Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns (ETS)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of this study is to develop and evaluate the efficacy of five tailored DVDs in reducing exposure to environmental tobacco smoke (ETS) among low income pregnant/postpartum women.
Full description
BACKGROUND:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Women who attend their first prenatal visit by 16 weeks gestation
- Women exposed to tobacco smoke daily
Exclusion criteria
- Women expecting complications or multiple births
Trial design
Primary purpose
Allocation
Interventional model
Masking
650 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Thomas M. Lasater, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal