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Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline.

Arm II (motivational relapse prevention \[MRP\]): Same intervention as usual care, plus 30 minutes telephone counseling at 34 \& 36 weeks gestation then at 2, 4, 7, \& 16 weeks postpartum.

Arm III (enhanced MRP \[MRP+\]): Same intervention as usual care and telephone counseling as MRP, plus 1 hour in-person counseling at 30-33 weeks gestation \& 8 weeks postpartum.

Usual care of self-help materials and advice for staying cigarette free

Smoking Prevention Usual Care

6 x 30 minute counseling sessions over the telephone

Counseling Intervention

David Wetter, PhD, BS, BA

RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy.

PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy.

OBJECTIVES:

* Develop and evaluate 2 "Motivational Relapse Prevention" (MRP) treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy.
* Assess MRP and Enhanced MRP (MRP+) effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP+ effects on abstinence.
* Assess the cost-effectiveness of both the MRP and MRP+ treatments relative to each other and to usual care for reducing postpartum smoking relapse.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 intervention arms.

* Arm I (usual care \[UC\]): Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.
* Arm II (motivational relapse prevention \[MRP\]): Participants receive the same intervention as in arm I. Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2, 4, 7, and 16 weeks postpartum.
* Arm III (enhanced MRP \[MRP+\]): Participants receive the same intervention as in arm I and telephone counseling as in arm II. Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum.

Participants in all arms complete questionnaires at baseline, at 30-33 weeks gestation, and then at 8 and 26 weeks postpartum.

Participants are followed at 8 and 26 weeks postpartum.

PROJECTED ACCRUAL: A total of 450 participants will be accrued for this study.

Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy

Smoking Relapse Prevention Among Postpartum Women

Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment

Cigarettes smoked per day at 26 weeks following study treatment

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for smoking prevention usual care