Education and Counseling for Abstinence From Tobacco After Pregnancy
NCT ID: NCT00139529
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
757 participants
INTERVENTIONAL
2006-03-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Motivational Interviewing Telephone Counseling
Participants will receive up to 5 phone calls.
Educational Intervention
Educational intervention will be completed during pregnancy.
2
Participants will receive an educational intervention during pregnancy.
Educational Intervention
Educational intervention will be completed during pregnancy.
Interventions
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Motivational Interviewing Telephone Counseling
Participants will receive up to 5 phone calls.
Educational Intervention
Educational intervention will be completed during pregnancy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* No telephone access
16 Years
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Brown University
OTHER
Responsible Party
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Patricia M. Risica
Asst Professor (Research)
Principal Investigators
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Patricia M. Risica, DrPH
Role: PRINCIPAL_INVESTIGATOR
Brown University
Locations
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Brown University
Providence, Rhode Island, United States
Countries
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Other Identifiers
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248
Identifier Type: -
Identifier Source: org_study_id