Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns (ETS)
Recruitment status was Recruiting
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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 |
- 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 |
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| Contact: Thomas M. Lasater, PhD | 401-863-6550 | Thomas_Lasater@Brown.edu |
| 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 | |
| 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 June 18, 2013