CClinicalTrials.gg
Status unknownNCT00142623ETSUpdated Jul 30, 2008

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

An interventional study of Tailored DVDs in Cardiovascular Diseases and Heart Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Status unknown at 1 site in United States. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2008-07-30.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 650 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women who attend their first prenatal visit by 16 weeks gestation
  • Women exposed to tobacco smoke daily

Exclusion criteria

Exclusion Criteria:

  • Women expecting complications or multiple births
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
650 participants (estimated)

Study arms

  • Experimental
    1

    Use of five tailored "take-home" DVDs aimed at reducing exposure to ETS

    Behavioral: Tailored DVDs

  • No intervention
    2

    Usual care

Interventions

  • BehavioralTailored DVDs

    Five DVDs aimed at reducing exposure to ETS

06

What researchers measure

Primary outcomes

  1. Saliva cotinine concentration of mother

    Time frame: Measured at 34 weeks gestation

  2. ETS self-report

    Time frame: Measured at 34 weeks gestation and 6 months postpartum

  3. ETS exposure of infant by self-report of mother

    Time frame: Measured at 6 months postpartum

  4. Salvia cotinine concentration of infant

    Time frame: Measured at 6 months postpartum

07

Study locations

1 of 1 sites recruiting
  • Brown University
    Providence, Rhode Island 02903, United States
    • Thomas M. Lasater, PhD · Contact · THOMAS_LASATER@BROWN.EDU · 401-793-8316
    • Thomas M. Lasater, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00142623
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
First posted
Sep 2, 2005
Start date
Feb 2006
Primary completion
Feb 2009 (estimated)
Completion
Feb 2009 (estimated)
Last update
Jul 30, 2008

Study contacts

Thomas M. Lasater, PhD
Contact
Thomas_Lasater@Brown.edu
401-863-6550
Thomas M. Lasater, PhD
principal investigator · Brown University
Patricia M. Risica, DrPH
principal investigator · Brown University
Maureen Phipps, MD
principal investigator · Brown University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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