Home » Trials » SLCTR/2018/028


School-based physical activity intervention in 11-13 year-old adolescents -

SLCTR Registration Number

SLCTR/2018/028


Date of Registration

31 Aug 2018

The date of last modification

Sep 06, 2018



Application Summary


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 of 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)


Trial Details


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


Assignment

Parallel


Purpose

Prevention


Purpose


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

  1. Male and female adolescent school children between 11-13 years of age
  2. Informed written assent of the adolescent school children and consent of the parents/guardian is obtained

Exclusion criteria

  1. Long standing illness or on long term medication (specifically long standing renal disorders, those on steroids or on anticoagulant therapy
  2. Any recent fractures, dislocations, muscle or ligament injury which may affect participation in physical activity
  3. If they have failed any physical examinations done prior to any sporting activity
  4. Medical advice not to participate in competitive sports


Primary outcome(s)

  1. Duration of moderate-to-vigorous physical activities (MVPA) as determined by a validated interviewer- administered physical activity recall questionnaire that includes the MVPAs done during the whole day including the school based physical activity intervention.

  2. Rate of MVPA, as determined by dividing the number of students engaged in MVPA by total number of students allocated to either the intervention or control group (as recommended in the literature).

  3. Sitting time including screen time as determined by a validated interviewer- administered questionnaire


Primary outcome(s) - Time of assessment(s)

All outcomes will be measured at baseline and at the end of the 3-month intervention period


Secondary outcome

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.

  1. Cardiovascular fitness (using 20 m extended run between cones)
  2. Muscular strength and endurance (using 900 push-ups and curl ups)
  3. Flexibility (using back saver sit and reach test)
  4. Body composition (using Bio electrical Impedance Analysis with gold standard validated equations)

Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Recruiting


State of ethics review approval

Approved by Ethics Review Committee, Faculty of Medicine, University of Colombo on 15th December 2016 ( EC-16-192), Extended on 15th December 2017


Funding source

International Atomic Energy Association (IAEA) technical cooperation project SRL/06/035



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None