Tobacco Use and Smoking Behavior Clinical Trial
Official title:
Monitoring Secondhand Smoke Exposure in Buildings in Armenia: Controlled Trial
This study was designed to test the hypothesis whether a novel intervention that uses
motivational interviewing along with immediate feedback and follow-up counseling calls is
effective in educating the household members about the health hazards of smoking and
secondhand smoke exposure and reducing children exposure to secondhand smoke at households
in Armenia.
The study was a randomized control trial with two arms: intervention and control groups.
The sample population for the study included households with a non-smoking mother and at
least one child 2 to 6 years of age residing with at least one daily smoker. The study team
recruited the households through pediatrician's offices in polyclinics (primary healthcare
facilities) utilizing multistage random sampling. Trained interviewers made two baseline
(one week apart) and two 4-month follow-up household visits to conduct measurements,
interviews and intervention. Measurements included surveys, air nicotine monitoring in homes
and hair samples from children to assess changes in nicotine concentration over time.
SHS concentration was estimated by sampling vapor-phase nicotine using a filter badge
treated with sodium bisulfate. Airborne nicotine monitors were used in all homes to measure
SHS concentration at baseline and 4 month follow-up. At least one monitor was used in each
home, preferably in the main room in which the family congregates.
Personal exposure to SHS in 2-6 years old children was assessed using biological samples of
hair. A small sample of hair (approximately 30 - 50 strands, 2-3 cm) was cut near the hair
root from the back of the scalp where there is the most uniform growth pattern between
individuals which minimizes the variability of the results.
The intervention included an in-person counseling session with distribution of a tailored
educational brochure and demonstration/feedback measurement of indoor PM2.5 (at second
baseline visit); it also included one and two months follow-up counseling calls. The control
group received only a brief educational leaflet on the hazards of second-hand smoke
exposure.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | November 2010 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years and older |
| Eligibility |
Inclusion Criteria: - At least one child 2 to 6 years of age - Non-smoking mother - At least one daily smoker - Child's exposed to second smoke of at least 1 cigarette per day Exclusion Criteria: - Mother's pregnancy - Child's hair less than 2 cm in length after stretching out - Residing out of Yerevan |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Armenia | College of Health Sciences, American University of Armenia | Yerevan |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins Bloomberg School of Public Health | American University of Armenia |
Armenia,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in child's hair nicotine concentration | baseline and 4-month follow-up | No | |
| Primary | change in air nicotine concentration | baseline and 4-month follow-up | No | |
| Secondary | change in the respondents' knowledge on hazards of smoking and secondhand smoke | baseline and 4-month follow-up | No | |
| Secondary | change in frequency of smoking in the presence of the child | baseline and 4-month follow-up | No | |
| Secondary | change in household smoking restrictions | baseline and 4-month follow-up | No |