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Trial registered on ANZCTR
Registration number
ACTRN12617001412325
Ethics application status
Approved
Date submitted
2/10/2017
Date registered
5/10/2017
Date last updated
13/11/2019
Date data sharing statement initially provided
8/02/2019
Date results provided
13/11/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Peer mentoring for eating disorders patients - evaluation of a pilot program
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Scientific title
Peer mentoring for eating disorders patients - evaluation of a pilot program
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Secondary ID [1]
293010
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eating Disorders
304920
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Condition category
Condition code
Mental Health
304250
304250
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0
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Eating disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The program will involve 13 un-structured mentoring sessions of up to 3 hours each, ideally completed fortnightly, over 6 months. Mentoring activities are guided by each individualised mentee "Wellness Plan" formulated during Session 1. This focuses on the mentee’s short-term goals in the following domains: living circumstances and skills, health, self-care, social relationships and connectedness, creative interests and hobbies, work/career and education, identity and sense of self, community roles and responsibilities. The Wellness Plan also outlines the mentee’s current recovery strategies (e.g., thoughts, feelings, behaviours, characteristics, personal qualities, interests, activities, relationships) that support the mentee to remain healthy as well as articulate warning signs (e.g., symptoms, thoughts, images, feelings, mood, behaviours) that indicate additional professional support or treatment should be sought. Mentors will also complete their own amended Wellness Plan which allows them to document self-care strategies and identify potential risks to ensure that program staff can support and ensure the mentor role is not detrimental to their continued health and wellbeing.
Sessions 2-12 of the mentoring activities focus on supporting the mentee to work toward their identified goals through community-based activities such as supermarket shopping, self-care activities, reconnecting with community or navigating social interactions involving food. Mentors share aspects of their own recovery stories to promote hope and provide an empathic response to the challenges associated with recovery.
Mentees will be assigned to one mentor. However, mentors may be assigned to more than one mentee.
All mentoring sessions will ideally be face-to-face. When face-to-face sessions are not practical, sessions may be completed over the telephone. Sessions 1 and 13 will be completed on-site at EDV, with sessions 2-12 being delivered in a variety of community settings i.e. local shopping centres, parks, cafes. Mentees and mentors will not be permitted to meet in either person’s home.
Adherence to the mentoring sessions will be monitored by EDV staff who will assist in scheduling mentoring sessions and providing support to mentees and mentors.
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Intervention code [1]
299248
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Eating disorder symptomatology in mentees assessed with the Eating Disorders Examination Questionnaire (EDE-Q)
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Assessment method [1]
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Timepoint [1]
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Completion of mentoring (i.e. 6 months)
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Primary outcome [2]
303533
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Quality of life in mentees assessed with the Assessment of Quality of Life (AQoL)
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Assessment method [2]
303533
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Timepoint [2]
303533
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Completion of mentoring (i.e. 6 months)
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Secondary outcome [1]
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Hospital re-admission rates in mentees assessed through indication on the participant demographic and medical information form.
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Assessment method [1]
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Timepoint [1]
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Completion of mentoring (i.e. 6 months)
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Secondary outcome [2]
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Eating disorder symptomatology in mentors assessed with the Eating Disorders Examination Questionnaire (EDE-Q)
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Assessment method [2]
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Timepoint [2]
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Completion of mentoring (i.e. 6 months)
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Secondary outcome [3]
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Quality of life in mentors assessed with the Assessment of Quality of Life (AQoL)
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Assessment method [3]
339436
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Timepoint [3]
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Completion of mentoring (i.e. 6 months)
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Secondary outcome [4]
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Hospital admission rates in mentors assessed through indication on the participant demographic and medical information form.
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Assessment method [4]
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Timepoint [4]
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Completion of mentoring (i.e. 6 months)
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Eligibility
Key inclusion criteria
Inclusion criteria for mentees include:
- Transitioning out of the Body Image & Eating Disorders Treatment & Recovery Service (BETRS) inpatient program at the Austin Hospital or transitioning in/out of the BETRS outpatient/day patient program; or the Melbourne Clinic
- Current diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder or eating disorder not otherwise specified) according to the Diagnostic & Statistical Manual of Mental Disorders (DSM-5)
- Currently actively receiving treatment
Inclusion criteria for mentors include:
- Recovery from an eating disorder for a minimum of 2 years
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria for mentors and mentees include anyone who is at serious risk of harm to oneself or another, as determined by the clinical team, for example, individuals at high risk of suicide.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Both mentees and mentors participating in the peer mentor program will be evaluataed across different timepoints in this study.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Up to 30 participants in the mentor group will berecruited. Up to 30 participants in the mentee group will also be recruited. This will enable sufficient power to identify differences between time points.
Using qualitative estimates of sample size, the proposed participant numbers is deemed be sufficient to capture the variance in information that occurs within each participant group. Guest and colleagues (Guest et al., 2006) argue that data saturation, the point at which no new (additional) information related to the research aims and objectives is found in the data, occurs after as few as six interviews, with all information (themes) fully elucidated after 12 interviews. Our prior clinical-based qualitative research (Pritchard et al., 2016; Warren et al., in press-a; Warren et al., in press-b) indicates that this varies considerably based on the population under study, but typically occurs after 7 and 14 interviews.
