Development and evaluation of a school-based smoking prevention intervention for 13-14 year old adolescents in Malaysia
| ISRCTN | ISRCTN98023400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98023400 |
| Protocol serial number | UPE:40/200/19/2761 |
| Sponsor | Ministry of Health Malaysia |
| Funders | Ministry of Health Malaysia, The Health Promotion Unit, Sabah Health Department, The Non-Communicable Disease Unit, Sabah Health Department |
- Submission date
- 23/05/2016
- Registration date
- 25/05/2016
- Last edited
- 02/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cigarette smoking is the primary cause of premature death in Malaysia. Adolescent smoking is a particular problem, at around 20.2%. Preventing teenagers from smoking and encouraging them to stay off cigarettes are particularly important public health objectives for the Malaysian government. It is possible that adolescents may listen to their peers more with regards to smoking attitudes and behaviour than to adults. The aim of this study is to develop a school-based peer-led anti-smoking programme for 13-14 year olds in the Malaysian state of Sabah and evaluate its effectiveness in relation to smoking-related attitudes and behaviour.
Who can participate?
All Form 1 pupils attending the eight selected schools who attended school on the day of questionnaire administration.
What does the study involve?
Participating schools are randomly allocated to one of two groups. Schools in the first group continue with their usual practice of health promotion, such as health talks targeted at the whole school. A selection of pupils attending schools in the second group, take part in the three day training programme to be anti-smoking peer supporters. This involves watching videos, having talks and discussions and taking part in role playing and team building exercises. On returning to school, the pupils are asked to have informal anti-smoking conversations with their classmates. For pupils who took part in the peer educator programme, immediately before, at the start of the third day and at the end of the third day, a number of questionnaires are completed about their attitudes to smoking. Additionally, at the start of the study and then again after 7 months, all Form 1 pupils complete a number of questionnaires about whether they have talked to a peer educator about smoking and their attitudes towards smoking.
What are the possible benefits and risks of participating?
Participants may benefit from the training which included tips on how to communicate with other people. There is a small risk that some participants may experience mocking by their classmates for attempting to promote non-smoking.
Where is the study run from?
The study is run from the Sabah Health Department and takes place in eight schools located in Sabah (Malaysia)
When is the study starting and how long is it expected to run for?
March 2011 to March 2012
Who is funding the study?
1. Ministry of Health Malaysia (Malaysia)
2. The Health Promotion Unit, Sabah Health Department (Malaysia)
3. The Non-Communicable Disease Unit, Sabah Health Department (Malaysia)
Who is the main contact?
Dr Wolfgang Markham
Wolfgang.Markham@warwick.ac.uk
Contact information
Public
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0003-4086-1449 |
|---|---|
| Phone | +44 2476 5741239 |
| Wolfgang.Markham@warwick.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot pragmatic cluster randomised control trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | A pilot pragmatic cluster randomised control trial of a school-based peer-led anti-smoking intervention for 13-14 year olds in Malaysia |
| Study objectives | Trained anti-smoking peer supporters will promote non-smoking among their 13-14 year old Malaysian classmates through informal conversations. |
| Ethics approval(s) | 1. Research Promotion and Co-ordination Committee of the Economic Planning Unit of The Prime Minister’s Department in Malaysia 2. Biomedical Research Ethics Committee, University of Warwick |
| Health condition(s) or problem(s) studied | Adolescent smoking |
| Intervention | Schools are randomly allocated to one of two groups through concealed stratified randomisation. Control arm: Schools in the control arm receive usual care in the form of health promotion activities such as health talks that targeted the whole school, delivered by designated Health Promotion Officers who had attended a briefing session that focussed on guidelines for these activities. Intervention arm: Schools in the Intervention arm receive usual care plus the intervention. The intervention focuses on training pupils over three days off school premises to be anti-smoking peer supporters. Examples of activities during the training programme are: 1. Watching videos of the contents of cigarettes 2. Role plays of a variety of scripted scenarios some of which were smoking-related scenarios 3. Lectures on for example the important elements of communication and tips on how to be a good listener 4. Team building exercises 5. Reflection session on commitment to family 6. Practicing how to use the log book to record their smoking-related activity on their return to school after training On return to school peer educators are asked to have informal anti-smoking conversations with their classmates. Baseline and follow-up questionnaires were administered to all form 1 pupils in the control and intervention arms of the study who were present on the day of administration. Follow up questionnaires were administered 7 months after baseline questionnaires and 6 months after the peer supporters had been trained. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Smoking is measured via self-report questions at baseline and 7 months. |
| Key secondary outcome measure(s) |
Peer educators: |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 2118 |
| Key inclusion criteria | All Form 1 students attending the 8 selected schools who attended school on the day that the baseline and follow-up questionnaires were administered at their school. |
| Key exclusion criteria | Pupils who were absent on the day of questionnaire administration. |
| Date of first enrolment | 25/05/2011 |
| Date of final enrolment | 28/02/2012 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Mat Salleh Street
Sabah
Kota Kinabalu
88590
Malaysia
P.O.Box 11080
Sabah
Kota Kinabalu
88811
Malaysia
P.O.Box A-155
Sabah
Kota Kinabalu
89357
Malaysia
P.O.Box 235
Sabah
Kota Kinabalu
88856
Malaysia
P.O.Box A-290
Sabah
Inanam
89357
Malaysia
P.O.Box 464
Sabah
Keningau
89008
Malaysia
P.O.Box 55
Sabah
Keningau
89007
Malaysia
P.O.Box 2085
Sabah
Keningau
89008
Malaysia
P.O.Box 1613
Sabah
Keningau
89008
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/10/2017 | 02/03/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/03/2022: Publication reference added.
27/07/2016: internal review.
23/06/2016: Internal review.
