Reduction of Secondhand Smoke Exposure in Healthy Infants

Secondhand Smoke Exposure Clinical Trial

Official title:

Reduction of Secondhand Smoke Exposure in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821639
• Other study ID #: TUMS-6870
• Status: Completed
• Phase: N/A
• First received: January 11, 2009
• Last updated: October 4, 2009
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Secondhand Smoke Exposure

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant's urinary cotinine levels		At baseline and at a 3-month follow-up	No
Secondary	Home smoking bans status, Car smoking bans status, Parental cigarette consumption		At baseline and at a 3-month follow-up	No