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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00142623
First received: September 1, 2005
Last updated: July 29, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Behavioral: Tailored DVDs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing ETS Exposure of Pregnant Women and Newborns

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Saliva cotinine concentration of mother [ Time Frame: Measured at 34 weeks gestation ] [ Designated as safety issue: No ]
  • ETS self-report [ Time Frame: Measured at 34 weeks gestation and 6 months postpartum ] [ Designated as safety issue: No ]
  • ETS exposure of infant by self-report of mother [ Time Frame: Measured at 6 months postpartum ] [ Designated as safety issue: No ]
  • Salvia cotinine concentration of infant [ Time Frame: Measured at 6 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: February 2006
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: 2
Usual care

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142623

Contacts
Contact: Thomas M. Lasater, PhD 401-863-6550 Thomas_Lasater@Brown.edu

Locations
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02903
Contact: Thomas M. Lasater, PhD    401-793-8316    THOMAS_LASATER@BROWN.EDU   
Principal Investigator: Thomas M. Lasater, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas M. Lasater, PhD Brown University
Principal Investigator: Patricia M. Risica, DrPH Brown University
Principal Investigator: Maureen Phipps, MD Brown University
  More Information

No publications provided

Responsible Party: Thomas M. Lasater, PhD, Brown University
ClinicalTrials.gov Identifier: NCT00142623     History of Changes
Other Study ID Numbers: 249, R01 HL70947
Study First Received: September 1, 2005
Last Updated: July 29, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014