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

Reducing ETS Exposure of Pregnant Women and Newborns

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.

Study Overview

• Status: Unknown
• Conditions: Heart Diseases; Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Tailored DVDs

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.

• Study Type: Interventional
• Enrollment (Anticipated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas M. Lasater, PhD; Phone Number: 401-863-6550; Email: Thomas_Lasater@Brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Brown University
      • Contact: Thomas M. Lasater, PhD; Phone Number: 401-793-8316; Email: THOMAS_LASATER@BROWN.EDU
      • Principal Investigator: Thomas M. Lasater, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2; Usual care
Experimental: 1; Use of five tailored "take-home" DVDs aimed at reducing exposure to ETS	Behavioral: Tailored DVDs; Five DVDs aimed at reducing exposure to ETS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Saliva cotinine concentration of mother	Measured at 34 weeks gestation
ETS self-report	Measured at 34 weeks gestation and 6 months postpartum
ETS exposure of infant by self-report of mother	Measured at 6 months postpartum
Salvia cotinine concentration of infant	Measured at 6 months postpartum

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Patricia M. Risica, DrPH, Brown University; Principal Investigator: Thomas M. Lasater, PhD, Brown University; Principal Investigator: Maureen Phipps, MD, Brown University

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): February 1, 2009

Study Registration Dates

• First Submitted: September 1, 2005
• First Submitted That Met QC Criteria: September 1, 2005
• First Posted (Estimate): September 2, 2005

Study Record Updates

• Last Update Posted (Estimate): July 30, 2008
• Last Update Submitted That Met QC Criteria: July 29, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: 249; R01HL070947 (U.S. NIH Grant/Contract)