Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000030673
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
9/01/2014
Date last updated
9/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
School-based health promotion program to promote physical activity among adolescents in Hong Kong: a pilot study
Scientific title
School-based health promotion program to promote physical activity among adolescents in Hong Kong: a pilot study
Secondary ID [1] 283796 0
None
Universal Trial Number (UTN)
U1111-1151-4854
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 290774 0
Condition category
Condition code
Public Health 291137 291137 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The school-based health education and exercise program consists of eighteen 1-hour sessions which will be held on a weekly basis. The program is scheduled according to the school calendar, and there will be no sessions during exam period, special school events, and school holidays. The content of the program include 1) health education workshops (5 hours) on the benefits and basis knowledge about physical activity; 2) Fitness-walking exercise (3 hours) and 3) skill training sessions (10 hours) on skipping (for boys and girls), street dancing (for girls) and martial arts (for boys).

To encourage students' participation and adherence to the program, the program activities will be designed as team-based activities or games so students can learn in a fun and relaxing atmosphere. The activities are facilitated by instructors and coaches who are currently studying in college, and these "big brothers big sisters" will stand as a role model for the students. The research team will also work closely with the school teachers on any feedback throughout the program. Students who complete 80% of the program will be awarded with an attendance certificate.
Intervention code [1] 288480 0
Behaviour
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 291123 0
Level of Physical Activity is assessed by a self-reported measure using the Chinese version of the Children's Leisure Activities Study Survey (CLASS) Questionnaire validated for Hong Kong Chinese students (Huang et. al., 2009)
Timepoint [1] 291123 0
Baseline (before program begins) and immediate after the program (6-7 months from baseline depending on individual school schedules)
Primary outcome [2] 291124 0
Perception towards physical activity is assessed by self-administered questionnaire with items measuring 1) self-efficacy related to physical activity, 2) family and peer support for physical activity, and 3) physical self-description
Timepoint [2] 291124 0
Baseline (before program begins) and immediate after the program (6-7 months from baseline depending on individual school schedules)
Secondary outcome [1] 306030 0
Physical fitness is measured by physical fitness assessment on the following items: Grip strength, Push-up test, Standing board jump, Traditional curl up, Sit –and- reach, and 6/9-minute run/walk test
Timepoint [1] 306030 0
Baseline (before program begins) and immediate after the program (6-7 months from baseline depending on individual school schedules)

Eligibility
Key inclusion criteria
i) Form 1 and Form 2 students studying in the particpating schools;
ii) those with physical activity level below the Standard Indicator (participating in moderate- to vigorous- intensity physical activities for 30 minutes for at least 3 times a week) at the baseline assessment; and
iii) students with signed informed consent by parents for participation
Minimum age
12 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with physical activity level above the Standard Indicator (participating in moderate- to vigorous- intensity physical activities for 30 minutes for at least 3 times a week) at the baseline assessment; unwillingness to attend the health education class on a weekly basis as part of the intervention program; as judged by the investigators as ineligible to participate the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Form 1 and Form 2 students aged 12-14 will be invited to join the study. Information of the study will be sent via the school teachers to parents and the students. After obtaining informed consent, students will be invited to complete a physical fitness assessment and a questionnaire survey. Eligible students from the intervention schools will be invited to participate in the intervention program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nonrandomized trial
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
Descriptive statistics will be calculated for demographic characteristics, physical fitness test results, physical activty level, perceptions on physical activity. Data will be presented as mean (standard deviation), median (inter-quartile range) for skewed variables and frequency (percentage) as appropriate. A p-value less than 0.05 will be considered statistically significant. PASW Statistics 18 for Windows (formerly SPSS Statistics) (SPSS Inc., Chicago, IL, USA) will be used for statistical analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/09/2013
Actual
25/09/2013
Date of last participant enrolment
Anticipated
14/11/2013
Actual
14/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 5690 0
Hong Kong
State/province [1] 5690 0

Funding & Sponsors
Funding source category [1] 288452 0
Charities/Societies/Foundations
Name [1] 288452 0
Freddy Zimmern Sports Foundation
Country [1] 288452 0
Hong Kong
Primary sponsor type
University
Name
The Chinese University of Hong Kong
Address
Shatin, New Territories
Country
Hong Kong
Secondary sponsor category [1] 287155 0
None
Name [1] 287155 0
Address [1] 287155 0
Country [1] 287155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290324 0
Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 290324 0
Ethics committee country [1] 290324 0
Hong Kong
Date submitted for ethics approval [1] 290324 0
14/08/2013
Approval date [1] 290324 0
02/10/2013
Ethics approval number [1] 290324 0
CRE-2013.457

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

Contacts
Principal investigator
Name 45090 0
Dr Anisha Abraham
Address 45090 0
4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories
Country 45090 0
Hong Kong
Phone 45090 0
+852 2252-8776
Fax 45090 0
Email 45090 0
[email protected]
Contact person for public queries
Name 45091 0
Stella Chow
Address 45091 0
4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories
Country 45091 0
Hong Kong
Phone 45091 0
+852 2252-8466
Fax 45091 0
Email 45091 0
[email protected]
Contact person for scientific queries
Name 45092 0
Anisha Abraham
Address 45092 0
4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories
Country 45092 0
Hong Kong
Phone 45092 0
+852 2252-8776
Fax 45092 0
Email 45092 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.