Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000879662
Ethics application status
Approved
Date submitted
25/07/2023
Date registered
16/08/2023
Date last updated
16/08/2023
Date data sharing statement initially provided
16/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of a brief body image digital intervention for adults with binge eating behaviours
Scientific title
Evaluation of the efficacy of a brief body image digital intervention for adults with binge eating behaviours
Secondary ID [1] 310180 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
binge eating 330771 0
Condition category
Condition code
Mental Health 327768 327768 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mind-2-Body is an online brief intervention for body image based on five key components of Cognitive Behaviour Therapy (CBT). These five lessons cover learning 1) positive body image strategies (self-compassion, gratitude, body functionality, appreciation, and body neutrality); 2) Mind & body relaxation; 3) Combating problematic body image thoughts; 4) combating problematic body image behaviours; 5) removing negative body image triggers.
The content is delivered via an online browser (podia.com). In this, participants learn strategies via videos, texts, images, mini-lectures delivered by Dr. Mariel Messer and via homework tasks.
This program will take approx 60 minutes to complete. Participants are asked to complete the program in one sitting. Homework tasks will take approximately 90 minutes to complete.
This program is purely self-guided. Website analytics from Podia will provide details on number of participant log ins, time spent on the intervention, and lessons completed.
Intervention code [1] 326581 0
Prevention
Intervention code [2] 326653 0
Treatment: Other
Comparator / control treatment
The control group will complete the baseline measure and same two follow-up surveys as the experimental group at 4-weeks and 8-weeks post intervention. They will then receive access to the body image program at the conclusion of the 8-week assessment.
Control group
Active

Outcomes
Primary outcome [1] 335444 0
Negative body image (Body Shape Questionnaire)
Timepoint [1] 335444 0
Baseline, 4-weeks (primary end-point) and 8-weeks post-intervention
Secondary outcome [1] 424545 0
Binge eating (Eating Pathology Symptoms Inventory Binge eating scale).
Timepoint [1] 424545 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [2] 424716 0
Body image flexibility (Body Image Acceptance and Action Questionnaire 5-item version)
Timepoint [2] 424716 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [3] 424717 0
Body image functionality appreciation (Body image functionality appreciation scale 7-item version).
Timepoint [3] 424717 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [4] 424718 0
Short forms of the Body Appreciation Scale-2 (BAS-2SF)
Timepoint [4] 424718 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [5] 424719 0
Eating disorder psychopathology (Eating Disorder Examination Questionnaire)
Timepoint [5] 424719 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [6] 424720 0
Self esteem (Single-Item Self-Esteem Scale)
Timepoint [6] 424720 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [7] 424721 0
Psychosocial health (4-item Patient Health Questionnaire)
Timepoint [7] 424721 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [8] 424722 0
Satisfaction with body image program via a single item: "I am satisfied with the Mind-2-Body intervention".
Timepoint [8] 424722 0
Baseline, 4-weeks and 8-weeks post-intervention
Secondary outcome [9] 424723 0
Attitudes to help-seeking via single, study derived items:
"I feel confident to seek help for my binge eating behaviour" 0 = not at all confident, 10 = extremely confident).

"I feel confident to seek help for my body image" 0 = not at all confident, 10 = extremely confident).

"I feel motivated to seek help for my binge eating behaviour" 0 = not at all motivated 10 = extremely motivated).

"I feel motivated to seek help for my body image" 0 = not at all motivated, 10 = extremely motivated).

I am willing to seek help for my binge eating or body image problems

I am willing to complete an online intervention for body image to improve my binge eating behaviour

I would prefer face-to-face treatment delivered by a professional for body image and binge eating compared to completing an online intervention

I believe completing an online intervention for body image could improve my binge eating behaviour


Timepoint [9] 424723 0
Baseline, 4-weeks and 8-weeks post-intervention

Eligibility
Key inclusion criteria
Inclusion criteria will be deliberately kept broad, given that we want to reach a broad population of individuals wanting to address binge eating behaviour, consistent with previous trials of internet-based programs (e.g., Jacobi et al 2007). The inclusion criteria will be adults aged 18 years or over, who have access to the Internet, and who self-report the presence of recurrent binge eating (eating a large amount of food in a short period, accompanied by sense of loss of control), defined as one episode per every two weeks, on average, over the past three months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Not yet recruiting
Date of first participant enrolment
Anticipated
21/08/2023
Actual
Date of last participant enrolment
Anticipated
16/10/2023
Actual
Date of last data collection
Anticipated
4/12/2023
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25659 0
United States of America
State/province [1] 25659 0

