<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/NCT02258568</url>
  </required_header>
  <id_info>
    <org_study_id>PN-II-RU-TE-2012-3-0209</org_study_id>
    <nct_id>NCT02258568</nct_id>
  </id_info>
  <brief_title>Postnatal Smoking Relapse, Its Associated Risk Factors, and a Proactive Sustainable Preventive Intervention</brief_title>
  <acronym>PRISM</acronym>
  <official_title>Postnatal Smoking Relapse, Its Associated Risk Factors, and a Proactive Sustainable Preventive Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Babes-Bolyai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Babes-Bolyai University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the extent of postpartum smoking relapse among Romanian women, the&#xD;
      associated risk factors, and will develop, implement, and pilot-test a randomized trial&#xD;
      smoking relapse intervention incorporating innovative research concepts in a social and&#xD;
      cultural acceptable manner. The primary hypothesis is that the intervention will increase&#xD;
      mothers' smoking abstinence rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overview.&#xD;
&#xD;
      This four-year longitudinal project will enroll a total of 425 women who spontaneously quit&#xD;
      smoking during pregnancy. The recruitment will take place during the delivery hospital stay&#xD;
      in two of the largest obstetric-gynecology hospitals in Cluj-Napoca, Romania. The&#xD;
      investigators will design, pre-test (Objective 1), apply, and evaluate a postpartum smoking&#xD;
      relapse preventive randomized intervention among the first 250 recruited women and their&#xD;
      husbands (Objective 2): 125 couples in the intervention group and 125 couples in the control&#xD;
      group, comparing the women's relapse rates at 6 months postpartum. The project will continue&#xD;
      to enroll and follow-up 175 additional women for a total of 300 not subjected to the&#xD;
      intervention (125+175) to assess the extent of postpartum smoking relapse and associated risk&#xD;
      factors in a prospective cohort study (Objective 3).&#xD;
&#xD;
      The work plan.&#xD;
&#xD;
      The first 6 months of the project consisted of a preparatory phase. Objective 1 was completed&#xD;
      in the first 9 months of the project, and milestones included focus groups, interviews with&#xD;
      women, their husbands, and medical staff, the design of the intervention and pre-testing its&#xD;
      acceptability. Objective 2 is completed between months 10-24 of the project. Milestones&#xD;
      include: recruiting 250 couples (months 10-30), applying the intervention (months 10-33), the&#xD;
      follow-up assessment (months 16-36), and preliminary analyses (months 13-36). Objective 3 is&#xD;
      completed between months 19-45 of the project. Milestones include: recruiting 175 additional&#xD;
      women (months 19-39), the follow-up assessment (months 25-45), and preliminary analyses&#xD;
      (months 22-45). The last 12 months (months 37-48) of the project will be used to conclude the&#xD;
      project, including finalizing the database and analyses, preparing a final report, and&#xD;
      preparing articles for publication.&#xD;
&#xD;
      Objective 1: Design, pre-test, and refine an innovative intervention for preventing smoking&#xD;
      relapse after pregnancy to maximize feasibility and potential impact.&#xD;
&#xD;
      This objective represented the qualitative developmental phase of the postpartum relapse&#xD;
      intervention in order to tailor the intervention to the needs of the target population. The&#xD;
      focus-groups and interviews aimed to qualitatively explore the issues related to the women's&#xD;
      motivation and self-efficacy, the two key components of the planned intervention. To develop&#xD;
      the postpartum smoking relapse intervention strategy the Motivation and Problem Solving&#xD;
      (MAPS) strategy of Reitzel and colleagues was followed, the newest approach in the relapse&#xD;
      prevention field, incorporating both motivational and self-efficacy components into the&#xD;
      intervention, adapted to local attitudes and preferences. MAPS was successful in preventing&#xD;
      relapse. The intervention is based on Motivational Interviewing and the seminal relapse&#xD;
      prevention model, probably the most prominent theory of smoking cessation and relapse.&#xD;
      Self-efficacy is viewed as the principal causal determinant of successful abstinence, among&#xD;
      other individual and contextual factors, is hypothesized to increase. The model also&#xD;
      specifies that the individual needs to be sufficiently motivated to avoid relapse. Briefly,&#xD;
      the phone counseling sessions consist of information about the benefits of abstinence to&#xD;
      increase motivation, and helping women identify and manage high-risk relapse situations,&#xD;
      therefore enhancing their self-efficacy. The aim is to deliver consistent repeated advice by&#xD;
      a trained professional over the phone in the postpartum period. Following the newest&#xD;
