<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/NCT02210832</url>
  </required_header>
  <id_info>
    <org_study_id>1R01HD075669-01</org_study_id>
    <secondary_id>R01HD075669-01</secondary_id>
    <nct_id>NCT02210832</nct_id>
  </id_info>
  <brief_title>Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women</brief_title>
  <official_title>Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators will examine whether adding financial incentives to current best practices for&#xD;
      smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a&#xD;
      telephone quit line) increases cessation rates and improves infant health. While more&#xD;
      expensive upfront compared to best practices alone, the investigators hypothesize that this&#xD;
      treatment approach will be economically justified by the later cost savings associated with&#xD;
      more women quitting, having healthier babies, and needing less healthcare. It should also&#xD;
      help to reduce the greater risk for health problems often seen among those who less well off&#xD;
      economically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the&#xD;
      U.S. Most pregnant smokers continue smoking through pregnancy producing serious immediate and&#xD;
      longer-term adverse health consequences for the infant. Smoking during pregnancy is highly&#xD;
      associated with economic disadvantage and a substantive contributor to health disparities.&#xD;
&#xD;
      Efficacious interventions are available, but cessation rates are low (&lt;20%) and improvements&#xD;
      in birth outcomes often modest or absent. Current treatments usually entail relatively brief,&#xD;
      lower-cost interventions (e.g., pregnancy specific quit lines). There is broad consensus that&#xD;
      more effective interventions are sorely needed. This team of investigators has developed a&#xD;
      novel behavioral economic intervention in which women earn financial incentives contingent on&#xD;
      smoking abstinence. In a metaanalysis of treatments for smoking during pregnancy, effect&#xD;
      sizes achieved with financial incentives were several fold larger than those achieved with&#xD;
      lower intensity approaches or medications. The intervention also appears to improve birth&#xD;
      outcomes and increase breastfeeding duration. While highly promising, further research is&#xD;
      needed in at least three areas. (1) The evidence on birth outcomes and breastfeeding is from&#xD;
      studies that combined data across trials rather than a single prospective trial, (2) whether&#xD;
      the intervention produces other postpartum improvements in health has not been investigated,&#xD;
      and (3) the overall cost-effectiveness of this approach has not been examined.&#xD;
&#xD;
      To examine these unanswered questions, the investigators are proposing a randomized,&#xD;
      controlled clinical trial comparing the efficacy and cost effectiveness through one year&#xD;
      postpartum of current best practices for smoking cessation during pregnancy vs. best&#xD;
      practices plus financial incentives among 230 pregnant, Medicaid recipients. A third&#xD;
      condition of 115 pregnant nonsmokers matched to the smokers on sociodemographic and health&#xD;
      conditions will be included as well to compare the extent to which the treatments reduce the&#xD;
      burden of smoking and to estimate how much more might be accomplished by further improvements&#xD;
      in this incentives intervention without exceeding cost-effectiveness.&#xD;
&#xD;
      The investigators hypothesize that best practices plus financial incentives will be more&#xD;
      effective than usual care practices alone, that the incentives intervention will be cost&#xD;
      effective, and that while adding the incentives reduces a greater proportion of the health&#xD;
      and economic burden of smoking than best practices alone, more can be done while remaining&#xD;
      cost effective.&#xD;
&#xD;
      Overall, the proposed study has the potential to substantially advance knowledge on&#xD;
      cost-effective smoking cessation for pregnant women. Importantly, because of the strong&#xD;
      association between smoking during pregnancy and economic disadvantage, the proposed study&#xD;
      also has the potential to contribute new knowledge relevant to reducing the serious&#xD;
      challenges of health disparities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 31, 2014</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment</measure>
    <time_frame>collected once per women at approximately 28-weeks gestation in each of the two smoking arms</time_frame>
    <description>Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>7-day Point Prevalence Abstinence Postpartum</measure>
    <time_frame>Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum</time_frame>
    <description>Compare two treatment arms on 7-day point-prevalence abstinence assessed at 2-, 4-, 8-, 12-, 24- and 48-weeks postpartum. Abstinence was defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding in the Three Trial Arms</measure>
    <time_frame>Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum</time_frame>
    <description>Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding While Abstinent From Smoking</measure>
    <time_frame>Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum</time_frame>
    <description>We compared the three trial arms on the percent of women who reported breastfeeding and were biochemically confirmed to be abstinent from smoking at each postpartum assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).</measure>
    <time_frame>Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.</time_frame>
    <description>The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.</measure>
    <time_frame>Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.</time_frame>
    <description>Reporting mean total scores and SEM from the Minnesota Nicotine Withdrawal Scale (MNWS). Total score is an average of 7 items, with each item on a 0 (none) to 4 (severe) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Growth in First Year of Life</measure>
    <time_frame>delivery, 24-week, and 50-week postpartum assessments</time_frame>
    <description>Infant growth (length &amp; weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth Outcomes (% Small for Gestational Age Deliveries)</measure>
    <time_frame>delivery</time_frame>
    <description>Birth outcomes were compared between the three study arms. Small for gestational age was defined as &lt;10th percentile using INTERGROWTH-21st [2021] https://intergrowth21.tghn.org/about/about-us/.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth Outcomes (Percent Preterm [&lt;37 Weeks] Deliveries)</measure>
    <time_frame>at delivery</time_frame>
    <description>Compared the three trials conditions on preterm deliveries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth Outcomes (NICU Admissions)</measure>
    <time_frame>at delivery</time_frame>
    <description>Compared three trial conditions on percent of NICU admissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ages &amp; Stages Questionnaire (ASQ)</measure>
    <time_frame>24- and 48-weeks postpartum</time_frame>
