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Trial registered on ANZCTR


Registration number
ACTRN12619000810112
Ethics application status
Approved
Date submitted
15/05/2019
Date registered
4/06/2019
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Expanding the reach and delivery of Media Smart-Targeted: An online intervention found to both reduce eating disorder onset and increase eating disorder remission
Scientific title
Expanding the reach and delivery of Media Smart-Targeted: An online intervention found to both reduce eating disorder onset and increase eating disorder remission
Secondary ID [1] 298252 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study from ACTRN12618001156279. We are expanding the research to include 13-25 year-old females and males, rather than 18-25 year-old women in the first trial. We are also investigating if rate of program completion impacts on outcomes.

Health condition
Health condition(s) or problem(s) studied:
eating disorders 312851 0
body image 312852 0
Condition category
Condition code
Mental Health 311352 311352 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Media Smart-Targeted (MST) is a 9-module mobile website designed to reduce eating disorder risk (ED: e.g., anorexia nervosa, bulimia nervosa, binge eating disorder). The program includes content targeting: media internalisation, social media usage, emotion regulation, and helpful eating habits. Examples of learning content includes: find online advertisements that stereotype men, women and lifestyle then make a virtual poster to ‘send-up’ these stereotypes; video clips showing various techniques used pre and post photography to manipulate images presented in media; strategies for reducing appearance checking and managing emotions when feeling distressed (e.g., 3-minute breathing space, distress tolerance strategies); and, activities aimed at eliciting personal values then focusing on short and long-term goal setting and the plans needed to reach these.

MST is an adapted form of the school-based program Media Smart that has shown positive effects in young-adolescents.

MST is a self-guided website (i.e., no moderator involved). Participants cannot see other participants responses. Participants are asked to complete homework tasks after each module (e.g., experiment with reducing social media use). Each module takes approximately 20 minutes to complete and involves watching educational videos, reading relevant information and typing answers to questions.

In this RCT, there will be two versions of MST: 1) weekly release of modules as per previous research (i.e., 9 weeks in duration), and 2) user can choose their rate of program completion (i.e., number of weeks not determined but it is assumed that this will generally be less than 9 weeks). Module adherence will be monitored by website diagnostic data that will record dates, time and duration of logins.
Intervention code [1] 314496 0
Prevention
Intervention code [2] 314595 0
Treatment: Other
Comparator / control treatment
The control group will receive a single email with 10 tips on positive body image in an email. This is the same control intervention that we used in the previous RCT. Thus there will be 3 groups in total: MST- Standard (weekly release of modules); MST-Flexible (user chooses own pace); and control group.
Control group
Active

Outcomes
Primary outcome [1] 320083 0
Eating disorder diagnosis will be assessed using diagnostic items in the Eating Disorder Examination - Questionnaire. This is a self-report measure.
Timepoint [1] 320083 0
Baseline, post-program, 6-month follow-up, 12-month follow-up (primary time point)
Primary outcome [2] 320084 0
Disordered eating (continuous measure) will be assessed using the 4 sub scales and combined Total score from the Eating Disorder Examination - Questionnaire. This is a self-report measure.
Timepoint [2] 320084 0
Baseline, post-program, 6-month follow-up, 12-month follow-up (primary time point)
Secondary outcome [1] 370467 0
Media internalisation will be assessed using the Sociocultural Attitudes Towards Appearance Questionnaire - 3, a self-report measure.
Timepoint [1] 370467 0
Baseline, post-program, 6-month follow-up, 12-month follow-up (primary time point)
Secondary outcome [2] 370468 0
Depressive symptoms will be assessed using the Depression, Anxiety Stress Scale - Short Form. This is a self-report measure.
Timepoint [2] 370468 0
Baseline, post-program, 6-month follow-up, 12-month follow-up (primary time point)
Secondary outcome [3] 370469 0
Psychological distress will be assessed using the Clinical Outcomes in Routine Evaluation (CORE-10) measure. This is a self-report measure.
Timepoint [3] 370469 0
Baseline, post-program, 6-month follow-up, 12-month follow-up (primary time point)
Secondary outcome [4] 370470 0
Clinical impairment will be assessed using the self-report Clinical Impairment Assessment Questionnaire.
Timepoint [4] 370470 0
Baseline, post-program, 6-month follow-up, 12-month follow-up (primary time point)
Secondary outcome [5] 370471 0
Social media use using a self-report measure that combines items from two previous studies exploring social media use and its relationship with body image. These references are:

Tiggemann M, Slater A. NetGirls: The Internet, Facebook, and body image concern in adolescent girls. Int J Eat Disord. 2013;46(6):630-633.

