Education and Counseling for Abstinence From Tobacco After Pregnancy

Postpartum Maintenance of Abstinence From Tobacco

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Motivational Interviewing Telephone Counseling; Behavioral: Educational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Smoking status	Measured at 1, 3, 6, and 12 months postpartum
ETS exposure	Measured at 1, 3, 6, and 12 months postpartum
Urine cotinine analyses	Measured at 1, 3, 6, and 12 months postpartum

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Patricia M. Risica, DrPH, Brown University

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 29, 2005
• First Submitted That Met QC Criteria: August 29, 2005
• First Posted (Estimate): August 31, 2005

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: 248; R01HL077608 (U.S. NIH Grant/Contract)