    <description>The ASQ assesses infant development in five areas (communication [Comm], gross motor [GM], fine motor [FM], problem solving [PrbSlv], personal-social [PerSoc]); Each area includes six items, each with a possible value of 0, 5, 10, along with a cutoff to dichotomize infants into typical/normal vs. monitor/potential delay categories for an area. Scores in each area are compared to norms; scores with 1 standard deviation of the norm mean are categorized as typical/normal and those greater than one standard deviation below the norm mean are categorized as monitor/potential delay. We report the dichotomized outcomes for each of the six areas at the 24-week and 48-week assessments noting the number of infants in each treatment condition in the monitor/potential delay category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth Outcome: Gestational Age at Delivery</measure>
    <time_frame>at delivery</time_frame>
    <description>Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Per Participant</measure>
    <time_frame>Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).</time_frame>
    <description>Cost per participant for BP+FI and BP interventions. These costs per participant are used in calculation of the Incremental Cost Effectiveness Ratio (ICER). This ICER measure is the added healthcare sector cost per participant for BP+FI compared to BP relative to estimated net health gain per participant (QALY). Maternal net health gains in QALYs from cessation difference between treatment conditions at 24 weeks postpartum were based on Stapleton &amp; West, 2012, Nicotine Tob Res; 14: 463-71.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Years Gained (QALYs)</measure>
    <time_frame>24 weeks postpartum</time_frame>
    <description>Smoking abstinence at the 24-week assessment was converted into quality of life years gained using standardized tables reported in Stapleton &amp; West, 2012, Nicotine Tob Res; 14: 463-71.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental Cost Effectiveness Ratio (ICER)</measure>
    <time_frame>24 weeks postpartum</time_frame>
    <description>A summary measure representing the economic value of an intervention (BP+FI) compared with an alternative (BP). The measure type used below is 'number' due to the fact that this measure is simply a ratio of mean dollars divided by mean years gained between the treatment conditions. Thus there was no alternative measure type that could be used or measure of dispersion available.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Additional Birth Outcome: Mean Birth Weight</measure>
    <time_frame>at delivery</time_frame>
    <description>Birth weight was obtained for each infant from the birth record and expressed in grams. We report the group mean and standard error for each treatment condition.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">257</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>Best practices for pregnant smokers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five As plus referral to pregnancy-specific tobacco quit line</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Best practices plus financial incentives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Never-smoker comparison condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Best practices</intervention_name>
    <arm_group_label>Best practices for pregnant smokers</arm_group_label>
    <arm_group_label>Best practices plus financial incentives</arm_group_label>
    <other_name>Five As plus referral to pregnancy-specific quit line</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>financial incentives</intervention_name>
    <description>financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
    <arm_group_label>Best practices plus financial incentives</arm_group_label>
    <other_name>contingency management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for two intervention arms:&#xD;
&#xD;
          -  report being smokers at the time that they learned of the current pregnancy;&#xD;
&#xD;
          -  report smoking in the 7 days prior to the first prenatal care visit with biochemical&#xD;
             verification;&#xD;
&#xD;
          -  &lt; 25 weeks gestation;&#xD;
&#xD;
          -  English speaking;&#xD;
&#xD;
          -  plan on remaining in the geographical area through 12months postpartum.&#xD;
&#xD;
        Inclusion Criteria for never-smoker comparison condition:&#xD;
&#xD;
          -  report being nonsmokers at the time they learned of the current pregnancy;&#xD;
&#xD;
          -  report no smoking in the past 6 month;&#xD;
&#xD;
          -  Biochemical verification of non-smoker status;&#xD;
&#xD;
          -  report smoking &lt; 100 cigarettes in their lifetime;&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  &gt; 25 weeks gestation;&#xD;
&#xD;
          -  unavailable for routine assessments through 1 year postpartum;&#xD;
&#xD;
          -  opioid substitution therapy;&#xD;
&#xD;
          -  untreated/unstable serious mental illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen T Higgins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Vermont, University Health Center Campus</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Higgins ST, Washio Y, Heil SH, Solomon LJ, Gaalema DE, Higgins TM, Bernstein IM. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med. 2012 Nov;55 Suppl(Suppl):S33-40. doi: 10.1016/j.ypmed.2011.12.016. Epub 2011 Dec 27.</citation>
    <PMID>22227223</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <results_first_submitted>November 10, 2021</results_first_submitted>
  <results_first_submitted_qc>August 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2023</results_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Stephen T. Higgins, PhD</investigator_full_name>
    <investigator_title>Professor of Psychiatry and Psychology</investigator_title>
  </responsible_party>
  <keyword>smoking</keyword>
  <keyword>pregnancy</keyword>
  <keyword>cessation</keyword>
  <keyword>incentives</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT02210832/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Best Practices for Pregnant Smokers</title>
          <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
        </group>
        <group group_id="P2">
          <title>Best Practices Plus Financial Incentives</title>
          <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
        </group>
        <group group_id="P3">
          <title>Never-smoker Comparison Condition</title>
          <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy termination .</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Women who aborted were removed from the study as per convention in this research area. A total of 8 women were removed for this reason, 3, 4, and 1 in Best practices for pregnant smokers, Best practices plus financial incentives, and Never-smoker comparison conditions.</population>
      <group_list>
        <group group_id="B1">
          <title>Best Practices for Pregnant Smokers</title>
          <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
        </group>
        <group group_id="B2">
          <title>Best Practices Plus Financial Incentives</title>