      approaches in the field, the smoking husbands/partners are also targeted with brief&#xD;
      motivational advice using the birth as a teachable moment to quit. Two psychologists were&#xD;
      trained to deliver the phone motivational advice. Self help materials were also created and&#xD;
      are distributed to all 250 women participating in the trial. A randomization algorithm was&#xD;
      set up to assign patients into the intervention or control groups.&#xD;
&#xD;
      Objective 2: Implement and evaluate an intervention to prevent maternal smoking relapse after&#xD;
      pregnancy in a randomized controlled trial setting.&#xD;
&#xD;
      Participants. The aim is to recruit 250 pre-randomized (125 intervention vs. 125 control&#xD;
      group) mothers at birth who quit smoking in the 2 months before pregnancy or no later than&#xD;
      the end of 1st pregnancy trimester and remained abstinent until delivery, biochemically&#xD;
      confirmed through expired carbon monoxide. The mothers are approached during the delivery&#xD;
      hospital stay in two of the largest obstetrics-gynecology clinics in Cluj-Napoca, Romania.&#xD;
      Enrollment criteria include willingness and ability to participate in the study, age 18 or&#xD;
      older, married or living with a stable partner, with a mobile phone, and willing to provide&#xD;
      mobile phone contact for their husband or partner. Their husband or life partner is also&#xD;
      approached and invited into the study at recruitment, if present, or by phone in the first&#xD;
      weeks after birth.&#xD;
&#xD;
      Procedures. At enrollment, all 250 participants are given self-help materials and 5-10 min of&#xD;
      brief advice offered by the trained research personnel consisting of encouragement to remain&#xD;
      quit, and a review of the smoking risks and the benefits of abstinence. The mothers in the&#xD;
      intervention group additionally receive three telephone-based counseling sessions delivered&#xD;
      by trained professionals over the phone at 1 week, 1 month, and 3 months after birth. All&#xD;
      smoking husbands or partners of the mothers in the intervention group are contacted in the&#xD;
      first weeks after birth and are offered one phone motivational session to quit and support&#xD;
      their wife's abstinence. To incentivize the couples to remain in the study and to appreciate&#xD;
      their time and effort, gift certificates are mailed for baby-related merchandise around the&#xD;
      1-month and 6-month follow-up contacts.&#xD;
&#xD;
      Outcomes. The project follows-up with the couples at 6 months postpartum. Postpartum maternal&#xD;
      abstinence is the main outcome, defined as maintaining smoke-free status continuously until&#xD;
      the 6-month follow-up. The postpartum maternal abstinence is biochemically verified through&#xD;
      expired carbon monoxide (CO) at 6-months postpartum (CO) &lt;10 ppm. Secondary outcomes of&#xD;
      interest are the maternal number of cigarettes smoked, self-efficacy, and motivation. The&#xD;
      self-reported smoke status of the husband/partner is another outcome of interest.&#xD;
&#xD;
      Maternal characteristics. An extended prenatal questionnaire is used at recruitment and at&#xD;
      the 6-month follow-up. Based on the prior literature on the predictors of postpartum relapse,&#xD;
      the questionnaire includes demographics (such as age, education, and ethnicity), health&#xD;
      history (prior pregnancies history, contraception use and feelings about the pregnancy),&#xD;
      mental health (depressive symptoms, stress, anxiety), nicotine dependence before quitting, an&#xD;
      extensive section on smoking knowledge and attitudes, other substance use, breast feeding,&#xD;
      and having a life partner who smokes (as reported by the new mother).&#xD;
&#xD;
      Analytical plan. The required sample (100 intervention vs. 100 control at final follow-up)&#xD;
      was calculated assuming abstinence rates of 0.3-0.4 (70% or 60% relapse) in the control group&#xD;
      compared to anticipated 0.5-0.6 in intervention group, in order to attain 80% statistical&#xD;
      power to detect the difference in two-tailed comparisons, alpha 0.05. Beginning with 125&#xD;
      couples in the intervention vs. 125 in the control group at enrollment, consistent with prior&#xD;
      projects in Romania, 20% attrition is assumed by the final follow-up at 6 months after birth&#xD;
      (100 vs. 100). To evaluate the effectiveness of the intervention, initially unadjusted&#xD;
      comparisons of the outcomes in intervention vs. the control groups will be performed.&#xD;
      Regression analyses will be used to adjust for group dissimilarities when differences have&#xD;
      p-values less than 0.10. A cost-benefit analysis of the intervention will also be performed.&#xD;
      The intervention costs will be compared to the health benefits derived from increased mother&#xD;
      abstinence rates, increased father quit rates, and reduced family exposure to tobacco smoke.&#xD;
      The health benefits will be monetized using estimates available in the research literature.&#xD;
