Trial Review

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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
Sex
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
2/03/2020
Actual
13/02/2020
Date of last participant enrolment
Anticipated
1/10/2020
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
242
Accrual to date
153
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
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
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
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
[email protected]
Contact person for public queries
Name 97035 0
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
[email protected]
Contact person for scientific queries
Name 97036 0
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
[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


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.