CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
in-person counseling +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01630356
NCT01630356N/ACompleted

Monitoring Secondhand Smoke Exposure in Buildings in Armenia: Controlled Trial

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jun 28, 2012·Updated Jun 28, 2012

In Brief

A clinical study evaluating in-person counseling, Demonstration of PM2.5 Pollution, and 2 other interventions for Tobacco Use and Smoking Behavior. Completed, enrolled 250 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArmenia

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2012
Enrollment StartApr 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.0 years ago

Interventions

in-person counselingbehavioral

The interventionist provided in person counseling on eliminating child exposure to tobacco smoke to at least one daily smoker and a non-smoker mother in the household. The counseling session emphasized the following issues: a) importance of healthy environment at home, b) health dangers of smoking and exposure to secondhand smoke, c) why and how to quit smoking, and d) how to keep home air smoke-free.

Demonstration of PM2.5 Pollutiondevice

The study team measured the particulate matter (PM2.5) in the air using the TSI AM 510 Aerosol SidePak to compare the quality of indoor air with outdoor air and demonstrate the effect of smoking on indoor air quality in the intervention households. After completing the Side Pack PM2.5 measurement, the interventionist immediately downloaded the data to a laptop to visualize the results through graphical presentation of the PM2.5 fluctuations to family members.

Follow-up Counseling Callsbehavioral

Interventionists made two follow-up counseling calls to the primary contact in the intervention households, usually a non-smoking mother at one and two months after the in-person counseling session. These calls aimed at a) assessing the progress in meeting the goals set earlier, b) counseling on barriers to the change, and c) encouraging study participants to maintain the success or to set new goals. These calls also provided opportunity for the participants to ask questions or clarify issues

Printed materialbehavioral

The intervention group families received the tailored and culturally adjusted educational brochure developed by the study team. The control group received a brief educational leaflet on the hazards of SHS developed by the US Environmental Protection Agency.