ANZCTR - Registration

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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

28/07/2024

Date data sharing statement initially provided

16/08/2023

Date results provided

28/07/2024

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]

Nil known.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

binge eating

Condition category

Condition code

Mental Health

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]

Prevention

Intervention code [2]

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]

Negative body image (Body Shape Questionnaire)

Timepoint [1]

Baseline, 4-weeks (primary end-point) and 8-weeks post-intervention

Secondary outcome [1]

Binge eating (Eating Pathology Symptoms Inventory Binge eating scale).

Timepoint [1]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [2]

Body image flexibility (Body Image Acceptance and Action Questionnaire 5-item version)

Timepoint [2]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [3]

Body image functionality appreciation (Body image functionality appreciation scale 7-item version).

Timepoint [3]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [4]

Short forms of the Body Appreciation Scale-2 (BAS-2SF)

Timepoint [4]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [5]

Eating disorder psychopathology (Eating Disorder Examination Questionnaire)

Timepoint [5]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [6]

Self esteem (Single-Item Self-Esteem Scale)

Timepoint [6]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [7]

Psychosocial health (4-item Patient Health Questionnaire)

Timepoint [7]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [8]

Satisfaction with body image program via a single item: "I am satisfied with the Mind-2-Body intervention".

Timepoint [8]

Baseline, 4-weeks and 8-weeks post-intervention

Secondary outcome [9]

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]

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

Completed

Date of first participant enrolment

Anticipated

21/08/2023

Actual

17/08/2023

Date of last participant enrolment

Anticipated

16/10/2023

Actual

17/10/2023

Date of last data collection

Anticipated

4/12/2023

Actual

6/12/2023

Sample size

Target

72

Accrual to date

Final

200

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

1 Gheringhap Street, Geelong VIC Australia 3220

Country [1]

Australia

Funding source category [2]

University

Name [2]

Deakin University

Address [2]

1 Gheringhap Street, Geelong, VIA Australia 3220

Country [2]

Australia

Primary sponsor type

University

Name

Deakin University

Address

1 Gheringhap Street, Geelong VIC Australia 3220

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

DEAKIN UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE

Ethics committee address [1]

1 Gheringhap Street, Geelong VIC Australia 3220

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/07/2023

Ethics approval number [1]

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

Dr Mariel Messer

Address

Deakin University, 1 Gheringhap Street, Geelong VIC 3220

Country

Australia

Phone

+61423499252

Fax

Email

[email protected]

Contact person for public queries

Name

Mariel Messer

Address

Deakin University, 1 Gheringhap Street, Geelong VIC 3220

Country

Australia

Phone

+61 423499252

Fax

Email

[email protected]

Contact person for scientific queries

Name

Mariel Messer

Address

Deakin University, 1 Gheringhap Street, Geelong VIC 3220

Country

Australia

Phone

+61 423499252

Fax

Email

[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.	Type	Citation	Link	Email	Other Details	Attachment
19788	Informed consent form					386280-(Uploaded-24-07-2023-14-09-47)-Study-related document.docx
19789	Study 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

No additional documents have been identified.