Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001156279
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
13/07/2018
Date last updated
13/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Online prevention of disordered eating in at-risk young-adult women: A two-country pragmatic randomised controlled trial
Scientific title
Online prevention of disordered eating in at-risk young-adult women: A two-country pragmatic randomised controlled trial
Secondary ID [1] 295486 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 308751 0
disordered eating
 308752 0
substance use 308753 0
alcohol use
 308754 0
suicide risk 308755 0
depressive symptoms 308756 0
Condition category
Condition code
Mental Health 307684 307684 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were allocated to just one condition: Media Smart-Targeted; Student Bodies; or, control. Media Smart-Targeted and Student Bodies were both 9 modules long with 1 module released per week. Both programs featured a mixture of: reading material; images; videos; reflection tasks; and homework tasks that were generated specifically for the intervention (i.e., not publicly available). For both programs, modules took up to 30 minutes to complete, but often less than this. Adherence was measured through: website analytics of modules accessed and completed and qualitative feedback at the conclusion of each module.
1. Media Smart-Targeted: 9 module online mobile website that is an adapted for high-risk young-adult women from the school-based Media Smart program for universal classes of young-adolescent girls and boys.
2. Student Bodies: 9 module online mobile website that is a highly regarded international eating disorder prevention program for young-adult women
Intervention code [1] 301802 0
Prevention
Intervention code [2] 301803 0
Behaviour
Intervention code [3] 301804 0
Early detection / Screening
Comparator / control treatment
An email of 10 tips for positive body image
Control group
Active

Outcomes
Primary outcome [1] 306671 0
Disordered eating (dichotomous): this was measured by the Eating Disorder Examination -Questionnaire (EDE-Q: Fairburn and Beglin, 1994) and was defined as having a global EDE-Q score >= 1 SD of the community mean (i.e., 2.46: Mond et al., 2004), and the presence of one or more of the following in the previous 4-week period: objective bulimic episode; fasting; vomiting or laxatives to control weight; or BMI <18.5.
Timepoint [1] 306671 0
Assessments were taken at baseline, post-program, 6- and 12-month follow-up, with this final timepoint being the point of determining prevention and treatment effects.
Secondary outcome [1] 349185 0
Eating disorder diagnoses: this was measured by the diagnostic items from the (EDE-Q) for: anorexia nervosa, bulimia nervosa, binge eating disorder, and other specific feeding and eating disorder. Whilst this variable has overlap with the disordered eating variable, it does provide more specific information about the type of eating disorder diagnosis and the requirements for diagnosis were greater than for disordered eating.
Timepoint [1] 349185 0
Assessments were taken at baseline, post-program, 6- and 12-month follow-up, with this final timepoint being the point of determining prevention and treatment effects.
Secondary outcome [2] 349186 0
Depressive symptoms were assessed using the Depression Scale from the Depression, Anxiety, Stress Scale (DASS-21: Lovibond & Lovibond, 1995).
Timepoint [2] 349186 0
Baseline, post-program, 6- and 12-month follow-up
Secondary outcome [3] 349187 0
Suicidality was assessed using 6 items from the Suicidality section of the MINI International Schedule (Lecrubier, et al., 1997).
Timepoint [3] 349187 0
Baseline, post-program, 6- and 12-month follow-up
Secondary outcome [4] 349188 0
Alcohol use was assessed using 3 items from the Alcohol Dependence section of the MINI International Schedule (Lecrubier, et al., 1997). The screening question was "In the past 12 months, have you drunk 3 or more alcoholic beverages in a 3-hour period, on 3 or more occasions?" and this was followed-up with a question about withdrawal effects and tolerance.
Timepoint [4] 349188 0
Baseline, post-program, 6- and 12-month follow-up
Secondary outcome [5] 349189 0
Media Internalisation was assessed using the Sociocultural Attitudes Towards Appearance Questionnaire-3 (Thompson et al., 2004)
Timepoint [5] 349189 0
Baseline, post-program, 6- and 12-month follow-up
Secondary outcome [6] 349317 0
Recreational drug use was assessed using 3 items from the Substance Dependence section of the MINI International Schedule (Lecrubier, et al., 1997). The screening question was "In the past 12 months, have you taken a recreational drug/s (not alcohol) more than once to get high, to feel elated, to get “a buzz” or to change your mood?" and this was followed-up with a question about withdrawal effects and tolerance
Timepoint [6] 349317 0
Baseline, post-program, 6-month and 12-month follow-up
Secondary outcome [7] 349318 0
Quality of life - Mental was assessed using the Medical Outcome Studies Short Form Scales – Mental Component Scale (Ware et al., 1993)
Timepoint [7] 349318 0
Baseline, post-program, 6-month follow-up and 12-month follow-up