          <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
        </group>
        <group group_id="B3">
          <title>Never-smoker Comparison Condition</title>
          <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
        </group>
        <group group_id="B4">
          <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="88"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="80"/>
            <count group_id="B4" value="249"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.6" spread="5.5"/>
                    <measurement group_id="B2" value="25.4" spread="5.0"/>
                    <measurement group_id="B3" value="25.6" spread="5.0"/>
                    <measurement group_id="B4" value="25.87" spread="5.17"/>
                  </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="88"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="80"/>
                    <measurement group_id="B4" value="249"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="72"/>
                    <measurement group_id="B4" value="228"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="80"/>
                    <measurement group_id="B4" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes smoked per day pre-pregnancy</title>
          <units>cigarettes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.27" spread="9.42"/>
                    <measurement group_id="B2" value="19.25" spread="9.87"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="12.51" spread="6.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes smoked per day at 1st antepartum visit</title>
          <units>cigarettes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.92" spread="6.18"/>
                    <measurement group_id="B2" value="8.99" spread="5.21"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="6.30" spread="3.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age started smoking (yrs)</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.47" spread="2.96"/>
                    <measurement group_id="B2" value="15.10" spread="2.92"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="10.19" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>% living with other smokers</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>% with no smoking allowed in home</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>% with none or few family who smoke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>% attempted to quit prepregnancy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title># quit attempts during pregnancy</title>
          <units>attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.73" spread="2.35"/>
                    <measurement group_id="B2" value="0.57" spread="0.97"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0.43" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Minnesota Nicotine Withdrawal Scale total score; scale: 0 (none) to 4 (severe);average item scores</title>
          <description>Minnesota Nicotine Withdrawal Scale We report mean Total Scores (minimum = 0 [no discomfort], maximum = 4 [severe discomfort]) There are 8 scale items, each is scored 0 to 4. Total Scores reflect the average of the eight items.&#xD;
We report the average the average Total Score and standard deviation in each treatment condition.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.60" spread="0.75"/>
                    <measurement group_id="B2" value="1.37" spread="0.76"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="0.99" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerstrom Test for Nicotine Dependence</title>
          <description>The Fagerstrom Test for Nicotine Dependence is a 6-item scale Four items are scored Yes-No with Yes = 1 and No = 0. Two items have four response options each scored 1-4 with lower scores indicating less dependence Items are summed for each test taker to get a total score with a range of 0 (no dependence) to 10 (intense dependence).&#xD;
We report the average participant score and standard deviation for each treatment condition.</description>
          <units>0-10 scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.33" spread="2.30"/>
                    <measurement group_id="B2" value="3.98" spread="2.07"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                    <measurement group_id="B4" value="2.77" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>% endorsing that smoking will greatly harm baby</title>
          <description>Item is scored on 0 (not at all) to 4 (a lot); there is a &quot;don't know&quot; item that is recoded as missing. Scale is dichotomized by collapsing items 1-3 vs. 4. We report the number of participants indicating a score of 4.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stress rating scale for past week from 0 (none) to 10 (extreme)</title>
          <description>This is a single item scale on which each participant rates their past week's stress as 0 (none) to 10 (extreme). We report the mean score and standard deviation for each treatment condition.</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.3" spread="2.2"/>
                    <measurement group_id="B2" value="5.0" spread="2.5"/>
                    <measurement group_id="B3" value="3.3" spread="2.1"/>
                    <measurement group_id="B4" value="4.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Beck Depression Inventory total score</title>
          <description>The Beck Depression Inventory contains items 21 items each scored 0 (least) to 3 (most). Item scores are summed for a total score ranging from 0-63. We report the mean total score and standard deviation for each treatment condition.</description>
          <units>units on a 0-63 scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.8" spread="8.6"/>
                    <measurement group_id="B2" value="10.0" spread="7.4"/>
                    <measurement group_id="B3" value="5.8" spread="5.2"/>
                    <measurement group_id="B4" value="9.5" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment</title>
        <description>Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing</description>
        <time_frame>collected once per women at approximately 28-weeks gestation in each of the two smoking arms</time_frame>
        <population>Comparison of women in two smoking-cessation arms</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
        </group_list>
        <measure>
          <title>7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment</title>
          <description>Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing</description>
          <population>Comparison of women in two smoking-cessation arms</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hypothesized that women assigned to Best practices plus financial incentives would achieve greater abstinence than women assigned to Best practices only.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>38.27% vs. 9.09%</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>p value is not adjusted for multiple comparisons. A priori threshold for significance was P &lt; 0.05.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>chi square test statistic = 20.23, df = 1</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>7-day Point Prevalence Abstinence Postpartum</title>
