CClinicalTrials.gg
CompletedNCT00821639Updated Oct 6, 2009

Reduction of Secondhand Smoke Exposure in Healthy Infants

An interventional study of Counseling, educational pamphlet and a sticker in Secondhand Smoke Exposure, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-06.

Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
Up to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Secondhand Smoke Exposure
03

In context

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Parent(s) reporting consumption of other addictive substances
  • Parent(s) in smoking cessation treatment
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
130 participants (actual)

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.

06

What researchers measure

Primary outcomes

  1. Infant's urinary cotinine levels

    Time frame: At baseline and at a 3-month follow-up

Secondary outcomes

  1. Home smoking bans status, Car smoking bans status, Parental cigarette consumption

    Time frame: At baseline and at a 3-month follow-up

07

Study locations

1 site
  • Tehran University of Medical Sciences
    Tehran, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00821639
Lead sponsor
Tehran University of Medical Sciences
First posted
Jan 13, 2009
Start date
Jul 2008
Primary completion
May 2009
Completion
Jul 2009
Last update
Oct 6, 2009

Study contacts

Azam Baheiraei, MPH, PhD
principal investigator · Tehran University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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