Reduction of Secondhand Smoke Exposure in Healthy Infants - Full Text View

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00821639

Purpose

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.

Condition	Intervention
Secondhand Smoke Exposure	Behavioral: Counseling sessions and an educational pamphlet and a sticker

MedlinePlus related topics: Smoking Smoking and Youth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment
Official Title:	Reduction of Secondhand Smoke Exposure in Healthy Infants

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

Home smoking bans status [ Time Frame: At baseline and at a 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Car smoking bans status, Parental cigarette consumption, Infant's urinary cotinine levels [ Time Frame: At baseline and at a 3-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	up to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821639

Contacts

Contact: Azam Baheiraei, MPH,PhD

+98 21 66922221 ext 292

abaheiraei@gmail.com

Locations

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

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Principal Investigator:

Azam Baheiraei, MPH, PhD

Tehran University of Medical Sciences

More Information

No publications provided

Responsible Party:	Tehran Univeristy of Medical Sciences ( Azam Baheiraei MPH,PhD/Principle Investigator )
Study ID Numbers:	TUMS-6870
Study First Received:	January 11, 2009
Last Updated:	January 11, 2009
ClinicalTrials.gov Identifier:	NCT00821639 History of Changes
Health Authority:	Iran: Ministry of Health

Study placed in the following topic categories:

Smoking
Healthy

ClinicalTrials.gov processed this record on May 06, 2009