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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

469 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-04-30

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Smoking Prevention Usual Care

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

Smoking Prevention Usual Care

Intervention Type BEHAVIORAL

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

MRP

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.

Smoking Prevention Usual Care

Intervention Type BEHAVIORAL

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

Counseling Intervention

Intervention Type BEHAVIORAL

6 x 30 minute counseling sessions over the telephone

Enhanced MRP +

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.

Smoking Prevention Usual Care

Intervention Type BEHAVIORAL

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

Counseling Intervention

Intervention Type BEHAVIORAL

6 x 30 minute counseling sessions over the telephone

Counseling Intervention

Intervention Type BEHAVIORAL

2 in-person counseling sessions

Interventions

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Smoking Prevention Usual Care

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

Intervention Type BEHAVIORAL

Counseling Intervention

6 x 30 minute counseling sessions over the telephone

Intervention Type BEHAVIORAL

Counseling Intervention

2 in-person counseling sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. age 18 or older
2. former smoker who quit during pregnancy as assessed via self-report
3. smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
4. gestational age \< 33 weeks and ability to attend an in-person visit at University of Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age
5. can speak, read and write in English.
6. must have a functioning home or personal cell phone