<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02211430</url>
  </required_header>
  <id_info>
    <org_study_id>02-832</org_study_id>
    <secondary_id>TURSG-02-227-01-PBP</secondary_id>
    <nct_id>NCT02211430</nct_id>
  </id_info>
  <brief_title>Smoking Cessation for Low-Income Pregnant Women</brief_title>
  <acronym>ACS</acronym>
  <official_title>Smoking Cessation for Low-Income Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fox Chase Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant&#xD;
      women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To&#xD;
      this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation&#xD;
      intervention for low-income, minority women conducted in the prenatal and postpartum phases.&#xD;
      Considering the strong link between tobacco use and cancer risk, the development of effective&#xD;
      smoking cessation treatments has important health implications for cancer prevention and&#xD;
      control initiatives. The aims to be addressed are:&#xD;
&#xD;
      Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation&#xD;
      intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e.,&#xD;
      continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short-&#xD;
      and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show&#xD;
      reduced rates of tobacco use, versus those in the BP, over time.&#xD;
&#xD;
      Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of&#xD;
      behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced&#xD;
      fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is&#xD;
      hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on&#xD;
      change of smoking behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rates of Smoking Among Pregnant and Postpartum Women.&#xD;
&#xD;
      Despite the well-established health risks of prenatal and postpartum smoking, a sizable&#xD;
      number of pregnant women and new mothers smoke. About 30% of US women who become pregnant&#xD;
      smoke. Only 20-40% of these women spontaneously quit upon learning of their pregnancy.&#xD;
      Although an additional 3-16% of pregnant smokers may quit later in pregnancy, the majority&#xD;
      continue to smoke throughout, with 15-30% relapsing. Research has also indicated that smoking&#xD;
      cessation rates are lower among low-income pregnant women (6-14%) versus more affluent&#xD;
      populations. Less educated, lower SES, unemployed women who have a higher addiction to&#xD;
      nicotine are at greatest risk for smoking throughout their pregnancy, while pregnant women&#xD;
      with higher levels of education and income are more likely to quit. These differential&#xD;
      smoking rates result in elevated rates of high-risk pregnancies for low SES and less educated&#xD;
      women, vs. higher SES and educated women. While some research has demonstrated moderate&#xD;
      success with prenatal smoking cessation interventions, relapse remains a prominent concern.&#xD;
      Indeed, more than a quarter of women who quit spontaneously relapse by 6-weeks postpartum,&#xD;
      with relapse rates reported as high as 60-80% by 6-months postpartum. The highest relapse&#xD;
      rates have been found among women with low income and little education.&#xD;
&#xD;
      Smoking Cessation Interventions for Prenatal and Postpartum Women.&#xD;
&#xD;
      To date, the efficacy of available smoking cessation interventions has been disappointing.&#xD;
      The current literature on tobacco control indicates that cognitive-affective factors&#xD;
      (including perceived risk, self-efficacy, fatalism, decisional balance, and affect) need to&#xD;
      be considered when designing smoking cessation protocols. Yet, the behavioral treatments that&#xD;
      have been tested for pregnant smokers focus on the use of self-help guides, basic skills&#xD;
      training, and education, neglecting the individual's cognitive-affective profile of barriers.&#xD;
      This limitation is paralleled by a similar void in the broader smoking cessation literature.&#xD;
      When these characteristics are addressed, they have been considered in isolation, without&#xD;
      attention to the full spectrum of cognitive-affective barriers to quitting (i.e., the&#xD;
      interventions focus on only 1 barrier such as perceived risk or depression). Not&#xD;
      surprisingly, among intervention studies with pregnant women, only 3 produced quit rates&#xD;
      above 20%.&#xD;
&#xD;
      Thus, research now needs to build upon these guidelines to develop more potent smoking&#xD;
      cessation interventions. The design of our intervention is directly responsive to the call&#xD;
