Home » Trials » SLCTR/2014/033
A Randomized Controlled Trial on the effect of multiple interventions for women’s empowerment on the reduction of secondhand smoking in Sri Lanka
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SLCTR Registration Number
SLCTR/2014/033
Date of Registration
The date of last modification
Apr 30, 2019
Trial Status
Scientific Title of Trial
A Randomized Controlled Trial on the effect of multiple interventions for women’s empowerment on the reduction of secondhand smoking in Sri Lanka
Public Title of Trial
A study promoting the right to smoke free living among women in Sri Lanka
Disease or Health Condition(s) Studied
Passive smoking
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1161-4306
Any other number(s) assigned to the trial and issuing authority
P/82/04/2014 (University of Kelaniya)
What is the research question being addressed?
Will multiple interventions to promote the right to smoke-free living reduce second hand smoking among married women?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Placebo
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study will be carried out in Kalutara district, Sri Lanka. Participants will be selected using multistage sampling.
Three MOH areas in the Kaluthara District will be randomly selected for the intervention, and three MOH areas will be randomly selected as controls.
The study will be conducted in two components.
Eligible participants will be recruited based on PHM areas (cluster sampling). A total of 370 women will be recruited in each arm.
The intervention group will be invited to participate in two workshops and two meetings, where health education interventions will be delivered in a culturally appropriate manner on 1. right to smoke free living 2. Second hand smoke (SHS) exposure risk 3. health effects of SHS 4. comprehensive smoke-free laws in workplaces and public places
The intervention will be offered to the Public Health Staff in the 3 control MOH areas at the end of the study period.
Eligible participants will be recruited based on the relevant classes in the selected schools (cluster sampling). A total of 1000 school children will be recruited in each arm.
The intervention group will be invited to participate in a workshop, two health education sessions and a life skills building session. 1. right to smoke free living 2. SHS exposure risk 3. health effects of SHS 4. comprehensive smoke-free laws in workplaces and public places
The intervention will be offered to the Public Health Staff in the 3 control MOH areas at the end of the study period.
Resource persons for the interventions will be Consultant Community Physicians, Psychiatrists and Pulmonologists, as well as MOH and field health personnel (PHNS, PHI, PHM).
Inclusion criteria
Component 1 : married women aged between 18-65 years
Component 2 : school children attending grades 7, 8 and 9 in government schools
Exclusion criteria
Component 1 : 1. Age <18 years 2. Unmarried
Component 2: 1. Non consent by parents 2. Non assent by school children to participate
Primary outcome(s)
|
1.
Component 1 : knowledge and attitude on passive smoking, right to smoke free living (using pretested validated questionnaires) Component 2 : knowledge and attitude on passive smoking, right to smoke free living life skills (using pretested validated questionnaires) |
[ Component 1 : At baseline and at the end of 6 months following the intervention Component 2 : At baseline, 6 months and 1 year following the intervention ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
household sample 370X2 School children 1000X2
Countries of recruitment
Sri Lanka
Anticipated start date
2014-11-25
Anticipated end date
2015-12-31
Date of first enrollment
2015-07-01
Date of study completion
Recruitment status
Recruiting
Funding source
World Health Organization (Grant number SESRL1408462)
Regulatory approvals
Status
Approved
Date of Approval
2014-04-09
Approval number
P/82/04/2014
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr MAAP Alagiyawanna
Consultant Community Physician
Health Education Bureau
No 2,
Kynsy Road,
Colombo 8
Mob: 0773997805
ajithalagi@yahoo.com
Contact Person for Public Queries
Dr MAAP Alagiyawanna
Consultant Community Physician
Health Education Bureau
No 2,
Kynsy Road,
Colombo 8
Mob: 0773997805
ajithalagi@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
