Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000513011
Ethics application status
Approved
Date submitted
17/06/2010
Date registered
22/06/2010
Date last updated
22/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of the “Girls on the Go!” program amongst high school young women to address low self esteem and poor body image
Scientific title
Amongst high school-aged young women, does the “Girls on the Go!” program generate superior outcomes compared to no intervention in terms of self esteem and body image
Secondary ID [1] 252036 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychiatric morbidity (poor self esteem, poor body image, body dissatisfaction, poor self confidence, dieting behaviour) 257578 0
Condition category
Condition code
Mental Health 257750 257750 0 0
Eating disorders
Public Health 257774 257774 0 0
Health promotion/education
Mental Health 257751 257751 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The “Girls on the Go!” program is a 10-week intervention designed to assist young women in improving self-esteem, body image, confidence and general health and wellbeing. The program is delivered from an empowerment model whereby the young women are actively involved in the planning and implementation of the activities they feel will best benefit them. Participants engage in discussion and activities design to address a particular topic. Weekly themes include: introductions, body image, safety and assertiveness, a healthy mind, physical activity, trust and confidence and celebration. Areas of health and wellbeing are addressed throughout the program. The program is facilitated by Youth Workers and takes place outside of the school environment.
There is one session per week. The first Girls on the Go session lasts for 1 hour, the next 8 sessions last for 2.5 hours, the final session lasts for 6 hours and includes a celebration.
Intervention code [1] 256674 0
Prevention
Intervention code [2] 256673 0
Behaviour
Intervention code [3] 256675 0
Lifestyle
Comparator / control treatment
The control will be a no intervention condition. Participants on the waiting list to receive this program will form this control condition.
Control group
Active

Outcomes
Primary outcome [1] 258630 0
Rosenberg self-esteem scale
Timepoint [1] 258630 0
Intervention group:
Immediately before "Girls on the Go!" program commencement.
Immediately following "Girls on the Go!" program completion.
Control group:
Two assessments will also be taken for control group participants at equivalent time points, however they will not be receiving this intervention between these assessments.
Primary outcome [2] 258644 0
Clinical Impairment Assessment developed by Bohn et al (2008).
Timepoint [2] 258644 0
Intervention group:
Immediately before "Girls on the Go!" program commencement.
Immediately following "Girls on the Go!" program completion.
Control group:
Two assessments will also be taken for control group participants at equivalent time points, however they will not be receiving this intervention between these assessments.
Secondary outcome [1] 264616 0
Froman and Owen's Health Self-Efficacy Measure
Timepoint [1] 264616 0
Intervention group:
Immediately before "Girls on the Go!" program commencement.
Immediately following "Girls on the Go!" program completion.
Control group:
Two assessments will also be taken for control group participants at equivalent time points, however they will not be receiving this intervention between these assessments.
Secondary outcome [2] 264615 0
Body Dissatisfaction subscale of the Eating Disorders Inventory (Garner, Olmstead & Polivy)
Timepoint [2] 264615 0
Intervention group:
Immediately before "Girls on the Go!" program commencement.
Immediately following "Girls on the Go!" program completion.
Control group:
Two assessments will also be taken for control group participants at equivalent time points, however they will not be receiving this intervention between these assessments.
Secondary outcome [3] 264586 0
Katz Mendelson and White body satisfaction scale
Timepoint [3] 264586 0
Intervention group:
Immediately before "Girls on the Go!" program commencement.
Immediately following "Girls on the Go!" program completion.
Control group:
Two assessments will also be taken for control group participants at equivalent time points, however they will not be receiving this intervention between these assessments.
Secondary outcome [4] 264617 0
Dutch Eating Behaviour Questionnaire for Children
Timepoint [4] 264617 0
Intervention group:
Immediately before "Girls on the Go!" program commencement.
Immediately following "Girls on the Go!" program completion.
Control group:
Two assessments will also be taken for control group participants at equivalent time points, however they will not be receiving this intervention between these assessments.

