Education and Counseling for Abstinence From Tobacco After Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia M. Risica, Brown University
ClinicalTrials.gov Identifier:
NCT00139529
First received: August 29, 2005
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Behavioral: Motivational Interviewing Telephone Counseling
Behavioral: Educational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Postpartum Maintenance of Abstinence From Tobacco

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Smoking status [ Time Frame: Measured at 1, 3, 6, and 12 months postpartum ] [ Designated as safety issue: No ]
  • ETS exposure [ Time Frame: Measured at 1, 3, 6, and 12 months postpartum ] [ Designated as safety issue: No ]
  • Urine cotinine analyses [ Time Frame: Measured at 1, 3, 6, and 12 months postpartum ] [ Designated as safety issue: No ]

Enrollment: 757
Study Start Date: March 2006
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139529

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Thomas M. Lasater, PhD Brown University
Principal Investigator: Patricia M. Risica, DrPH Brown University
Principal Investigator: Belinda Borrelli, PhD Brown University
  More Information

No publications provided

Responsible Party: Patricia M. Risica, Asst Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT00139529     History of Changes
Other Study ID Numbers: 248, R01HL077608, R01 HL77608
Study First Received: August 29, 2005
Last Updated: August 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 29, 2014