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Trial registered on ANZCTR
Registration number
ACTRN12617000157370
Ethics application status
Approved
Date submitted
23/01/2017
Date registered
30/01/2017
Date last updated
30/01/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The impact of a school-based health and well-being program for adolescent girls on levels of well-being, mindfulness, screen-time and physical activity.
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Scientific title
The impact of a school-based health and well-being program for adolescent girls on levels of well-being, mindfulness, screen-time and physical activity.
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Secondary ID [1]
290992
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Nil Known
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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:
Mental Health
301752
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Stress levels
301753
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Anxiety
301754
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Physical Inactivity
301755
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Depression
301756
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Body Image Concerns
301757
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Condition category
Condition code
Mental Health
301451
301451
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0
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Anxiety
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Mental Health
301458
301458
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Health and Wellbeing for Girls will be run as a Grade 8 (ages 13-14 years) endorsed elective course during normal curriculum time in 2017. The elective course will be implemented and evaluated as a group randomized controlled trial (RCT) in one secondary school. All students who choose to complete the elective course in 2017 will be randomised by class into either the intervention group (who complete the program Semester 1) or the wait-list control group (who will receive the program in Semester 2). There will be four (4) classes involved in the study, with approximately 90 girls participating in the program in 2017.
The Health and Wellbeing for Girls program is an evidence-based program that will be delivered by two experienced and qualified physical education teachers. It will be delivered within 5 hours of curriculum time per fortnight over two school terms (20 weeks), and includes relevant and enjoyable theory and practical components relating to mindfulness, wellbeing, physical activity behaviours, socio-emotional health and resilience. The feasibility and the effectiveness of the 20-week multi-component curriculum program for improving a range of health and wellbeing outcomes in adolescent girls in the school setting will be assessed using validated measures at baseline (Week 1 Term 1 2017) and at 6-months (Week 1 Term 3 2017). Participants will also be asked to give their opinions about the program via a short evaluation survey at the completion of the program.
Information provided to the classes includes activities on:
Self - acceptance and awareness,
Cyber bullying / The effects of Social Media and Coping Strategies
Understanding that Body Image and Self Esteem can be improved
Sexual Health and Assertiveness / Recognising our Strengths
Stages of Girlhood / Girlhood to Womanhood
Drugs and their Impact on Decision Making
Importance of Positive Thinking On Achievement
Improving relationships amongst girls.
Mindfulness meditation techniques are taught, along with Yoga, 3 minute High Intensity Interval Training, Fitness activities and Games.
5 one-hour sessions are delivered during the fortnight in which PowerPoint presentations, video clips and questions, along with discussion group formats are utilised.
Register of attendance at every lesson is monitored electronically and a lesson register is kept by the teacher.
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Intervention code [1]
296950
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Behaviour
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Comparator / control treatment
Health and Wellbeing for Girls will be run as a Grade 8 (ages 13-14 years) endorsed elective course during normal curriculum time in 2017. The elective course will be implemented and evaluated as a group randomized controlled trial (RCT) in one secondary school. All students who choose to complete the elective course in 2017 will be randomised by class into either the intervention group (who complete the program Semester 1) or the wait-list control group (who will receive the program in Semester 2). There will be four (4) classes involved in the study, with approximately 90 girls participating in the program in 2017. Semester 2 will begin approximately six months after Semester 1. (19.7.17)
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Control group
Active
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Outcomes
Primary outcome [1]
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How does a school-based health and wellbeing program impact on the wellbeing levels of adolescent girls?
Psychological well-being: Diener and colleagues’ psychological flourishing scale (Diener et al., 2010) will be used to measure subjective well-being.
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Assessment method [1]
300840
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Timepoint [1]
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Six months
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Secondary outcome [1]
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Psychological Health: Strength and Difficulties Questionnaire ( SDQ): Goodman, 2201;Goodman, Meltzer & Bailey, 2003)
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Assessment method [1]
331009
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Timepoint [1]
331009
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Six months
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Secondary outcome [2]
331010
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Mindfulness: Child and Adolescent Mindfulness Measure ( CAMM) ( Greco, Baer & Smith, 2011)
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Assessment method [2]
331010
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Timepoint [2]
331010
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Six months
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Secondary outcome [3]
331011
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. Motivation: Behavioural Regulations in Exercise Questionnaire - 2 ( BREQ-2) ( Markland & Tobin, 2004)
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Assessment method [3]
331011
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Timepoint [3]
331011
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Six months
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Secondary outcome [4]
331117
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Self-Compassion: Self -Compassion ( Neff, 2016)
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Assessment method [4]
331117
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Timepoint [4]
331117
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6 months
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Secondary outcome [5]
331118
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Rumination: Rumination Scale ( Treynor, Gonzalez & Nolen-Hoeksema, 2003)
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Assessment method [5]
331118
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Timepoint [5]
331118
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6 months
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Secondary outcome [6]
331119
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Screen Time: Adolescent sedentary Activity Questionnaire ( ASAQ ( Hardy, Booth & Okely, 2007)
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Assessment method [6]
331119
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Timepoint [6]
331119
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6 months
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Secondary outcome [7]
331120
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Social Health: A modified version of the Hemmingway: measure of adolescent connectedness ( Karcher & Sass, 2010)
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Assessment method [7]
331120
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Timepoint [7]
331120
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6 months
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Secondary outcome [8]
331121
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Physical Activity: Physical Activity levels will be measured using a pedometer for seven days. ( Scheider, Crouter & Lukajic, 2003)
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Assessment method [8]
331121
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Timepoint [8]
331121
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6 months
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Eligibility
Key inclusion criteria
Health and Wellbeing for Girls will be run as a Grade 8 (ages 13-14 years) endorsed elective course during normal curriculum time in 2017, so all Grade 8 students enrolled in this elective course will be invited and eligible to participate in the study.
