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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the delivery of an online intervention for eating disorder symptoms impact outcome?
Scientific title
Static versus interactive online interventions for eating disorder symptoms: Secondary analyses from a randomized controlled trial
Secondary ID [1] 302585 0
Universal Trial Number (UTN)
Trial acronym
Linked study record
This will be a secondary trial nested within an ongoing larger randomized controlled trial (ACTRN12619001438145). In this secondary trial, participants originally assigned to the waiting list will receive the intervention at post-test. However, at post-test these participants will be randomized to one of two versions of the online program - an interactive, multimedia-based intervention vs a static intervention.

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 319468 0
Condition category
Condition code
Mental Health 317435 317435 0 0
Eating disorders

Study type
Description of intervention(s) / exposure
This is a secondary trial nested within a larger ongoing randomized controlled trial of an internet-based intervention for eating disorder symptoms (ACTRN12619001438145).

In this larger ongoing trial, participants were randomized to either an intervention or wait-list control. The secondary trial capitalizes on the wait-list arm of the trial. Participants originally assigned to the wait-list will receive access to the internet intervention at 4 weeks post-test. However, prior to receiving access, they will again be randomized to one of two different conditions: the interactive, multimedia internet intervention (experimental condition) or the statistic-text based internet intervention (control condition).

The experimental condition is an interactive, multimedia, 4-session internet-based intervention designed to target dietary restraint and binge eating. The intervention is described also in the main trial

The intervention is composed of 4 sessions. The 4 different sessions include:
1. Psycho-education: information on what dieting means, when it can become harmful, and why it can promote binge eating.
2. Self-monitoring: the importance of monitoring behaviors, thoughts, and emotions related to food, eating, and dieting
3. Regular eating: participants taught how to adopt a pattern of regular, flexible eating approach.
4. Food exposure: participants are taught how to overcome fear and anxiety around "forbidden" foods.

Each session will take around 30-60 minutes to complete, and participants will be encouraged to practice the strategies taught in each session on a daily basis. Therefore, total time commitment will vary from person to person. Participants will be encouraged to stay on each session for around 7 days prior to moving to the next session, although they will be instructed that they can go at a pace that suits themselves.

Each session will include: interactive video tutorials discussing the content of the session and how to implement the prescribed strategies; info-graphics that present content in an engaging and novel ways; written text; downloadable handouts to complete the prescribed activities; and multiple choice quizzes designed to consolidate learning.

We will also monitor adherence or engagement to the intervention via Google Analytics (e.g., number of page views, time spent on page).

Intervention code [1] 318870 0
Comparator / control treatment
The control condition will be a statistic version of the same online intervention. That is, participants will be presented with identical content to the experimental condition, but the difference is that the content will be presented in written [static] text format only. In this way, all of the interactive (i.e., quizzes, digital monitoring form) and multimedia (i.e., video tutorials, info-graphs) content will be removed.
Control group

Primary outcome [1] 325471 0
EDE-Q dietary restraint (same primary outcome used in the larger, ongoing trial)
Timepoint [1] 325471 0
4 weeks post randomization
Primary outcome [2] 325472 0
Objective binge eating frequency over the past month, as assessed by a single item from the Eating Disorder Examination Questionnaire (same primary outcome used in the larger, ongoing trial)
Timepoint [2] 325472 0
4 weeks post-randomization
Secondary outcome [1] 388064 0
EDE-Q global scores
Timepoint [1] 388064 0
4 weeks post-randomization
Secondary outcome [2] 388065 0
Inflexible eating questionnaire scores
Timepoint [2] 388065 0
4 weeks post-randomization
Secondary outcome [3] 388066 0
Dichotomous thinking in eating disorder scale - eating subscale scores
Timepoint [3] 388066 0
4-weeks post-randomization
Secondary outcome [4] 388067 0
PHQ-4 total scores
Timepoint [4] 388067 0
4 weeks post-randomization
Secondary outcome [5] 388068 0
Disihibition subscale from the TFEQ
Timepoint [5] 388068 0
4 weeks post-randomization

Key inclusion criteria
As per the larger ongoing RCT, the inclusion criteria are as follows:

a) Male or female adults ( > 17 years)
b) Who want to improve their eating patterns
c) Who have access to the internet

Note that this is identical inclusion criteria employed in the main RCT of waitlist participants: ACTRN12619001438145
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

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

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 307016 0
Name [1] 307016 0
Deakin University
Address [1] 307016 0
221 Burwood Hwy, Burwood VIC 3125
Country [1] 307016 0
Primary sponsor type
Deakin University
221 Burwood Hwy, Burwood VIC 3125
Secondary sponsor category [1] 307587 0
Name [1] 307587 0
Address [1] 307587 0
Country [1] 307587 0

Ethics approval
Ethics application status
Ethics committee name [1] 307148 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 307148 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125, Australia
Ethics committee country [1] 307148 0
Date submitted for ethics approval [1] 307148 0
Approval date [1] 307148 0
Ethics approval number [1] 307148 0

Brief summary
Although internet interventions can effectively address key eating disorder symptoms, it is not yet known whether the mode of content delivery impact engagement, outcomes, and dropout. This randomized controlled trial will compare a static (i.e., written text content online) versus interactive (i.e., multimedia content with embedded activities) internet intervention on eating disorder symptoms. This trial is nested within a larger RCT (ACTRN12619001437156), in which participants originally randomized to the wait-list arm of that trial will be subsequently randomized to either the static or interactive intervention at post-test (once the wait-list period ends). The two interventions are identical in content, with the only difference being the mode of delivery.
Trial website
Trial related presentations / publications
Public notes
For this nested, phase 2 study, we anticipate our final participant enrolment around late Feb 2021 (26/02/21). As such, all data should be collected by late March 2021 (26/03).

Principal investigator
Name 106198 0
Dr Jake Linardon
Address 106198 0
Deakin University
221 Burwood Highway, Burwood, VIC 3125, Australia
Country 106198 0
Phone 106198 0
Fax 106198 0
Email 106198 0
Contact person for public queries
Name 106199 0
Dr Jake Linardon
Address 106199 0
Deakin University
221 Burwood Highway, Burwood, VIC 3125, Australia
Country 106199 0
Phone 106199 0
Fax 106199 0
Email 106199 0
Contact person for scientific queries
Name 106200 0
Dr Jake Linardon
Address 106200 0
Deakin University
221 Burwood Highway, Burwood, VIC 3125, Australia
Country 106200 0
Phone 106200 0
+61 421666585
Fax 106200 0
Email 106200 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
We do not have ethical clearance to publicly share the data
What supporting documents are/will be available?
No other documents available
Summary results
No Results