NCT00142623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
650

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 30, 2008

Status Verified

July 1, 2008

Enrollment Period

3 years

First QC Date

September 1, 2005

Last Update Submit

July 29, 2008

Conditions

Cardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (4)

  • Saliva cotinine concentration of mother

    Measured at 34 weeks gestation

  • ETS self-report

    Measured at 34 weeks gestation and 6 months postpartum

  • ETS exposure of infant by self-report of mother

    Measured at 6 months postpartum

  • Salvia cotinine concentration of infant

    Measured at 6 months postpartum

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Tailored DVDs

2

NO INTERVENTION

Usual care

Interventions

Tailored DVDsBEHAVIORAL

Five DVDs aimed at reducing exposure to ETS

1

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Women expecting complications or multiple births

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • Thomas M. Lasater, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Patricia M. Risica, DrPH

    Brown University

    PRINCIPAL INVESTIGATOR

  • Maureen Phipps, MD

    Brown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas M. Lasater, PhD

CONTACT

401-863-6550Thomas_Lasater@Brown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

February 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 30, 2008

Record last verified: 2008-07

Locations

US(1)