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Controlled Trial to Reduce Secondhand Smoke Exposure at Homes in Armenia

This study has been completed.
Sponsor:
Collaborator:
American University of Armenia
Information provided by (Responsible Party):
Frances Stillman, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01630356
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Tobacco Use and Smoking Behavior
Behavioral: in-person counseling
Device: Demonstration of PM2.5 Pollution
Behavioral: Follow-up Counseling Calls
Behavioral: Printed material

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Monitoring Secondhand Smoke Exposure in Buildings in Armenia: Controlled Trial

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • change in child's hair nicotine concentration [ Time Frame: baseline and 4-month follow-up ] [ Designated as safety issue: No ]
  • change in air nicotine concentration [ Time Frame: baseline and 4-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in the respondents' knowledge on hazards of smoking and secondhand smoke [ Time Frame: baseline and 4-month follow-up ] [ Designated as safety issue: No ]
  • change in frequency of smoking in the presence of the child [ Time Frame: baseline and 4-month follow-up ] [ Designated as safety issue: No ]
  • change in household smoking restrictions [ Time Frame: baseline and 4-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: April 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group Behavioral: in-person counseling
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.
Device: Demonstration of PM2.5 Pollution
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.
Behavioral: Follow-up Counseling Calls
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
Behavioral: Printed material

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.

Active Comparator: Control group Behavioral: Printed material

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.


  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630356

Locations
Armenia
College of Health Sciences, American University of Armenia
Yerevan, Armenia, 0019
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
American University of Armenia
Investigators
Principal Investigator: Frances A Stillman, Ed.D Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frances Stillman, Ed. D, Johns Hopkins Bloomberg School of Public Health, Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01630356     History of Changes
Other Study ID Numbers: IRB 00002501
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board
Armenia: Ministry of Health

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Secondhand Smoke
Nicotine
Indoor Air Pollution

ClinicalTrials.gov processed this record on November 25, 2014