Counseling, educational pamphlet and a sticker in Secondhand Smoke Exposure - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Secondhand Smoke Exposure

Intervention / Treatment

Behavioral: Counseling, educational pamphlet and a sticker

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

Iran, Islamic Republic of
- - Tehran, Iran, Islamic Republic of
    - Tehran University of Medical Sciences

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.

Sponsor

Tehran University of Medical Sciences

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