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Trial registered on ANZCTR
Registration number
ACTRN12621000353897
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
29/03/2021
Date last updated
20/06/2022
Date data sharing statement initially provided
29/03/2021
Date results provided
20/06/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Piloting a Treatment to Address Social Media Use and Eating Disorder Risk in University Students
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Scientific title
Piloting a Self-Criticism Intervention Addressing the Relationship Between Social Media Use and Eating Disorder Risk in University Students
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Secondary ID [1]
303276
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eating disorders
320554
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Self-criticism
320555
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Body image dissatisfaction
320556
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Condition category
Condition code
Mental Health
318411
318411
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0
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Eating disorders
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Mental Health
318759
318759
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Primary intervention: self-criticism intervention.
Participants are emailed a set of intervention modules in fillable PDF format, which use CBT techniques to address self-criticism in the context of appearance and social media. These are self-guided interventions which can be completed either on the computer or printed to be completed in hard copy. The intervention comprises 4 modules, each of which takes approximately 15 minutes to complete, and which we will ask that they complete over one week. Because the intervention is delivered to participants digitally, it can be completed by participants in the location of their choosing. Participants will be asked to complete questionnaires of primary and secondary outcomes at baseline, post-treatment, and one-week follow-up (the latter of which is optional).
The intervention modules are not available from another source; this study is designed to test their feasibility and this is the first time they are being trialled. The first intervention module provides psychoeducation about self-criticism and self-compassion and the homework task asks participants to record 5 instances over a couple of days where they either self-criticise or use self-compassion. In the second module, the participant is asked to reflect on what they learned from the homework task, further psychoeducation about self-criticism and self-compassion is provided, and they complete a questionnaire about self-compassion to help them determine the things that get in the way of using self-compassion. The homework task for the second module is to run a behaviour experiment over the next 2 days where they use self-criticism one day and self-compassion the next day and record the outcomes of each approach. The third module includes a homework review, guides the development of individualised self-compassionate messages, and runs through an imagery rescripting exercise about a recent instance of self-compassion. The module three homework is to review the rescripted memory the following day. The final module includes a homework review, a problem-solving exercise around how to make changes to the way one uses social media to make it less likely to cause self-criticism about one's body and appearance. The homework for this final module is to implement the plan made during the problem-solving exercise and evaluate whether it has been helpful. There is one homework task per module, so 4 tasks in total, and each is designed to take 5-10 minutes to complete. The modules ask that participants complete each homework task before starting the next module.
Intervention adherence will be assessed by questions in the post-treatment questionnaires asking for estimates of how much of the modules and the homework they completed.
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Active control: social media curation intervention.
Participants are emailed a set of intervention modules in fillable PDF format, which use CBT techniques to encourage participants to problem-solve their social media use and its impact on how they feel about their appearance. These are self-guided interventions which can be completed either on the computer or printed to be completed in hard copy. The intervention comprises 4 modules, each of which takes approximately 15 minutes to complete, and which we will ask that they complete over one week. Because the intervention is delivered to participants digitally, it can be completed by participants in the location of their choosing. Participants will be asked to complete questionnaires of primary and secondary outcomes at baseline, post-treatment, and one-week follow-up (the latter of which is optional).
The intervention modules are not available from another source; this study is designed to test their feasibility and this is the first time they are being trialled. The first intervention module provides psychoeducation about social media and its relationship to eating disorder risk, and the homework task asks participants to record for 2 days when and why they use social media, and how it makes them feel. In the second module, the participant is asked to reflect on what they learned from the homework task and psychoeducation about social media literacy is provided. The homework task for the second module is to record examples of inauthentic/unrealistic things they see on social media. The third module includes a homework review and then asks participants to start considering the positives and negatives about their social media use and how they might be able to change it to make it more positive. The module three homework is to record over 2 days the types of content they see on social media and whether seeing that impacts them positively or negatively. The final module includes a homework review and then guides participants through the process of "curating their feed" - making changes to their social media use so that it may impact more positively on their wellbeing. The homework for this final module is to implement the plan for curating their feed and evaluate how social media impacts on their feelings now. There is one homework task per module, so 4 tasks in total, and each is designed to take 5-10 minutes to complete. The modules ask that participants complete each homework task before starting the next module.
Intervention adherence will be assessed by questions in the post-treatment questionnaires asking for estimates of how much of the modules and the homework they completed.
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Intervention code [1]
319629
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Behaviour
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Intervention code [2]
319870
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Treatment: Other
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Comparator / control treatment
Control: waitlist.
Participants assigned to this condition will complete baseline questionnaires, then post-treatment questionnaires of secondary outcome measures a week later, and then an optional one-week follow-up questionnaire following that. Following this, they will be provided the self-criticism intervention modules via email. The modules will be sent after the primary researcher confirms that they have completed the post-treatment questionnaires if they do not consent to be contacted for follow-up. If they do consent to be contacted for the follow-up questionnaires, the modules will be sent after the primary researcher confirms that they have completed the follow-up questionnaires or 2 weeks after first being sent the link to the follow-up questionnaires (whichever occurs first).
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Control group
Active
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Outcomes
Primary outcome [1]
326391
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Feasibility, assessed by % of module completion (self-reported using study-specific item: "Can you please enter an estimate of how much (as a percentage) of the intervention modules you completed (i.e., how much you read and how many questions you answered in the PDFs)?")
