Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns
NCT ID: NCT00142623
Last Updated: 2008-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
650 participants
INTERVENTIONAL
2006-02-28
2009-02-28
Brief Summary
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Detailed Description
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The Healthy People 2010 Objectives address the importance of smoking cessation during pregnancy and the importance of reducing ETS exposure among children and adults. This study will use a new combination of existing technologies to maximize the appropriateness of prenatal and postpartum education concerning ETS exposure in an innovative, inexpensive, and widely applicable approach. The use of tailored DVDs is practical, feasible, and inexpensive enough to be attractive to clinics serving low-income and minority women. A large number of video segments will be produced utilizing live actors, animation, and word slates. About 10 segments will be computer-selected for the videos for each woman based on her responses to four self-assessments. No studies to date have included multiple doses of tailored video education, or used DVDs in this way.
DESIGN NARRATIVE:
This two-arm randomized study is designed to develop and evaluate the efficacy of five tailored DVDs in reducing exposure to ETS among low-income pregnant/postpartum women. The overall purposes of the study are 1) to develop an innovative intervention (tailored "take-home" DVDs) to help pregnant women maximize their pregnancy outcome and their new infant's health through reduction in exposure to ETS and 2) to study the feasibility and efficacy of this intervention compared with a usual care group. This innovative technology will be field tested in collaboration with six prenatal clinics that serve primarily low-income, African American, Latina, and minority women to address two specific aims. Specific aim 1: To test the efficacy of tailored video (TV) versus usual care (UC) approaches in terms of reducing the ETS exposure among fetuses of nonsmoking, low-income women during pregnancy (assessed at 34 weeks gestation using saliva cotinine concentration and ETS self-report) and among infants (as measured by saliva cotinine concentration and mothers' self-reports at 6 months postpartum). Specific aim 2: To test the efficacy of TV versus UC approaches in terms of reducing the exposure of the fetuses of low-income, smoking women to tobacco smoke during pregnancy (assessed at 34 weeks gestation using saliva cotinine concentrations of the pregnant women and smoking and ETS self-reports) and to their infants (as measured by saliva cotinine concentration from the infant at 6 months postpartum and self-reports of infant exposure by the new mothers). Because of the lack of data on reducing ETS exposure amongst low-income and minority women, intensive formative and extensive process evaluation components are included.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
Use of five tailored "take-home" DVDs aimed at reducing exposure to ETS
Tailored DVDs
Five DVDs aimed at reducing exposure to ETS
2
Usual care
No interventions assigned to this group
Interventions
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Tailored DVDs
Five DVDs aimed at reducing exposure to ETS
Eligibility Criteria
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Inclusion Criteria
* Women exposed to tobacco smoke daily
Exclusion Criteria
16 Years
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Brown University
Principal Investigators
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Thomas M. Lasater, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Patricia M. Risica, DrPH
Role: PRINCIPAL_INVESTIGATOR
Brown University
Maureen Phipps, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Locations
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Brown University
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Thomas M. Lasater, PhD
Role: primary
Other Identifiers
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249
Identifier Type: -
Identifier Source: org_study_id