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

This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2008

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00142623
  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

MedlinePlus related topics:   Heart Disease in Women    Heart Diseases    Smoking    Smoking and Youth   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Reducing ETS Exposure of Pregnant Women and Newborns

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
1: Experimental
Use of five tailored "take-home" DVDs aimed at reducing exposure to ETS
Behavioral: Tailored DVDs
Five DVDs aimed at reducing exposure to ETS
2: No Intervention
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

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


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

Study placed in the following topic categories:
Smoking
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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