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Completed

NCT Number: NCT00821639

Reduction of Secondhand Smoke Exposure in Healthy Infants

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.

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Key information

Conditions

Secondhand Smoke Exposure

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tehran University of Medical Sciences

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling, educational pamphlet and a sticker

Behavioral

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.

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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2009
Registry last updated
Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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