      for the development of more creative and powerful behavioral interventions to replace the&#xD;
      current best available programs. Guided by the Cognitive-Social Health Information Processing&#xD;
      (C-SHIP) model and based on our related behavior change protocols for low-income populations,&#xD;
      our approach is tailored to the woman's cognitive-affective profile of barriers to initial,&#xD;
      and sustained, uptake of smoking cessation.&#xD;
&#xD;
      Determinants of Smoking Cessation Among Pregnant Women.&#xD;
&#xD;
      The exploration of psychological factors as potential mediators of behavior change appears to&#xD;
      be particularly promising. The specific cognitive and affective processes proposed by the&#xD;
      C-SHIP model as determinants of the uptake of individual health-protective behaviors (e.g.,&#xD;
      smoking cessation) include: 1) perceived risk; 2) self-efficacy and fatalistic beliefs; 3)&#xD;
      expectancies of consequences (i.e., the pros and cons of cessation); and 4) emotional&#xD;
      distress. Over the past decade, a sizable literature has accumulated with respect to the&#xD;
      psychological correlates of smoking behavior.&#xD;
&#xD;
      Procedures and Interventions&#xD;
&#xD;
      Women who were between 1-25 weeks gestation were asked to participate in a study aimed at&#xD;
      learning about smoking cessation techniques for quitting and relapse prevention. Following&#xD;
      recruitment and informed consent, participants were randomly assigned to one of two groups,&#xD;
      which varied in intensity: 1) the control group, which provided a brief counseling of&#xD;
      educational advice and assistance for quitting during each session or 2) a more intensive&#xD;
      theoretically-guided smoking cessation intervention group based on the team's&#xD;
      Cognitive-Social Health Information Processing Model (C-SHIP ), which assessed and addressed&#xD;
      the participant's distinctive pattern of risk perceptions, expectancies and beliefs, and&#xD;
      affective reactions. Through prompts and role-play exercises in the context of in-person&#xD;
      counseling, potential barriers to cessation can be triggered in a safe, supportive&#xD;
      environment. Baseline and follow-up assessments were conducted at 13-25 weeks gestation,&#xD;
      26-38 weeks gestation, 2-6 weeks postpartum and 20-22 weeks postpartum.&#xD;
&#xD;
      Best Practice (BP) control condition consisted of two on-site 10-15 minutes sessions (session&#xD;
      1 and 3), pick up a smoking cessation guide/brochure (session 2), and receive an educational&#xD;
      new letter by mail (booster session). CBC intervention included two 45 minutes on-site&#xD;
      counseling sessions session 1 and 3), one 15-minutes on-site counseling session (session 2),&#xD;
      and one 15-minutes phone session (booster session).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2002</start_date>
  <completion_date type="Actual">March 2007</completion_date>
  <primary_completion_date type="Actual">March 2007</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking Cessation Status</measure>
    <time_frame>prepartum follow-up (26-38 weeks gestation)</time_frame>
    <description>Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking Cessation Status</measure>
    <time_frame>postpartum follow-up (2-6 weeks postpartum)</time_frame>
    <description>Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking Cessation Status</measure>
    <time_frame>3-month post intervention follow up (20-22 weeks postpartum)</time_frame>
    <description>Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Number of Cigarettes Smoked Per Day in Past 7 Days</measure>
    <time_frame>prepartum follow-up (26-38 weeks gestation)</time_frame>
    <description>Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Cigarettes Smoked Per Day in Past 7 Days</measure>
    <time_frame>postpartum follow-up (2-6 weeks postpartum)</time_frame>
    <description>Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Cigarettes Smoked Per Day in Past 7 Days</measure>
    <time_frame>3-month post intervention follow up (20-22 weeks postpartum)</time_frame>
    <description>Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">277</enrollment>
  <condition>Pregnancy</condition>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Cognitive-Behavioral Counseling (CBC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive-Behavioral Counseling (CBC) consists of two 45-minute on-site intervention sessions (session 1 and 3), one 15 minute on-site session (session 2), and one 15-minutes phone session (booster session).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Best Practice (BP) Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Best Practice (BP) Control Condition consists of two 10-15 min, on-site intervention sessions (session 1 and 3), one brochure pick-up (session 2), and receipt of a newsletter by mail (booster session).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-Behavioral Counseling (CBC)</intervention_name>
