Preventing Postpartum Return to Smoking

STUDY DESIGN:

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 32 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.

SETTING:

We will recruit women for this study from 10 sites: Duke University Health Systems, Durham
County Health Services, Person County Health Department, Orange County Health Department,
Alamance County Health Department, Wake County Human Services, Durham OB, Harris and Smith
(Durham), Womack Army Medical Center (WAMC), and Cape Fear Valley on the Fort Bragg Army
Installation in Fayetteville, North Carolina.

SAMPLE:

The sample will be 400 women. To be eligible for the study women must be: 1) 18 years of age
or older 2) speak English 3) registered for prenatal care and 4) 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.

Eligible women will need to have been continuously abstinent from tobacco for at least 1
month prior to their risk assessment, which will occur between 28 and 32 weeks of pregnancy.

RECRUITMENT:

Initial Screening and Recruitment. At Duke and the Durham County Health Department, each
week, all new obstetric patient charts are reviewed, and women with a history of tobacco use
are sent a letter from their providers informing them of the study and asking them to call a
toll-free number if they prefer not to be contacted about study participation. Women who do
not call are contacted and screened for eligibility. At all other sites, nurses screen
women and ask women to complete a contact sheet so that study staff can contact them.

Nurse Case Managers (NCM) contact women when they are between 28 and 32 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.
Data is collected at the woman's prenatal clinic or at her home if she prefers or if her
next prenatal appointment is outside our recruitment time frame.

Randomization procedures. Randomization occurs at each study site (Duke and WAMC). At each
site, women are randomized to treatment or control condition with proportional risk
categories represented in treatment and control groups. Women assigned to the control arm
receive a tobacco control and family-centered relapse prevention booklet, Forever Free for
Baby and Me.

RISK ASSESSMENT:

A risk profile is created for women based on the assessment of bio-behavioral (BB),
pregnancy-specific (PS), and co-condition (CC) risk factors.

All follow-up data collection is conducted face-to-face by a blinded staff member (not Nurse
Case Manager).