Trial Review

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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
Scientific title
Peer mentoring for eating disorders patients - evaluation of a pilot program
Secondary ID [1] 293010 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 304920 0
Condition category
Condition code
Mental Health 304250 304250 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299248 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303532 0
Eating disorder symptomatology in mentees assessed with the Eating Disorders Examination Questionnaire (EDE-Q)
Timepoint [1] 303532 0
Completion of mentoring (i.e. 6 months)
Primary outcome [2] 303533 0
Quality of life in mentees assessed with the Assessment of Quality of Life (AQoL)
Timepoint [2] 303533 0
Completion of mentoring (i.e. 6 months)
Secondary outcome [1] 339214 0
Hospital re-admission rates in mentees assessed through indication on the participant demographic and medical information form.
Timepoint [1] 339214 0
Completion of mentoring (i.e. 6 months)
Secondary outcome [2] 339435 0
Eating disorder symptomatology in mentors assessed with the Eating Disorders Examination Questionnaire (EDE-Q)
Timepoint [2] 339435 0
Completion of mentoring (i.e. 6 months)
Secondary outcome [3] 339436 0
Quality of life in mentors assessed with the Assessment of Quality of Life (AQoL)
Timepoint [3] 339436 0
Completion of mentoring (i.e. 6 months)
Secondary outcome [4] 339437 0
Hospital admission rates in mentors assessed through indication on the participant demographic and medical information form.
Timepoint [4] 339437 0
Completion of mentoring (i.e. 6 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Both mentees and mentors participating in the peer mentor program will be evaluataed across different timepoints in this study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/01/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
13/10/2018
Date of last data collection
Anticipated
9/11/2019
Actual
7/04/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9124 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 9125 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 10324 0
The Melbourne Clinic - Richmond
Recruitment postcode(s) [1] 17630 0
3065 - Fitzroy
Recruitment postcode(s) [2] 17631 0
3084 - Heidelberg
Recruitment postcode(s) [3] 21992 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 297637 0
Charities/Societies/Foundations
Name [1] 297637 0
William Buckland Foundation
Country [1] 297637 0
Australia
Funding source category [2] 297638 0
Charities/Societies/Foundations
Name [2] 297638 0
Ian Potter Foundation
Country [2] 297638 0
Australia
Funding source category [3] 297639 0
Charities/Societies/Foundations
Name [3] 297639 0
John T Reid Charitable Trust
Country [3] 297639 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 296657 0
Hospital
Name [1] 296657 0
St Vincent's Hospital
Address [1] 296657 0
Level 2, 46 Nicholson St, Fitzroy VIC 3065
Country [1] 296657 0
Australia
Secondary sponsor category [2] 296681 0
Hospital
Name [2] 296681 0
Eating Disorders Victoria
Address [2] 296681 0
16 Lulie St, Abbotsford VIC 3067
Country [2] 296681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298724 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 298724 0
Ethics committee country [1] 298724 0
Australia
Date submitted for ethics approval [1] 298724 0
21/10/2016
Approval date [1] 298724 0
17/11/2016
Ethics approval number [1] 298724 0
HREC/16/Austin/415
Ethics committee name [2] 298742 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [2] 298742 0
Ethics committee country [2] 298742 0
Australia
Date submitted for ethics approval [2] 298742 0
18/11/2016
Approval date [2] 298742 0
29/11/2016
Ethics approval number [2] 298742 0
HREC204/16
Ethics committee name [3] 299855 0
The Melbourne Clinic Human Research Ethics Committee
Ethics committee address [3] 299855 0
Ethics committee country [3] 299855 0
Australia
Date submitted for ethics approval [3] 299855 0
24/01/2018
Approval date [3] 299855 0
06/03/2018
Ethics approval number [3] 299855 0
TMC#301

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

Contacts
Principal investigator
Name 78022 0
A/Prof Richard Newton
Address 78022 0
Austin Hospital
145 Studley Rd, Heidelberg VIC 3084
Country 78022 0
Australia
Phone 78022 0
+61 417 366 223
Fax 78022 0
Email 78022 0
[email protected]
Contact person for public queries
Name 78023 0
Andrea Phillipou
Address 78023 0
Swinburne University of Technology
PO Box 218 (H99)
Hawthorn
VIC 3122
Country 78023 0
Australia
Phone 78023 0
+61 3 9214 8755
Fax 78023 0
Email 78023 0
[email protected]
Contact person for scientific queries
Name 78024 0
Andrea Phillipou
Address 78024 0
Swinburne University of Technology
PO Box 218 (H99)
Hawthorn
VIC 3122
Country 78024 0
Australia
Phone 78024 0
+61 3 9214 8755
Fax 78024 0
Email 78024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
EmbasePeer mentoring for eating disorders: Evaluation of a pilot program.2018https://dx.doi.org/10.1186/s40814-018-0268-6
N.B. These documents automatically identified may not have been verified by the study sponsor.