Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001024831
Ethics application status
Approved
Date submitted
25/06/2021
Date registered
5/08/2021
Date last updated
5/08/2021
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Choosing your own digital intervention for recurrent binge eating
Scientific title
Do participant preferences matter? Relative efficacy of a forced versus preferred digital intervention for recurrent binge eating.
Secondary ID [1] 304619 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study from ACTRN12621000914864. In this sub-study, participants allocated to the waiting list in the parent study will again be re-randomized to one of two intervention groups once they are about to receive access at the post-test period. These two groups will form part of this sub-study.

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 322540 0
Binge eating 322541 0
Condition category
Condition code
Mental Health 320170 320170 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two different digital interventions for binge eating. In this trial, participants will be randomized to one of two groups: (1) they will be provided one of the below two intervention programs at random ("forced"); (2) they will be asked to select which intervention program they would prefer to receive based on a small description of each ("preferred").

The first program 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 cognitive-behavioural therapy (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 (created specifically for the purposes of this study) 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] 320970 0
Treatment: Other
Intervention code [2] 320971 0
Behaviour
Comparator / control treatment
The forced intervention is the control group. This involves allocating one of the two digital programs at random
Control group
Active

Outcomes
Primary outcome [1] 328053 0
Eating disorder psychopathology (global scores from the Eating Disorder Examination Questionnaire)
Timepoint [1] 328053 0
Primary time-point (post-test) = 4 weeks after randomization.
Primary outcome [2] 328054 0
Objective binge eating frequency over the past 28 days (assessed via a single item from the EDE-Q).
Timepoint [2] 328054 0
Primary time-point (post-test) = 4 weeks after randomization.
Secondary outcome [1] 397355 0
Dietary restraint (EDE-Q subscale)
Timepoint [1] 397355 0
4 weeks after randomization.
Secondary outcome [2] 397356 0
shape concerns (EDE-Q subscale)
Timepoint [2] 397356 0
4 weeks after randomization.
Secondary outcome [3] 397357 0
Weight concerns (EDE-Q subscale)
Timepoint [3] 397357 0
4 weeks after randomization.
Secondary outcome [4] 397358 0
Eating concerns (EDE-Q subscale)
Timepoint [4] 397358 0
4 weeks after randomization.
Secondary outcome [5] 397360 0
Subjective binge eating frequency (single EDE-Q item)
Timepoint [5] 397360 0
4 weeks after randomization.
Secondary outcome [6] 397361 0
Depressive symptoms (PHQ-2)
Timepoint [6] 397361 0
4 weeks after randomization.
Secondary outcome [7] 397362 0
Anxiety symptoms (PHQ-2)
Timepoint [7] 397362 0
4 weeks after randomization.
Secondary outcome [8] 397363 0
Body image flexibility (BIAAQ-4)
Timepoint [8] 397363 0
4 weeks after randomization.
Secondary outcome [9] 397364 0
Body appreciation (BAS-2 3-item version)
Timepoint [9] 397364 0
4 weeks after randomization.
Secondary outcome [10] 397365 0
Functionality appreciation (FAS-7)
Timepoint [10] 397365 0
4 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
12/08/2021
Actual
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308979 0
University
Name [1] 308979 0
Deakin University
Country [1] 308979 0
Australia
Funding source category [2] 308980 0
Government body
Name [2] 308980 0
NHMRC
Country [2] 308980 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 309915 0
None
Name [1] 309915 0
Address [1] 309915 0
Country [1] 309915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308872 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 308872 0
Ethics committee country [1] 308872 0
Australia
Date submitted for ethics approval [1] 308872 0
14/01/2021
Approval date [1] 308872 0
29/04/2021
Ethics approval number [1] 308872 0

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

Contacts
Principal investigator
Name 112174 0
Dr Jake Linardon
Address 112174 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 112174 0
Australia
Phone 112174 0
+61421666585
Fax 112174 0
Email 112174 0
[email protected]
Contact person for public queries
Name 112175 0
Jake Linardon
Address 112175 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 112175 0
Australia
Phone 112175 0
+61421666585
Fax 112175 0
Email 112175 0
[email protected]
Contact person for scientific queries
Name 112176 0
Jake Linardon
Address 112176 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 112176 0
Australia
Phone 112176 0
+61421666585
Fax 112176 0
Email 112176 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEffects of Participant's Choice of Different Digital Interventions on Outcomes for Binge-Spectrum Eating Disorders: A Pilot Doubly Randomized Preference Trial.2023https://dx.doi.org/10.1016/j.beth.2022.09.007
N.B. These documents automatically identified may not have been verified by the study sponsor.