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Preventing Postpartum Return to Smoking (Quit for Two)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00917943
First received: June 10, 2009
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

STUDY PURPOSE:

Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy.

Aim 2. To determine the association of baseline risk assessment variables (dependence, motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco, depression, weight concerns, and partner/household smoking and support) with time to resumption.

A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points.

  1. Between 28 and 34 weeks of pregnancy
  2. 6-weeks postpartum
  3. 6-months postpartum
  4. 12-months postpartum

Women who report not smoking at any of the assessment points will be asked to provide a saliva sample for analysis of tobacco constituents and a breath sample to assess carbon monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one of four levels of stepped-care that includes:

  1. One in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.
  2. Risk profiles will be used to match the intervention to each woman's needs.
  3. Women randomized to the control arm will receive the booklet, Forever Free for Baby and Me and usual prenatal and postpartum care.

We are recruiting 400 women for this study from 11 sites in the Durham/ Raleigh/ Chapel Hill NC area and Fayetteville NC.


Condition Intervention
Smoking
 Behavioral: Tailored Counseling Intervention Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Smoking Resumption-Prevention is Postpartum Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy. [ Time Frame: 12 months postpartum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the association of baseline risk assessment variables with time to resumption. [ Time Frame: 12 months postpartum ] [ Designated as safety issue: Yes ]

Enrollment: 386
Study Start Date: April 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailored Counseling Intervention Arm
Bio-behavioral and pregnancy-specific factors are used to triage women in the treatment arm to one of four levels of stepped-care that includes one in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.
 Behavioral: Tailored Counseling Intervention Arm
Study staff contact women when they are between 28 and 34 weeks pregnant, confirm their non-smoking status, and make an appointment to explain the study further, obtain written informed consent, conduct the risk assessment, and collect baseline data. Bio-behavioral and pregnancy-specific factors are used to triage women in the treatment arm to one of four levels of stepped-care that includes one in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.
Other Name: Nurse Counseling
No Intervention: Control Arm
Women randomized to the control arm receive the booklet, Forever Free for Baby and Me: A Guide to Remaining Smoke Free and usual prenatal and postpartum care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Speak English
  • Registered for prenatal care
  • Have a history of smoking (defined as having smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant)
  • Will need to have been continuously abstinent from tobacco for at least 1 month prior to their risk assessment
  • Women will be eligible if they stopped smoking upon learning of their pregnancies and have been continuously abstinent (self-initiated quitters), or if they continued to smoke during the first few months of pregnancy but have been continuously abstinent from 24 to 28 weeks.

Exclusion Criteria:

  • Any women who stopped smoking and resumed by the 34-week risk assessment will be ineligible.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917943

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Kathryn I Pollak, PhD Duke University
Principal Investigator: Evan Myers, MD, MPH Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00917943     History of Changes
Other Study ID Numbers: Pro00004337, 1 R01 NR009429-01A2
Study First Received: June 10, 2009
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
smoking
pregnancy
counseling
prevention
 tailored intervention
postpartum
women
cessation

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013