        <description>Compare two treatment arms on 7-day point-prevalence abstinence assessed at 2-, 4-, 8-, 12-, 24- and 48-weeks postpartum. Abstinence was defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing</description>
        <time_frame>Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum</time_frame>
        <population>Hypothesized that women assigned to Best practices plus financial incentives would achieve greater smoking abstinence than women assigned to Best practices only.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
        </group_list>
        <measure>
          <title>7-day Point Prevalence Abstinence Postpartum</title>
          <description>Compare two treatment arms on 7-day point-prevalence abstinence assessed at 2-, 4-, 8-, 12-, 24- and 48-weeks postpartum. Abstinence was defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing</description>
          <population>Hypothesized that women assigned to Best practices plus financial incentives would achieve greater smoking abstinence than women assigned to Best practices only.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
            <method_desc>Used generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Trial condition by assessment time interaction</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>chi square test statistic = 21.93, df=7</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Breastfeeding in the Three Trial Arms</title>
        <description>Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments</description>
        <time_frame>Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum</time_frame>
        <population>Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Breastfeeding in the Three Trial Arms</title>
          <description>Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments</description>
          <population>Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Interaction of trial condition and time</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.48</p_value>
            <p_value_desc>chi square test statistic = 9.52, df = 10</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Breastfeeding While Abstinent From Smoking</title>
        <description>We compared the three trial arms on the percent of women who reported breastfeeding and were biochemically confirmed to be abstinent from smoking at each postpartum assessment.</description>
        <time_frame>Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum</time_frame>
        <population>Comparing women in each trial condition who reported breastfeeding and were biochemically confirmed abstinent from smoking at each postpartum assessment. Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Breastfeeding While Abstinent From Smoking</title>
          <description>We compared the three trial arms on the percent of women who reported breastfeeding and were biochemically confirmed to be abstinent from smoking at each postpartum assessment.</description>
          <population>Comparing women in each trial condition who reported breastfeeding and were biochemically confirmed abstinent from smoking at each postpartum assessment. Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Examining main effect of treatment condition.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>chi square test statistic = 33.51, df = 2</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing interaction of treatment condition and assessment time</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.89</p_value>
            <p_value_desc>chi square test statistic = 5.00, df = 10.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).</title>
        <description>The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.</description>
        <time_frame>Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.</time_frame>
        <population>Comparing between women assigned to the two smoking-cessation trial conditions.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
        </group_list>
        <measure>
          <title>Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).</title>
          <description>The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.</description>
          <population>Comparing between women assigned to the two smoking-cessation trial conditions.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>early antepartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" spread="0.14"/>
                    <measurement group_id="O2" value="1.75" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>late antepartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="0.14"/>
                    <measurement group_id="O2" value="1.52" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="0.15"/>
                    <measurement group_id="O2" value="1.39" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" spread="0.15"/>
                    <measurement group_id="O2" value="1.55" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.27" spread="0.15"/>
                    <measurement group_id="O2" value="1.75" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="0.14"/>
                    <measurement group_id="O2" value="1.72" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.15"/>
                    <measurement group_id="O2" value="1.97" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" spread="0.16"/>
                    <measurement group_id="O2" value="1.99" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Method was mixed model repeated measures analysis of covariance.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.</title>
        <description>Reporting mean total scores and SEM from the Minnesota Nicotine Withdrawal Scale (MNWS). Total score is an average of 7 items, with each item on a 0 (none) to 4 (severe) scale.</description>
        <time_frame>Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.</time_frame>
        <population>Comparing women assigned to the two smoking-cessation trial conditions.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
        </group_list>
        <measure>
          <title>Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.</title>
          <description>Reporting mean total scores and SEM from the Minnesota Nicotine Withdrawal Scale (MNWS). Total score is an average of 7 items, with each item on a 0 (none) to 4 (severe) scale.</description>
          <population>Comparing women assigned to the two smoking-cessation trial conditions.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Early antepartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.47" spread="0.08"/>
                    <measurement group_id="O2" value="1.02" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Late antepartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" spread="0.08"/>
                    <measurement group_id="O2" value="0.93" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.08"/>
                    <measurement group_id="O2" value="0.70" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.08"/>
                    <measurement group_id="O2" value="0.68" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="0.08"/>
