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Cardiovascular DiseasesETSNCT00142623

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

A study testing Tailored DVDs in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Cardiovascular Diseases, Heart Diseases
What is being tested?
Tailored DVDs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
1 siteUnited States
Study dates
Feb 2006to Feb 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Women who attend their first prenatal visit by 16 weeks gestation
  • Women exposed to tobacco smoke daily

Who cannot join

  • Women expecting complications or multiple births

Trial locations and contacts

1 site in 1 country.

Thomas M. Lasater, PhD contact

401-863-6550

Thomas_Lasater@Brown.edu

United States1 site, 1 recruiting
  • Brown University

    Providence, Rhode Island, 02903

    Thomas M. Lasater, PhD, 401-793-8316, THOMAS_LASATER@BROWN.EDU

    Thomas M. Lasater, PhD

    Recruiting

Other trials in United States

About this study

Official title: Reducing ETS Exposure of Pregnant Women and Newborns

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.

Read the 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.

Being tested
Tailored DVDs
Medical subject headings
Cardiovascular Diseases, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored DVDsBehavioural

    Five DVDs aimed at reducing exposure to ETS

Study groups in NCT00142623
Study groupRoleWhat they receive
1ExperimentalUse of five tailored "take-home" DVDs aimed at reducing exposure to ETS
Receives: Behavioral: Tailored DVDs
2No interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Saliva cotinine concentration of mother

    Measured: Measured at 34 weeks gestation

  2. ETS self-report

    Measured: Measured at 34 weeks gestation and 6 months postpartum

  3. ETS exposure of infant by self-report of mother

    Measured: Measured at 6 months postpartum

  4. Salvia cotinine concentration of infant

    Measured: Measured at 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startFeb 2006
  3. Primary completionFeb 2009 (estimated)
  4. Study completionFeb 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00142623
Sponsor's protocol ID
249
Other IDs
R01HL070947
Acronym
ETS
Status last verified
Jul 2008
First submitted
1 Sep 2005
Last updated
30 Jul 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Tailored DVDs in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas M. Lasater, PhD (401-863-6550, Thomas_Lasater@Brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Saliva cotinine concentration of mother (time frame: Measured at 34 weeks gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2008.

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