- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00821639
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
-
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.
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.
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