Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000654651
Ethics application status
Approved
Date submitted
2/06/2023
Date registered
16/06/2023
Date last updated
22/07/2024
Date data sharing statement initially provided
16/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Body Image Single-Session Interventions
Scientific title
Comparing the impact of different online single session interventions on body dissatisfaction, eating psychopathology, and mood in first year university students with body dissatisfaction.
Secondary ID [1] 309822 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body image dissatisfaction 330238 0
Condition category
Condition code
Mental Health 327108 327108 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following completion of baseline demographic questions and state and trait measures, participants are randomly allocated to one of three interventions or a control group. All three interventions are Single Session Interventions (SSI), brief interventions that require no more than 30 minutes to complete. One of the interventions has been adapted from an existing SSI, Project Personality https://osf.io/259jv/ The other two single session interventions were created for this study are thus new content, not available from another source. All three SSIs are delivered using the Qualtrics platform and are completely online, individual, and self-paced (not guided). The content on Qualtrics includes text and images presented on embedded Powerpoint slides. The questions during each SSI included qualitative reflections, in part to check comprehension. Quantitative items are also included at the end of each SSI as a manipulation check (for example rating how much various components were covered to check understanding). Qualtrics also collects data on question completion and time spent completing tasks.

The Body Neutrality SSI starts by asking participants to help the researchers work on way to help improve body image for young people. Psychoeducation about body image is provided, followed by an overview of body neutrality. Examples of young people learning about body neutrality are provided. The SSI then covers strategies to increase body neutrality and encourages participants to participant in tasks at each step, including responding to body image thoughts and feelings with mindfulness, appreciating the body's functionality, caring and respecting the body, acknowledging that self-worth encompasses many things (de-emphasising the role appearance has in self-worth), and practical strategies to pick from and commit to trying over the coming week. Participants are then provided with their individualised body neutrality plan based on their responses to the activities. After a final testimonial from a young person and concluding remarks, participants are asked questions to reflect on what they have learned and to provide feedback about the SSI. Reflection and comprehension questions are also asked several times throughout the SSI.

The Body Positivity SSI is similar to the Body Neutrality SSI. It starts by asking participants to help the researchers work on way to help improve body image for young people. Psychoeducation about body image is provided, followed by an overview of body positivity. Examples of young people learning about body positivity are provided. The SSI then covers strategies to increase body positivity and encourages participants to participant in tasks at each step, including replacing negative body image thoughts and feelings with body positive alternatives, appreciating what is loved about the body, caring and respecting the body, acknowledging that self-worth encompasses many things (de-emphasising the role appearance has in self-worth), and practical strategies to pick from and commit to trying over the coming week. Participants are then provided with their individualised body positivity plan based on their responses to the activities. After a final testimonial from a young person and concluding remarks, participants are asked questions to reflect on what they have learned and to provide feedback about the SSI. Reflection and comprehension questions are also asked several times throughout the SSI.

The third SSI, titled Adaptive Brain, was adapted from an existing project (link provided above). It starts by asking participants to help the researchers work on the best ways to provide information about the brain to people experiencing eating disorders. Case studies with cartoon figures are provided as examples of young people with eating disorders. Research on the impact of starvation on the brain is provided, followed by psychoeducation on how the brain is adaptive and can be changed. Examples such as the famous Phineas Cage case is provided. Participants are asked questions to reflect on what they have learned and are asked to imagine themselves in different scenarios, such as having an eating disorder and speaking to someone else who has an eating disorder. This is to assess understanding of the adaptive brain psychoeducation and its application to hypothetical scenarios.

Following completion of the SSI (or control) participants are allocated to, they complete state measures for a second time. One week later, they are asked to complete the trait measures as a follow-up.
Intervention code [1] 326254 0
Behaviour
Intervention code [2] 326255 0
Treatment: Other
Comparator / control treatment
Participants in the control group are asked to complete a time-matched writing task designed to be non-emotive and be neither harmful nor beneficial. Participants will be asked to write about and describe their bedroom to someone has never seen it. They will be given prompts (for example, "what colour are your walls?".
Control group
Active

