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Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns

Reducing ETS Exposure of Pregnant Women and Newborns

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00142623
Acronym
ETS
Enrollment
650
Registered
2005-09-02
Start date
2006-02-28
Completion date
2009-02-28
Last updated
2008-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALTailored DVDs

Five DVDs aimed at reducing exposure to ETS

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Saliva cotinine concentration of motherMeasured at 34 weeks gestation
ETS self-reportMeasured at 34 weeks gestation and 6 months postpartum
ETS exposure of infant by self-report of motherMeasured at 6 months postpartum
Salvia cotinine concentration of infantMeasured at 6 months postpartum

Countries

United States

Contacts

Primary ContactThomas M. Lasater, PhD
Thomas_Lasater@Brown.edu401-863-6550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026