Funding & Sponsors
Funding source category [1] 314346 0
University
Name [1] 314346 0
Deakin University
Country [1] 314346 0
Australia
Funding source category [2] 314348 0
University
Name [2] 314348 0
Deakin University
Country [2] 314348 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap Street, Geelong VIC Australia 3220
Country
Australia
Secondary sponsor category [1] 316294 0
None
Name [1] 316294 0
None
Address [1] 316294 0
None
Country [1] 316294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313443 0
DEAKIN UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 313443 0
1 Gheringhap Street, Geelong VIC Australia 3220
Ethics committee country [1] 313443 0
Australia
Date submitted for ethics approval [1] 313443 0
Approval date [1] 313443 0
21/07/2023
Ethics approval number [1] 313443 0

Summary
Brief summary
DEAKIN UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE approved the following study design:
There are two phases to this study.
Phase 1 will involve all respondents to study advertisements to complete a brief screener to determine their eligibility. Those who meet eligibility criteria will then complete an online questionnaire battery that will ask them about their demographics, eating behaviour, self-esteem, body image, and attitudes and acceptability of online interventions. Participants who complete this questionnaire battery will then be randomly allocated via a computer-generated sequence to one of two conditions (Mind-2-Body or wait-list). Participants allocated to the online program will have access to the content of the program immediately and will be asked to practice the exercises as often as they like, and whenever they feel it would be useful. Mind-2-Body is a single-session program that can be completed via an online platform in about 60 minutes. It consists of 5 lessons designed to help people improve their body image, with each step offering a key exercise grounded in cognitive, behavioral, or mindfulness principles. Participants allocated to the wait-list will be notified that they will have access to the program 8-weeks after baseline.

Phase 2 will occur at the end of the 4-week intervention phase. For both groups, phase 2 involves completing the baseline questionnaire again 4-weeks after the baseline assessment was completed. This will be to assess for the acceptability and efficacy of Mind-2-Body. Participants allocated to the immediate intervention group will also be asked some brief questions about their experiences with the intervention and will be offered an opportunity to debrief about the study with the Principal Investigator (Dr Messer), either via email or telephone. All participants will complete a final follow-up survey at 8 weeks from baseline. The entire study is therefore done online, and no face to face contact with participants is required. All participants will be reimbursed $25 for the 4-week post survey, and $25 for the 8-week post-survey.

It is hypothesised that those allocated to the body image intervention will show lower levels of negative body image, lower levels of binge eating and eating disorder psychopathology, higher levels of positive body image (appreciation/functionality, flexibility), self-esteem and mental health, and improved attitudes to help-seeking at 4 and 8 weeks post-intervention compared to the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128178 0
Dr Mariel Messer
Address 128178 0
Deakin University, 1 Gheringhap Street, Geelong VIC 3220
Country 128178 0
Australia
Phone 128178 0
+61423499252
Fax 128178 0
Email 128178 0
[email protected]
Contact person for public queries
Name 128179 0
Dr Mariel Messer
Address 128179 0
Deakin University, 1 Gheringhap Street, Geelong VIC 3220
Country 128179 0
Australia
Phone 128179 0
+61 423499252
Fax 128179 0
Email 128179 0
[email protected]
Contact person for scientific queries
Name 128180 0
Dr Mariel Messer
Address 128180 0
Deakin University, 1 Gheringhap Street, Geelong VIC 3220
Country 128180 0
Australia
Phone 128180 0
+61 423499252
Fax 128180 0
Email 128180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All information will be de-identified (i.e., a unique ID number will be assigned to participants survey responses).

De-identified individual participant data of published results only will be shared.
When will data be available (start and end dates)?
November 2023 until November 2028.
Available to whom?
data will be stored according to the Open Science Framework. Participants can request access to de-identified data which will be available as aggregate data only.
Available for what types of analyses?
Multi-level modelling
How or where can data be obtained?
On request from Dr. Mariel Messer ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19788Informed consent form    386280-(Uploaded-24-07-2023-14-09-47)-Study-related document.docx
19789Study protocol    386280-(Uploaded-24-07-2023-14-10-14)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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