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
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.
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.
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.
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Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Exclusion Criteria:
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
Participants will receive an educational intervention during pregnancy.
Behavioral: Educational Intervention
Participants will receive up to 5 phone calls.
Educational intervention will be completed during pregnancy.
Smoking status
Time frame: Measured at 1, 3, 6, and 12 months postpartum
ETS exposure
Time frame: Measured at 1, 3, 6, and 12 months postpartum
Urine cotinine analyses
Time frame: Measured at 1, 3, 6, and 12 months postpartum
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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