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Trial registered on ANZCTR


Registration number
ACTRN12619001438145
Ethics application status
Approved
Date submitted
2/10/2019
Date registered
17/10/2019
Date last updated
12/03/2020
Date data sharing statement initially provided
17/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing eating disorder symptoms through a smartphone app
Scientific title
The efficacy of a app-based smartphone intervention for reducing eating disorder symptoms: A randomized controlled trial
Secondary ID [1] 299463 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorder 314680 0
Condition category
Condition code
Mental Health 313027 313027 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered via a smartphone app. The intervention is designed to address core eating disorder symptoms and maintaining factors. There will be 4 modules to this intervention, and participants will be asked to complete these modules in order. The content covering each module is as follows:
1. Psycho-education: information about the eating disorder cycle and relevant maintaining factors of eating disorder behaviors.
2. Self-monitoring and regular eating: module designed to address extreme dietary restraint patterns.
3. Emotion regulation: module designed to promote adaptive emotion regulation strategies (e.g., problem solving, mindfulness)
4. Body image: module designed to provide techniques around how to promote a positive body image and reduce a negative body image.

Participants will be encouraged to commence each new module after around 7 days, although they will be instructed that they can go at a pace that suits them. Each module will take approximately 1 hour to complete, and participants will be encouraged to implement the strategies prescribed in each module on a daily basis.
Each module will contain various audio recordings of a professional describing and guiding the intervention content and what is required; various quizzes to facilitate learning; text boxes for participants to read; and writing spaces for participants to record their thoughts, feelings and behaviors to certain exercises.
Text message reminders will be provided on a weekly basis to enhance adherence to the intervention.
Intervention code [1] 315714 0
Prevention
Comparator / control treatment
Wait-list control (participants will have access to the smartphone app after the intervention phase)
The wait-list will last 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 321579 0
EDE-Q global scores
Timepoint [1] 321579 0
Post-test (6 weeks post-baseline)
Secondary outcome [1] 375426 0
Binge eating frequency
This will be assessed via a single item (item 14) on the widely used Eating Disorder Examination Questionnaire (Fairburn & Beglin, 1994).
Timepoint [1] 375426 0
Post-test (6 weeks post-baseline)
Secondary outcome [2] 375427 0
EDE-Q weight concerns
Timepoint [2] 375427 0
Post-test (6 weeks post-baseline)
Secondary outcome [3] 375428 0
EDE-Q shape concern
Timepoint [3] 375428 0
Post-test (6 weeks post-baseline)
Secondary outcome [4] 375429 0
EDE-Q dietary restraint
Timepoint [4] 375429 0
Post-test (6 weeks post-baseline)
Secondary outcome [5] 375430 0
Clinical Impairment Assessment scores
Timepoint [5] 375430 0
Post-test (6 weeks post-baseline)
Secondary outcome [6] 375431 0
Depression Anxiety Stress Scale - Total Score
Timepoint [6] 375431 0
Post-test (6 weeks post-baseline)
Secondary outcome [7] 375432 0
General well-being scores (WEMWBS)
Timepoint [7] 375432 0
Post-test (6 weeks post-baseline)

Eligibility
Key inclusion criteria
1) Male or females
2) Aged 18 years or over
3) Owns a smartphone
4) Experienced at least one episode of binge eating over the past 4 weeks.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Minor (< 18 years)
2) Not symptomatic (defined as not having experienced an episode of binge eating over the past 4 weeks)

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303963 0
University
Name [1] 303963 0
Deakin University
Address [1] 303963 0
221 Burwood Hwy, Burwood VIC 3125
Country [1] 303963 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125, Australia
Country
Australia
Secondary sponsor category [1] 304133 0
None
Name [1] 304133 0
NA
Address [1] 304133 0
NA
Country [1] 304133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304464 0
Deakin Research Ethics Committee
Ethics committee address [1] 304464 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125, Australia
Ethics committee country [1] 304464 0
Australia
Date submitted for ethics approval [1] 304464 0
15/04/2019
Approval date [1] 304464 0
29/05/2019
Ethics approval number [1] 304464 0

Summary
Brief summary
Novel methods of intervention delivery that factor in scalability, cost-effectiveness, and engagement of hard-to-reach populations are urgently needed to address concerns that fewer than 25% of people with eating disorder symptoms seek or receive treatment. Preliminary evidence indicates that interventions delivered via smartphone apps can effectively address eating disorder symptoms. However, randomized controlled trials of stand alone app-based smartphone interventions have yet to be conducted.

The present RCT examines the efficacy of an app-based cognitive-behavioural intervention delivered via a smartphone on eating disorder symptoms.

The hypothesis is: Participants allocated to the smartphone intervention will experience significantly greater reductions in eating disorder symptoms, quality of life impairment, and psychological distress at post-test (6 weeks from baseline) relative to participants allocated to the wait-list control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97034 0
Dr Jake Linardon
Address 97034 0
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country 97034 0
Australia
Phone 97034 0
+61 3 924 46308
Fax 97034 0
Email 97034 0
Jake.linardon@deakin.edu.au
Contact person for public queries
Name 97035 0
Dr Jake Linardon
Address 97035 0
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country 97035 0
Australia
Phone 97035 0
+61 3 924 46308
Fax 97035 0
Email 97035 0
Jake.linardon@deakin.edu.au
Contact person for scientific queries
Name 97036 0
Dr Jake Linardon
Address 97036 0
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country 97036 0
Australia
Phone 97036 0
+61 3 924 46308
Fax 97036 0
Email 97036 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
What supporting documents are/will be available?
No other documents available
Summary results
No Results