Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001096145p
Ethics application status
Submitted, not yet approved
Date submitted
10/07/2019
Date registered
9/08/2019
Date last updated
9/08/2019
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Insights in body esteem: Exploring people's experience of body image
Scientific title
Insights in Body Esteem: Exploring Australian adults experience of body image
Secondary ID [1] 298511 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body esteem 313346 0
Condition category
Condition code
Public Health 311787 311787 0 0
Other public health
Mental Health 311850 311850 0 0
Eating disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to explore the relationship between body esteem and daily functioning in a sample of Australians (18 years and over) to inform future prevention interventions for eating disorders. This observational study involves participants completing a single occasion anonymous de-identified survey instrument. The study will be conducted annually, to explore the changes in these parameters and relationships over time. This study is not a longitudinal cohort study. It is expected to take between 15 and 20 minutes to complete.
Intervention code [1] 314782 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320522 0
body image/appearance - A composite score for this outcome will be calculated from three items on the survey instrument (Q9, Q10, Q11). Two of these items (Q9, Q10) have been selected from the Body Image Disturbance Questionnaire (BIDQ; Cash, T.F et al, 2004) and modified for this study. The third item (Q11) was developed in response to input from the advisory panel and previous research conducted in this area.
Timepoint [1] 320522 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey..
Primary outcome [2] 320838 0
Determinants of body image: A composite score for this outcome will be derived from six questions in the survey (Q12,13,14,15,16,17). Three items (Q13-15) have been drawn from the Socio-Cultural Attitudes Towards Appearance Questionnaire (SATAQ-3; Thompson, J.K et al, 2011) and modified for this study. One item (Q17) has been drawn from the Perception of Teasing (POT; Thompson, J.K, 1995) Scale. Two further items have been developed for this study from consultation with the advisory group and past research in this area.
Timepoint [2] 320838 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Primary outcome [3] 320839 0
Importance of body image - A composite outcome score will be calculated from two items on the survey instrument (Q7, Q8), which are items which have been modified from the Importance of Thinness Scale (Schutz, H.K, 2002).
Timepoint [3] 320839 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [1] 371913 0
Bullying and teasing: Two separate outcome variables will be used to measure bullying and teasing:
1. Presence/ absence of bullying/ teasing: The participant will either score '2' (Yes) or '0' (No) dependent on whether they indicate they have/have not been bullied and teased in relation their physical appearance (Q18,) If they indicate they are 'unsure' - they will be scored 1 (Unsure). This question was developed as a screening question for this survey. Only the participants who have scored 1 or 2 on this question will be asked to complete the question relating to the impact of the bullying/ teasing on the person. This is a separate secondary variable listed below.
Timepoint [1] 371913 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [2] 373003 0
Impact of Bullying/teasing: Participants who indicated on Q18 they either have or are 'unsure' whether they have experienced bullying or teasing in relation to their appearance, will be asked to complete item (q19), which will lead to a composite score being calculated with regard to the impact of the bullying/teasing . This composite score will be calculated by adding the score for each of the different items listed in Q19. Question 19, has been drawn from the Perception of Teasing Scale (POT; Thompson, J.K, 1995) and modified for this study. Participants who have indicated they have never experienced bullying /teasing in relation to their appearance on Q18 will automatically receive a score of '0' on this item, but will not be required to complete the question.
Timepoint [2] 373003 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [3] 373004 0
Social functioning: A composite outcome score will be calculated from nine statements in q20 of the survey instrument. These items were drawn from the Body Image Disturbance Questionnaire (BIDQ; Cash, T.F et al, 2004) and modified for this research.
Timepoint [3] 373004 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [4] 373005 0
Dieting behaviour: Question (Q21) assessing dieting behaviour has specifically been developed for this study from previous research which has identified behaviours which are frequently associated with poor body image.
Timepoint [4] 373005 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [5] 373006 0
Eating disorder diagnosis: This survey question (Q25) has been developed for this study and reflects the most common eating disorder diagnoses in the population.
Timepoint [5] 373006 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [6] 373007 0
Screening measure eating disorder: Q27 in this survey is a screening question to identify participants who may have disordered eating, but who may not yet have been diagnosed or meet full diagnostic criteria for an eating disorder. Q27 in the survey contains the questions from the The SCOFF questionnaire (Morgan et al 1999), which is a simple, five-question screening measure to assess the possible presence of an eating disorder..
Timepoint [6] 373007 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [7] 373008 0
Mental health: Q26 in the survey assesses the experience of common health health issues (e.g., depression, anxiety, substance use/misuse). This question was developed for this survey. The possible outcomes reflect either/ or the most common mental health diagnoses and those which are most frequently co-morbid with eating disordered behaviour.
Timepoint [7] 373008 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [8] 373009 0
Physical health- The participants assessment of their physical health has been assessed with one item (Q28). Simple self-report assessments of health status, like the question used in this study, have frequently been used in other research and have been shown to be comparative and good predictors of health status (Eriksson et al. 2001).
Timepoint [8] 373009 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [9] 373456 0
Help/ help seeking will be assessed by three separate outcome measures (Q22,23,24). These questions have been developed for this research and based on the most frequently endorsed areas of where help is typically sought / gained.

The three different questions assess different areas of help. These three outcomes have been listed consecutively as secondary outcomes. The first outcome is:
Universal prevention/ help: Q22 assesses the areas where the participant has gained information about body image, without actively seeking this information.
Timepoint [9] 373456 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [10] 373457 0
Informal help seeking: Q23 assesses a number of informal sources from which the participant may have sought help.
Timepoint [10] 373457 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.
Secondary outcome [11] 373458 0
Formal help seeking: Q24 assesses a number of formal source/s from which the participant may have sought help. .
Timepoint [11] 373458 0
This is an observational study which does not measure the effectiveness / lack of effectiveness of a study. It is a cross-sectional study. This primary outcome is measured once at the time of the survey.

Eligibility
Key inclusion criteria
The participants must be:
- aged 18 years and over, and
- reside in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subject to inclusion criteria, there are no exclusion criteria.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
1700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303057 0
Charities/Societies/Foundations
Name [1] 303057 0
Butterfly Foundation
Country [1] 303057 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Butterfly Foundation
Address
Butterfly Foundation, 103 Alexander Street Crows Nest NSW 2065
Country
Australia
Secondary sponsor category [1] 303038 0
None
Name [1] 303038 0
Address [1] 303038 0
Country [1] 303038 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303607 0
Bellberry Limited
Ethics committee address [1] 303607 0
Ethics committee country [1] 303607 0
Australia
Date submitted for ethics approval [1] 303607 0
11/07/2019
Approval date [1] 303607 0
Ethics approval number [1] 303607 0

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

Contacts
Principal investigator
Name 94238 0
Ms Melissa Wilton
Address 94238 0
Butterfly Foundation, 103 Alexander Street Crows Nest NSW 2065
Country 94238 0
Australia
Phone 94238 0
+61402259652
Fax 94238 0
Email 94238 0
[email protected]
Contact person for public queries
Name 94239 0
Melissa Wilton
Address 94239 0
Butterfly Foundation, 103 Alexander Street Crows Nest NSW 2065
Country 94239 0
Australia
Phone 94239 0
+61402259652
Fax 94239 0
Email 94239 0
[email protected]
Contact person for scientific queries
Name 94240 0
Melissa Wilton
Address 94240 0
Butterfly Foundation, 103 Alexander Street Crows Nest NSW 2065
Country 94240 0
Australia
Phone 94240 0
+61402259652
Fax 94240 0
Email 94240 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.