Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000515493
Ethics application status
Approved
Date submitted
13/11/2024
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial addressing body image on social media in adults
Scientific title
A social network theory informed pilot randomised controlled trial addressing body image on social media in adults
Secondary ID [1] 314261 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
body image 335743 0
disordered eating 337190 0
Condition category
Condition code
Mental Health 332298 332298 0 0
Eating disorders
Mental Health 333824 333824 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Reshape intervention seeks to reduce body dissatisfaction and providing advice and strategies around using social media in a safe way (including building resilience through social media literacy skills). The program presents visual and audio content and participants will work through 3 modules, 1 per week. Each module takes approximately 20-30 minutes to complete, plus a homework/reflective activity (~10 minutes for each). An example of a homework/reflective activity is to try using some self-prescribed strategies to improve their social media experience over the week. Some strategies include identifying and following positive accounts, or practicing mindfulness while using social media.

The program is accessed through an online website. Participants are instructed to work through the modules independently at their own pace and complete homework/reflection activities where necessary. A self-compassion lens is used throughout. Broadly, the intervention covers the following topics: (1) Social media is not real – discussion and activities around social comparisons, (2) Unpacking social media messages - how to spot subtle messaging and avoid getting manipulated. (3) Values at the core - exploring their values and how their social media use can more closely align with these. Online platform/website analytics records participant engagement with modules.
Intervention code [1] 329956 0
Lifestyle
Comparator / control treatment
Waitlist control. These will be offered the intervention after the 3 month follow-up survey
Control group
Active

Outcomes
Primary outcome [1] 339874 0
Facial appearance concerns
Timepoint [1] 339874 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline). The primary timepoint is post-intervention.
Primary outcome [2] 341587 0
Body dissatisfaction
Timepoint [2] 341587 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline). The primary timepoint is post-intervention.
Primary outcome [3] 341588 0
Disordered eating
Timepoint [3] 341588 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline). The primary timepoint is post-intervention.
Secondary outcome [1] 441726 0
Social media content exposure
Timepoint [1] 441726 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [2] 446964 0
Social media photo editing
Timepoint [2] 446964 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [3] 446965 0
Internalisation of appearance ideals
Timepoint [3] 446965 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [4] 446966 0
Social media comparisons
Timepoint [4] 446966 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [5] 446967 0
Depressive symptoms
Timepoint [5] 446967 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [6] 446968 0
Motivations for using social media
Timepoint [6] 446968 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [7] 446969 0
Social media literacy
Timepoint [7] 446969 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline)..
Secondary outcome [8] 446970 0
Desire for cosmetic surgery
Timepoint [8] 446970 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [9] 446971 0
Body image flexibility
Timepoint [9] 446971 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).
Secondary outcome [10] 447716 0
TikTok Usage
Timepoint [10] 447716 0
Baseline and post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline).
Secondary outcome [11] 448005 0
Social media frequency
Timepoint [11] 448005 0
Baseline, post-intervention (i.e., after 3-weeks of intervention access / 1 month post baseline), 3-month follow-up (i.e., 4 months post baseline).

Eligibility
Key inclusion criteria
Participants will be:
18 years or older,
fluent English speakers,
social media users,
living in Australia,
experiencing body/eating concerns.

This latter criterion will be determined using the 6-item InsideOut Institute-Screener (IOI-S; Bryant et al., 2021). The IOI-S is a digital screening tool designed to assess broad eating disorder risk and symptomatology, validated for individuals aged 14 and over. It covers six facets of common eating disorder psychopathology including an individual’s relationship with food, the extent to which body shape and weight determines self-worth, preoccupation with food or body weight, food-related anxiety, loss of control overeating, and compensatory behaviour. It is not a diagnostic tool or comprehensive assessment, but can be used to indicate moderate risk of significant body and eating concerns (>13; Bryant et al., 2023) - hence we used this cut-off.
Minimum age
18 Years
Maximum age
No limit
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)
Participants will be randomised via the survey software Qualtrics
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We aim to obtain equivalent groups at baseline based on randomization to the two arms of the study. Randomisation will be achieved through Qualtrics on a 1:1 basis. As this is done once the participants complete the baseline survey, and automated by simple randomisation through Qualtrics itself, the researchers will not bias randomization
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/10/2024
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
2/11/2025
Actual
Sample size
Target
197
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317814 0
University
Name [1] 317814 0
Deakin University Postdoctoral Research Fellowship
Country [1] 317814 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 320144 0
None
Name [1] 320144 0
Address [1] 320144 0
Country [1] 320144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316498 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 316498 0
Ethics committee country [1] 316498 0
Australia
Date submitted for ethics approval [1] 316498 0
28/09/2023
Approval date [1] 316498 0
06/12/2023
Ethics approval number [1] 316498 0

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

Contacts
Principal investigator
Name 138086 0
Dr Hannah Jarman
Address 138086 0
221 Burwood Highway, Deakin University, Burwood, Victoria 3125,
Country 138086 0
Australia
Phone 138086 0
+61 435 753 403
Fax 138086 0
Email 138086 0
[email protected]
Contact person for public queries
Name 138087 0
Hannah Jarman
Address 138087 0
221 Burwood Highway, Deakin University, Burwood, Victoria 3125,
Country 138087 0
Australia
Phone 138087 0
+61 03 9244 6100
Fax 138087 0
Email 138087 0
[email protected]
Contact person for scientific queries
Name 138088 0
Hannah Jarman
Address 138088 0
221 Burwood Highway, Deakin University, Burwood, Victoria 3125,
Country 138088 0
Australia
Phone 138088 0
+61 03 9244 6100
Fax 138088 0
Email 138088 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24346Ethical approval    2023320-231206-A-AM-o.pdf



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.