<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/NCT02237898</url>
  </required_header>
  <id_info>
    <org_study_id>1407014326</org_study_id>
    <secondary_id>5R01CA195654</secondary_id>
    <nct_id>NCT02237898</nct_id>
  </id_info>
  <brief_title>Harnessing the Power of Technology: MOMBA for Postpartum Smoking</brief_title>
  <official_title>SCH: INT: Harnessing the Power of Technology: MOMBA for Postpartum Smoking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Through a smartphone platform, financial incentives for smoking abstinence in postpartum&#xD;
      women can be delivered remotely, thus minimizing the need for participants to come to the&#xD;
      office to receive traditional contingency management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of the proposal are:&#xD;
&#xD;
        1. To develop through a 15-month pilot study, a novel smartphone-based system, Momba&#xD;
           Smoking, that can be used in further relapse prevention trials for postpartum smokers.&#xD;
&#xD;
        2. To determine, through a pilot randomized controlled trial, the potential feasibility,&#xD;
           acceptability, and methodological parameters that are necessary to design a subsequent,&#xD;
           appropriately powered, randomized controlled trial of the Momba Smoking smartphone-based&#xD;
           system.&#xD;
&#xD;
        3. To advance discovery and understanding on the use of technology to translate smoking&#xD;
           cessation interventions from clinical to community settings through the training of the&#xD;
           next generation of scientists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">May 13, 2019</completion_date>
  <primary_completion_date type="Actual">May 13, 2019</primary_completion_date>
  <phase>Phase 1</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>Acceptability</measure>
    <time_frame>3 and 9 months</time_frame>
    <description>Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend.&#xD;
Question: &quot;How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enrollment Rate</measure>
    <time_frame>15 months</time_frame>
    <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of &gt; 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Remote Detection</measure>
    <time_frame>15 months</time_frame>
    <description>Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention: Number of Participants Remaining in Study at 12 Weeks</measure>
    <time_frame>15 months</time_frame>
    <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visit Attendance / Challenge Completion</measure>
    <time_frame>15 months</time_frame>
    <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance.&#xD;
MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks.&#xD;
Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Short Term Abstinence From Smoking</measure>
    <time_frame>3 months</time_frame>
    <description>Secondary outcome - Short term abstinence from smoking. Immediate smoking prevalence as determined by # of negative breath tests and self-reports; the pilot will also utilize urine tests to measure negative cotinine levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up</measure>
    <time_frame>9 months</time_frame>
    <description>Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up</measure>
    <time_frame>15 months</time_frame>
    <description>Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>MoMba Contingency Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study will provide access to the web-based MoMba Live Long application &amp; Sensodrone™ carbon-monoxide sensor for purposes of researching the acceptability of the smartphone application, operating and functioning of it, and providing remote contingency management for smoking cessation to postpartum women.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Office contingency management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MoMba Live Long app &amp; Sensordrone™ carbon-monoxide sensor</intervention_name>
    <description>MoMba Live Long application &amp; Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely</description>
    <arm_group_label>MoMba Contingency Management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Office contingency management</intervention_name>
    <description>A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.</description>
    <arm_group_label>Office contingency management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sensordrone™ carbon-monoxide sensor</intervention_name>
    <description>A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.</description>
    <arm_group_label>MoMba Contingency Management</arm_group_label>
    <arm_group_label>Office contingency management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MoMba Live Long Smartphone application</intervention_name>
    <description>The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.</description>
    <arm_group_label>MoMba Contingency Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are over the age of 18&#xD;
&#xD;
          -  Speak English&#xD;
&#xD;
          -  Second or third trimester of pregnancy&#xD;
&#xD;
          -  Smoking in the third trimester of pregnancy&#xD;
&#xD;
          -  No complicating general medical or psychiatric conditions (including marijuana use).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving other smoking cessation medication&#xD;
&#xD;
          -  Planning to move out of New Haven in the next 15 months&#xD;
&#xD;
          -  Actively suicidal, psychotic or unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan V Smith, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>March 10, 2020</results_first_submitted>
  <results_first_submitted_qc>May 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 21, 2020</results_first_posted>
  <last_update_submitted>May 8, 2020</last_update_submitted>
  <last_update_submitted_qc>May 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco cessation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carbon Monoxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT02237898/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MoMba Contingency Management</title>
          <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
        </group>
        <group group_id="P2">
          <title>Office Contingency Management</title>
          <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 12 Weeks of CM</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 3 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 9 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 15 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MoMba Contingency Management</title>
          <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
        </group>
        <group group_id="B2">
          <title>Office Contingency Management</title>
