Reduction of Secondhand Smoke Exposure in Healthy Infants

NCT ID: NCT00821639

Last Updated: 2009-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Secondhand Smoke Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran Univeristy of Medical Sciences

Principal Investigators

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Azam Baheiraei, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Tehran University of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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TUMS-6870

Identifier Type: -

Identifier Source: org_study_id

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