                    <measurement group_id="O2" value="0.68" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86" spread="0.08"/>
                    <measurement group_id="O2" value="0.59" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="0.08"/>
                    <measurement group_id="O2" value="0.78" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="0.8"/>
                    <measurement group_id="O2" value="0.84" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Examine interaction of treatment condition and assessment time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>F[7,922]=3.62</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Repeated measures analysis of covariance was conducted with Bonferroni corrections for post-doc tests and across repeated assessments.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Method was mixed model repeated measures analysis of covariance.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infant Growth in First Year of Life</title>
        <description>Infant growth (length &amp; weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.</description>
        <time_frame>delivery, 24-week, and 50-week postpartum assessments</time_frame>
        <population>There was data available for one or more assessments for 79, 67, and 77 of infants born to mothers in the Best practices, Best practices plus financial incentives, and never-smoker conditions. We compared body mass index (BMI) percentile scores between infants from the three trial conditions at delivery, 24-weeks postpartum, and 48-weeks postpartum.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Infant Growth in First Year of Life</title>
          <description>Infant growth (length &amp; weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.</description>
          <population>There was data available for one or more assessments for 79, 67, and 77 of infants born to mothers in the Best practices, Best practices plus financial incentives, and never-smoker conditions. We compared body mass index (BMI) percentile scores between infants from the three trial conditions at delivery, 24-weeks postpartum, and 48-weeks postpartum.</population>
          <units>BMI Percentile</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.39" spread="3.35"/>
                    <measurement group_id="O2" value="34.92" spread="3.51"/>
                    <measurement group_id="O3" value="40.56" spread="3.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.19" spread="3.36"/>
                    <measurement group_id="O2" value="59.14" spread="3.71"/>
                    <measurement group_id="O3" value="46.15" spread="3.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-weeks postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.97" spread="3.73"/>
                    <measurement group_id="O2" value="65.69" spread="4.06"/>
                    <measurement group_id="O3" value="66.62" spread="3.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Method was mixed model repeated measures analysis of covariance.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Birth Outcomes (% Small for Gestational Age Deliveries)</title>
        <description>Birth outcomes were compared between the three study arms. Small for gestational age was defined as &lt;10th percentile using INTERGROWTH-21st [2021] https://intergrowth21.tghn.org/about/about-us/.</description>
        <time_frame>delivery</time_frame>
        <population>Comparison of three trial conditions on SGA deliveries</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Birth Outcomes (% Small for Gestational Age Deliveries)</title>
          <description>Birth outcomes were compared between the three study arms. Small for gestational age was defined as &lt;10th percentile using INTERGROWTH-21st [2021] https://intergrowth21.tghn.org/about/about-us/.</description>
          <population>Comparison of three trial conditions on SGA deliveries</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Small for Gestational Age</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal size for gestational age</title>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="68"/>
                    <measurement group_id="O3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Method is logistic regression adjusted for covariates.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Birth Outcomes (Percent Preterm [&lt;37 Weeks] Deliveries)</title>
        <description>Compared the three trials conditions on preterm deliveries.</description>
        <time_frame>at delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Birth Outcomes (Percent Preterm [&lt;37 Weeks] Deliveries)</title>
          <description>Compared the three trials conditions on preterm deliveries.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>preterm</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;/= 37 weeks</title>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Birth Outcomes (NICU Admissions)</title>
        <description>Compared three trial conditions on percent of NICU admissions</description>
        <time_frame>at delivery</time_frame>
        <population>Compared three trial conditions on NICU admissions.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Birth Outcomes (NICU Admissions)</title>
          <description>Compared three trial conditions on percent of NICU admissions</description>
          <population>Compared three trial conditions on NICU admissions.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NICU admitted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no NICU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ages &amp; Stages Questionnaire (ASQ)</title>
        <description>The ASQ assesses infant development in five areas (communication [Comm], gross motor [GM], fine motor [FM], problem solving [PrbSlv], personal-social [PerSoc]); Each area includes six items, each with a possible value of 0, 5, 10, along with a cutoff to dichotomize infants into typical/normal vs. monitor/potential delay categories for an area. Scores in each area are compared to norms; scores with 1 standard deviation of the norm mean are categorized as typical/normal and those greater than one standard deviation below the norm mean are categorized as monitor/potential delay. We report the dichotomized outcomes for each of the six areas at the 24-week and 48-week assessments noting the number of infants in each treatment condition in the monitor/potential delay category.</description>
        <time_frame>24- and 48-weeks postpartum</time_frame>
        <population>Overall number of participants analyzed represents the number of participants for whom we obtained data on this outcome at 24-weeks postpartum; at 48-weeks the overall number analyzed were 69, 56, and 72 in Best Practices, Best Practices plus financial incentives, and never-smokers, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Ages &amp; Stages Questionnaire (ASQ)</title>
