Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000955516
Ethics application status
Approved
Date submitted
3/07/2024
Date registered
6/08/2024
Date last updated
6/08/2024
Date data sharing statement initially provided
6/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the feasibility and efficacy of a single-session intervention for reducing eating disorder risk-factors in an at-risk eating disorder population
Scientific title
Testing the feasibility and efficacy of a single-session intervention for reducing eating disorder risk-factors in adults aged 17 to 25 who are at-risk of developing an eating disorder.
Secondary ID [1] 311254 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disordered eating 332472 0
Perfectionism 334561 0
Condition category
Condition code
Mental Health 329167 329167 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete a brief (approximately 25 minute) online, self-guided, video-based psychoeducational module providing information, videos and exercises focussing on cognitive flexibility and perfectionism, The module is supplemented with reflection activities immediately after the videos. The reflection activities will take a combined total of 5 minutes to complete and are based on the presented content
Intervention code [1] 327709 0
Prevention
Intervention code [2] 329140 0
Treatment: Other
Comparator / control treatment
Waitlist control (WLC) participants in the WLC will complete the same measures as the treatment condition at the same time points (baseline, 1-week post-treatment, 1-month follow up, 3-month follow-up). Following the completion of the 3-month follow-up questionnaires, participants into the WLC will be offered the Metacognitive Training (MCT) intervention.
Control group
Active

Outcomes
Primary outcome [1] 337006 0
Weight Shape and Eating Concerns - this will be assessed as a composite measure as the ED-15 measures both of these constructs
Timepoint [1] 337006 0
Baseline, 1-Week Post-Intervention (primary timepoint), 1-month post-intervention, 3-month follow-up
Secondary outcome [1] 430350 0
Perfectionism
Timepoint [1] 430350 0
Baseline, 1-week post-treatment, 1 month post-treatment, 3-month follow-up
Secondary outcome [2] 430351 0
Cognitive Flexibility
Timepoint [2] 430351 0
Baseline, 1-week post-treatment, 1 month-post treatment, 3-month follow-up
Secondary outcome [3] 430352 0
Mood
Timepoint [3] 430352 0
Baseline, 1-week post-treatment, 1- month post treatment, 3-month follow-up

Eligibility
Key inclusion criteria
High on eating disorder risk factors including scoring greater than 47 on the Weight Concern Scale and being between the ages of 18-25,English proficiency
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Allocation of participants performed via Qualtrics survey (online randomisation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Performed by Qualtrics survey (online randomisation).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To compare the reduction in disordered eating symptoms across two groups (intervention and waitlist control) at post-intervention, linear mixed modelling will be used.

Secondary statistical analysis: To compare the reduction in all observed symptoms across two groups (intervention and waitlist control) at post-intervention, linear mixed modelling will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/08/2024
Actual
Date of last participant enrolment
Anticipated
4/10/2024
Actual
Date of last data collection
Anticipated
3/01/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26385 0
United Kingdom
State/province [1] 26385 0
Country [2] 26386 0
United States of America
State/province [2] 26386 0
Country [3] 26387 0
Canada
State/province [3] 26387 0
Country [4] 26388 0
South Africa
State/province [4] 26388 0

Funding & Sponsors
Funding source category [1] 315509 0
University
Name [1] 315509 0
Flinders University
Country [1] 315509 0
Australia
Primary sponsor type
Individual
Name
Matthew Thompson, Flinders University
Address
Country
Australia
Secondary sponsor category [1] 319014 0
None
Name [1] 319014 0
None
Address [1] 319014 0
Country [1] 319014 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314414 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 314414 0
https://staff-projects.flinders.edu.au/research-support/integrity/human-ethics
Ethics committee country [1] 314414 0
Australia
Date submitted for ethics approval [1] 314414 0
06/06/2024
Approval date [1] 314414 0
10/06/2024
Ethics approval number [1] 314414 0

Summary
Brief summary
This study aims to improve acceptability and usability, as well as further determine the efficacy of a single-session intervention for reducing eating disorder risk factors. To test this, participants will be recruited from Prolific. Participants will be screened for eating disorder risk using the Weight Concern Scale. Those considered to have elevated weight and shape concerns (and hence be at-risk of eating disorder development) will complete other baseline measures of perfectionism, cognitive flexibility, mood and an additional measure of weight and shape concern. Participants will be randomly allocated to complete the intervention or be in a waitlist control condition. Following this, participants will complete the same measures at 1-week post-intervention, 1- month follow-up, and 3-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131490 0
Mr Matthew Thompson
Address 131490 0
Flinders University, Sturt Road, Bedford Park South Australia 5042
Country 131490 0
Australia
Phone 131490 0
+61 8 8201 3082
Fax 131490 0
Email 131490 0
[email protected]
Contact person for public queries
Name 131491 0
Matthew Thompson
Address 131491 0
Flinders University, Sturt Road, Bedford Park South Australia 5042
Country 131491 0
Australia
Phone 131491 0
+61 8 8201 3082
Fax 131491 0
Email 131491 0
[email protected]
Contact person for scientific queries
Name 131492 0
Matthew Thompson
Address 131492 0
Flinders University, Sturt Road, Bedford Park South Australia 5042
Country 131492 0
Australia
Phone 131492 0
+61 8 8201 3082
Fax 131492 0
Email 131492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Raw data from the participants' self-report questionnaires. All data will first be de-identified.
When will data be available (start and end dates)?
Available following publication, no specified end date.
Available to whom?
Open Access
Available for what types of analyses?
Verification studies, meta-analyses or reviews.
How or where can data be obtained?
Data files will be available from the open science framework database: https://osf.io/
Prior to data being uploaded to OSF, interested parties can contact Matthew Thompson [email protected]


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.