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Trial registered on ANZCTR


Registration number
ACTRN12621000914864
Ethics application status
Approved
Date submitted
3/06/2021
Date registered
14/07/2021
Date last updated
14/07/2021
Date data sharing statement initially provided
14/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital mental health interventions for recurrent binge eating
Scientific title
Efficacy of internet- and app-based interventions for recurrent binge eating. A three-armed randomized controlled trial.
Secondary ID [1] 304394 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 322187 0
Binge eating 322188 0
Condition category
Condition code
Mental Health 319878 319878 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two digital interventions delivered in this trial.

The first will be a internet-based intervention designed to primarily target extreme dietary restraint as the mechanism to reduce binge eating.
The internet intervention is composed of 4 sessions.
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.

The second digital intervention will be delivered only via a smartphone app. The app is based on transdiagnostic CBT (Fairburn, 2008) in that it is designed to target a range of factors implicated in the maintenance of binge eating (e.g., overvaluation with weight/shape, extreme dietary restraint & mood intolerance).

There are also 4 modules to this app:
1. Psychoeducation about binge eating and its cycle
2. Implementing self-monitoring and regular eating
3. Learning healthy coping strategies through acceptance, mindfulness, and problem solving
4. Building a better body image

Each session/module of the two interventions 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. The total duration of the interventions will be 4 weeks, though participants have the opportunity to continue using the interventions after this period.

Each session/module will include: written text, quizzes/ interactive video or audio recordings discussing the content of the session and how to implement the prescribed strategies; downloadable handouts to complete the prescribed activities; and quizzes designed to consolidate learning.

Adherence will be monitored by assessing whether participants complete each of the sessions/modules, including how much of the session/module will be completed.
Intervention code [1] 320754 0
Treatment: Other
Intervention code [2] 320969 0
Behaviour
Comparator / control treatment
The control condition will be a wait-list. Participants allocated to the waitlist will be notified that they can receive one of two of the digital interventions at post-test (4 weeks from baseline).
Control group
Placebo

Outcomes
Primary outcome [1] 327751 0
Eating disorder psychopathology (global scores from the Eating Disorder Examination Questionnaire)
Timepoint [1] 327751 0
Primary time-point (post-test) = 4 weeks after randomization.
Follow-up time-point = 8 weeks after randomization.
Primary outcome [2] 327752 0
Objective binge eating frequency over the past 28 days (assessed via a single item from the EDE-Q).
Timepoint [2] 327752 0
Primary time-point (post-test) = 4 weeks after randomization.
Follow-up time-point = 8 weeks after randomization.
Secondary outcome [1] 396435 0
Dietary restraint (EDE-Q subscale)
Timepoint [1] 396435 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [2] 396436 0
shape concerns (EDE-Q subscale)
Timepoint [2] 396436 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [3] 396437 0
Weight concerns (EDE-Q subscale)
Timepoint [3] 396437 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [4] 396438 0
Eating concerns (EDE-Q subscale)
Timepoint [4] 396438 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [5] 396439 0
Subjective binge eating frequency (single EDE-Q item)
Timepoint [5] 396439 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [6] 396440 0
Depressive symptoms (PHQ-2)
Timepoint [6] 396440 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [7] 396441 0
Anxiety symptoms (PHQ-2)
Timepoint [7] 396441 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [8] 396442 0
Body image flexibility (BIAAQ-4)
Timepoint [8] 396442 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [9] 396443 0
Body appreciation (BAS-2 3-item version)
Timepoint [9] 396443 0
4 weeks after randomization.
8 weeks after randomization.
Secondary outcome [10] 396444 0
Functionality appreciation (FAS-7)
Timepoint [10] 396444 0
4 weeks after randomization.
8 weeks after randomization.

Eligibility
Key inclusion criteria
Participants must:
1) Be aged 18 years or over
2) Have access to the internet or smartphone
3) Experience the presence of recurrent binge eating, defined as binge eating at least once per fortnight, on average, over the past 3 months via self-report.
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 will be 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)
Researchers will not be aware of any upcoming assignments as the randomisation process will be done completely online via Qualtrics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed via Qualtrics' randomisation function.
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
2/08/2021
Actual
Date of last participant enrolment
Anticipated
9/08/2021
Actual
Date of last data collection
Anticipated
9/10/2021
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308763 0
University
Name [1] 308763 0
Deakin University
Country [1] 308763 0
Australia
Funding source category [2] 308766 0
Government body
Name [2] 308766 0
NHMRC
Country [2] 308766 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 309667 0
None
Name [1] 309667 0
Address [1] 309667 0
Country [1] 309667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308679 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 308679 0
Ethics committee country [1] 308679 0
Australia
Date submitted for ethics approval [1] 308679 0
14/01/2021
Approval date [1] 308679 0
29/04/2021
Ethics approval number [1] 308679 0

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

Contacts
Principal investigator
Name 111534 0
Dr Jake Linardon
Address 111534 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 111534 0
Australia
Phone 111534 0
+61421666585
Fax 111534 0
Email 111534 0
jake.linardon@deakin.edu.au
Contact person for public queries
Name 111535 0
Jake Linardon
Address 111535 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 111535 0
Australia
Phone 111535 0
+61421666585
Fax 111535 0
Email 111535 0
jake.linardon@deakin.edu.au
Contact person for scientific queries
Name 111536 0
Jake Linardon
Address 111536 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 111536 0
Australia
Phone 111536 0
+61421666585
Fax 111536 0
Email 111536 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
Do not have ethical clearance.


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.