<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/NCT03796208</url>
  </required_header>
  <id_info>
    <org_study_id>45062</org_study_id>
    <secondary_id>1R34DA046005-01</secondary_id>
    <nct_id>NCT03796208</nct_id>
  </id_info>
  <brief_title>Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women</brief_title>
  <acronym>B-EPIC</acronym>
  <official_title>Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kristin Ashford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests an intervention for tobacco cessation (named B-EPIC) in an established&#xD;
      community medication assisted treatment (MAT) clinic for pregnant and postpartum women with&#xD;
      opioid dependence. Half of the participants will receive the intervention for tobacco&#xD;
      cessation, which is standard cessation counseling from the provider plus additional cessation&#xD;
      support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants&#xD;
      will receive standard tobacco cessation from their provider. The project will also determine&#xD;
      the economic impact of the B-EPIC intervention on healthcare expenditures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will use a prospective, 2-group, randomized, comparative effectiveness design to&#xD;
      determine if the B-EPIC tobacco intervention is superior to tobacco 'treatment as usual&#xD;
      (TAU)' for opioid dependent pregnant women maintained on buprenorphine; the outcomes for the&#xD;
      first aim will be quitting smoking and/or reducing cigarette consumption during pregnancy.&#xD;
      The project design also will determine the economic impact the B-EPIC intervention&#xD;
      (10-months) has on healthcare expenditures.&#xD;
&#xD;
      After informed consent, eligible participants will be randomized (1:1) to the B-EPIC group&#xD;
      (tobacco intervention) or TAU tobacco treatment (control group). All will continue to receive&#xD;
      opioid dependence treatment with buprenorphine, regardless of treatment assignment.&#xD;
&#xD;
      Women enrolled in the control group are informed of the risks of tobacco use and benefits of&#xD;
      quitting using the American College of Obstetricians and Gynecologists (ACOG) 5'A's approach&#xD;
      by their healthcare provider. This standard tobacco cessation counseling takes approximately&#xD;
      5-15 minutes, and is offered at each prenatal and postpartum appointment.&#xD;
&#xD;
      Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four&#xD;
      core components: 1) Individualized tobacco treatment plus supplemental counseling, 2)&#xD;
      Biomarker validation and feedback, 3) Change in maternal thought process and adoption of&#xD;
      healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed.&#xD;
      The initial assessment for this intervention takes 60 minutes, with follow-up sessions&#xD;
      typically lasting 15-20 minutes. The intervention will be led by a certified tobacco&#xD;
      treatment specialist (CTTS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">May 24, 2021</completion_date>
  <primary_completion_date type="Actual">May 24, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Number of Cigarettes Smoked Per Day</measure>
    <time_frame>up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Urine Cotinine Concentration Level</measure>
    <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Electronic Cigarette Usage Per Day</measure>
    <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cigarette Dependence</measure>
    <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Electronic Cigarette Dependence</measure>
    <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Depression Over Time</measure>
    <time_frame>Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 &amp; 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 &amp; 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as &quot;possible depression&quot;. A score of greater than 0 on item 10 indicates &quot;suicidal thoughts&quot;. Data will be presented as the change in depression over time compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Anxiety Over Time</measure>
    <time_frame>Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Perceived Stress Over Time</measure>
    <time_frame>Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
    <description>Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Tobacco Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment As Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will be randomized to tobacco treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC)</intervention_name>
    <description>Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
    <arm_group_label>Tobacco Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment As Usual</intervention_name>
    <description>Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
    <arm_group_label>Treatment As Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of opioid dependence with participation in the University of&#xD;
             Kentucky Healthcare and Baptist Health Lexington buprenorphine treatment program&#xD;
&#xD;
          -  Less than 24 weeks gestation&#xD;
&#xD;
          -  Age 18-49 years old&#xD;
&#xD;
          -  Diagnosis of current tobacco use disorder&#xD;
&#xD;
          -  Read or write in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current prisoner status&#xD;
&#xD;
          -  Current severe mental illness (e.g., bipolar disorder with current mania, current&#xD;
             suicidal ideation)&#xD;
&#xD;
          -  Alcohol or sedative/hypnotic dependence that requires medical intervention&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All participants in this study will be pregnant females.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Ashford</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amanda Fallin-Bennett</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Health Lexington</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Polk Dalton Clinic</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>May 19, 2022</results_first_submitted>
  <results_first_submitted_qc>June 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 15, 2022</results_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Kristin Ashford</investigator_full_name>
    <investigator_title>Professor and Dean of Undergraduate Faculty Affairs</investigator_title>
  </responsible_party>
  <keyword>Opioid Use Disorder</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>tobacco</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share data.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03796208/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Number of individuals consented and further screened for eligibility = 79; Number of participants randomized to intervention = 40; Number of participants randomized to treatment as usual = 38</recruitment_details>
      <pre_assignment_details>Participants may have been excluded prior to randomization for the following reason:&#xD;
1. Withdrawal (changed mind)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tobacco Intervention</title>
          <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
        </group>
        <group group_id="P2">
          <title>Treatment As Usual</title>
          <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Loss of pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Changed prenatal clinics</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tobacco Intervention</title>
          <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
        </group>
        <group group_id="B2">
          <title>Treatment As Usual</title>
