Home » Trials » SLCTR/2018/028
School-based physical activity intervention in 11-13 year-old adolescents
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SLCTR Registration Number
SLCTR/2018/028
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
School-based physical activity intervention in 11-13 year-old adolescents
Public Title of Trial
School-based physical activity intervention in 11-13 year-old adolescents
Disease or Health Condition(s) Studied
Physical fitness
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1207-5750
Any other number(s) assigned to the trial and issuing authority
EC-16-192 (ERC, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Is 3-month school-based physical activity programme effective in improving the behavior and health-related physical fitness parameters among 11-13 year-old adolescent school children?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Intervention(s) planned
The intervention programme was designed using data from a comprehensive situational analysis. The existing National and International policies and guidelines were considered in designing the intervention (Please see the intervention details document)
Study setting: Twelve (12) government schools within the Colombo Municipal Council Area which are listed under the Ministry of Education.
Method of randomization: Cluster randomization using the schools as clusters
Selection criteria
• Availability of physical education and health sciences subject in the school curriculum
• Availability of basic resources (Physical Education teachers, game equipment, play grounds or space for outdoor sports activities)
• Have at least one qualified PE teacher or instructor within the school
The girls and boys schools will be listed separately. Thereafter 06 boys’ schools and 06 girls’ schools will be randomly selected from the screened list using random number tables. Within each group of boys and girls schools separately, a block randomization procedure will be used to ensure 3 in the intervention and 3 in the control group.
Intervention
The physical activity intervention is designed as 3 comparable physical activity programmes lasting for 30 minutes (different activities in each programme to avoid monotony). Each programme consist of following,
i. Warm up: 05 minutes (aerobics and dynamic stretching for major muscle groups of the body)
ii. Flexibility and endurance training activities (including cardiovascular endurance): 08 minutes (mainly focusing on major muscle groups of upper limbs, lower limbs and trunk)
iii. Strength training activities: 06 minutes (mainly focusing on major muscle groups of upper limbs, lower limbs and trunk)
iv. Cool down: 03 minutes (slow rhythmic aerobic activities)
v. Fun games: 08 minutes
The intervention will be delivered by trained physical education teachers. The physical activity programme is designed for 30 minutes. It will be conducted within the school hours, on 3 weekdays (Monday, Wednesday and Friday) for 3 consecutive months.
The control group will not receive any intervention programme and they would be continuing only the 2 periods of health and physical education subject as in the individual school curriculum.
The intervention group will be doing the physical activity intervention programme in addition to the 2 periods of health and physical education subject as in the individual school curriculum.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
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[ All outcomes will be measured at baseline and at the end of the 3-month intervention period ] |
Secondary outcome(s)
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1.
Improvement of the following health related physical fitness parameters will be assessed between the control and intervention groups at the baseline and 3 months post intervention.
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[ All outcomes will be measured at baseline and at the end of the 3-month intervention period ] |
Target number/sample size
360 (180 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-09-03
Anticipated end date
2019-03-01
Date of first enrollment
2018-09-03
Date of study completion
Recruitment status
Recruiting
Funding source
International Atomic Energy Association (IAEA) technical cooperation project SRL/06/035
Regulatory approvals
Status
Approved
Date of Approval
2016-12-15
Approval number
EC-16-192 (extended on 15.12.2017)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Pulani Lanerolle
Professor in Biochemistry
Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo, Sri Lanka
Tel: 011-2697947
Mob: 0772122212
Fax: 0112697485
pulanil@yahoo.co.uk
Contact Person for Public Queries
Prof. VP Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo
Tel: 011-2688748
Mob: 0777766595
Fax: 0112691581
pujithaw@yahoo.com
Primary study sponsor/organization
Prof. Pulani Lanerolle
Professor in Nutrition
Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo, Sri Lanka
Tel: 011-2697947
Fax: 0112697485
pulanil@yahoo.co.uk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