Outcomes
Primary outcome [1] 334972 0
Trait body image flexibility, measured using the Body Image Acceptance and Action Questionnaire (BIAAQ; Ferreira, Pinto-Gouveia, & Duarte, 2011)
Timepoint [1] 334972 0
Baseline and 1-week follow-up
Primary outcome [2] 334973 0
Trait eating disorder psychopathology, measured using the Eating Disorder Examination Questionnaire (Fairburn & Beglin, 1994)
Timepoint [2] 334973 0
Baseline and 1-week follow-up
Primary outcome [3] 334975 0
Trait depressive symptoms as measured by the depression subscale of the Depression Anxiety and Stress Scales 21 (Lovibond & Lovibond, 1995)
Timepoint [3] 334975 0
Baseline and 1-week follow-up
Secondary outcome [1] 422600 0
Trait self-efficacy, as measured by the Self-Efficacy Scale (Sherer et al., 1982)
Timepoint [1] 422600 0
Baseline and 1-week follow-up
Secondary outcome [2] 422601 0
Trait hope, as measured by the Trait Hope Scale (Synder et al., 1991)
Timepoint [2] 422601 0
Baseline and 1-week follow-up
Secondary outcome [3] 422602 0
State body image satisfaction, as measured by the Body Image State Scale (Cash et al., 2002)
Timepoint [3] 422602 0
Baseline and post-intervention (immediately after completing the intervention)
Secondary outcome [4] 422603 0
State mood, as measured by the Positive And Negative Affect Schedule (Watson et al., 1998)
Timepoint [4] 422603 0
Baseline and post-intervention (immediately after completing the intervention)
Secondary outcome [5] 422604 0
State hope, as measured by the State Hope Scale (Synder et al., 1996)
Timepoint [5] 422604 0
Baseline and post-intervention (immediately after completing the intervention)
Secondary outcome [6] 422605 0
Trait social media use, as measured by the Appearance Subscale of the Motivations for Social Media Use Scale (Rodgers et al., 2020).
Timepoint [6] 422605 0
Baseline and 1-week follow-up
Secondary outcome [7] 422606 0
Acceptability of each SSI (quantitative rating of how much each concept is liked using a 5-point Likert scale, qualitative responses to describe rating and to provide feedback on what could be improved. Questions designed for purpose of the study, for example "Why did you give this rating (out of 5)? You might like to tell us the things you like or dislike about body neutrality")
Timepoint [7] 422606 0
Post-intervention (immediately after completing the intervention)

Eligibility
Key inclusion criteria
First year university students who have increased weight concern, as measured by a score of 47 or more on the Weight Concerns Scale (Killen et al., 1994)
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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomise function provided by Qualtrics (i.e., computer software).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
31/07/2023
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314008 0
University
Name [1] 314008 0
Flinders University
Country [1] 314008 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park, South Australia 5042
Country
Australia
Secondary sponsor category [1] 315894 0
None
Name [1] 315894 0
Address [1] 315894 0
Country [1] 315894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313145 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 313145 0
Ethics committee country [1] 313145 0
Australia
Date submitted for ethics approval [1] 313145 0
21/05/2023
Approval date [1] 313145 0
30/06/2023
Ethics approval number [1] 313145 0

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

Contacts
Principal investigator
Name 127146 0
Dr Mia Pellizzer
Address 127146 0
Flinders University, Sturt Rd, Bedford Park South Australia 5042
Country 127146 0
Australia
Phone 127146 0
+61 08 82013664
Fax 127146 0
Email 127146 0
[email protected]
Contact person for public queries
Name 127147 0
Mia Pellizzer
Address 127147 0
Flinders University, Sturt Rd, Bedford Park South Australia 5042
Country 127147 0
Australia
Phone 127147 0
+61 08 82013664
Fax 127147 0
Email 127147 0
[email protected]
Contact person for scientific queries
Name 127148 0
Mia Pellizzer
Address 127148 0
Flinders University, Sturt Rd, Bedford Park South Australia 5042
Country 127148 0
Australia
Phone 127148 0
+61 08 8201 3664
Fax 127148 0
Email 127148 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?
All deidentified IPD
When will data be available (start and end dates)?
Data will be available one year following publication, with no end date determined at this time
Available to whom?
Case-by-case basis at the discretion of the researchers
Available for what types of analyses?
At this time, we plan to make data available for any purpose, but will review on a case-by-case basis
How or where can data be obtained?
Access subject to approval by primary researcher: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19359Ethical approval  [email protected]



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.