Clinical trial NCT00917943: Preventing Postpartum Return to Smoking
Official title: Smoking Resumption-Prevention is Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
pregnancy
counseling
prevention
tailored intervention
postpartum
women
cessation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-06-11
Enrollment: 386
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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).

Eligibility 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.

Primary outcomes:
measure: To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy.
timeFrame: 12 months postpartum
Secondary outcomes:
measure: To determine the association of baseline risk assessment variables with time to resumption.
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Kathryn I Pollak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Evan Myers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: