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CompletedNCT00139529Updated Dec 23, 2015

Education and Counseling for Abstinence From Tobacco After Pregnancy

An interventional study of Motivational Interviewing Telephone Counseling and Educational Intervention in Cardiovascular Diseases and Heart Diseases, sponsored by Brown University. Completed at 1 site in United States. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-12-23.

Sponsored by Brown University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
757
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

Study 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.

Read the detailed description

BACKGROUND:

Pregnancy is an ideal time to help underserved young women to stop smoking cigarettes and remain abstinent for life. The field has made great progress in assisting women to quit during this time. Unfortunately, maintenance of this highly significant behavior change is dismal. Up to 75% of those who quit for pregnancy end up returning to smoking after delivery of the newborn. For underserved women, pregnancy is one of the few times that they have an extended contact with the health care system. Therefore, there is an opportunity to help these women quit smoking for the health of their fetus in addition to their own health. To date, there has been insufficient research on how best to maintain abstinence during the critical postpartum period, during which a unique constellation of risk factors (including sleep deprivation, variations in negative mood, and increased stress) heighten the probability of relapse. The potential payoff is enormous. The literature, while not extensive, provides sufficient guidance and justification for the specific approach and intervention components the study has chosen.

DESIGN NARRATIVE:

This study will develop and field test a maintenance of smoking abstinence program to be 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. The study will compare biologically confirmed postpartum smoking relapse rates of women who receive an educational intervention during pregnancy combined with sustained telephone counseling after that intervention, with women who receive only an educational intervention. Participants will begin at 28 weeks prenatal and will be followed through 1, 3, 6, and 12 months postpartum.

The specific aims of the current maintenance study are: 1) to compare biochemically confirmed smoking abstinence rates of women who quit smoking during their pregnancy and who receive an intervention based on telephone counseling using motivational interviewing versus quitters who receive usual care, maintenance of abstinence will be assessed at 1, 3, 6, and 12 months postpartum; and 2) to collect both qualitative and quantitative data to better understand short term and long term maintenance mediators and moderators of abstinence postpartum for women of low socioeconomic status (SES) who quit smoking during pregnancy.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 757 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Smoked tobacco immediately before pregnancy

Exclusion criteria

Exclusion Criteria:

  • Smoked tobacco in the previous 7 days when contacted at 28 weeks gestation
  • No telephone access
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
757 participants (actual)

Study arms

  • Experimental
    1

    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 Counseling · Behavioral: Educational Intervention

  • Active comparator
    2

    Participants will receive an educational intervention during pregnancy.

    Behavioral: Educational Intervention

Interventions

  • BehavioralMotivational Interviewing Telephone Counseling

    Participants will receive up to 5 phone calls.

  • BehavioralEducational Intervention

    Educational intervention will be completed during pregnancy.

06

What researchers measure

Primary outcomes

  1. Smoking status

    Time frame: Measured at 1, 3, 6, and 12 months postpartum

  2. ETS exposure

    Time frame: Measured at 1, 3, 6, and 12 months postpartum

  3. Urine cotinine analyses

    Time frame: Measured at 1, 3, 6, and 12 months postpartum

07

Study locations

1 site
  • Brown University
    Providence, Rhode Island 02903, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00139529
Lead sponsor
Brown University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Patricia M. Risica (Asst Professor (Research), Brown University) — Principal investigator
First posted
Aug 31, 2005
Start date
Mar 2006
Primary completion
May 2011
Completion
Aug 2011
Last update
Dec 23, 2015

Study contacts

Patricia M. Risica, DrPH
principal investigator · Brown University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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