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Preventing Postpartum Return to Smoking

NCT00917943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2013-04-10

No results posted yet for this study

Summary

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.

Conditions

  • Smoking

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Kathryn I Pollak, PhD · Duke University

  • Evan Myers, MD, MPH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00917943 on ClinicalTrials.gov