NCT00139529

Brief Summary

The purpose of this study is to develop and field test a maintenance of smoking abstinence program designed for a predominately low-income, high-risk population of women from a wide variety of ethnic and racial backgrounds who have quit smoking because of (or during) their pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
757

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

5.2 years

First QC Date

August 29, 2005

Last Update Submit

December 21, 2015

Conditions

Cardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (3)

  • Smoking status

    Measured at 1, 3, 6, and 12 months postpartum

  • ETS exposure

    Measured at 1, 3, 6, and 12 months postpartum

  • Urine cotinine analyses

    Measured at 1, 3, 6, and 12 months postpartum

Study Arms (2)

1

EXPERIMENTAL

Participants will receive an educational intervention during pregnancy combined with a motivational interviewing program using telephone counseling to prevent postpartum relapse to tobacco use.

Behavioral: Motivational Interviewing Telephone CounselingBehavioral: Educational Intervention

2

ACTIVE COMPARATOR

Participants will receive an educational intervention during pregnancy.

Behavioral: Educational Intervention

Interventions

Motivational Interviewing Telephone CounselingBEHAVIORAL

Participants will receive up to 5 phone calls.

1
Educational InterventionBEHAVIORAL

Educational intervention will be completed during pregnancy.

12

Eligibility Criteria

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

You may qualify if:

  • Smoked tobacco immediately before pregnancy

You may not qualify if:

  • Smoked tobacco in the previous 7 days when contacted at 28 weeks gestation
  • No telephone access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Patricia M. Risica, DrPH

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor (Research)

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

March 1, 2006

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

US(1)