Education and Counseling for Abstinence From Tobacco After Pregnancy

Cardiovascular Diseases Clinical Trial

Official title:

Postpartum Maintenance of Abstinence From Tobacco

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139529
• Other study ID #: 248
• Secondary ID: R01HL077608
• Status: Completed
• Phase: N/A
• First received: August 29, 2005
• Last updated: December 21, 2015
• Start date: March 2006
• Est. completion date: August 2011

Study information

• Verified date: December 2015
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Behavioral:
• Motivational Interviewing Telephone Counseling
Participants will receive up to 5 phone calls.
• Educational Intervention
Educational intervention will be completed during pregnancy.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking status		Measured at 1, 3, 6, and 12 months postpartum	No
Primary	ETS exposure		Measured at 1, 3, 6, and 12 months postpartum	No
Primary	Urine cotinine analyses		Measured at 1, 3, 6, and 12 months postpartum	No