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Minimum age
13
Years
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Maximum age
14
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin toss.
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Participation in this research is entirely your choice and only those students who have provided explicit written consent will be included in the study. If a student does not agree to participate, they will complete the Health and Wellbeing for Girls elective course as usual but will not complete any of the assessments associated with this study (questionnaires or physical activity monitoring).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/01/2017
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Actual
31/01/2017
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Date of last participant enrolment
Anticipated
31/01/2017
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Actual
31/01/2017
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Date of last data collection
Anticipated
3/07/2017
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Actual
31/07/2017
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Sample size
Target
90
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Accrual to date
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Final
90
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
15154
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2287 - Wallsend
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Newcastle
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Address [1]
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University Drive Callaghan NSW 2308
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Newcastle
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Address
University Drive Callaghan NSW 2308
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Country
Australia
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Secondary sponsor category [1]
294234
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None
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Name [1]
294234
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Address [1]
294234
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Country [1]
294234
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296748
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University of Newcastle Ethics Committee- Human Research Ethics Committee
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Ethics committee address [1]
296748
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University Drive Callaghan Newcastle NSW 2308
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Ethics committee country [1]
296748
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Australia
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Date submitted for ethics approval [1]
296748
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02/12/2016
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Approval date [1]
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07/12/2016
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Ethics approval number [1]
296748
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H-2016-0399
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Summary
Brief summary
It is well recognised that wellbeing has close links with learning (NSW Department of Education and Communities, 2015b); where improvements in wellbeing have the potential to bring about positive change in self -concept and a lack thereof, can negatively affect a student’s engagement and success in learning (NSW Department of Education and Communities, 2015b). Consequently, there has been increased attention given to the study of wellbeing over the past decade, particularly in educational or school settings. The wellbeing of adolescents has become a recent focus in public health due to the prevalence and rise in mental health disorders in this age group in recent times (with approximately 20% of adolescents worldwide having a diagnosed mental health illness) (Patton et al., 2012); and with the negative health consequences associated with physical inactivity trends in this age group (World Health Organisation, 2014). In Australia, the proportion of young people aged 16–24 years having high or very high levels of psychological distress is approximately 9%, the prevalence of mental disorders is approximately 26% (Australian Institute of Health and Welfare, 2011), and almost 80% of adolescents are not meeting physical activity guidelines (Hallal et al., 2012). Mental disorders and physical inactivity are now considered leading causes of ill-health in this age group, often with lasting effects throughout adulthood (Kieling et al., 2011; Kohl III et al., 2012; World Health Organisation, 2014). Of note, there is a distinct gender pattern in physical and mental health after the age of 13 years, with adolescent girls generally reporting more mental health problems than boys and exhibit lower levels of physical activity (Beets, Bornstein, Beighle, B.J., & Morgan, 2010; Myrin & Lagerstrom, 2008; Nitzko & Seiffge-Krenke, 2009) When combined with inadequate coping strategies, increased stress levels in the adolescent years can have profound and negative health consequences (including anxiety and depression) (Chrousos, 2009; Dougall, Hyman, Hayward, McFeeley, & Baum, 2001; K. A. McLaughlin & Hatzenbuehler, 2009a, 2009b; K. J. McLaughlin, Baran, & Conrad, 2009; Seiffge-Krenke, Aunola, & Nurmi, 2009)
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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
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Dr Narelle Eather
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Address
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University of Newcastle
University Drive Callaghan NSW 2308
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Country
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Australia
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Phone
71942
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+61 425 302 312
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Fax
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Email
71942
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[email protected]
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Contact person for public queries
Name
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Karen White
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Address
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Callaghan College Wallsend Campus
Macquarie St Wallsend NSW 2287
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Country
71943
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Australia
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Phone
71943
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+61 409 812 787
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Fax
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Email
71943
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[email protected]
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Contact person for scientific queries
Name
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Narelle Eather
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Address
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University of Newcastle
University Drive Callaghan NSW 2308
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Country
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Australia
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Phone
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+61 425 302 312
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Fax
71944
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Email
71944
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[email protected]
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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.
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