Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142623
Status:
UNKNOWN
Last Update Posted:
2008-07-30
First Post:
2005-09-01
Brief Title:
Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Reducing ETS Exposure of Pregnant Women and Newborns
Status:
UNKNOWN
Status Verified Date:
2008-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETS
Brief 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 pregnantpostpartum women
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 pregnantpostpartum 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 infants 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
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 pregnantpostpartum 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 infants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070947 | NIH | None | httpsreporternihgovquickSearchR01HL070947 |