Slater A, Varsani N, Diedrichs PC. # fitspo or# loveyourself? The impact of fitspiration and self-compassion Instagram images on women’s body image, self-compassion, and mood. Body image. 2017;22:87-96.
Timepoint [5] 370471 0
Baseline, post-program, 6-month follow-up, 12-month follow-up (primary time point).

Eligibility
Key inclusion criteria
Aged 13-25 years and wishing to improve body image
Minimum age
13 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
suicide risk (e.g., have a suicide plan); alcohol or substance abuse (e.g., withdrawal effects); or, severe anorexia (i.e., body mass index < 15.0).

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)
Computer randomisation will be used, thus the researchers will not be involved in this process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The website will used simple randomisation, stratified by age, sex, and eating disorder diagnosis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All aspects of the research will be conducted online. Participants will complete baseline measures and following this will be automatically randomised to one of the 3 study conditions (assuming exclusion criteria are not met).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analyses of comparison between groups on changes in disordered eating (and all continuous variables), will be based upon linear mixed-effects models (LMM) with random intercepts. Models will include fixed effects for group (MST-Flexible, MST-Standard, controls), time (post-program, 6-month follow-up and 12-month follow-up), gender (females, males) and age (13-17 years; 18-25 years), as well as interaction effects. Baseline scores will be used as a covariate. All analyses will control for accessing external (face-to-face) treatment at any point.

For dichotomous clinical outcomes (e.g., ED diagnosis) logistic regressions will be used. In particular, prevention effects (e.g., new ED cases) and treatment effects (e.g., symptomatic at baseline but not at later points). Potential moderators will be explored to investigate 1) what variables predict level of user engagement and 2) what variables predict greater benefit from standard vs flexible MST delivery. Moderators will include: baseline ED diagnosis; severity of disordered eating; previous treatment; depressive symptoms; gender; and age.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
31/10/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
1383
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302792 0
Charities/Societies/Foundations
Name [1] 302792 0
Australian Rotary Health
Country [1] 302792 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Dr Simon Wilksch
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 302739 0
None
Name [1] 302739 0
None
Address [1] 302739 0
None
Country [1] 302739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303383 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 303383 0
Ethics committee country [1] 303383 0
Australia
Date submitted for ethics approval [1] 303383 0
15/02/2019
Approval date [1] 303383 0
01/04/2019
Ethics approval number [1] 303383 0
8287

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

Contacts
Principal investigator
Name 93482 0
Dr Simon Wilksch
Address 93482 0
Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 93482 0
Australia
Phone 93482 0
+61 8 8201 7996
Fax 93482 0
Email 93482 0
simon.wilksch@flinders.edu.au
Contact person for public queries
Name 93483 0
Simon Wilksch
Address 93483 0
Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 93483 0
Australia
Phone 93483 0
+61 8 8201 7996
Fax 93483 0
Email 93483 0
simon.wilksch@flinders.edu.au
Contact person for scientific queries
Name 93484 0
Simon Wilksch
Address 93484 0
Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 93484 0
Australia
Phone 93484 0
+61 8 8201 7996
Fax 93484 0
Email 93484 0
simon.wilksch@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been applied for or approved by the Ethics Committee.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2106Informed consent form    377606-(Uploaded-15-05-2019-14-07-34)-Study-related document.doc
2107Informed consent form    377606-(Uploaded-15-05-2019-14-07-50)-Study-related document.doc
2108Informed consent form    377606-(Uploaded-15-05-2019-14-08-08)-Study-related document.docx



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.