Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000716662
Ethics application status
Approved
Date submitted
4/11/2005
Date registered
4/11/2005
Date last updated
10/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Martial arts for health in adolescents
Scientific title
Kung Fu for overweight and obese adolescents: A randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 866 0
Condition category
Condition code
Diet and Nutrition 933 933 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kung Fu - 3 x 1 hour sessions each week for 6 months. All classes will be supervised and led by an instructor
Intervention code [1] 751 0
None
Comparator / control treatment
Tai Chi - 3 x 1 hour sessions each week for 6 months. All classes will be supervised and led by an instructor
Control group
Placebo

Outcomes
Primary outcome [1] 1222 0
Body composition (DXA)
Timepoint [1] 1222 0
Measured at baseline (before randomisation) and at follow up (6 months)
Secondary outcome [1] 2225 0
Metabolic Markers (insulin resistance, cholesterol)
Timepoint [1] 2225 0
Measured at baseline (before randomisation) and at follow up (6 months).
Secondary outcome [2] 2226 0
Muscle performance
Timepoint [2] 2226 0
Measured at baseline (before randomisation) and at follow up (6 months).
Secondary outcome [3] 2227 0
Aerobic fitness
Timepoint [3] 2227 0
Measured at baseline (before randomisation) and at follow up (6 months).
Secondary outcome [4] 2228 0
Self-perception
Timepoint [4] 2228 0
Measured at baseline (before randomisation) and at follow up (6 months).
Secondary outcome [5] 2229 0
Habitual physical activity
Timepoint [5] 2229 0
Measured at baseline (before randomisation) and at follow up (6 months).
Secondary outcome [6] 2230 0
Food intake.
Timepoint [6] 2230 0
Measured at baseline (before randomisation) and at follow up (6 months).

Eligibility
Key inclusion criteria
In school years 6-12. Overweight/obese (based on international cutoff values of body mass index (BMI) for children). Sedentary. No previous martial arts experience (in past 3y). No contraindications to exercise.
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Refusing randomisation; having a health condition which precludes them from the tesing and training involved in the trial; having other commitments which would interfere with their compliance to the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An investigator otherwise not involved with study subjects performed the randomisation, and informed the assessor after a subject's baseline testing was completed. The assessor then informed the subject of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation program, performed by researcher not otherwise involved with study subjects, stratified by gender and body mass index
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1030 0
University
Name [1] 1030 0
The University of Sydney, Exercise, Health & Performance Faculty Research Group
Country [1] 1030 0
Australia
Primary sponsor type
Hospital
Name
The Department of Adolescent Medicine, The Children's Hospital at Westmead
Address
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 894 0
None
Name [1] 894 0
(N/A)
Address [1] 894 0
Country [1] 894 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36085 0
Address 36085 0
Country 36085 0
Phone 36085 0
Fax 36085 0
Email 36085 0
Contact person for public queries
Name 9940 0
Tracey Tsang
Address 9940 0
32 White Cedar Dr
Castle Hill NSW 2154
Country 9940 0
Australia
Phone 9940 0
+61 2 98948003
Fax 9940 0
Email 9940 0
ttsa6920@mail.usyd.edu.au
Contact person for scientific queries
Name 868 0
Tracey Tsang
Address 868 0
32 White Cedar Dr
Castle Hill NSW 2154
Country 868 0
Australia
Phone 868 0
+61 2 98948003
Fax 868 0
Email 868 0
ttsa6920@mail.usyd.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.