          <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.08" spread="6.17"/>
                    <measurement group_id="B2" value="28.93" spread="5.54"/>
                    <measurement group_id="B3" value="29.92" spread="5.82"/>
                  </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="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race / Ethnicity</title>
              <category_list>
                <category>
                  <title>White, non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American, Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White, Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American, Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerstrom Test for Nicotine Dependence</title>
          <description>Score ranging from 0-10, higher score indicates more nicotine dependence.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.58" spread="2.02"/>
                    <measurement group_id="B2" value="4.07" spread="2.06"/>
                    <measurement group_id="B3" value="3.85" spread="2.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number Cigarettes Per Day in Past Month</title>
          <description>The question asked to the participant was &quot;How many tobacco cigarettes a day have you smoked on average during the last month?&quot; One measure was collected from this question &quot;the average number of cigarettes smoked per day during the last month&quot; per participant. This &quot;average number of cigarettes smoked per day during the last month&quot; was presented in the description.</description>
          <units>cigarettes / day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7" lower_limit="5" upper_limit="10"/>
                    <measurement group_id="B2" value="7" lower_limit="4" upper_limit="20"/>
                    <measurement group_id="B3" value="7" lower_limit="5" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of cigarettes smoked in past 7 days</title>
          <description>The number of cigarettes smoked in the past 7 days was collected through the self-report timeline follow-back. The average number of cigarettes smoked per day in the past 7 days was calculated as the sum of number of cigarettes smoked per day divided by 7.</description>
          <units>cigarettes / day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" lower_limit="4.8" upper_limit="8.5"/>
                    <measurement group_id="B2" value="5.5" lower_limit="3" upper_limit="8"/>
                    <measurement group_id="B3" value="6" lower_limit="4" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acceptability</title>
        <description>Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend.&#xD;
Question: &quot;How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?&quot;</description>
        <time_frame>3 and 9 months</time_frame>
        <population>This measure was assessed at the 3 and 9 month follow-up assessment. Not all participants who were enrolled completed these assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>MoMba Contingency Management</title>
            <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
          </group>
          <group group_id="O2">
            <title>Office Contingency Management</title>
            <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability</title>
          <description>Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend.&#xD;
Question: &quot;How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?&quot;</description>
          <population>This measure was assessed at the 3 and 9 month follow-up assessment. Not all participants who were enrolled completed these assessments.</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="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 month follow-up assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Highly Unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Likely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly Likely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-month follow-up assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Highly Unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Likely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly Likely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Enrollment Rate</title>
        <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of &gt; 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake.</description>
        <time_frame>15 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Eligible From Screening</title>
            <description>Women who were eligible for participation in the study from screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Enrollment Rate</title>
          <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of &gt; 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Remote Detection</title>
        <description>Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments.</description>
        <time_frame>15 months</time_frame>
        <population>The correlation between the piCO+™, Sensordrone™ and urine cotinine levels are considered and the unit analyzed is a visit, data collected during the first week of office visits and at follow-up assessments. Of participants enrolled, 4 participants who completed a baseline did not attend week 1 and thus didn't contribute any data to this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>MoMba Contingency Management</title>
            <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
          </group>
          <group group_id="O2">
            <title>Office Contingency Management</title>
            <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
          </group>
        </group_list>
        <measure>
          <title>Remote Detection</title>
          <description>Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments.</description>
          <population>The correlation between the piCO+™, Sensordrone™ and urine cotinine levels are considered and the unit analyzed is a visit, data collected during the first week of office visits and at follow-up assessments. Of participants enrolled, 4 participants who completed a baseline did not attend week 1 and thus didn't contribute any data to this analysis.</population>
          <units>correlation</units>
          <param>Number</param>
          <units_analyzed>Unique visits</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Unique visits</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensordrone and Pico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93"/>
                    <measurement group_id="O2" value="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensordrone and Urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76"/>