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Assessment method [1]
326391
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Timepoint [1]
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Post-treatment (1 week post-randomisation)
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Primary outcome [2]
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Feasibility, assessed by % of homework completion (self-reported using study-specific item: "Can you please enter an estimate of how much (as a percentage) of the homework tasks you completed?")
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Assessment method [2]
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Timepoint [2]
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Post-treatment (1 week post-randomisation)
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Primary outcome [3]
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Acceptability of the intervention (qualitative feedback provided via online post-treatment questionnaires using study-specific items: "What did you like about the intervention?", "What did you dislike about the intervention?", and "Do you have any other feedback for us?")
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Assessment method [3]
326393
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Timepoint [3]
326393
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Post-treatment (1 week post-randomisation)
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Secondary outcome [1]
391289
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Cohen's d effect size change in using social media for appearance-related reasons, measured using the appearance motivations subscale of the Motivations for Social Media Use Scale (MSMU; Rodgers et al., 2020)
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Assessment method [1]
391289
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Timepoint [1]
391289
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Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
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Secondary outcome [2]
391290
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Cohen's d effect size change in appearance comparison, measured using the Physical Appearance Comparison Scale - Revised (PACS-R; Schaefer & Thompson, 2014)
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Assessment method [2]
391290
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Timepoint [2]
391290
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Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
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Secondary outcome [3]
391291
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Cohen's d effect size change in self-criticism, measured with the self-criticism subscale of the Reconstructed Depressive Experiences Questionnaire (RecDEQ; Bagby et al., 1994)
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Assessment method [3]
391291
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Timepoint [3]
391291
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Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
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Secondary outcome [4]
391292
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Cohen's d effect size change in body image flexibility, measured using the Body Image Acceptance and Action Questionnaire (BIAAQ; Ferreira, Pinto-Gouveia, & Duarte, 2011)
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Assessment method [4]
391292
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Timepoint [4]
391292
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Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
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Secondary outcome [5]
391293
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Cohen's d effect size change in disordered eating, measured using the Short Form of the Eating Disorder Examination Questionnaire (EDE-QS; Gideon et al., 2016)
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Assessment method [5]
391293
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Timepoint [5]
391293
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Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
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Eligibility
Key inclusion criteria
Participants must be university students aged 17 to 25 who are fluent in English and feel that they use social media for appearance-related reasons.
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Minimum age
17
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
People who are currently undergoing treatment for self-criticism, body image concerns, or disordered eating.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to conditions will be carried out automatically by a function embedded in the online baseline questionnaires, so with no involvement by the researchers.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomise function provided by Qualtrics (i.e., computer software).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
2/03/2021
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Date of last participant enrolment
Anticipated
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Actual
14/10/2021
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Date of last data collection
Anticipated
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Actual
26/10/2021
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Sample size
Target
80
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Accrual to date
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Final
202
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
307686
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University
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Name [1]
307686
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Flinders University
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Address [1]
307686
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Sturt Rd, Bedford Park, South Australia 5042
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Country [1]
307686
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Australia
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Funding source category [2]
308004
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Government body
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Name [2]
308004
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Australian Government Department of Education, Skills and Employment
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Address [2]
308004
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GPO Box 9880
Canberra ACT 2601
Australia
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Country [2]
308004
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
Sturt Rd, Bedford Park, South Australia 5042
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Country
Australia
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Secondary sponsor category [1]
308441
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None
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Name [1]
308441
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Address [1]
308441
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Country [1]
308441
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307722
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Flinders University Human Research Ethics Committee
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Ethics committee address [1]
307722
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Flinders University Sturt Road, Bedford Park, South Australia, 5042
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Ethics committee country [1]
307722
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Australia
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Date submitted for ethics approval [1]
307722
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Approval date [1]
307722
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30/09/2020
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Ethics approval number [1]
307722
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Summary
Brief summary
This project will test a new intervention that aims to prevent people's social media use from causing them to feel dissatisfied with their body and experience disordered eating. The intervention uses exercises designed to help people reduce their self-criticism and increase their self-compassion when using social media. The project will assess how much participants engage with the intervention, request their feedback on it, and determine whether there is evidence that it may help to prevent disordered eating. Because this intervention has not been tested before, we do not know if it will be effective or acceptable, but we hope that it will reduce appearance comparison, self-criticism, and disordered eating, and increase body image flexibility.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
108274
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Ms Madelaine de Valle
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Address
108274
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Flinders University, Sturt Rd, Bedford Park South Australia 5042
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Country
108274
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Australia
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Phone
108274
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+61 8 8201 7821
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Fax
108274
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Email
108274
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[email protected]
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Contact person for public queries
Name
108275
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Madelaine de Valle
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Address
108275
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Flinders University, Sturt Rd, Bedford Park South Australia 5042
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Country
108275
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Australia
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Phone
108275
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+61 8 8201 7821
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Fax
108275
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Email
108275
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[email protected]
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Contact person for scientific queries
Name
108276
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Madelaine de Valle
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Address
108276
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Flinders University, Sturt Rd, Bedford Park South Australia 5042
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Country
108276
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Australia
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Phone
108276
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+61 8 8201 7821
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Fax
108276
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Email
108276
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All deidentified IPD.
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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.
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Available to whom?
Case-by-case basis at the discretion of the researchers.
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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.
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How or where can data be obtained?
Access subject to approval by primary researcher:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
10417
Ethical approval
[email protected]
10418
Informed consent form
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Targeting the link between social media and eating disorder risk: A randomized controlled pilot study.
2022
https://dx.doi.org/10.1002/eat.23756
N.B. These documents automatically identified may not have been verified by the study sponsor.
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