Clinical trial NCT01630356: Controlled Trial to Reduce Secondhand Smoke Exposure at Homes in Armenia
Official title: Monitoring Secondhand Smoke Exposure in Buildings in Armenia: Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use and Smoking Behavior
Keywords: Secondhand Smoke
Nicotine
Indoor Air Pollution
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: American University of Armenia
First posted: 2012-06-28
Enrollment: 250
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: change in child's hair nicotine concentration
timeFrame: baseline and 4-month follow-up
measure: change in air nicotine concentration
timeFrame: baseline and 4-month follow-up
Secondary outcomes:
measure: change in the respondents' knowledge on hazards of smoking and secondhand smoke
timeFrame: baseline and 4-month follow-up
measure: change in frequency of smoking in the presence of the child
timeFrame: baseline and 4-month follow-up
measure: change in household smoking restrictions
timeFrame: baseline and 4-month follow-up
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: College of Health Sciences, American University of Armenia
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Frances A Stillman, Ed.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wipfli H, Avila-Tang E, Navas-Acien A, Kim S, Onicescu G, Yuan J, Breysse P, Samet JM; Famri Homes Study Investigators. Secondhand smoke exposure among women and children: evidence from 31 countries. Am J Public Health. 2008 Apr;98(4):672-9. doi: 10.2105/AJPH.2007.126631. Epub 2008 Feb 28.
citation: Al-Delaimy WK. Hair as a biomarker for exposure to tobacco smoke. Tob Control. 2002 Sep;11(3):176-82. doi: 10.1136/tc.11.3.176.
citation: Hovell MF, Meltzer SB, Wahlgren DR, Matt GE, Hofstetter CR, Jones JA, Meltzer EO, Bernert JT, Pirkle JL. Asthma management and environmental tobacco smoke exposure reduction in Latino children: a controlled trial. Pediatrics. 2002 Nov;110(5):946-56. doi: 10.1542/peds.110.5.946.
citation: Emmons KM, Hammond SK, Fava JL, Velicer WF, Evans JL, Monroe AD. A randomized trial to reduce passive smoke exposure in low-income households with young children. Pediatrics. 2001 Jul;108(1):18-24. doi: 10.1542/peds.108.1.18.
citation: Gehrman CA, Hovell MF. Protecting children from environmental tobacco smoke (ETS) exposure: a critical review. Nicotine Tob Res. 2003 Jun;5(3):289-301. doi: 10.1080/1462220031000094231.
citation: Harutyunyan A, Movsisyan N, Petrosyan V, Petrosyan D, Stillman F. Reducing children's exposure to secondhand smoke at home: a randomized trial. Pediatrics. 2013 Dec;132(6):1071-80. doi: 10.1542/peds.2012-2351. Epub 2013 Nov 4.