This study, a two group randomized controlled 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 counseling sessions. For mothers, one being face to face and two telephone counseling and for fathers we will conduct three telephone counseling. The control group receives no intervention. Both groups will also complete a Fagerstrom test for nicotine dependence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801171791N1
Registration date:2009-08-08, 1388/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-08-08, 1388/05/17
Registrant information
Name
Azam Baheiraei
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
baheiraei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2008-06-21, 1387/04/01
Expected recruitment end date
2009-06-01, 1388/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Reduction of Secondhand Smoke Exposure in Healthy Infants
Public title
Reduction of Secondhand Smoke Exposure in Healthy Infants
Purpose
Prevention
Inclusion/Exclusion 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
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
The U.S. National Institues of Health
Secondary trial Id
NCT00821639
Registration date
2009-01-11, 1387/10/22
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Tehran University of Medical Sciences and Health Services
City
Tehran
Postal code
15745-1453
Approval date
empty
Ethics committee reference number
6870
Health conditions studied
1
Description of health condition studied
Effect of intervention on smoker parents on home, car and outside of home and car smoking bans status and Infant's urinary cotinine levels
ICD-10 code
Z58.7
ICD-10 code description
Passive smoking
Primary outcomes
1
Description
Home smoking bans status
Timepoint
3 months
Method of measurement
Face to face interview; questionnaire consists of three parts, demographic characteristic, home situation and smoking situation
Secondary outcomes
1
Description
Car smoking bans status
Timepoint
3 months
Method of measurement
Face to face interview
2
Description
Parental cigarette consumption
Timepoint
3 months
Method of measurement
Face to face interview
3
Description
Infant's urinary cotinine levels
Timepoint
3 months
Method of measurement
The urine will be analyzed in laboratory of the Tarbiat Modarres University
Intervention groups
1
Description
Counseling sessions, one face to face counseling for both parents, two telephone counseling for mother and three telephone counseling for father and an educational pamphlet and a sticker
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ayat child health center affilliated with Tehran University of Medical Sciences and Health se
Full name of responsible person
Dr Kianoosh Kiaei
Street address
In front of Shariati park, Shariati street, Shariati city, behind padegan Ghale morghi
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Azam Baheiraei
Street address
Tehran University of Medical Sciences and Health Services
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Azam Baheiraei
Position
Assistant Professor, MPH in Health Promotion, PhD
Other areas of specialty/work
Street address
Tehran University of Medical Sciences and Health Services
City
Tehran
Postal code
1453-15745
Phone
+98 21 6692 2221 ext. 292
Fax
+98 21 6690 4252
Email
abaheiraei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Azam Baheiraei
Position
Assistant Professor, MPH in Health Promotion, PhD
Other areas of specialty/work
Street address
Tehran University of Medical Sciences and Health Services
City
Tehran
Postal code
15745-1453
Phone
+98 21 6692 2221
Fax
+98 21 6690 4252
Email
abaheiraei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Azam Baheiraei
Position
Assistant Professor, MPH in Health Promotion, PhD
Other areas of specialty/work
Street address
Tehran University of Medical Sciences and Health Services
City
Tehran
Postal code
15745-1453
Phone
+98 21 6692 2221
Fax
+98 21 6690 4252
Email
abaheiraei@gmail.con
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)