Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001310752
Ethics application status
Approved
Date submitted
22/11/2013
Date registered
25/11/2013
Date last updated
10/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a resistance training program (Cross-Fit Teens) on physiological and psychological health in adolescents: A randomized controlled trial.
Scientific title
The CrossFit Teens Program: Evaluating intervention effects on adolescent body composition, fitness and psychological health.
Secondary ID [1] 283641 0
nil
Universal Trial Number (UTN)
U1111-1150-6761
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body Composition 290583 0
Physical Fitness 290584 0
Psychological health 290585 0
Condition category
Condition code
Public Health 290976 290976 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the feasibility and preliminary efficacy of an 8 week resistance training program (CrossFit Teens) for improving fitness, psychological adjustment, cognitive functioning, and self-esteem in secondary school students.

Research design:
The study will involve a group-randomised controlled trial with participants randomised to treatment conditions by class group (Control or CrossFit Teens intervention)

The CrossFit Teens program:
Program:2 x week (45-1hr)

Delivery: 2 x Qualified instructors
Location: On school campus
Cost: Sessions provided free of charge
No. of participants: 15 - 30 per session

Research questions
1) What are the effects of CrossFit training on health-related fitness in adolescents?
2) What are the effects of CrossFit training on resistance training skill levels of adolescents?
3) What are the effects of CrossFit training on self-esteem in adolescents?
4) What are the effects of CrossFit training on psychological adjustment in adolescents?
5) What are the effects of CrossFit training on cognitive functioning in adolescents?


Recruitment, setting and participants
One independent school from the Hunter Region will be recruited with a target recruitment of 60 students. The School Principal and Sports Organiser / Head of Sport will be contacted and invited to participate in the study. Eligible study participants will be adolescent boys and girls in Grade 9/10 (3rd and 4th year of secondary school) attending the school. All students with signed consent will be eligible to participate unless medically unable to participate.
Intervention
Overview of intervention. CrossFit Teens is a cross energy “threshold” program which is designed to improve strength, power, flexibility, speed accuracy, agility, cardiovascular endurance, stamina, co-ordination and balance (fitness components). The CrossFit methodology of programming is based on individual performance blended with the unique atmosphere of the “group training” and game setting to engage teenage participants.
Intervention code [1] 288339 0
Behaviour
Intervention code [2] 288340 0
Lifestyle
Comparator / control treatment
Participants in the control conditions will participate on their normal physical education and sport lessons during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 290952 0
Weight Status measured by waist circumference, BMI and BMIz score
Timepoint [1] 290952 0
Baseline - 8 weeks
Primary outcome [2] 290953 0
Physical fitness
Cardio respiratory fitness measured by the 20m shuttle run test
Muscular fitness measured by grip strength dynamometer, standing broad jump, curl up, push-up test
Flexible measured by the back saver sit and reach
Timepoint [2] 290953 0
Baseline - immediate post-intervention (8 weeks)
Secondary outcome [1] 305673 0
Psychological adjustment and self esteem measured by the strengths and difficulties questionnaire and the physical self description questionnaire
Timepoint [1] 305673 0
Baseline- Immediate Post-intervention (8-weeks)
Secondary outcome [2] 305682 0
Resistance training skill measured by the Resistance Training Skill Battery
Timepoint [2] 305682 0
Baseline to immediate post intervention (8weeks)

Eligibility
Key inclusion criteria
One independent school from the Hunter Region will be recruited with a target recruitment of 60 students. The School Principal and Sports Organiser / Head of Sport will be contacted and invited to participate in the study. Eligible study participants will be adolescent boys and girls in Grade 9/10 (3rd and 4th year of secondary school) attending the school. All students with signed consent will be eligible to participate unless medically unable to participate.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injury or illness preventing participation in assessments

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)
The study will involve a group-randomised controlled trial with participants randomised to treatment conditions by class group (Control or CrossFit Teens intervention) using an independent 3rd party to allocate conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Independent person will allocate consenting participants by class group to either the treatment or control using a blinded draw method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The CrossFit Teens program:
Program:2 x week (45-1hr)

Delivery: 2 x Qualified instructors
Location: On school campus
Cost: Sessions provided free of charge
No. of participants: 15-30 per session
Time: Term 3 (July-September), 2013.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be conducted using both an intention-to-treat analysis and completers’ analysis with an assumption of no change from baseline for those with missing data. Main and interaction effects for all primary and secondary outcome variables will then be determined by using repeated measures ANOVA and simple ANCOVA with the pre-test for each group used to adjust the post-test. Data analysis will be undertaken using SPSS (Statistical Package for the Social Sciences) with differences between treatment groups being considered statistically significant at p greater than or equal to 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2013
Actual
15/07/2013
Date of last participant enrolment
Anticipated
17/07/2013
Actual
17/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7578 0
2308 - Callaghan

Funding & Sponsors
Funding source category [1] 288321 0
University
Name [1] 288321 0
The University of Newcastle
Country [1] 288321 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan, NSW, 2308.
Country
Australia
Secondary sponsor category [1] 287037 0
Other Collaborative groups
Name [1] 287037 0
NSW Institute for Educational Research
Address [1] 287037 0
resident

Mrs Anne Forbes

Australian Catholic University
40 Edward St North Sydney NSW 2060
Country [1] 287037 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290215 0
The University of Newcastle Ethics Committee
Ethics committee address [1] 290215 0
Ethics committee country [1] 290215 0
Australia
Date submitted for ethics approval [1] 290215 0
Approval date [1] 290215 0
10/07/2013
Ethics approval number [1] 290215 0
H-2013-0138

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

Contacts
Principal investigator
Name 44490 0
Dr Narelle Eather
Address 44490 0
The University of Newcastle
HPE3:10 University Drive
Callaghan, NSW 2308.
Country 44490 0
Australia
Phone 44490 0
+61249216232
Fax 44490 0
Email 44490 0
[email protected]
Contact person for public queries
Name 44491 0
Narelle Eather
Address 44491 0
The University of Newcastle
HPE3:10 University Drive
Callaghan, NSW 2308.
Country 44491 0
Australia
Phone 44491 0
+61249216232
Fax 44491 0
Email 44491 0
[email protected]
Contact person for scientific queries
Name 44492 0
NArelle Eather
Address 44492 0
The University of Newcastle
HPE3:10 University Drive
Callaghan, nsw 2308.
Country 44492 0
Australia
Phone 44492 0
+61249216232
Fax 44492 0
Email 44492 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
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