Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
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.
Secondary ID [1] 290992 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 301752 0
Stress levels 301753 0
Anxiety 301754 0
Physical Inactivity 301755 0
Depression 301756 0
Body Image Concerns 301757 0
Condition category
Condition code
Mental Health 301451 301451 0 0
Anxiety
Mental Health 301458 301458 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 296950 0
Behaviour
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)
Control group
Active

Outcomes
Primary outcome [1] 300840 0
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.
Timepoint [1] 300840 0
Six months
Secondary outcome [1] 331009 0
Psychological Health: Strength and Difficulties Questionnaire ( SDQ): Goodman, 2201;Goodman, Meltzer & Bailey, 2003)
Timepoint [1] 331009 0
Six months
Secondary outcome [2] 331010 0
Mindfulness: Child and Adolescent Mindfulness Measure ( CAMM) ( Greco, Baer & Smith, 2011)
Timepoint [2] 331010 0
Six months
Secondary outcome [3] 331011 0

. Motivation: Behavioural Regulations in Exercise Questionnaire - 2 ( BREQ-2) ( Markland & Tobin, 2004)
Timepoint [3] 331011 0
Six months
Secondary outcome [4] 331117 0
Self-Compassion: Self -Compassion ( Neff, 2016)
Timepoint [4] 331117 0
6 months
Secondary outcome [5] 331118 0
Rumination: Rumination Scale ( Treynor, Gonzalez & Nolen-Hoeksema, 2003)
Timepoint [5] 331118 0
6 months
Secondary outcome [6] 331119 0
Screen Time: Adolescent sedentary Activity Questionnaire ( ASAQ ( Hardy, Booth & Okely, 2007)
Timepoint [6] 331119 0
6 months
Secondary outcome [7] 331120 0
Social Health: A modified version of the Hemmingway: measure of adolescent connectedness ( Karcher & Sass, 2010)
Timepoint [7] 331120 0
6 months
Secondary outcome [8] 331121 0
Physical Activity: Physical Activity levels will be measured using a pedometer for seven days. ( Scheider, Crouter & Lukajic, 2003)
Timepoint [8] 331121 0
6 months

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.
Minimum age
13 Years
Maximum age
14 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin toss.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2017
Actual
31/01/2017
Date of last participant enrolment
Anticipated
31/01/2017
Actual
31/01/2017
Date of last data collection
Anticipated
3/07/2017
Actual
31/07/2017
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15154 0
2287 - Wallsend

Funding & Sponsors
Funding source category [1] 295415 0
University
Name [1] 295415 0
University of Newcastle
Country [1] 295415 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294234 0
None
Name [1] 294234 0
Address [1] 294234 0
Country [1] 294234 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296748 0
University of Newcastle Ethics Committee- Human Research Ethics Committee
Ethics committee address [1] 296748 0
Ethics committee country [1] 296748 0
Australia
Date submitted for ethics approval [1] 296748 0
02/12/2016
Approval date [1] 296748 0
07/12/2016
Ethics approval number [1] 296748 0
H-2016-0399

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

Contacts
Principal investigator
Name 71942 0
Dr Narelle Eather
Address 71942 0
University of Newcastle
University Drive Callaghan NSW 2308
Country 71942 0
Australia
Phone 71942 0
+61 425 302 312
Fax 71942 0
Email 71942 0
[email protected]
Contact person for public queries
Name 71943 0
Karen White
Address 71943 0
Callaghan College Wallsend Campus
Macquarie St Wallsend NSW 2287
Country 71943 0
Australia
Phone 71943 0
+61 409 812 787
Fax 71943 0
Email 71943 0
[email protected]
Contact person for scientific queries
Name 71944 0
Narelle Eather
Address 71944 0
University of Newcastle
University Drive Callaghan NSW 2308
Country 71944 0
Australia
Phone 71944 0
+61 425 302 312
Fax 71944 0
Email 71944 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.