ANZCTR - Registration

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12625000704493p

Ethics application status

Submitted, not yet approved

Date submitted

17/06/2025

Date registered

2/07/2025

Date last updated

2/07/2025

Date data sharing statement initially provided

2/07/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Helping Adults With Binge Eating: Testing an Online Program With Optional Follow-Up Support

Scientific title

Efficacy of A Stepped-Care Online Program in Treating Objective Binge Eating Frequency and Eating Disorder Psychopathology for Adults With Recurrent Binge Eating: A Randomised Controlled Trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

eating disorder

Condition category

Condition code

Mental Health

Eating disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study is testing a two-step online program for adults who experience recurrent binge eating.
Everyone in the study will first complete a short, self-guided online single session that provides helpful information about binge eating and practical tools to begin making changes. This will take approx 30 min to complete.

These practical tools are educational in nature (no direct therapeutic strategies) and include facts, statistics, and examples of binge eating and binge eating disorder. The mode of delivery is primarily text based with graphical designs (no videos provided). Usage of the single session intervention will be tracked by a back-end system that captures how far someone has progressed through the program (via how many pages they click through).

Two weeks later, participants will be asked about any changes in their eating behaviours. Those who show early improvement will continue with self-monitoring only. Those who do not show enough improvement will be randomly assigned to one of the following:

1. A six-week online self-help program based on Cognitive Behaviour Therapy (CBT).; this program aims to normalize eating, restructure thoughts around weight and shape, and challenge faulty beliefs about dieting.

2. A six-week online self-help program based on Dialectical Behaviour Therapy (DBT): this program aims to foster mindfulness, emotional regulation and distress tolerance.

3. A waitlist.

For both programs, participants will be encouraged to engage in the exercises daily, but complete the modules (5 each) one week at a time. It will take approx. 60 mins to complete a module. Multimodal content delivery formats are provided for both interventions, including written text, videos, audio records, and graphics. Homework exercises (e.g., diary monitoring) will be embedded within the programs. Back-end website analytics will capture various metrics of engagement, including number of logins, time spent on the program, exercises clicked on etc.

Intervention code [1]

Behaviour

Comparator / control treatment

A waitlist group (6 weeks)

Control group

Active

Outcomes

Primary outcome [1]

Objective binge eating frequency

Timepoint [1]

Baseline and 8 weeks from baseline.

Primary outcome [2]

Eating disorder psychopathology

Timepoint [2]

Baseline and 8 weeks post baseline

Secondary outcome [1]

Weight concern

Timepoint [1]

Baseline and 8 weeks post baseline

Secondary outcome [2]

Shape concerns

Timepoint [2]

Baseline and 8 weeks post- baseline

Secondary outcome [3]

Eating concerns

Timepoint [3]

Baseline and 8 weeks post baseline

Secondary outcome [4]

dietary restraint

Timepoint [4]

Baseline and 8 weeks post baseline

Secondary outcome [5]

Compensatory behaviors (composite outcome defined as the average number of self-induced vomiting episodes, laxative use, and driven exercise episodes over the past month).

Timepoint [5]

Baseline and 8 weeks post baseline

Eligibility

Key inclusion criteria

Key Inclusion Criteria:
Adults aged 18 years or older

Able to read and understand English

Currently experiencing recurrent binge eating (defined as having at least one episode of loss-of-control eating every two weeks, on average, over the past three months)

Access to the internet and a device to complete the online program

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

No other exclusion criteria employed

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation will be automated and embedded within the Qualtrics survey platform. Allocation to intervention conditions for Step 2 non-responders will be determined by a computer-generated random sequence, ensuring that group assignment is concealed from both participants and study investigators at the time of allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer-generated randomisation sequence will be used to allocate Step 2 non-responders to one of three conditions: digital CBT (40%), digital DBT (40%), or waitlist control (20%). The randomisation sequence will be programmed into the Qualtrics platform and implemented automatically to ensure unbiased group assignme

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

Not yet recruiting

Date of first participant enrolment

Anticipated

1/09/2025

Actual

Date of last participant enrolment

Anticipated

10/12/2025

Actual

Date of last data collection

Anticipated

10/02/2026

Actual

Sample size

Target

293

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (DUHREC)

Ethics committee address [1]

https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/06/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study is testing whether a two-step, online support program can help adults reduce binge eating. Everyone will begin with a brief, self-guided online session about binge eating. Two weeks later, those who still need support will be randomly offered one of three options: a digital program based on cognitive behaviour therapy (CBT), a program based on dialectical behaviour therapy (DBT), or no additional support for now. We want to find out if these follow-up programs help reduce binge eating more than doing nothing further, and whether CBT or DBT works better. The study also aims to identify who benefits most from each step.

Hypothesis: non early responders randomized to online CBT or DBT will experience greater reduction in primary outcome symptom measures than non-early responders randomized to waitlist and will not differ significantly to early strong responders.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jake Linardon

Address

Deakin University, 75 Pigdons Road Waurn Ponds VIC 3216

Country

Australia

Phone

+61 3 924 46308

Fax

[email protected]

Contact person for public queries

Name

Jake Linardon

Address

Deakin University 75 Pigdons Road Waurn Ponds VIC 3216

Country

Australia

Phone

+61 3 924 46308

Fax

[email protected]

Contact person for scientific queries

Name

Jake Linardon

Address

Deakin University 75 Pigdons Road Waurn Ponds VIC 3216

Country

Australia

Phone

+61 3 924 46308

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: We are not seeking ethics approval for sharing individual patient 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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically