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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Brown University
Providence, Rhode Island, 02903
Thomas M. Lasater, PhD, 401-793-8316, THOMAS_LASATER@BROWN.EDU
Thomas M. Lasater, PhD
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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Use of five tailored "take-home" DVDs aimed at reducing exposure to ETS Receives: Behavioral: Tailored DVDs |
| 2 | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva cotinine concentration of mother
Measured: Measured at 34 weeks gestation
ETS self-report
Measured: Measured at 34 weeks gestation and 6 months postpartum
ETS exposure of infant by self-report of mother
Measured: Measured at 6 months postpartum
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.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2006
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas M. Lasater, PhD, Principal investigator, Brown UniversityPatricia M. Risica, DrPH, Principal investigator, Brown UniversityMaureen Phipps, MD, Principal investigator, Brown University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing ETS Exposure of Pregnant Women and Newborns
- ClinicalTrials.gov ID
- NCT00142623
- Acronym / sponsor ID
- ETS / 249
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Feb 2006
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Tailored DVDsUse of five tailored "take-home" DVDs aimed at reducing exposure to ETS |
| 2 | No intervention | –Usual care |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women who attend their first prenatal visit by 16 weeks gestation
- Women exposed to tobacco smoke daily
Key exclusion criteria (1 listed)
- Women expecting complications or multiple births
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored DVDsFive DVDs aimed at reducing exposure to ETS | Behavioural | 1 |
Primary outcome
Saliva cotinine concentration of mother
Time frame: Measured at 34 weeks gestation
ETS self-report
Time frame: Measured at 34 weeks gestation and 6 months postpartum
ETS exposure of infant by self-report of mother
Time frame: Measured at 6 months postpartum
Salvia cotinine concentration of infant
Time frame: Measured at 6 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M. Lasater, PhD principal investigator
Brown University
Patricia M. Risica, DrPH principal investigator
Brown University
Maureen Phipps, MD principal investigator
Brown University
1 site in 1 country: see every site and its status.
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.