Reduction of Secondhand Smoke Exposure in Healthy Infants

October 4, 2009 updated by: Tehran University of Medical Sciences
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infant's urinary cotinine levels
Time Frame: At baseline and at a 3-month follow-up
At baseline and at a 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Home smoking bans status, Car smoking bans status, Parental cigarette consumption
Time Frame: At baseline and at a 3-month follow-up
At baseline and at a 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Azam Baheiraei, MPH, PhD, Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 11, 2009

First Submitted That Met QC Criteria

January 11, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 4, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • TUMS-6870

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Secondhand Smoke Exposure

Clinical Trials on Counseling, educational pamphlet and a sticker

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