Quantitative analyses will include within-groups analyses of variance (ANOVAs) and non-parametric assessments between time points, for mentees and mentors separately. Using the six-stage approach described by Braun and Clarke (2006), thematic analysis will be undertaken to identify key themes in the data.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
20/01/2017
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Date of last participant enrolment
Anticipated
30/06/2018
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Actual
13/10/2018
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Date of last data collection
Anticipated
9/11/2019
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Actual
7/04/2019
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
9124
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [2]
9125
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [3]
10324
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The Melbourne Clinic - Richmond
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Recruitment postcode(s) [1]
17630
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3065 - Fitzroy
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Recruitment postcode(s) [2]
17631
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3084 - Heidelberg
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Recruitment postcode(s) [3]
21992
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3121 - Richmond
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Funding & Sponsors
Funding source category [1]
297637
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Charities/Societies/Foundations
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Name [1]
297637
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William Buckland Foundation
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Address [1]
297637
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Level 1, 575 Bourke St
Melbourne
Vic 3000
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Country [1]
297637
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Australia
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Funding source category [2]
297638
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Charities/Societies/Foundations
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Name [2]
297638
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Ian Potter Foundation
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Address [2]
297638
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Level 3, 111 Collins St, Melbourne VIC 3000
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Country [2]
297638
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Australia
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Funding source category [3]
297639
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Charities/Societies/Foundations
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Name [3]
297639
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John T Reid Charitable Trust
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Address [3]
297639
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PO Box 438
Canterbury VIC 3126
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Country [3]
297639
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Australia
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Primary sponsor type
Hospital
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Name
Austin Hospital
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Address
145 Studley Rd, Heidelberg VIC 3084
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Country
Australia
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Secondary sponsor category [1]
296657
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Hospital
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Name [1]
296657
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St Vincent's Hospital
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Address [1]
296657
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Level 2, 46 Nicholson St, Fitzroy VIC 3065
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Country [1]
296657
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Australia
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Secondary sponsor category [2]
296681
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Hospital
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Name [2]
296681
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Eating Disorders Victoria
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Address [2]
296681
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16 Lulie St, Abbotsford VIC 3067
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Country [2]
296681
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298724
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
298724
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Research Ethics Office for Research Level 8, Harold Stokes Building Austin Health PO Box 5555 Heidelberg Victoria Australia 3084
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Ethics committee country [1]
298724
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Australia
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Date submitted for ethics approval [1]
298724
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21/10/2016
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Approval date [1]
298724
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17/11/2016
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Ethics approval number [1]
298724
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HREC/16/Austin/415
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Ethics committee name [2]
298742
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [2]
298742
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Research Governance Unit St Vincent's Hospital PO Box 2900 Fitzroy VIC 3065
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Ethics committee country [2]
298742
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Australia
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Date submitted for ethics approval [2]
298742
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18/11/2016
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Approval date [2]
298742
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29/11/2016
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Ethics approval number [2]
298742
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HREC204/16
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Ethics committee name [3]
299855
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The Melbourne Clinic Human Research Ethics Committee
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Ethics committee address [3]
299855
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130 Church St, Richmond VIC 3121
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Ethics committee country [3]
299855
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Australia
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Date submitted for ethics approval [3]
299855
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24/01/2018
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Approval date [3]
299855
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06/03/2018
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Ethics approval number [3]
299855
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TMC#301
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Summary
Brief summary
Eating Disorders Victoria (EDV), the Austin Hospital and St Vincent’s Hospital are partnering to develop, pilot and evaluate a peer mentoring program for people with eating disorders exiting hospital programs. This program is intended to address a service gap for people who require additional support to sustain recovery while living independently. It uses a peer support model, harnessing the experience of people who have recovered from eating disorders, with regular de-briefing and supervision. The aims of this research are to evaluate the outcomes of the pilot program on both mentees and mentors. Patients leaving the Austin Hospital or Melbourne Clinic, or tranisitioning to/from BETRS day program will be linked with an EDV peer mentor who has recovered from an eating disorder. They will participate in a semi-structured mentoring program with regular activities and one-on-one mentoring (3-hour, fortnightly sessions). These sessions will run over 6 months. In addition, participants (mentees and mentors) will undertake feedback and de-briefing sessions throughout the program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
78022
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A/Prof Richard Newton
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Address
78022
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Austin Hospital
145 Studley Rd, Heidelberg VIC 3084
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Country
78022
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Australia
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Phone
78022
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+61 417 366 223
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Fax
78022
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Email
78022
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RichardNewton@phcn.vic.gov.au
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Contact person for public queries
Name
78023
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Andrea Phillipou
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Address
78023
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Swinburne University of Technology
PO Box 218 (H99)
Hawthorn
VIC 3122
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Country
78023
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Australia
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Phone
78023
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+61 3 9214 8755
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Fax
78023
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Email
78023
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andreaphillipou@swin.edu.au
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Contact person for scientific queries
Name
78024
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Andrea Phillipou
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Address
78024
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Swinburne University of Technology
PO Box 218 (H99)
Hawthorn
VIC 3122
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Country
78024
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Australia
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Phone
78024
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+61 3 9214 8755
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Fax
78024
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Email
78024
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andreaphillipou@swin.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Beveridge J, Phillipou A, Jenkins Z, Newton R, Bre...
[
More Details
]
373741-(Uploaded-06-11-2019-13-19-02)-Journal results publication.pdf
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Peer mentoring for eating disorders: Evaluation of a pilot program.
2018
https://dx.doi.org/10.1186/s40814-018-0268-6
N.B. These documents automatically identified may not have been verified by the study sponsor.
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