Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000166471
Ethics application status
Approved
Date submitted
15/01/2025
Date registered
13/02/2025
Date last updated
13/02/2025
Date data sharing statement initially provided
13/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
R U Beautiful? A "prevention-is better-than-cure" Group Intervention Study on Cognitive and Psychological Factors Influencing Body Image in Young Women
Scientific title
R U Beautiful?
A "prevention-is better-than-cure" Body Image Group Intervention Study on cognitive and psychological factors influencing appearance in women aged 18 to 35
Secondary ID [1] 312908 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body Image 335062 0
Disordered Eating Behaviours 335063 0
Condition category
Condition code
Mental Health 331571 331571 0 0
Eating disorders
Mental Health 331572 331572 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to conduct a novel randomised controlled trial (two arms) to compare the efficacy of “The Body Project- Active Control Arm”, by comparing it to a “Body Plus Project- Experimental Arm” (the original Body Project plus an additional component of metacognitive training in 96 women, (aged 18-35) in the Australian student and community sample. We aim to investigate and elucidate important, previously under-researched psychological and neurocognitive risk factors that have been implicated in the development, escalation and maintenance of poor body image and related comorbidities. We also plan to obtain participant experience feedback post intervention to determine implementation aspects for further iterations of this intervention.
The metacognitive training (puzzles, paper-pen tasks, group brainstorming) will take place for 15 minutes at the beginning of each of the first three sessions, lasting for 15 minutes. The 4th and the last session will include 20 minutes of metacognitive training at the beginning of the session. This metacognitive module will consist of face to face in-session activities that have been designed to strengthen cognitive styles (how we think). Participants will be asked to either work in pairs or individually with these activities. Brief homework activities have been designed based on previous empirical findings. As this is a co-led intervention, peer leaders will be trained to deliver the metacognitive module by an academic clinical psychologist and researcher Dr. Jayanthi Raman. Given this is a pilot study, we will assess participant experience at post-completion of the group intervention.

Arm 2 Experimental Arm: The Body Project Plus. Sessions 1-3: The original 60 minutes of Body Project developed by Eric Stice, Paul Rohde & Heather Shaw, compressed to 45 minutes (sessions 1-3) and to 40 minutes (session 4)- delivered in co-led group format over 4 consecutive weeks by peer educators (who have undergone Body Project training by a trained clinical psychologist) and a clinical psychologist (who has undergone Body Project training with Eric Stice.
PLUS
15 minutes of the MetaMind (Metacognitive training) pilot module in sessions 1-3 and 20 minutes in session 4, developed by Dr. Jay Raman and Prof. Camilla Dahlgren. A hallmark feature of this intervention manual is the theme-congruent metacognitive training. Each brain-directed training component will be accompanied by a metacognitive training component that is directly related to a body image related concern, thereby forming meaningful connectivity between the metacognitive learning and the pragmatics of everyday body image challenges faced by young women.
Groups of 6-8 participants 4 sessions @ 60 min/week for 4 weeks.
MetaMind Session 1: Theme: Cognitive Flexibility & Attentional Bias - 15 minutes. Introduction, Icebreaker exercises, Game: Focus Flip/Attentional Switch- Work in pairs and group brainstorm, Homework. MetaMind Session 2: Recap, Homework discussion, Theme Attentional Bias. Game: Spot it/Selective Attention- Work in pairs and group brainstorm. MetaMind Session 3: Theme: New ways of thinking. Game 1: Random Generation- Work in pairs and group brain storm; Game 2: Pebble story generator. Pair-work and group brainstorm. MetaMind Session 4: Theme Central Coherence- The All of Everything- 10 minutes, Story reading- Individual exercise followed by group brainstorm; Letter to group leaders- Consolidation exercise.
The duration of all homework sessions would range between 10 and 15 minutes each week.
Intervention code [1] 329441 0
Prevention
Intervention code [2] 329442 0
Behaviour
Comparator / control treatment
The active control arm will comprise of the original Body Project Intervention developed by Eric Stice, Paul Rohde & Heather Shaw (as per details stated above). The active control arm will match the experimental arm in duration, mode and time, i.e., Groups of 6-8 participants 4 sessions @ 60 min/week for 4 weeks, Face to Face Group Intervention.

Arm 1: Active Control- The Body Project , developed by Eric Stice, Paul Rohde & Heather Shaw- delivered in co-led group format over 4 consecutive weeks by peer educators (who have undergone Body Project training by a trained clinical psychologist) and a clinical psychologist (who has undergone Body Project training with Eric Stice.)
Groups of 6-8 participants 4 sessions @ 60 min/week for 4 weeks. Group discussions, interactive mode, some paper pencil tasks.
Session 1: Introduction, voluntary commitment and overview, definition and origin of the thin ideal, costs associated with the thin ideal and homework. Session 2: Recap, letter to adolescent girl. mirror exercise debriefing, in session role- plays to discourage the pursuit of thin ideal and homework. Session 3: Recap, role- play on disrupting thin ideal statements, reasons for signing up, behavioural challenge, top 10 list debriefing and homework. Session 4: Recap, discussion on behavioural challenge, body activism, letter to a younger self, benefits of group and closure, self-affirmation exercise, homework and closure.

