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

Primary Purpose

Cardiovascular Diseases, Heart Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored DVDs
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brown UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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

Usual care

Outcomes

Primary Outcome Measures

Saliva cotinine concentration of mother
ETS self-report
ETS exposure of infant by self-report of mother
Salvia cotinine concentration of infant

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
July 29, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00142623
Brief Title
Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns
Acronym
ETS
Official Title
Reducing ETS Exposure of Pregnant Women and Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 pregnant/postpartum 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Use of five tailored "take-home" DVDs aimed at reducing exposure to ETS
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Tailored DVDs
Intervention Description
Five DVDs aimed at reducing exposure to ETS
Primary Outcome Measure Information:
Title
Saliva cotinine concentration of mother
Time Frame
Measured at 34 weeks gestation
Title
ETS self-report
Time Frame
Measured at 34 weeks gestation and 6 months postpartum
Title
ETS exposure of infant by self-report of mother
Time Frame
Measured at 6 months postpartum
Title
Salvia cotinine concentration of infant
Time Frame
Measured at 6 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas M. Lasater, PhD
Phone
401-863-6550
Email
Thomas_Lasater@Brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M. Lasater, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia M. Risica, DrPH
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maureen Phipps, MD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas M. Lasater, PhD
Phone
401-793-8316
Email
THOMAS_LASATER@BROWN.EDU
First Name & Middle Initial & Last Name & Degree
Thomas M. Lasater, PhD

12. IPD Sharing Statement

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

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