          <description>The ASQ assesses infant development in five areas (communication [Comm], gross motor [GM], fine motor [FM], problem solving [PrbSlv], personal-social [PerSoc]); Each area includes six items, each with a possible value of 0, 5, 10, along with a cutoff to dichotomize infants into typical/normal vs. monitor/potential delay categories for an area. Scores in each area are compared to norms; scores with 1 standard deviation of the norm mean are categorized as typical/normal and those greater than one standard deviation below the norm mean are categorized as monitor/potential delay. We report the dichotomized outcomes for each of the six areas at the 24-week and 48-week assessments noting the number of infants in each treatment condition in the monitor/potential delay category.</description>
          <population>Overall number of participants analyzed represents the number of participants for whom we obtained data on this outcome at 24-weeks postpartum; at 48-weeks the overall number analyzed were 69, 56, and 72 in Best Practices, Best Practices plus financial incentives, and never-smokers, respectively.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Comm at 24-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comm at 48-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM at 24-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM at 48-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FM at 24-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FM at 48-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PrbSlv at 24-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PrbSlv at 48-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PerSoc at 24-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PerSoc at 48-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Birth Outcome: Gestational Age at Delivery</title>
        <description>Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.</description>
        <time_frame>at delivery</time_frame>
        <population>Birth outcomes were obtained from 88, 76, and 79 infants born to women in the best practices, best practices plus financial incentives, and never-smoker conditions.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Birth Outcome: Gestational Age at Delivery</title>
          <description>Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.</description>
          <population>Birth outcomes were obtained from 88, 76, and 79 infants born to women in the best practices, best practices plus financial incentives, and never-smoker conditions.</population>
          <units>gestational age (weeks)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.18" spread="0.22"/>
                    <measurement group_id="O2" value="38.69" spread="0.23"/>
                    <measurement group_id="O3" value="39.35" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost Per Participant</title>
        <description>Cost per participant for BP+FI and BP interventions. These costs per participant are used in calculation of the Incremental Cost Effectiveness Ratio (ICER). This ICER measure is the added healthcare sector cost per participant for BP+FI compared to BP relative to estimated net health gain per participant (QALY). Maternal net health gains in QALYs from cessation difference between treatment conditions at 24 weeks postpartum were based on Stapleton &amp; West, 2012, Nicotine Tob Res; 14: 463-71.</description>
        <time_frame>Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).</time_frame>
        <population>All participants treated in best practices plus financial incentives and best practices trial conditions.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices Financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O2">
            <title>Best Practices</title>
            <description>Best Practices: 5As plus referral to tobacco quit line</description>
          </group>
        </group_list>
        <measure>
          <title>Cost Per Participant</title>
          <description>Cost per participant for BP+FI and BP interventions. These costs per participant are used in calculation of the Incremental Cost Effectiveness Ratio (ICER). This ICER measure is the added healthcare sector cost per participant for BP+FI compared to BP relative to estimated net health gain per participant (QALY). Maternal net health gains in QALYs from cessation difference between treatment conditions at 24 weeks postpartum were based on Stapleton &amp; West, 2012, Nicotine Tob Res; 14: 463-71.</description>
          <population>All participants treated in best practices plus financial incentives and best practices trial conditions.</population>
          <units>U.S. dollars</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23007.01" spread="1284.83"/>
                    <measurement group_id="O2" value="22372.25" spread="1594.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Years Gained (QALYs)</title>
        <description>Smoking abstinence at the 24-week assessment was converted into quality of life years gained using standardized tables reported in Stapleton &amp; West, 2012, Nicotine Tob Res; 14: 463-71.</description>
        <time_frame>24 weeks postpartum</time_frame>
        <population>Analysis of results for this measure cannot be reported separately for each treatment arm. Thus, treatment conditions were combined because the outcome is the difference in quality of life years gained (QALYs) between conditions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Best Practices and Best Practices Plus Financial Incentives</title>
            <description>Best practices: Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Years Gained (QALYs)</title>
          <description>Smoking abstinence at the 24-week assessment was converted into quality of life years gained using standardized tables reported in Stapleton &amp; West, 2012, Nicotine Tob Res; 14: 463-71.</description>
          <population>Analysis of results for this measure cannot be reported separately for each treatment arm. Thus, treatment conditions were combined because the outcome is the difference in quality of life years gained (QALYs) between conditions.</population>
          <units>net years gained</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0267" spread="0.0412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incremental Cost Effectiveness Ratio (ICER)</title>
        <description>A summary measure representing the economic value of an intervention (BP+FI) compared with an alternative (BP). The measure type used below is 'number' due to the fact that this measure is simply a ratio of mean dollars divided by mean years gained between the treatment conditions. Thus there was no alternative measure type that could be used or measure of dispersion available.</description>
        <time_frame>24 weeks postpartum</time_frame>
        <population>Treatment conditions were combined because the ICER outcome is a measure of the economic benefit of the BP+FI intervention relative to the BP comparator.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Best Practices and Best Practices Plus Financial Incentives</title>
            <description>Best practices: Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.</description>
          </group>
        </group_list>
        <measure>
          <title>Incremental Cost Effectiveness Ratio (ICER)</title>
          <description>A summary measure representing the economic value of an intervention (BP+FI) compared with an alternative (BP). The measure type used below is 'number' due to the fact that this measure is simply a ratio of mean dollars divided by mean years gained between the treatment conditions. Thus there was no alternative measure type that could be used or measure of dispersion available.</description>
