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Tobacco Use and Smoking BehaviorNCT01630356

Controlled Trial to Reduce Secondhand Smoke Exposure at Homes in Armenia

A study testing in-person counseling, Demonstration of PM2.5 Pollution and Follow-up Counseling Calls in people with Tobacco Use and Smoking Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Armenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Tobacco Use and Smoking Behavior
What is being tested?
in-person counseling, Demonstration of PM2.5 Pollution and Follow-up Counseling Calls
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteArmenia
Study dates
Apr 2010to Nov 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Mother's pregnancy
  • Child's hair less than 2 cm in length after stretching out
  • Residing out of Yerevan

Trial locations and contacts

1 site in 1 country.

Armenia1 site

  • College of Health Sciences, American University of Armenia

    Yerevan, 0019

Other trials in Armenia

About this study

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.

Read more

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.

Being tested
in-person counseling, Demonstration of PM2.5 Pollution, Follow-up Counseling Calls, Printed material
Keywords
Secondhand Smoke, Nicotine, Indoor Air Pollution
Medical subject headings
Tobacco Use, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • in-person counselingBehavioural

    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 CallsBehavioural

    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 materialBehavioural

    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.

Study groups in NCT01630356
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Behavioral: in-person counseling; Device: Demonstration of PM2.5 Pollution; Behavioral: Follow-up Counseling Calls; Behavioral: Printed material
Control groupActive comparatorNot described
Receives: Behavioral: Printed material

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in child's hair nicotine concentration

    Measured: baseline and 4-month follow-up

  2. change in air nicotine concentration

    Measured: baseline and 4-month follow-up

Secondary outcomes (3)

  1. change in the respondents' knowledge on hazards of smoking and secondhand smoke

    Measured: baseline and 4-month follow-up

  2. change in frequency of smoking in the presence of the child

    Measured: baseline and 4-month follow-up

  3. change in household smoking restrictions

    Measured: baseline and 4-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2012 (estimated)
  2. Study startApr 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01630356
Sponsor's protocol ID
IRB 00002501
Status last verified
Jun 2012
First submitted
26 Jun 2012
Last updated
28 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18309121

  • 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.

    PubMed 12198265

  • 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.

    PubMed 12415035

  • 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.

    PubMed 11433049

  • 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.

    PubMed 12791524

  • 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.

    PubMed 24190686

Questions about this trial

What is this clinical trial studying?

A study testing in-person counseling, Demonstration of PM2.5 Pollution and Follow-up Counseling Calls in people with Tobacco Use and Smoking Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Armenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in child's hair nicotine concentration (time frame: baseline and 4-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01630356, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.

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