Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000439549p
Ethics application status
Submitted, not yet approved
Date submitted
19/03/2024
Date registered
10/04/2024
Date last updated
10/04/2024
Date data sharing statement initially provided
10/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Short Intervention for Intuitive Eating
Scientific title
A Randomized Controlled Trial of a Single Session Web-Intervention on Intuitive Eating for Individuals with Recurrent Binge Eating
Secondary ID [1] 311765 0
Nik known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Binge eating 333268 0
Disordered eating 333269 0
Condition category
Condition code
Mental Health 329964 329964 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being trialled is called "Mindful Plate".

"Mindful plate" is a self-guided online intervention for binge and disordered and is designed to be completed in a single 1-hour session. The intervention will comprise of 5 psychoeducational modules with skill-based exercises that have been evidenced to promote intuitive eating and a healthy relationship with food and alleviate symptoms of binge eating. The intervention format will be mostly text-based, with several graphics and short videos. Optional supplementary intervention materials (e.g., additional quizzes, take home worksheets, more skill-based activities) will also be provided for those interested to further develop their intuitive eating skills. These worksheets will be designed specifically for this study.

The intervention content is designed to help people develop flexible and healthy eating patterns by (1) Gaining Body Attunement (e.g., listening to their natural internal hunger / satiety cues) and (2) Removing Obstacles to Body Attunement (e.g., challenging thoughts, beliefs and dieting rules). The psychoeducational modules addresses a range of topics including benefits of intuitive eating, mindfulness, risks associated with chronic dieting, body image concerns etc. Some interactive activities are also included (e.g., self-scoring quizzes to help participants reflect and consolidate their understanding of the intervention content).

No specific strategies will be used to monitor adherence to the intervention as it is completely self-guided, however, participants will be reminded via email by the research team to complete the post-intervention and follow-up survey batteries.
Intervention code [1] 328219 0
Behaviour
Intervention code [2] 328220 0
Lifestyle
Comparator / control treatment
The comparator will be a wait-list control group who will get delayed access to the intervention after 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 337723 0
Intuitive eating behaviour
Timepoint [1] 337723 0
Baseline, 2 weeks post-intervention (primary timepoint), and 6 weeks follow-up.
Primary outcome [2] 337724 0
Disordered eating
Timepoint [2] 337724 0
Baseline, 2 weeks post-intervention (primary timepoint), and 6-weeks follow-up.
Primary outcome [3] 337871 0
Binge eating symptoms
Timepoint [3] 337871 0
Baseline, 2 weeks post-intervention (primary timepoint), 6 weeks followup.
Secondary outcome [1] 432969 0
Body Appreciation
Timepoint [1] 432969 0
Baseline, 2 weeks post-intervention, and 6 weeks follow-up.
Secondary outcome [2] 432970 0
Interoceptive awareness (body listening)
Timepoint [2] 432970 0
Baseline, 2 weeks post-intervention, and 6 weeks follow-up.
Secondary outcome [3] 432972 0
Acceptability
Timepoint [3] 432972 0
2 weeks post-intervention
Secondary outcome [4] 433555 0
Help-seeking behaviour
Timepoint [4] 433555 0
2 weeks post-intervention

Eligibility
Key inclusion criteria
Eligible participants are individuals who :
1. are 18 years and over
2. read and understand English
3. experience regular binge eating (1 binge episode per fortnight, in the past 3 months)
4. have access to a computer and internet connection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the individual does not experience binge or disordered eating or is below 18 years of age.

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)
Allocation will be automatically conducted via Qualtrics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants in the intervention condition will be given immediate access to the intervention upon uptake. Participants in the waitlist condition will receive delayed access to the same intervention 6 weeks later.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
12/07/2024
Actual
Date of last data collection
Anticipated
26/08/2024
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316100 0
Self funded/Unfunded
Name [1] 316100 0
Country [1] 316100 0
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318268 0
None
Name [1] 318268 0
Address [1] 318268 0
Country [1] 318268 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314927 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 314927 0
https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168
Ethics committee country [1] 314927 0
Australia
Date submitted for ethics approval [1] 314927 0
21/03/2024
Approval date [1] 314927 0
Ethics approval number [1] 314927 0

Summary
Brief summary
The primary purpose of this study is to test the effectiveness of an online single-session intervention (SSI) for reducing binge and disordered eating behaviours by teaching skills and techniques for intuitive eating.

It is hypothesized that participants in the immediate intervention group will have decreased binge and disordered eating symptoms at post-intervention compared to participants in the waitlist control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133158 0
Dr Jake Linardon
Address 133158 0
Deakin University Burwood Campus 221 Burwood Hwy, Burwood, VIC 3125
Country 133158 0
Australia
Phone 133158 0
+61 0421666585
Fax 133158 0
Email 133158 0
jake.linardon@deakin.edu.au
Contact person for public queries
Name 133159 0
Jake Linardon
Address 133159 0
Deakin University Burwood Campus 221 Burwood Hwy, Burwood, VIC 3125
Country 133159 0
Australia
Phone 133159 0
+61 0421666585
Fax 133159 0
Email 133159 0
jake.linardon@deakin.edu.au
Contact person for scientific queries
Name 133160 0
Jake Linardon
Address 133160 0
Deakin University Burwood Campus 221 Burwood Hwy, Burwood, VIC 3125
Country 133160 0
Australia
Phone 133160 0
+61 0421666585
Fax 133160 0
Email 133160 0
jake.linardon@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data of participants' responses on the IE-2, ED-15, BAS-2SF, MAIA-2 (body listening subscale), and acceptability items may be shared on open science repositories, or may be used for secondary analysis.

Please note that all data will be completely unidentifiable. NO personal/identifiable data (e.g., participant names or emails) will be shared.
When will data be available (start and end dates)?
Data will be made available upon publication of study findings in an academic journal.
Available to whom?
Some journals/publishers require data to be shared/made available during the publication process (such as open access or mediated-access repositories).
Available for what types of analyses?
No specific type of analysis
How or where can data be obtained?
Open science repositories

Dr Jake Linardon can be contacted regarding the IPD until the data repositories are available via email (jake.linardon@deakin.edu.au).


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.