Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001070820
Ethics application status
Approved
Date submitted
4/10/2012
Date registered
5/10/2012
Date last updated
8/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Smoking prevention programs in schools in Aceh, Indonesia
Scientific title
The Impact of school-based smoking prevention programs on smoking knowledge, attitude, intention, and behaviours among adolescents in Aceh, Indonesia
Secondary ID [1] 281342 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking prevention and cessation 287568 0
Condition category
Condition code
Public Health 287894 287894 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: The health-based intervention: comprised eight sessions of health-based education about smoking prevention program. The intervention was installed into relevant schools' subjects and lasted about two hours of schools' normal class per week, over eight weeks period. The trained schoolteachers and health educator/professionals administered the intervention to students in the students' usual classrooms.
Arm 2: The Islamic-based intervention: comprised eight sessions of Islamic-based education about smoking prevention program. The intervention was installed into relevant schools' subjects and lasted about two hours of schools' normal class per week, over eight weeks period. The trained schoolteachers and/or Islamic leaders with in-depth knowledge in Islamic teaching and smoking prevention program administered the intervention to students in the students' usual classrooms.
Arm 3: The Combined intervention: comprises eight sessions of smoking prevention program based on the health and Islamic approach. The intervention was installed into relevant schools' subjects and lasted about two hours of schools' normal class per week over eight weeks period. The trained health educator/professionals, schoolteachers and/or Islamic leaders with in-depth knowledge in smoking prevention program and Islamic teaching administered the intervention to students in the students' usual classrooms.
Intervention code [1] 285807 0
Prevention
Intervention code [2] 285808 0
Behaviour
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 288106 0
Smoking knowledge, attitude, intentions, and behaviours assessed by self-report questionnaire prepared specifically for the use in this study, based on the educational material to be delivered in the three interventions approaches. Some of the questions were adapted from relevant questions of previous studies.
Timepoint [1] 288106 0
Baseline, one week after intervention completion, and six months after intervention completion.
Secondary outcome [1] 299440 0
Evaluating participants and providers' perceptions and experiences with the interventions using open-ended survey, group discussions, and interviews.
Timepoint [1] 299440 0
After the interventions

Eligibility
Key inclusion criteria
Students in the selected schools who provided personal and parental/guardian written consent.
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students in the selected schools who could not provide personal and parental/guardian written consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1). Eight schools were conveniently selected for the study with the help of head of the Education Department of the district.
2). The Selected schools were assigned to be either a control group or one of the intervention groups using random sampling procedure, with two schools per each group.
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1). Listed schools numbers
2). Generated group code
3). Generated random numbers using Microsoft exel
4). Sorted, copied, and pasted the random numbers with the group code
5). Summarized the result.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
476
Accrual to date
Final
Recruitment outside Australia
Country [1] 4584 0
Indonesia
State/province [1] 4584 0
Aceh

Funding & Sponsors
Funding source category [1] 286107 0
University
Name [1] 286107 0
Faculty of Health Sciences, Flinders University
Country [1] 286107 0
Australia
Primary sponsor type
University
Name
Faculty of Health Sciences, Flinders University
Address
Health Science Building, Registry Road, Bedford Park, SA 5001
Country
Australia
Secondary sponsor category [1] 284920 0
None
Name [1] 284920 0
Address [1] 284920 0
Country [1] 284920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288155 0
The Social and Behavioural Research Ethics Committee
Ethics committee address [1] 288155 0
Ethics committee country [1] 288155 0
Australia
Date submitted for ethics approval [1] 288155 0
Approval date [1] 288155 0
30/09/2010
Ethics approval number [1] 288155 0
4971

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

Contacts
Principal investigator
Name 34791 0
Address 34791 0
Country 34791 0
Phone 34791 0
Fax 34791 0
Email 34791 0
Contact person for public queries
Name 18038 0
Paul R. Ward
Address 18038 0
Discipline of Public Health
School of Medicine, Flinders University
Level 2 Health Science Building
Registry Road, Bedford Park
Adelaide, South Australia 5001
Country 18038 0
Australia
Phone 18038 0
+61 8 72218415
Fax 18038 0
+61 8 72218424
Email 18038 0
[email protected]
Contact person for scientific queries
Name 8966 0
Teuku Tahlil
Address 8966 0
Discipline of Public Health
School of Medicine, Flinders University
Level 2 Health Science Building
Registry Road, Bedford Park
Adelaide, South Australia 5001
Country 8966 0
Australia
Phone 8966 0
+61 8 72218442
Fax 8966 0
+61 8 72218424
Email 8966 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
SourceTitleYear of PublicationDOI
EmbaseThe impact of education programs on smoking prevention: a randomized controlled trial among 11 to 14 year olds in Aceh, Indonesia.2013https://dx.doi.org/10.1186/1471-2458-13-367
EmbaseSix-months follow-up of a cluster randomized trial of school-based smoking prevention education programs in Aceh, Indonesia.2015https://dx.doi.org/10.1186/s12889-015-2428-4
N.B. These documents automatically identified may not have been verified by the study sponsor.