Preventing Postpartum Return to Smoking

Smoking Clinical Trial

— Quit for Two  

Official title:

Smoking Resumption-Prevention is Postpartum Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917943
• Other study ID #: Pro00004337
• Secondary ID: 1R01NR009429-01A
• Status: Completed
• Phase: N/A
• First received: June 10, 2009
• Last updated: April 9, 2013
• Start date: April 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy.		12 months postpartum	Yes
Secondary	To determine the association of baseline risk assessment variables with time to resumption.		12 months postpartum	Yes