Eligibility
Key inclusion criteria
Participants were women aged 18-25 years from Australia and New Zealand who wished to improve their body image.
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. suicide risk (e.g., have a suicide plan)
2. alcohol or substance abuse (e.g., presence of withdrawal effects when reducing use)
3. self-reported 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)
Prospective participants self-referred to the study website, read the study information and completed consent procedures. They then completed online baseline questionnaires and if met inclusion criteria, were automatically randomised to one of the 3 conditions with randomisation stratified by age (18-21 years; 21.01 years- 25 years) and baseline scores on the Weight Concerns Scale (<47; >47: WCS: Killen et al., 1994).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Both prevention (disordered eating status) for those who did not have DE at baseline and treatment effects (DE status for those who had DE at baseline) were investigated. Odds ratios (OR) and 95% CI from logistic regressions were used to compare DE status at 12-month follow-up in the intervention groups relative to the control group.

Linear mixed models were used to assess the efficacy of programs on continuous measures of eating disorder risk factors and impairment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/11/2014
Date of last participant enrolment
Anticipated
Actual
1/11/2015
Date of last data collection
Anticipated
Actual
30/12/2016
Sample size
Target
510
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 10631 0
New Zealand
State/province [1] 10631 0

Funding & Sponsors
Funding source category [1] 300073 0
Government body
Name [1] 300073 0
NHRMC Mental Health Targeted Call for Research
Country [1] 300073 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Psychology
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 299471 0
None
Name [1] 299471 0
None
Address [1] 299471 0
None
Country [1] 299471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300920 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 300920 0
Flinders University
Sturt Road, Bedford Park | South Australia | 5042
GPO Box 2100 | Adelaide SA 5001
Ethics committee country [1] 300920 0
Australia
Date submitted for ethics approval [1] 300920 0
19/11/2012
Approval date [1] 300920 0
25/01/2013
Ethics approval number [1] 300920 0
5910

Summary
Brief summary
Eating disorders (ED) and disordered eating (DE) are widespread, serious problems. Efficacious prevention programs that can be delivered at-scale are needed. An online randomized-controlled trial of 2 online programs was conducted. Participants were young-adult women from Australia and New Zealand seeking to improve their body image. Media Smart-Targeted (MS-T) and Student Bodies (SB) were both 9-module interventions released weekly, whilst control participants received positive body image information. Outcome measures were completed at baseline, post-program, 6- and 12-month follow-up. It was expected that both interventions would be superior than controls at lowering eating disorder risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85282 0
Dr Simon Wilksch
Address 85282 0
Research Fellow in Psychology
Flinders University
GPO Box 2100 Adelaide SA 5001
Country 85282 0
Australia
Phone 85282 0
+61 8 82017996
Fax 85282 0
Email 85282 0
simon.wilksch@flinders.edu.au
Contact person for public queries
Name 85283 0
Dr Simon Wilksch
Address 85283 0
Research Fellow in Psychology
Flinders University
GPO Box 2100 Adelaide SA 5001
Country 85283 0
Australia
Phone 85283 0
+61 8 82017996
Fax 85283 0
Email 85283 0
simon.wilksch@flinders.edu.au
Contact person for scientific queries
Name 85284 0
Dr Simon Wilksch
Address 85284 0
Research Fellow in Psychology
Flinders University
GPO Box 2100 Adelaide SA 5001
Country 85284 0
Australia
Phone 85284 0
+61 8 82017996
Fax 85284 0
Email 85284 0
simon.wilksch@flinders.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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