Control group
Active

Outcomes
Primary outcome [1] 340359 0
Body-image related cognitive flexibility towards appearance
Timepoint [1] 340359 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [1] 443854 0
Depression
Timepoint [1] 443854 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [2] 443853 0
Disordered eating
Timepoint [2] 443853 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [3] 443863 0
Appearance Comparison
Timepoint [3] 443863 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [4] 443855 0
Client Satisfaction
Timepoint [4] 443855 0
End of 4-week Intervention
Secondary outcome [5] 444185 0
overvaluation of shape and weight
Timepoint [5] 444185 0
Baseline, End of 4-week Intervention, 3 and 6 Month Follow-Ups
Secondary outcome [6] 443858 0
Emotion Regulation
Timepoint [6] 443858 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [7] 443856 0
Eating Habit
Timepoint [7] 443856 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [8] 443852 0
Endorsement of Sociocultural Attitudes Towards Appearance
Timepoint [8] 443852 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [9] 443857 0
Self-compassion
Timepoint [9] 443857 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups
Secondary outcome [10] 443859 0
Metacognitive awareness
Timepoint [10] 443859 0
Baseline, End of 4-week Interventionand at 3 and 6 Month Follow-ups
Secondary outcome [11] 443864 0
Process Evaluation
Timepoint [11] 443864 0
End of 4-week Intervention
Secondary outcome [12] 443860 0
Cognitive Flexibility
Timepoint [12] 443860 0
Baseline, End of 4-week Intervention and at 3 and 6 Month Follow-ups

Eligibility
Key inclusion criteria
Aged 18 to 35 years old, identify as a woman, BMI > 18.5, living in Australia, can read, write and speak in English, able to attend 4 weekly, 60 minute intervention.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 18 years old, older than 35 years, not living in Australia, insufficient command of the English language, current serious mental health diagnosis (severe depression, suicidality, psychosis) and head injuries and/or neurological conditions. Given the high prevalence of eating disorders and problematic eating behaviours in the wider community, we have decided not to include Eating Disorders in Exclusion criteria. Individuals living with underweight (<18.5) however will be excluded from study participation.

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)
Yes. Allocation randomisation by sealed envelop internet based randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed envelope internet-based randomization
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We plan to do the first between-group outcome analyses after the end of treatment data collection and after each of the 3- and 6-month follow-up assessments. A sample size of 48 per group was determined through a power analysis to provide 80% power to detect a medium effect size with an alpha level of 0.05, accounting for an anticipated 15% dropout rate. SPSS will be used for data analyses. Baseline univariate between group tests will be done to compare groups on outcome variables, clinical and demographic data. Data will be analysed following “intention-to-treat” principles. Linear mixed effects modelling (Hedeker & Gibbons, 2006) will be used to test for between group differences in the continuous outcome measures. Participant experiences provided at the completion of intervention will be analysed using content analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
15/12/2027
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317340 0
University
Name [1] 317340 0
University of Newcastle
Country [1] 317340 0
Australia
Primary sponsor type
University
Name
School of Psychological Sciences, University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 319623 0
None
Name [1] 319623 0
Address [1] 319623 0
Country [1] 319623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316071 0
The University of Newcastle's Human Research Ethics Committee (HREC)
Ethics committee address [1] 316071 0
Ethics committee country [1] 316071 0
Australia
Date submitted for ethics approval [1] 316071 0
07/06/2024
Approval date [1] 316071 0
10/12/2024
Ethics approval number [1] 316071 0
H-2024-0169.

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

Contacts
Principal investigator
Name 136682 0
Dr Jayanthi (Jay) Raman
Address 136682 0
SO 111, Science Offices Building, Ourimbah Campus, University of Newcastle, NSW 2258
Country 136682 0
Australia
Phone 136682 0
+61408422850
Fax 136682 0
Email 136682 0
[email protected]
Contact person for public queries
Name 136683 0
Jayanthi (Jay) Raman
Address 136683 0
SO 111, Science Offices Building, Ourimbah Campus, University of Newcastle, NSW 2258
Country 136683 0
Australia
Phone 136683 0
+61408422850
Fax 136683 0
Email 136683 0
[email protected]
Contact person for scientific queries
Name 136684 0
Jayanthi (Jay) Raman
Address 136684 0
SO 111, Science Offices Building, Ourimbah Campus, University of Newcastle, NSW 2258
Country 136684 0
Australia
Phone 136684 0
+61408422850
Fax 136684 0
Email 136684 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:
• Available only to researchers who provide a methodologically sound proposal.Data availability will be considered on a case-by-case basis at the discretion of Principal Investigator or delegate.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial, after de-identification

What types of analyses could be done with individual participant data?
• Data will be made available only for the purpose, stated to achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Start Beginning 3 months following main results publication
End -Not yet determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data access subject to approval by Principal Investigator ([email protected]) or delegate.

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.