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

Cardiovascular Diseases Clinical Trial

— ETS  

Official title:

Reducing ETS Exposure of Pregnant Women and Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00142623
• Other study ID #: 249
• Secondary ID: R01HL070947
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2005
• Last updated: July 29, 2008
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: July 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: Thomas M. Lasater, PhD
• Phone: 401-863-6550
• Email: Thomas_Lasater[@]Brown.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Behavioral:
• Tailored DVDs
Five DVDs aimed at reducing exposure to ETS

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saliva cotinine concentration of mother		Measured at 34 weeks gestation	No
Primary	ETS self-report		Measured at 34 weeks gestation and 6 months postpartum	No
Primary	ETS exposure of infant by self-report of mother		Measured at 6 months postpartum	No
Primary	Salvia cotinine concentration of infant		Measured at 6 months postpartum	No