Preventing Postpartum Return to Smoking
Preventing Postpartum Return to Smoking
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.
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 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.

 SETTING:

 We will recruit women for this study from 11 sites: Duke University Health Systems, Durham
 County Health Services, Person County Health Department, Orange County Health Department,
 Alamance County Health Department, Guilford 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 34 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 34 weeks pregnant,
 confirm their non-smoking status, and make an appointment to explain the study further. Data
 Technicians obtain written consent, conduct 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).
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.