          <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="76"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.9" lower_limit="22.7" upper_limit="43.5"/>
                    <measurement group_id="B2" value="30.8" lower_limit="21.8" upper_limit="41.8"/>
                    <measurement group_id="B3" value="30.9" lower_limit="21.8" upper_limit="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in the Number of Cigarettes Smoked Per Day</title>
        <description>Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups.</description>
        <time_frame>up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on number of participants with cigarettes smoked per day data available at third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Enrollment (up to 31.6 weeks gestation) was not used in this analysis due to a change in the data collection format from categorical to continuous. Disruptions by COVID-19 created many challenges with longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Number of Cigarettes Smoked Per Day</title>
          <description>Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on number of participants with cigarettes smoked per day data available at third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Enrollment (up to 31.6 weeks gestation) was not used in this analysis due to a change in the data collection format from categorical to continuous. Disruptions by COVID-19 created many challenges with longitudinal data collection.</population>
          <units>cigarettes per day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-10" upper_limit="5"/>
                    <measurement group_id="O2" value="0" lower_limit="-5" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Urine Cotinine Concentration Level</title>
        <description>Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups.</description>
        <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on the number of participants with cotinine levels data available at enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change in the level of urine cotinine using NICALERT, an immunochromatographic assay test strip (Nymox Pharmaceutical Corporation, Montreal, Quebec). Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Urine Cotinine Concentration Level</title>
          <description>Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on the number of participants with cotinine levels data available at enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change in the level of urine cotinine using NICALERT, an immunochromatographic assay test strip (Nymox Pharmaceutical Corporation, Montreal, Quebec). Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
          <units>litmus levels</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.68"/>
                    <measurement group_id="O2" value="0.17" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Electronic Cigarette Usage Per Day</title>
        <description>Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups.</description>
        <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on the number of participants with self-report electronic cigarette (e-cig) usage per day and with data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Electronic Cigarette Usage Per Day</title>
          <description>Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on the number of participants with self-report electronic cigarette (e-cig) usage per day and with data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
          <units>e-cig use times per day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="18"/>
                    <measurement group_id="O2" value="-6" lower_limit="-20" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cigarette Dependence</title>
        <description>Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups.</description>
        <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on the number of participants with Fagerstrom Test for Cigarette Dependence data available at study time points enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cigarette Dependence</title>
          <description>Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on the number of participants with Fagerstrom Test for Cigarette Dependence data available at study time points enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.04" spread="3.14"/>
                    <measurement group_id="O2" value="1.42" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Electronic Cigarette Dependence</title>
        <description>Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups.</description>
        <time_frame>up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on the number of participants with Penn State Electronic Cigarette Dependence Index (PSECDI) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Electronic Cigarette Dependence</title>
          <description>Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on the number of participants with Penn State Electronic Cigarette Dependence Index (PSECDI) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0"/>
                    <measurement group_id="O2" value="-1.5" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Depression Over Time</title>
        <description>Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 &amp; 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 &amp; 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as &quot;possible depression&quot;. A score of greater than 0 on item 10 indicates &quot;suicidal thoughts&quot;. Data will be presented as the change in depression over time compared between groups.</description>
        <time_frame>Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on the number of participants with Edinburgh Postnatal Depression Scale (EPDS) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Depression Over Time</title>
          <description>Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 &amp; 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 &amp; 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as &quot;possible depression&quot;. A score of greater than 0 on item 10 indicates &quot;suicidal thoughts&quot;. Data will be presented as the change in depression over time compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on the number of participants with Edinburgh Postnatal Depression Scale (EPDS) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" spread="3.86"/>
                    <measurement group_id="O2" value="2.58" spread="5.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Anxiety Over Time</title>
        <description>Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups.</description>
        <time_frame>Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on the number of participants with Generalized Anxiety Disorder 7-item (GAD-7) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Anxiety Over Time</title>
          <description>Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on the number of participants with Generalized Anxiety Disorder 7-item (GAD-7) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="5.68"/>
                    <measurement group_id="O2" value="1.52" spread="4.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maternal Perceived Stress Over Time</title>
        <description>Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups.</description>
        <time_frame>Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))</time_frame>
        <population>Overall number of participants analyzed in each Group is based on the number of participants with Perceived Stress Scale 4-item (PSS4) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Tobacco Intervention</title>