      In addition, economic analyses will be presented for various scenarios in which the proposed&#xD;
      intervention can be integrated and sustained in the existing Romanian health system.&#xD;
&#xD;
      Objective 3. Assess the extent of postpartum smoking relapse and associated risk factors&#xD;
      among women who spontaneously quit smoking during pregnancy.&#xD;
&#xD;
      Participants. To assemble a larger sample of women who quit smoking during pregnancy, 175&#xD;
      additional women are recruited during the delivery hospital stay, for a total of 300 (125&#xD;
      from Objective 2 + 175) women not subjected to the intervention. For consistency, they are&#xD;
      offered the same self-help materials, brief advice, and gift certificate incentives (see&#xD;
      Objective 2).&#xD;
&#xD;
      Outcomes and maternal characteristics. Postpartum maternal abstinence at 6 months postpartum&#xD;
      are the main outcome of interest. A secondary outcome of interest is the maternal number of&#xD;
      cigarettes smoked postpartum. Associations with all the maternal characteristics described&#xD;
      above will be explored(see Objective 2), with a particular focus on the mental health, the&#xD;
      nicotine dependence before quitting, breast feeding, and having a partner who smokes.&#xD;
&#xD;
      Analytical plan. Descriptive and multivariate analyses will be used to compare the women who&#xD;
      relapse to the ones who remain abstinent. Descriptive analyses (counts and percentages) will&#xD;
      assess the extent of postpartum smoking relapse and explore unadjusted associations between&#xD;
      various characteristics and risk factors of the women and their postpartum smoking status:&#xD;
      abstinent vs. relapsed. Multivariate logistic analyses will uncover the independent,&#xD;
      adjusted, effects of individual and interacted factors, statistically adjusting for the&#xD;
      effects of all other variables included in the analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postpartum maternal smoking abstinence</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Defined as maintaining smoke-free status continuously until the 6-month follow-up. The postpartum maternal abstinence will be biochemically verified through expired carbon monoxide (CO) at 6-months postpartum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal number of cigarettes smoked</measure>
    <time_frame>6 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal self-efficacy scores on the Romanian version of the General Self Efficacy scale</measure>
    <time_frame>6 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal motivation scores on the Reasons for Quitting scale</measure>
    <time_frame>6 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported smoke status of the husband/partner.</measure>
    <time_frame>6 months postpartum</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">397</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>Smoking abstinence counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telephone motivational counseling sessions supporting smoking abstinence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Do not receive telephone motivational counseling sessions supporting smoking abstinence</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking abstinence counseling</intervention_name>
    <description>Telephone smoking abstinence counseling based on motivational interviewing concepts</description>
    <arm_group_label>Smoking abstinence counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness and ability to participate in the study&#xD;
&#xD;
          -  Married or living with a stable partner&#xD;
&#xD;
          -  Mobile phone&#xD;
&#xD;
          -  Willing to provide mobile phone contact for their husband or partner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt;18 (minor age in Romania)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristian I Meghea, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cluj School of Public Health</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400095</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Babes-Bolyai University</investigator_affiliation>
    <investigator_full_name>Cristian Ioan Meghea</investigator_full_name>
    <investigator_title>Scientific Researcher</investigator_title>
  </responsible_party>
  <keyword>Cigarette Smoking</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Postpartum smoking relapse</keyword>
  <keyword>Romania</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- 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/NCT02258568
org study id: PN-II-RU-TE-2012-3-0209
nct id: NCT02258568
lead sponsor: 
has dmc: No
This study will assess the extent of postpartum smoking relapse among Romanian women, the
      associated risk factors, and will develop, implement, and pilot-test a randomized trial
      smoking relapse intervention incorporating innovative research concepts in a social and
      cultural acceptable manner. The primary hypothesis is that the intervention will increase
      mothers' smoking abstinence rates.
Overview.

