Reduction of Secondhand Smoke Exposure in Healthy Infants

Not Applicable

Completed

• Conditions: Secondhand Smoke Exposure

• Registration Number: NCT00821639
• Lead Sponsor: Tehran University of Medical Sciences

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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-01-11
• Study First Submitted QC: 2009-01-11
• Study First Posted: 2009-01-13
• Primary Completion: 2009-05
• Study Completion: 2009-07
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-04
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Infant's urinary cotinine levels	At baseline and at a 3-month follow-up

Secondary Outcome Measures

Name	Time	Method
Home smoking bans status, Car smoking bans status, Parental cigarette consumption	At baseline and at a 3-month follow-up

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of