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Reduction of Secondhand Smoke Exposure in Healthy Infants

Reduction of Secondhand Smoke Exposure in Healthy Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00821639
Enrollment
130
Registered
2009-01-13
Start date
2008-07-31
Completion date
2009-07-31
Last updated
2009-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondhand Smoke Exposure

Brief summary

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

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.

Interventions

BEHAVIORALCounseling, 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.

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Infant's urinary cotinine levelsAt baseline and at a 3-month follow-up

Secondary

MeasureTime frame
Home smoking bans status, Car smoking bans status, Parental cigarette consumptionAt baseline and at a 3-month follow-up

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026