Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001437156p
Ethics application status
Submitted, not yet approved
Date submitted
2/10/2019
Date registered
17/10/2019
Date last updated
17/10/2019
Date data sharing statement initially provided
17/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a brief internet-based intervention designed to target harmful dieting behaviors
Scientific title
Randomized controlled trial of a brief internet-based intervention for reducing extreme dietary restraint: Effects on binge eating behavior.
Secondary ID [1] 299462 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 314679 0
Condition category
Condition code
Mental Health 313025 313025 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The brief internet-based intervention is designed to target extreme dietary restraint, the best replicated risk and maintaining factor for binge eating.
The intervention is composed of 4 sessions. The 4 different sessions include:
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.

Each session 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.

Each session will include: interactive videos discussing the content of the session and how to implement the prescribed strategies; written text; downloadable handouts to complete the prescribed activities; and quizzes designed to consolidate learning.

To monitor adherence, google analytics will be set up to examine the number of times a page was viewed and how long each page was viewed for.
Intervention code [1] 315713 0
Prevention
Comparator / control treatment
The control group will be encouraged to look through a free open access website (https://breakbingeeating.com) for general information and psycho-education on binge eating problems. This is designed to be a more active control group than a pure wait-list.
After the 4 week intervention phase, participants allocated to the control group will then have access to the internet intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 321577 0
Number of binge eating episodes over the past 28 days.
This will be assessed via a single item (item number 14) from the widely used Eating Disorder Examination Questionnaire (Fairburn & Beglin, 1994).
Timepoint [1] 321577 0
post-test (4 weeks from baseline)
Primary outcome [2] 321578 0
EDE-Q dietary restraint subscale
Timepoint [2] 321578 0
Post-test (4 weeks post-baseline)
Secondary outcome [1] 375419 0
EDE-Q global scores
Timepoint [1] 375419 0
post-test (4 weeks post-baseline)
Secondary outcome [2] 375420 0
Clinical Impairment assessment scores
Timepoint [2] 375420 0
post-test (4 weeks post-baseline)
Secondary outcome [3] 375421 0
Inflexible eating questionnaire scores
Timepoint [3] 375421 0
post-test (4 weeks post-baseline)
Secondary outcome [4] 375422 0
Dichotomous thinking in eating disorder scale - eating subscale scores
Timepoint [4] 375422 0
post-test (4 weeks post-baseline)
Secondary outcome [5] 375423 0
PHQ-4 total scores
Timepoint [5] 375423 0
post-test (4 weeks post-baseline)
Secondary outcome [6] 375424 0
Disihibition subscale from the TFEQ
Timepoint [6] 375424 0
post-test (4 weeks post-baseline)

Eligibility
Key inclusion criteria
Inclusion criteria is deliberately kept broad so that we can target the full spectrum of problem eating behaviors.. It includes:
a) Male or female adults ( > 17 years)
b) Who want to improve their eating patterns
c) Who have access to the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
31/08/2020
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303962 0
University
Name [1] 303962 0
Deakin University
Country [1] 303962 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, Vic, 3125
Country
Australia
Secondary sponsor category [1] 304131 0
None
Name [1] 304131 0
NA
Address [1] 304131 0
NA
Country [1] 304131 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304463 0
Deakin Research Ethics Committee
Ethics committee address [1] 304463 0
Ethics committee country [1] 304463 0
Australia
Date submitted for ethics approval [1] 304463 0
02/09/2019
Approval date [1] 304463 0
Ethics approval number [1] 304463 0

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

Contacts
Principal investigator
Name 97030 0
Dr Jake Linardon
Address 97030 0
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country 97030 0
Australia
Phone 97030 0
+61 3 924 46308
Fax 97030 0
Email 97030 0
[email protected]
Contact person for public queries
Name 97031 0
Jake Linardon
Address 97031 0
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country 97031 0
Australia
Phone 97031 0
+61 3 924 46308
Fax 97031 0
Email 97031 0
[email protected]
Contact person for scientific queries
Name 97032 0
Jake Linardon
Address 97032 0
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country 97032 0
Australia
Phone 97032 0
+61 3 924 46308
Fax 97032 0
Email 97032 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
We have not applied for ethical approval to share IPD 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.