          <population>Treatment conditions were combined because the ICER outcome is a measure of the economic benefit of the BP+FI intervention relative to the BP comparator.</population>
          <units>dollars per years gained</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Additional Birth Outcome: Mean Birth Weight</title>
        <description>Birth weight was obtained for each infant from the birth record and expressed in grams. We report the group mean and standard error for each treatment condition.</description>
        <time_frame>at delivery</time_frame>
        <population>Birth outcomes were obtained for 88, 76, and 79 infants of mothers in best practices, best practices plus financial incentives, and never-smokers.</population>
        <group_list>
          <group group_id="O1">
            <title>Best Practices for Pregnant Smokers</title>
            <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
          </group>
          <group group_id="O2">
            <title>Best Practices Plus Financial Incentives</title>
            <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
          </group>
          <group group_id="O3">
            <title>Never-smoker Comparison Condition</title>
            <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Birth Outcome: Mean Birth Weight</title>
          <description>Birth weight was obtained for each infant from the birth record and expressed in grams. We report the group mean and standard error for each treatment condition.</description>
          <population>Birth outcomes were obtained for 88, 76, and 79 infants of mothers in best practices, best practices plus financial incentives, and never-smokers.</population>
          <units>weight (grams)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3176.39" spread="46.74"/>
                    <measurement group_id="O2" value="3214.84" spread="50.11"/>
                    <measurement group_id="O3" value="3391.14" spread="49.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>ANCOVA</method>
            <method_desc>All comparisons adjusted for infant gestational age at time of delivery.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On average women were followed for 1 year, 6 months (end of 1st trimester of pregnancy through 1 year postpartum).</time_frame>
      <desc>We report the number of instances of pregnancy termination/fetal demise per treatment condition.</desc>
      <group_list>
        <group group_id="E1">
          <title>Best Practices for Pregnant Smokers</title>
          <description>Five As plus referral to pregnancy-specific tobacco quit line&#xD;
Best practices</description>
        </group>
        <group group_id="E2">
          <title>Best Practices Plus Financial Incentives</title>
          <description>Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.&#xD;
Best practices&#xD;
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence</description>
        </group>
        <group group_id="E3">
          <title>Never-smoker Comparison Condition</title>
          <description>We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy termination/fetal demise</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="81"/>
              </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>
    <point_of_contact>
      <name_or_title>Stephen T. Higgins</name_or_title>
      <organization>University of Vermont</organization>
      <phone>802-735-6267</phone>
      <email>stephen.higgins@uvm.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/NCT02210832
org study id: 1R01HD075669-01
secondary id: R01HD075669-01
nct id: NCT02210832
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Investigators will examine whether adding financial incentives to current best practices for
      smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a
      telephone quit line) increases cessation rates and improves infant health. While more
      expensive upfront compared to best practices alone, the investigators hypothesize that this
      treatment approach will be economically justified by the later cost savings associated with
      more women quitting, having healthier babies, and needing less healthcare. It should also
      help to reduce the greater risk for health problems often seen among those who less well off
      economically.
Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the
      U.S. Most pregnant smokers continue smoking through pregnancy producing serious immediate and
      longer-term adverse health consequences for the infant. Smoking during pregnancy is highly
      associated with economic disadvantage and a substantive contributor to health disparities.

      Efficacious interventions are available, but cessation rates are low (<20%) and improvements
      in birth outcomes often modest or absent. Current treatments usually entail relatively brief,
      lower-cost interventions (e.g., pregnancy specific quit lines). There is broad consensus that
      more effective interventions are sorely needed. This team of investigators has developed a
      novel behavioral economic intervention in which women earn financial incentives contingent on
      smoking abstinence. In a metaanalysis of treatments for smoking during pregnancy, effect
      sizes achieved with financial incentives were several fold larger than those achieved with
      lower intensity approaches or medications. The intervention also appears to improve birth
      outcomes and increase breastfeeding duration. While highly promising, further research is
      needed in at least three areas. (1) The evidence on birth outcomes and breastfeeding is from
      studies that combined data across trials rather than a single prospective trial, (2) whether
      the intervention produces other postpartum improvements in health has not been investigated,
      and (3) the overall cost-effectiveness of this approach has not been examined.

      To examine these unanswered questions, the investigators are proposing a randomized,
      controlled clinical trial comparing the efficacy and cost effectiveness through one year
      postpartum of current best practices for smoking cessation during pregnancy vs. best
      practices plus financial incentives among 230 pregnant, Medicaid recipients. A third
      condition of 115 pregnant nonsmokers matched to the smokers on sociodemographic and health
      conditions will be included as well to compare the extent to which the treatments reduce the
      burden of smoking and to estimate how much more might be accomplished by further improvements
      in this incentives intervention without exceeding cost-effectiveness.

      The investigators hypothesize that best practices plus financial incentives will be more
      effective than usual care practices alone, that the incentives intervention will be cost
      effective, and that while adding the incentives reduces a greater proportion of the health
      and economic burden of smoking than best practices alone, more can be done while remaining
      cost effective.

