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Reduction of Secondhand Smoke Exposure in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00821639
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Study Description
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Brief Summary:
The purpose of this study is to assess the effects of a health center based counselling method for the prevention of infant exposure to secondhand smoke.

Condition or disease Intervention/treatment Phase
Secondhand Smoke Exposure Behavioral: Counseling, educational pamphlet and a sticker Not Applicable

Detailed Description:
This study, a two group randomised controled trial, investigates whether an intervention for parents would persuade them to enforce smoking bans inside the home and in other locations. A total of 130 parents with children aged 12 months or younger will be recruited. Each group (n=65) will complete a baseline and follow up questionnaire. Urine samples from the infants will be collected to measure the amount of cotinine, a metabolite of nicotine. The parent-report and infant's urinary cotinine measures will be obtained at baseline and at a 3-month follow up. In the intervention group, parents will be given three counselling sessions. For mothers, one being face to face and two telephone counselling and for fathers we will conduct three telephone counselling. The control group receives no intervention. Both groups will also complete a Fagerstrom test for nicotine dependence.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction of Secondhand Smoke Exposure in Healthy Infants
Study Start Date : July 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : July 2009
Arms and Interventions
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Intervention Details:
  • Behavioral: Counseling, educational pamphlet and a sticker
    Infants exposed to secondhand smoke will be recruited and randomized based on parents to receive or not receive counseling, an educational pamphlet and a sticker on SHS.

Outcome Measures
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Primary Outcome Measures :
  1. Infant's urinary cotinine levels [ Time Frame: At baseline and at a 3-month follow-up ]

Secondary Outcome Measures :
  1. Home smoking bans status, Car smoking bans status, Parental cigarette consumption [ Time Frame: At baseline and at a 3-month follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Families with healthy infants under 12 months of age
  • The infant resides with at least one smoking parent
  • Parents being able to speak Persian and having a telephone

Exclusion Criteria:

  • Parent(s) reporting consumption of other addictive substances
  • Parent(s) in smoking cessation treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821639


Locations
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Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Azam Baheiraei, MPH, PhD Tehran University of Medical Sciences
More Information
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Responsible Party: Azam Baheiraei MPH,PhD/Principle Investigator, Tehran Univeristy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00821639    
Other Study ID Numbers: TUMS-6870
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009