      This four-year longitudinal project will enroll a total of 425 women who spontaneously quit
      smoking during pregnancy. The recruitment will take place during the delivery hospital stay
      in two of the largest obstetric-gynecology hospitals in Cluj-Napoca, Romania. The
      investigators will design, pre-test (Objective 1), apply, and evaluate a postpartum smoking
      relapse preventive randomized intervention among the first 250 recruited women and their
      husbands (Objective 2): 125 couples in the intervention group and 125 couples in the control
      group, comparing the women's relapse rates at 6 months postpartum. The project will continue
      to enroll and follow-up 175 additional women for a total of 300 not subjected to the
      intervention (125+175) to assess the extent of postpartum smoking relapse and associated risk
      factors in a prospective cohort study (Objective 3).

      The work plan.

      The first 6 months of the project consisted of a preparatory phase. Objective 1 was completed
      in the first 9 months of the project, and milestones included focus groups, interviews with
      women, their husbands, and medical staff, the design of the intervention and pre-testing its
      acceptability. Objective 2 is completed between months 10-24 of the project. Milestones
      include: recruiting 250 couples (months 10-30), applying the intervention (months 10-33), the
      follow-up assessment (months 16-36), and preliminary analyses (months 13-36). Objective 3 is
      completed between months 19-45 of the project. Milestones include: recruiting 175 additional
      women (months 19-39), the follow-up assessment (months 25-45), and preliminary analyses
      (months 22-45). The last 12 months (months 37-48) of the project will be used to conclude the
      project, including finalizing the database and analyses, preparing a final report, and
      preparing articles for publication.

      Objective 1: Design, pre-test, and refine an innovative intervention for preventing smoking
      relapse after pregnancy to maximize feasibility and potential impact.

      This objective represented the qualitative developmental phase of the postpartum relapse
      intervention in order to tailor the intervention to the needs of the target population. The
      focus-groups and interviews aimed to qualitatively explore the issues related to the women's
      motivation and self-efficacy, the two key components of the planned intervention. To develop
      the postpartum smoking relapse intervention strategy the Motivation and Problem Solving
      (MAPS) strategy of Reitzel and colleagues was followed, the newest approach in the relapse
      prevention field, incorporating both motivational and self-efficacy components into the
      intervention, adapted to local attitudes and preferences. MAPS was successful in preventing
      relapse. The intervention is based on Motivational Interviewing and the seminal relapse
      prevention model, probably the most prominent theory of smoking cessation and relapse.
      Self-efficacy is viewed as the principal causal determinant of successful abstinence, among
      other individual and contextual factors, is hypothesized to increase. The model also
      specifies that the individual needs to be sufficiently motivated to avoid relapse. Briefly,
      the phone counseling sessions consist of information about the benefits of abstinence to
      increase motivation, and helping women identify and manage high-risk relapse situations,
      therefore enhancing their self-efficacy. The aim is to deliver consistent repeated advice by
      a trained professional over the phone in the postpartum period. Following the newest
      approaches in the field, the smoking husbands/partners are also targeted with brief
      motivational advice using the birth as a teachable moment to quit. Two psychologists were
      trained to deliver the phone motivational advice. Self help materials were also created and
      are distributed to all 250 women participating in the trial. A randomization algorithm was
      set up to assign patients into the intervention or control groups.

      Objective 2: Implement and evaluate an intervention to prevent maternal smoking relapse after
      pregnancy in a randomized controlled trial setting.

      Participants. The aim is to recruit 250 pre-randomized (125 intervention vs. 125 control
      group) mothers at birth who quit smoking in the 2 months before pregnancy or no later than
      the end of 1st pregnancy trimester and remained abstinent until delivery, biochemically
      confirmed through expired carbon monoxide. The mothers are approached during the delivery
      hospital stay in two of the largest obstetrics-gynecology clinics in Cluj-Napoca, Romania.
      Enrollment criteria include willingness and ability to participate in the study, age 18 or
      older, married or living with a stable partner, with a mobile phone, and willing to provide
      mobile phone contact for their husband or partner. Their husband or life partner is also
      approached and invited into the study at recruitment, if present, or by phone in the first
      weeks after birth.

      Procedures. At enrollment, all 250 participants are given self-help materials and 5-10 min of
      brief advice offered by the trained research personnel consisting of encouragement to remain
      quit, and a review of the smoking risks and the benefits of abstinence. The mothers in the
      intervention group additionally receive three telephone-based counseling sessions delivered
      by trained professionals over the phone at 1 week, 1 month, and 3 months after birth. All
      smoking husbands or partners of the mothers in the intervention group are contacted in the
      first weeks after birth and are offered one phone motivational session to quit and support
      their wife's abstinence. To incentivize the couples to remain in the study and to appreciate
      their time and effort, gift certificates are mailed for baby-related merchandise around the
      1-month and 6-month follow-up contacts.

      Outcomes. The project follows-up with the couples at 6 months postpartum. Postpartum maternal
      abstinence is the main outcome, defined as maintaining smoke-free status continuously until
      the 6-month follow-up. The postpartum maternal abstinence is biochemically verified through
      expired carbon monoxide (CO) at 6-months postpartum (CO) <10 ppm. Secondary outcomes of
      interest are the maternal number of cigarettes smoked, self-efficacy, and motivation. The
      self-reported smoke status of the husband/partner is another outcome of interest.

