ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

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]

EDE-Q dietary restraint (same primary outcome used in the larger, ongoing trial)

Timepoint [1]

4 weeks post randomization

Primary outcome [2]

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]

4 weeks post-randomization

Secondary outcome [1]

EDE-Q global scores

Timepoint [1]

4 weeks post-randomization

Secondary outcome [2]

Inflexible eating questionnaire scores

Timepoint [2]

4 weeks post-randomization

Secondary outcome [3]

Dichotomous thinking in eating disorder scale - eating subscale scores

Timepoint [3]

4-weeks post-randomization

Secondary outcome [4]

PHQ-4 total scores

Timepoint [4]

4 weeks post-randomization

Secondary outcome [5]

Disihibition subscale from the TFEQ

Timepoint [5]

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]

University

Name [1]

Deakin University

Address [1]

221 Burwood Hwy, Burwood VIC 3125

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

221 Burwood Hwy, Burwood VIC 3125

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/09/2019

Ethics approval number [1]

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

Dr Jake Linardon

Address

Deakin University
221 Burwood Highway, Burwood, VIC 3125, Australia

Country

Australia

Phone

+61421666585

Fax

jake.linardon@deakin.edu.au

Contact person for public queries

Name

Jake Linardon

Address

Deakin University
221 Burwood Highway, Burwood, VIC 3125, Australia

Country

Australia

Phone

+61421666585

Fax

jake.linardon@deakin.edu.au

Contact person for scientific queries

Name

Jake Linardon

Address

Deakin University
221 Burwood Highway, Burwood, VIC 3125, Australia

Country

Australia

Phone

+61 421666585

Fax

jake.linardon@deakin.edu.au

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 Supporting Document Provided

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	Does the Method of Content Delivery Matter? Randomized Controlled Comparison of an Internet-Based Intervention for Eating Disorder Symptoms With and Without Interactive Functionality.	2022	https://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.

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Documents added manually

Documents added automatically