Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000016730
Ethics application status
Approved
Date submitted
2/01/2013
Date registered
7/01/2013
Date last updated
7/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of educational interventions for medical students in reducing negative attitudes and stigmatisation toward patients with anorexia nervosa
Scientific title
The effectiveness of educational interventions for medical students in reducing negative attitudes and stigmatisation toward patients with anorexia nervosa
Secondary ID [1] 281711 0
None
Universal Trial Number (UTN)
U1111-1137-6967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 288011 0
Condition category
Condition code
Mental Health 288386 288386 0 0
Eating disorders
Public Health 288416 288416 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Researchers will pilot two differing educational interventions on fourth year medicine students. One intervention will provide traditional educational information on anorexia nervosa (i.e., emphasising the influence of multiple factors in the development of anorexia nervosa). The second intervention will have a stronger biological and genetic focus, providing more emphasis on the biological and genetic contributions and maintaining factors to anorexia nervosa. Both interventions will go for approximately 1-1.5 hours (in a lecture style class) once over an eight week rotation (i.e., one intervention will be piloted in the first eight week rotation, the second intervention will be piloted in the next eight week rotation, and the control group the last eight week rotation).
Intervention code [1] 286250 0
Prevention
Comparator / control treatment
Control treatment will be a wait-list control (no treatment), consisting of students on a wait-list to attend the intervention/seminar with their allocated rotation group. Students will be offered one of the two interventions after a period of 8 weeks (i.e., during their fourth eight week rotation block)
Control group
Active

Outcomes
Primary outcome [1] 288559 0
Mean scores on the four subscales of the Eating Disorder Stigma Scale (Crisafulli et al., 2010)
Timepoint [1] 288559 0
Baseline (pre intervention), immediately post-intervention, and 2 months after intervention
Primary outcome [2] 288560 0
Mean scores on the three subscales of the Causal attributions Scale (Crisafulli et al., 2008; Stewart et al., 2006).
Timepoint [2] 288560 0
Baseline (pre-intervention), immediately post-intervention, and at 2 month follow-up.
Primary outcome [3] 288561 0
Mean score on the Characteristics and Affective Reaction Scales (Penn et al., 1994)
Timepoint [3] 288561 0
Baseline (pre-intervention), immediately post-intervention, and at 2 month follow-up
Secondary outcome [1] 300465 0
Mean scores on the two subscales of the Opinions Scale (Crisp et al., 2005).
Timepoint [1] 300465 0
Baseline (pre-intervention), immediately post-intervention, and at 2 month follow-up

Eligibility
Key inclusion criteria
Medicine student (fourth year)
No self-reported history of anorexia nervosa, as indicated by the Holmes et al. (1999) Level of Contact Report.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who indicate they have previously suffered from anorexia nervosa on the Level of Contact Report, will be deleted from the data set as educational interventions are unlikely to compete with or challenge the individual's own reasons/self-perception of their illness. These individuals will be allowed to attend the intervention to avoid identification and stigmatisation, however their responses will be removed from the data set.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involving a central administration site (Bond University).
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)

A university administration generator will assign fourth year medicine students randomly to rotation groups consisting of 18-20 students.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed multivariate analysis of variance

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286505 0
University
Name [1] 286505 0
Bond University
Country [1] 286505 0
Australia
Primary sponsor type
Individual
Name
Dr Peta Stapleton
Address
14 University Drive, Robina, 4226 (QLD)
Country
Australia
Secondary sponsor category [1] 285293 0
Individual
Name [1] 285293 0
Amy Bannatyne
Address [1] 285293 0
14 University Drive, Robina, 4226 (QLD)
Country [1] 285293 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288580 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 288580 0
Ethics committee country [1] 288580 0
Australia
Date submitted for ethics approval [1] 288580 0
Approval date [1] 288580 0
28/11/2012
Ethics approval number [1] 288580 0
RO1590

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

Contacts
Principal investigator
Name 36770 0
Dr Peta Stapleton
Address 36770 0
14 University Dr, Robina QLD 4226
Country 36770 0
Australia
Phone 36770 0
+61 07 5595 2515
Fax 36770 0
Email 36770 0
[email protected]
Contact person for public queries
Name 36771 0
Amy Bannatyne
Address 36771 0
14 University Dr, Robina QLD 4226
Country 36771 0
Australia
Phone 36771 0
+61 07 5595 2515
Fax 36771 0
Email 36771 0
[email protected]
Contact person for scientific queries
Name 36772 0
Amy Bannatyne
Address 36772 0
14 University Dr, Robina QLD 4226
Country 36772 0
Australia
Phone 36772 0
+61 07 5595 2515
Fax 36772 0
Email 36772 0
[email protected]

No information has been provided regarding IPD availability


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.