      Maternal characteristics. An extended prenatal questionnaire is used at recruitment and at
      the 6-month follow-up. Based on the prior literature on the predictors of postpartum relapse,
      the questionnaire includes demographics (such as age, education, and ethnicity), health
      history (prior pregnancies history, contraception use and feelings about the pregnancy),
      mental health (depressive symptoms, stress, anxiety), nicotine dependence before quitting, an
      extensive section on smoking knowledge and attitudes, other substance use, breast feeding,
      and having a life partner who smokes (as reported by the new mother).

      Analytical plan. The required sample (100 intervention vs. 100 control at final follow-up)
      was calculated assuming abstinence rates of 0.3-0.4 (70% or 60% relapse) in the control group
      compared to anticipated 0.5-0.6 in intervention group, in order to attain 80% statistical
      power to detect the difference in two-tailed comparisons, alpha 0.05. Beginning with 125
      couples in the intervention vs. 125 in the control group at enrollment, consistent with prior
      projects in Romania, 20% attrition is assumed by the final follow-up at 6 months after birth
      (100 vs. 100). To evaluate the effectiveness of the intervention, initially unadjusted
      comparisons of the outcomes in intervention vs. the control groups will be performed.
      Regression analyses will be used to adjust for group dissimilarities when differences have
      p-values less than 0.10. A cost-benefit analysis of the intervention will also be performed.
      The intervention costs will be compared to the health benefits derived from increased mother
      abstinence rates, increased father quit rates, and reduced family exposure to tobacco smoke.
      The health benefits will be monetized using estimates available in the research literature.
      In addition, economic analyses will be presented for various scenarios in which the proposed
      intervention can be integrated and sustained in the existing Romanian health system.

      Objective 3. Assess the extent of postpartum smoking relapse and associated risk factors
      among women who spontaneously quit smoking during pregnancy.

      Participants. To assemble a larger sample of women who quit smoking during pregnancy, 175
      additional women are recruited during the delivery hospital stay, for a total of 300 (125
      from Objective 2 + 175) women not subjected to the intervention. For consistency, they are
      offered the same self-help materials, brief advice, and gift certificate incentives (see
      Objective 2).

      Outcomes and maternal characteristics. Postpartum maternal abstinence at 6 months postpartum
      are the main outcome of interest. A secondary outcome of interest is the maternal number of
      cigarettes smoked postpartum. Associations with all the maternal characteristics described
      above will be explored(see Objective 2), with a particular focus on the mental health, the
      nicotine dependence before quitting, breast feeding, and having a partner who smokes.

      Analytical plan. Descriptive and multivariate analyses will be used to compare the women who
      relapse to the ones who remain abstinent. Descriptive analyses (counts and percentages) will
      assess the extent of postpartum smoking relapse and explore unadjusted associations between
      various characteristics and risk factors of the women and their postpartum smoking status:
      abstinent vs. relapsed. Multivariate logistic analyses will uncover the independent,
      adjusted, effects of individual and interacted factors, statistically adjusting for the
      effects of all other variables included in the analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postpartum maternal smoking abstinence
time frame: 6 months postpartum
description: Defined as maintaining smoke-free status continuously until the 6-month follow-up. The postpartum maternal abstinence will be biochemically verified through expired carbon monoxide (CO) at 6-months postpartum
measure: Maternal number of cigarettes smoked
time frame: 6 months postpartum
measure: Maternal self-efficacy scores on the Romanian version of the General Self Efficacy scale
time frame: 6 months postpartum
measure: Maternal motivation scores on the Reasons for Quitting scale
time frame: 6 months postpartum
measure: Self-reported smoke status of the husband/partner.
time frame: 6 months postpartum
arm group label: Smoking abstinence counseling
arm group type: Experimental
description: Telephone motivational counseling sessions supporting smoking abstinence
arm group label: Control
arm group type: No Intervention
description: Do not receive telephone motivational counseling sessions supporting smoking abstinence
intervention type: Behavioral
intervention name: Smoking abstinence counseling
description: Telephone smoking abstinence counseling based on motivational interviewing concepts
arm group label: Smoking abstinence counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cristian I Meghea, PhD
role: Principal Investigator
affiliation: Michigan State University
facility: 
country: Romania
responsible party type: Principal Investigator
investigator affiliation: Babes-Bolyai University
investigator full name: Cristian Ioan Meghea
investigator title: Scientific Researcher
mesh term: Recurrence