Trial Review

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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] 314687 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorder 337856 0
Condition category
Condition code
Mental Health 334187 334187 0 0
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] 331295 0
Behaviour
Comparator / control treatment
A waitlist group (6 weeks)
Control group
Active

Outcomes
Primary outcome [1] 341840 0
Objective binge eating frequency
Timepoint [1] 341840 0
Baseline and 8 weeks from baseline.
Primary outcome [2] 341841 0
Eating disorder psychopathology
Timepoint [2] 341841 0
Baseline and 8 weeks post baseline
Secondary outcome [1] 448810 0
Weight concern
Timepoint [1] 448810 0
Baseline and 8 weeks post baseline
Secondary outcome [2] 448811 0
Shape concerns
Timepoint [2] 448811 0
Baseline and 8 weeks post- baseline
Secondary outcome [3] 448812 0
Eating concerns
Timepoint [3] 448812 0
Baseline and 8 weeks post baseline
Secondary outcome [4] 448813 0
dietary restraint
Timepoint [4] 448813 0
Baseline and 8 weeks post baseline
Secondary outcome [5] 448814 0
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] 448814 0
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?
No
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] 319236 0
University
Name [1] 319236 0
Deakin University
Country [1] 319236 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 321704 0
None
Name [1] 321704 0
Address [1] 321704 0
Country [1] 321704 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317814 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 317814 0
Ethics committee country [1] 317814 0
Australia
Date submitted for ethics approval [1] 317814 0
17/06/2025
Approval date [1] 317814 0
Ethics approval number [1] 317814 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142242 0
Dr Jake Linardon
Address 142242 0
Deakin University, 75 Pigdons Road Waurn Ponds VIC 3216
Country 142242 0
Australia
Phone 142242 0
+61 3 924 46308
Fax 142242 0
Email 142242 0
[email protected]
Contact person for public queries
Name 142243 0
Jake Linardon
Address 142243 0
Deakin University 75 Pigdons Road Waurn Ponds VIC 3216
Country 142243 0
Australia
Phone 142243 0
+61 3 924 46308
Fax 142243 0
Email 142243 0
[email protected]
Contact person for scientific queries
Name 142244 0
Jake Linardon
Address 142244 0
Deakin University 75 Pigdons Road Waurn Ponds VIC 3216
Country 142244 0
Australia
Phone 142244 0
+61 3 924 46308
Fax 142244 0
Email 142244 0
[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.