            <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maternal Perceived Stress Over Time</title>
          <description>Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups.</description>
          <population>Overall number of participants analyzed in each Group is based on the number of participants with Perceived Stress Scale 4-item (PSS4) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="2.79"/>
                    <measurement group_id="O2" value="1.04" spread="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tobacco Intervention</title>
          <description>Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.&#xD;
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).</description>
        </group>
        <group group_id="E2">
          <title>Treatment As Usual</title>
          <description>Participants in this group will be randomized to tobacco treatment as usual.&#xD;
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Initial or prolonged hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Initial or prolonged hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Positive response to depression evaluation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Treatment for dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Incarceration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The B-EPIC study was significantly impacted by the COVID-19 pandemic in terms of recruitment, overall enrollment, and the ability to collect longitudinal data. In spite of the challenges, we were able to enroll 76% of the proposed number of participants in each group. However, power was estimated based on a sample size of 50 per group, and some group comparisons may not have reached significance due to a more limited power given the smaller sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kristin Ashford, PhD, Study MPI</name_or_title>
      <organization>University of Kentucky</organization>
      <phone>859-257-9333</phone>
      <email>khashf0@uky.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03796208
org study id: 45062
secondary id: 1R34DA046005-01
nct id: NCT03796208
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study tests an intervention for tobacco cessation (named B-EPIC) in an established
      community medication assisted treatment (MAT) clinic for pregnant and postpartum women with
      opioid dependence. Half of the participants will receive the intervention for tobacco
      cessation, which is standard cessation counseling from the provider plus additional cessation
      support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants
      will receive standard tobacco cessation from their provider. The project will also determine
      the economic impact of the B-EPIC intervention on healthcare expenditures.
The study will use a prospective, 2-group, randomized, comparative effectiveness design to
      determine if the B-EPIC tobacco intervention is superior to tobacco 'treatment as usual
      (TAU)' for opioid dependent pregnant women maintained on buprenorphine; the outcomes for the
      first aim will be quitting smoking and/or reducing cigarette consumption during pregnancy.
      The project design also will determine the economic impact the B-EPIC intervention
      (10-months) has on healthcare expenditures.

      After informed consent, eligible participants will be randomized (1:1) to the B-EPIC group
      (tobacco intervention) or TAU tobacco treatment (control group). All will continue to receive
      opioid dependence treatment with buprenorphine, regardless of treatment assignment.

      Women enrolled in the control group are informed of the risks of tobacco use and benefits of
      quitting using the American College of Obstetricians and Gynecologists (ACOG) 5'A's approach
      by their healthcare provider. This standard tobacco cessation counseling takes approximately
      5-15 minutes, and is offered at each prenatal and postpartum appointment.

      Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four
      core components: 1) Individualized tobacco treatment plus supplemental counseling, 2)
      Biomarker validation and feedback, 3) Change in maternal thought process and adoption of
      healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed.
      The initial assessment for this intervention takes 60 minutes, with follow-up sessions
      typically lasting 15-20 minutes. The intervention will be led by a certified tobacco
      treatment specialist (CTTS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Number of Cigarettes Smoked Per Day
time frame: up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
description: Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups.
measure: Change in Urine Cotinine Concentration Level
time frame: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
description: Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups.
measure: Change in Electronic Cigarette Usage Per Day
time frame: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
description: Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups.
measure: Change in Cigarette Dependence
time frame: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery))
description: Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups.
measure: Change in Electronic Cigarette Dependence
time frame: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
description: Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups.
measure: Change in Maternal Depression Over Time
time frame: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
description: Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups.
measure: Change in Maternal Anxiety Over Time
time frame: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
description: Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups.
measure: Change in Maternal Perceived Stress Over Time
time frame: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
description: Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups.
arm group label: Tobacco Intervention
arm group type: Experimental
description: Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
arm group label: Treatment As Usual
arm group type: Active Comparator
description: Participants in this group will be randomized to tobacco treatment as usual.
intervention type: Behavioral
intervention name: Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC)
description: Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
arm group label: Tobacco Intervention
intervention type: Behavioral
intervention name: Treatment As Usual
description: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
arm group label: Treatment As Usual
criteria: 
gender: Female
gender based: Yes
gender description: All participants in this study will be pregnant females.
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Kristin Ashford
role: Principal Investigator
affiliation: University of Kentucky
last name: Amanda Fallin-Bennett
role: Principal Investigator
affiliation: University of Kentucky
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Kristin Ashford
investigator title: Professor and Dean of Undergraduate Faculty Affairs
sharing ipd: No
ipd description: There is no plan to share data.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The B-EPIC study was significantly impacted by the COVID-19 pandemic in terms of recruitment, overall enrollment, and the ability to collect longitudinal data. In spite of the challenges, we were able to enroll 76% of the proposed number of participants in each group. However, power was estimated based on a sample size of 50 per group, and some group comparisons may not have reached significance due to a more limited power given the smaller sample size.
point of contact: 