Eligibility
Key inclusion criteria
Participants require one of:
Perceived poor or negative body image
Low self esteem
Inactivity in sports and exercise
Poor diet
Being overweight or underweight
Minimum age
10 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous participation in Girls on the Go! program

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Young women meeting the inclusion criteria will be identified by School Welfare Co-ordinators, School Nurses, School Counsellors, Physical Educators, Health and other Teachers. A “Girls on the Go!” program brochure is provided by investigators to these staff to assist them with identifying eligible students correctly. Referrals are then made by these school staff members to the Greater Dandenong Community Health Service. Eligibility for the program is checked by Greater Dandenong Community Health Service staff who then accept this referral.
The referring school will send a letter to the parent / guardian explaining that a referral to Greater Dandenong Community Health Service has been made. This letter outlines what the “Girls on the Go!” program entails. Parents are then required to sign a parent permission form.
The school then notifies Greater Dandenong Community Health Service that the parent permission form has been completed.
The person who enrolls schools into this trial will not be aware of the random allocation sequence at the time of enrolment. The School Welfare Coordinators who identify young women to be referred for this program will not be aware of the allocation of their school at the time of making the referral. The researchers gaining consent from participants' parents/guardians will be aware of the allocation of the school at the time of gaining consent.

A telephone call will then be made by an investigator to explain to the research project to the parent/guardian. A standardised telephone script will be followed. An interpreter service will be engaged where required. Verbal consent from the parent for the child to participate in the research project will be sought.
This trial involves randomisation of clusters (schools being the unit of randomisation). The allocation sequence will be concealed from the person recruiting schools into this trial but not from the person gaining individual participant consent to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random allocation sequence will be generated using a computer random number generator.
This is a central randomisation approach that was then communicated to researchers by e-mail (computer)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This will be a matched cluster randomised trial. Schools are matched into pairs based on size. The two largest schools are then split, with one being randomly allocated to the intervention and one to the control group. The next two largest are then split, followed by the two smallest.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
21/07/2010
Date of last participant enrolment
Anticipated
Actual
21/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
122
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 287664 0
Charities/Societies/Foundations
Name [1] 287664 0
The Butterfly Foundation
Country [1] 287664 0
Australia
Funding source category [2] 257144 0
Hospital
Name [2] 257144 0
Southern Health Emerging Researcher Fellowship
Country [2] 257144 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Terry Haines
Address
Allied Health Clinical Research Unit
Kingston Centre
Kingston Rd
Cheltenham 3192
Victoria
Country
Australia
Secondary sponsor category [1] 256404 0
None
Name [1] 256404 0
NA
Address [1] 256404 0
NA
Country [1] 256404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259188 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 259188 0
Ethics committee country [1] 259188 0
Australia
Date submitted for ethics approval [1] 259188 0
01/06/2010
Approval date [1] 259188 0
Ethics approval number [1] 259188 0
10119B

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

Contacts
Principal investigator
Name 31298 0
Ms Laura Tirlea
Address 31298 0
Laura Tirlea
PhD scholar
Monash University
Faculty of Medicine, Nursing and Health Sciences
Department of Nutrition and Dietetics
Level 1, 264 Ferntree Gully Rd,
Notting Hill
Vic, 3168
Country 31298 0
Australia
Phone 31298 0
+61 405 195 301
Fax 31298 0
Email 31298 0
laura.tirlea@monash.edu
Contact person for public queries
Name 14545 0
Ms Laura Tirlea
Address 14545 0
Greater Dandenong Community Health Service
55 Buckingham Ave
Springvale 3171
Victoria
Country 14545 0
Australia
Phone 14545 0
+61 3 85589152
Fax 14545 0
Email 14545 0
laura.tirlea@southernhealth.org.au
Contact person for scientific queries
Name 5473 0
Assoc Prof Terry Haines
Address 5473 0
Kingston Centre
Kingston Rd
Cheltenham 3192
Victoria
Country 5473 0
Australia
Phone 5473 0
+61 3 92651774
Fax 5473 0
Email 5473 0
terrence.haines@med.monash.edu.au

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Patient evaluations not made public.

Documents added automatically
No additional documents have been identified.