Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000014853
Ethics application status
Approved
Date submitted
22/10/2020
Date registered
12/01/2021
Date last updated
12/01/2021
Date data sharing statement initially provided
12/01/2021
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
Nil
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

Intervention/exposure
Study type
Interventional
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
Prevention
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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/10/2020
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
26/03/2021
Actual
Sample size
Target
450
Accrual to date
400
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307016 0
University
Name [1] 307016 0
Deakin University
Country [1] 307016 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 307587 0
None
Name [1] 307587 0
NA
Address [1] 307587 0
NA
Country [1] 307587 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 307148 0
Approval date [1] 307148 0
02/09/2019
Ethics approval number [1] 307148 0

Summary
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).

Contacts
Principal investigator
Name 106198 0
Dr Jake Linardon
Address 106198 0
Deakin University
221 Burwood Highway, Burwood, VIC 3125, Australia
Country 106198 0
Australia
Phone 106198 0
+61421666585
Fax 106198 0
Email 106198 0
jake.linardon@deakin.edu.au
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
Australia
Phone 106199 0
+61421666585
Fax 106199 0
Email 106199 0
jake.linardon@deakin.edu.au
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
Australia
Phone 106200 0
+61 421666585
Fax 106200 0
Email 106200 0
jake.linardon@deakin.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
We do not have ethical clearance to publicly share the data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes the Method of Content Delivery Matter? Randomized Controlled Comparison of an Internet-Based Intervention for Eating Disorder Symptoms With and Without Interactive Functionality.2022https://dx.doi.org/10.1016/j.beth.2021.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.