 147420 0
Email 147420 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?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: Open Science Framework (https://osf.io/hzyqv/)

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Interim results articleNohttps://doi.org/10.31219/osf.io/t5pxj_v1 Preprint

Documents added automatically
No additional documents have been identified.