Education and Counseling for Abstinence From Tobacco After Pregnancy
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Diseases Heart Diseases |
Behavioral: Motivational Interviewing Telephone Counseling Behavioral: Educational Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Postpartum Maintenance of Abstinence From Tobacco |
- Smoking status [ Time Frame: Measured at 1, 3, 6, and 12 months postpartum ] [ Designated as safety issue: No ]
- ETS exposure [ Time Frame: Measured at 1, 3, 6, and 12 months postpartum ] [ Designated as safety issue: No ]
- Urine cotinine analyses [ Time Frame: Measured at 1, 3, 6, and 12 months postpartum ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 476 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Participants will receive up to 5 phone calls.
Behavioral: Educational Intervention
Educational intervention will be completed during pregnancy.
|
|
Active Comparator: 2
Participants will receive an educational intervention during pregnancy.
|
Behavioral: Educational Intervention
Educational intervention will be completed during pregnancy.
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Smoked tobacco immediately before pregnancy
Exclusion Criteria:
- Smoked tobacco in the previous 7 days when contacted at 28 weeks gestation
- No telephone access
Contacts and Locations| United States, Rhode Island | |
| Brown University | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Thomas M. Lasater, PhD 401-793-8316 THOMAS_LASATER@BROWN.EDU | |
| Principal Investigator: Thomas M. Lasater, PhD | |
| Principal Investigator: | Thomas M. Lasater, PhD | Brown University |
| Principal Investigator: | Patricia M. Risica, DrPH | Brown University |
| Principal Investigator: | Belinda Borrelli, PhD | Brown University |
More Information
No publications provided
| Responsible Party: | Thomas M. Lasater, PhD, Brown University |
| ClinicalTrials.gov Identifier: | NCT00139529 History of Changes |
| Other Study ID Numbers: | 248, R01 HL77608 |
| Study First Received: | August 29, 2005 |
| Last Updated: | August 4, 2008 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Diseases |
ClinicalTrials.gov processed this record on May 19, 2013