    <description>Participants of CBC were educated about the effects of smoking on their personal health and their pregnancy during session 1 (45 minutes counseling), and were encouraged to explore their risk perceptions and emotions, for themselves and their unborn child. During session 2, the 15-minute counseling segment highlighted the cognitive and emotion barriers undermining the participant's motivation to quit and the self-regulatory techniques for resisting personal smoking triggers. Session 3 (45 minutes counseling) involved reviewing smoking status and smoking history over the course of the pregnancy, as well as the effects of smoking on both their health and the health of their infant. Booster session was held by phone for 15 min.</description>
    <arm_group_label>Cognitive-Behavioral Counseling (CBC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Best Practice (BC) Control</intervention_name>
    <description>For ethical considerations, and consistent with practice guidelines for treating tobacco addiction (Fiore et al., 2000) which mandates that every pregnant smoker be offered smoking cessation treatment, the control group has been designed to be comparable to the current &quot;best practice&quot; guidelines for smoking cessation treatments. This condition, devised from a review of the current literature, will include one brief (5-15 minutes) prenatal individual session (session 1) consisting of smoking cessation education and advice, on-site brochure pick up (session 2), and a second brief postpartum individual session (session 3) followed by receipt of a newsletter (session 4).</description>
    <arm_group_label>Best Practice (BP) Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being pregnant&#xD;
&#xD;
          -  Having smoked one puff of a cigarette in the 30 days prior to recruitment (1- 25 weeks&#xD;
             post-gestation)&#xD;
&#xD;
          -  Being 18 years or older&#xD;
&#xD;
          -  Being reachable by a telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An inability to communicate readily in English&#xD;
&#xD;
          -  Receiving substance abuse treatment and/or evidence of drug and alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Miller, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fox Chase Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>DiClemente CC, Dolan-Mullen P, Windsor RA. The process of pregnancy smoking cessation: implications for interventions. Tob Control. 2000;9 Suppl 3(Suppl 3):III16-21. doi: 10.1136/tc.9.suppl_3.iii16.</citation>
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  <reference>
    <citation>Engstrom, P., Clapper, M., Schnoll, R., &amp; Orleans, C.T. (2000). Prevention of tobacco-related cancers. Baltimore, MD: Williams and Wilkins Publishing.</citation>
  </reference>
  <reference>
    <citation>Miller, S.M. (2000). Tobacco-related cancers can be prevented and controlled. Primary Care &amp; Cancer, 20(6), 8-9.</citation>
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  <reference>
    <citation>Miller, S.M., &amp; Diefenbach, M. (1998). C-SHIP: A cognitive-social health information processing approach to cancer. In D. Krantz (Ed.), Perspectives in behavioral medicine. New Jersey: Lawrence Erlbaum.</citation>
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    <citation>Miller, S. M., &amp; Schnoll, R.A. (2000). Coping with stress: examples from the cancer context. In J. M. M. Lewis (Ed.), Handbook of Emotions. NY, NY: Plenum Press.</citation>
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  <verification_date>August 2014</verification_date>
  <study_first_submitted>May 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>pregnancy</keyword>
  <keyword>postpartum</keyword>
  <keyword>intervention</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02211430
org study id: 02-832
secondary id: TURSG-02-227-01-PBP
nct id: NCT02211430
lead sponsor: 
has dmc: No
To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant
      women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To
      this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation
      intervention for low-income, minority women conducted in the prenatal and postpartum phases.
      Considering the strong link between tobacco use and cancer risk, the development of effective
      smoking cessation treatments has important health implications for cancer prevention and
      control initiatives. The aims to be addressed are:

      Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation
      intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e.,
      continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short-
      and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show
      reduced rates of tobacco use, versus those in the BP, over time.

      Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of
      behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced
      fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is
      hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on
      change of smoking behaviors.
Rates of Smoking Among Pregnant and Postpartum Women.

      Despite the well-established health risks of prenatal and postpartum smoking, a sizable
      number of pregnant women and new mothers smoke. About 30% of US women who become pregnant
      smoke. Only 20-40% of these women spontaneously quit upon learning of their pregnancy.
      Although an additional 3-16% of pregnant smokers may quit later in pregnancy, the majority
      continue to smoke throughout, with 15-30% relapsing. Research has also indicated that smoking
      cessation rates are lower among low-income pregnant women (6-14%) versus more affluent
      populations. Less educated, lower SES, unemployed women who have a higher addiction to
      nicotine are at greatest risk for smoking throughout their pregnancy, while pregnant women
      with higher levels of education and income are more likely to quit. These differential
      smoking rates result in elevated rates of high-risk pregnancies for low SES and less educated
      women, vs. higher SES and educated women. While some research has demonstrated moderate
      success with prenatal smoking cessation interventions, relapse remains a prominent concern.
      Indeed, more than a quarter of women who quit spontaneously relapse by 6-weeks postpartum,
      with relapse rates reported as high as 60-80% by 6-months postpartum. The highest relapse
      rates have been found among women with low income and little education.

      Smoking Cessation Interventions for Prenatal and Postpartum Women.

      To date, the efficacy of available smoking cessation interventions has been disappointing.
      The current literature on tobacco control indicates that cognitive-affective factors
      (including perceived risk, self-efficacy, fatalism, decisional balance, and affect) need to
      be considered when designing smoking cessation protocols. Yet, the behavioral treatments that
      have been tested for pregnant smokers focus on the use of self-help guides, basic skills
      training, and education, neglecting the individual's cognitive-affective profile of barriers.
      This limitation is paralleled by a similar void in the broader smoking cessation literature.
      When these characteristics are addressed, they have been considered in isolation, without
      attention to the full spectrum of cognitive-affective barriers to quitting (i.e., the
      interventions focus on only 1 barrier such as perceived risk or depression). Not
      surprisingly, among intervention studies with pregnant women, only 3 produced quit rates
      above 20%.

      Thus, research now needs to build upon these guidelines to develop more potent smoking
      cessation interventions. The design of our intervention is directly responsive to the call
      for the development of more creative and powerful behavioral interventions to replace the
      current best available programs. Guided by the Cognitive-Social Health Information Processing
      (C-SHIP) model and based on our related behavior change protocols for low-income populations,
      our approach is tailored to the woman's cognitive-affective profile of barriers to initial,
      and sustained, uptake of smoking cessation.

      Determinants of Smoking Cessation Among Pregnant Women.

      The exploration of psychological factors as potential mediators of behavior change appears to
      be particularly promising. The specific cognitive and affective processes proposed by the
      C-SHIP model as determinants of the uptake of individual health-protective behaviors (e.g.,
      smoking cessation) include: 1) perceived risk; 2) self-efficacy and fatalistic beliefs; 3)
      expectancies of consequences (i.e., the pros and cons of cessation); and 4) emotional
      distress. Over the past decade, a sizable literature has accumulated with respect to the
      psychological correlates of smoking behavior.