      Overall, the proposed study has the potential to substantially advance knowledge on
      cost-effective smoking cessation for pregnant women. Importantly, because of the strong
      association between smoking during pregnancy and economic disadvantage, the proposed study
      also has the potential to contribute new knowledge relevant to reducing the serious
      challenges of health disparities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment
time frame: collected once per women at approximately 28-weeks gestation in each of the two smoking arms
description: Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing
measure: 7-day Point Prevalence Abstinence Postpartum
time frame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
description: Compare two treatment arms on 7-day point-prevalence abstinence assessed at 2-, 4-, 8-, 12-, 24- and 48-weeks postpartum. Abstinence was defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing
measure: Breastfeeding in the Three Trial Arms
time frame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
description: Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments
measure: Breastfeeding While Abstinent From Smoking
time frame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
description: We compared the three trial arms on the percent of women who reported breastfeeding and were biochemically confirmed to be abstinent from smoking at each postpartum assessment.
measure: Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
time frame: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
description: The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.
measure: Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
time frame: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
description: Reporting mean total scores and SEM from the Minnesota Nicotine Withdrawal Scale (MNWS). Total score is an average of 7 items, with each item on a 0 (none) to 4 (severe) scale.
measure: Infant Growth in First Year of Life
time frame: delivery, 24-week, and 50-week postpartum assessments
description: Infant growth (length & weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.
measure: Birth Outcomes (% Small for Gestational Age Deliveries)
time frame: delivery
description: Birth outcomes were compared between the three study arms. Small for gestational age was defined as <10th percentile using INTERGROWTH-21st [2021] https://intergrowth21.tghn.org/about/about-us/.
measure: Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)
time frame: at delivery
description: Compared the three trials conditions on preterm deliveries.
measure: Birth Outcomes (NICU Admissions)
time frame: at delivery
description: Compared three trial conditions on percent of NICU admissions
measure: Ages & Stages Questionnaire (ASQ)
time frame: 24- and 48-weeks postpartum
description: The ASQ assesses infant development in five areas (communication [Comm], gross motor [GM], fine motor [FM], problem solving [PrbSlv], personal-social [PerSoc]); Each area includes six items, each with a possible value of 0, 5, 10, along with a cutoff to dichotomize infants into typical/normal vs. monitor/potential delay categories for an area. Scores in each area are compared to norms; scores with 1 standard deviation of the norm mean are categorized as typical/normal and those greater than one standard deviation below the norm mean are categorized as monitor/potential delay. We report the dichotomized outcomes for each of the six areas at the 24-week and 48-week assessments noting the number of infants in each treatment condition in the monitor/potential delay category.
measure: Birth Outcome: Gestational Age at Delivery
time frame: at delivery
description: Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.
measure: Cost Per Participant
time frame: Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).
description: Cost per participant for BP+FI and BP interventions. These costs per participant are used in calculation of the Incremental Cost Effectiveness Ratio (ICER). This ICER measure is the added healthcare sector cost per participant for BP+FI compared to BP relative to estimated net health gain per participant (QALY). Maternal net health gains in QALYs from cessation difference between treatment conditions at 24 weeks postpartum were based on Stapleton & West, 2012, Nicotine Tob Res; 14: 463-71.
measure: Quality of Life Years Gained (QALYs)
time frame: 24 weeks postpartum
description: Smoking abstinence at the 24-week assessment was converted into quality of life years gained using standardized tables reported in Stapleton & West, 2012, Nicotine Tob Res; 14: 463-71.
measure: Incremental Cost Effectiveness Ratio (ICER)
time frame: 24 weeks postpartum
description: A summary measure representing the economic value of an intervention (BP+FI) compared with an alternative (BP). The measure type used below is 'number' due to the fact that this measure is simply a ratio of mean dollars divided by mean years gained between the treatment conditions. Thus there was no alternative measure type that could be used or measure of dispersion available.
measure: Additional Birth Outcome: Mean Birth Weight
time frame: at delivery
description: Birth weight was obtained for each infant from the birth record and expressed in grams. We report the group mean and standard error for each treatment condition.
arm group label: Best practices for pregnant smokers
arm group type: Experimental
description: Five As plus referral to pregnancy-specific tobacco quit line
arm group label: Best practices plus financial incentives
arm group type: Experimental
description: Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
arm group label: Never-smoker comparison condition
arm group type: No Intervention
description: We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
intervention type: Behavioral
intervention name: Best practices
arm group label: Best practices for pregnant smokers
arm group label: Best practices plus financial incentives
other name: Five As plus referral to pregnancy-specific quit line
intervention type: Behavioral
intervention name: financial incentives
description: financial incentives provided contingent on biochemically confirmed smoking abstinence
arm group label: Best practices plus financial incentives
other name: contingency management
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen T Higgins, PhD
role: Principal Investigator
affiliation: University of Vermont
facility: 
country: United States
citation: Higgins ST, Washio Y, Heil SH, Solomon LJ, Gaalema DE, Higgins TM, Bernstein IM. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med. 2012 Nov;55 Suppl(Suppl):S33-40. doi: 10.1016/j.ypmed.2011.12.016. Epub 2011 Dec 27.
PMID: 22227223
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Stephen T. Higgins, PhD
investigator title: Professor of Psychiatry and Psychology
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 