Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old
Other study identifiers
Sponsor study identifier
Secondary identifiers
interventional
375
1 country
2
Study Start
July 25, 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 5, 2010
Actual (reported)Study Completion
May 18, 2010
Actual (reported)Brief Summary
This study will: 1) test the effectiveness of a program to prevent the exposure of infants to environmental tobacco smoke; and 2) evaluate the health effects associated with prenatal and postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants. African-American and Hispanic women who are 18 years of age or older, and who are between 28 and 35 weeks pregnant may be eligible for this study. Participants complete an interview and home visit assessment and are then randomly assigned to participate in Program A or Program B of the study, as follows: Program A: Involves discussions with an Infant Health Advisor about parenting skills to promote child safety and infant growth and development, such as ways to prevent childhood injuries caused by falls, poisons, and other hazards. Program B: Involves discussions with an Infant Health Advisor about ways to prevent infant tobacco smoke exposure, such as how to adopt smoke-free household rules in the home and how to work with friends and family members to prevent the baby from being exposed to tobacco smoke. In addition, participants who smoked cigarettes before becoming pregnant or while pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby is born. Participants come to the clinic four times- once during a regularly scheduled prenatal visit and again when the baby is 6 weeks, 4 months, and 6 months old - to see the Infant Health Advisor for the activities described above in Program A or Program B. Between visits, the Advisor calls the participant to check on her progress regarding the program objectives. In addition, the study involves the following for all participants:
- Telephone interview during the week after joining the study to obtain information on participant's background, pregnancy and family history, tobacco use and exposure to other people's cigarette smoke during pregnancy, strategies to reduce tobacco use and exposure, stressful life events, drug and alcohol use during pregnancy, and sources of social support. Similar interviews are repeated when the baby is 6 weeks old, and again when the baby is 4 months, 6 months, and 12 months old.
- Home visit about 1 week after entering the study to check the home for possible safety hazards to the baby and to place one or more nicotine air monitors (small plastic objects that measure the amount of tobacco smoke in the air of each room). The home visitor returns a week late...
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Estimated enrollment
- 375 participants
- Study completion date
May 18, 2010
Actual (reported)- Listed locations
- 1 countries · 2 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
July 25, 2005
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
June 19, 2006
Actual (reported)First Posted
June 21, 2006
Actual (reported)Primary Completion
March 5, 2010
Actual (reported)Study Completion
May 18, 2010
Actual (reported)
- Last Updated
- July 2, 2017
- Status Verified
- May 18, 2011
- Last Update Submitted
- June 30, 2017