      Procedures and Interventions

      Women who were between 1-25 weeks gestation were asked to participate in a study aimed at
      learning about smoking cessation techniques for quitting and relapse prevention. Following
      recruitment and informed consent, participants were randomly assigned to one of two groups,
      which varied in intensity: 1) the control group, which provided a brief counseling of
      educational advice and assistance for quitting during each session or 2) a more intensive
      theoretically-guided smoking cessation intervention group based on the team's
      Cognitive-Social Health Information Processing Model (C-SHIP ), which assessed and addressed
      the participant's distinctive pattern of risk perceptions, expectancies and beliefs, and
      affective reactions. Through prompts and role-play exercises in the context of in-person
      counseling, potential barriers to cessation can be triggered in a safe, supportive
      environment. Baseline and follow-up assessments were conducted at 13-25 weeks gestation,
      26-38 weeks gestation, 2-6 weeks postpartum and 20-22 weeks postpartum.

      Best Practice (BP) control condition consisted of two on-site 10-15 minutes sessions (session
      1 and 3), pick up a smoking cessation guide/brochure (session 2), and receive an educational
      new letter by mail (booster session). CBC intervention included two 45 minutes on-site
      counseling sessions session 1 and 3), one 15-minutes on-site counseling session (session 2),
      and one 15-minutes phone session (booster session).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Smoking Cessation Status
time frame: prepartum follow-up (26-38 weeks gestation)
description: Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
measure: Smoking Cessation Status
time frame: postpartum follow-up (2-6 weeks postpartum)
description: Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
measure: Smoking Cessation Status
time frame: 3-month post intervention follow up (20-22 weeks postpartum)
description: Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
measure: Average Number of Cigarettes Smoked Per Day in Past 7 Days
time frame: prepartum follow-up (26-38 weeks gestation)
description: Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.
measure: Average Number of Cigarettes Smoked Per Day in Past 7 Days
time frame: postpartum follow-up (2-6 weeks postpartum)
description: Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.
measure: Average Number of Cigarettes Smoked Per Day in Past 7 Days
time frame: 3-month post intervention follow up (20-22 weeks postpartum)
description: Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.
arm group label: Cognitive-Behavioral Counseling (CBC)
arm group type: Experimental
description: Cognitive-Behavioral Counseling (CBC) consists of two 45-minute on-site intervention sessions (session 1 and 3), one 15 minute on-site session (session 2), and one 15-minutes phone session (booster session).
arm group label: Best Practice (BP) Control
arm group type: Active Comparator
description: Best Practice (BP) Control Condition consists of two 10-15 min, on-site intervention sessions (session 1 and 3), one brochure pick-up (session 2), and receipt of a newsletter by mail (booster session).
intervention type: Behavioral
intervention name: Cognitive-Behavioral Counseling (CBC)
description: Participants of CBC were educated about the effects of smoking on their personal health and their pregnancy during session 1 (45 minutes counseling), and were encouraged to explore their risk perceptions and emotions, for themselves and their unborn child. During session 2, the 15-minute counseling segment highlighted the cognitive and emotion barriers undermining the participant's motivation to quit and the self-regulatory techniques for resisting personal smoking triggers. Session 3 (45 minutes counseling) involved reviewing smoking status and smoking history over the course of the pregnancy, as well as the effects of smoking on both their health and the health of their infant. Booster session was held by phone for 15 min.
arm group label: Cognitive-Behavioral Counseling (CBC)
intervention type: Behavioral
intervention name: Best Practice (BC) Control
description: For ethical considerations, and consistent with practice guidelines for treating tobacco addiction (Fiore et al., 2000) which mandates that every pregnant smoker be offered smoking cessation treatment, the control group has been designed to be comparable to the current "best practice" guidelines for smoking cessation treatments. This condition, devised from a review of the current literature, will include one brief (5-15 minutes) prenatal individual session (session 1) consisting of smoking cessation education and advice, on-site brochure pick up (session 2), and a second brief postpartum individual session (session 3) followed by receipt of a newsletter (session 4).
arm group label: Best Practice (BP) Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanne Miller, Ph.D.
role: Principal Investigator
affiliation: Fox Chase Cancer Center
facility: 
country: United States
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responsible party type: Sponsor