                    <measurement group_id="O2" value="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pico and Urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81"/>
                    <measurement group_id="O2" value="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Retention: Number of Participants Remaining in Study at 12 Weeks</title>
        <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks).</description>
        <time_frame>15 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MoMba Contingency Management</title>
            <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
          </group>
          <group group_id="O2">
            <title>Office Contingency Management</title>
            <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention: Number of Participants Remaining in Study at 12 Weeks</title>
          <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks).</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="12"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visit Attendance / Challenge Completion</title>
        <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance.&#xD;
MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks.&#xD;
Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks.</description>
        <time_frame>15 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MoMba Contingency Management</title>
            <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process..&#xD;
Most breath tests will be completed remotely.</description>
          </group>
          <group group_id="O2">
            <title>Office Contingency Management</title>
            <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
          </group>
        </group_list>
        <measure>
          <title>Visit Attendance / Challenge Completion</title>
          <description>Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance.&#xD;
MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks.&#xD;
Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks.</description>
          <units>breath tests</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="15" upper_limit="22"/>
                    <measurement group_id="O2" value="21.5" lower_limit="20" upper_limit="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_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Short Term Abstinence From Smoking</title>
        <description>Secondary outcome - Short term abstinence from smoking. Immediate smoking prevalence as determined by # of negative breath tests and self-reports; the pilot will also utilize urine tests to measure negative cotinine levels.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MoMba Contingency Management</title>
            <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
          </group>
          <group group_id="O2">
            <title>Office Contingency Management</title>
            <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Short Term Abstinence From Smoking</title>
          <description>Secondary outcome - Short term abstinence from smoking. Immediate smoking prevalence as determined by # of negative breath tests and self-reports; the pilot will also utilize urine tests to measure negative cotinine levels.</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="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of negative breath tests using Sensordrone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of negative breath tests using piCO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-report (no smoking cigs in past 7 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine test (&lt;50ng)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up</title>
        <description>Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MoMba Contingency Management</title>
            <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
          </group>
          <group group_id="O2">
            <title>Office Contingency Management</title>
            <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up</title>
          <description>Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.</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="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of negative breath tests using Sensordrone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of negative breath tests using the piCO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last 7 days no smoking (from timeline followback)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up</title>
        <description>Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.</description>
        <time_frame>15 months</time_frame>
        <population>In the intervention group only 7/8 participants had data for the timeline follow back.</population>
        <group_list>
          <group group_id="O1">
            <title>MoMba Contingency Management</title>
            <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
          </group>
          <group group_id="O2">
            <title>Office Contingency Management</title>
            <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up</title>
          <description>Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.</description>
          <population>In the intervention group only 7/8 participants had data for the timeline follow back.</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="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of negative breath tests using Sensordrone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of negative breath tests using the piCO</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last 7 days no smoking (from timeline followback)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data on adverse events were collected during the course of the study (enrollment until the last follow-up at 15 months).</time_frame>
      <desc>The definition does not differ.&#xD;
Methods for reporting adverse events: Any serious, unanticipated and related adverse events or unanticipated problems involving risks to subjects or others will be reported in writing within 48 hours to the HIC and any appropriate funding and regulatory agencies. Fellow investigators and study personnel will be informed through regular study meetings and study sponsors will be informed within 5 days of the event becoming known to the principal investigator.</desc>
      <group_list>
        <group group_id="E1">
          <title>MoMba Contingency Management</title>
          <description>MoMba Contingency Management arm accesses the web-based MoMba Live Long application &amp; Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation.&#xD;
The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm).&#xD;
The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process.&#xD;
Most breath tests will be completed remotely.</description>
        </group>
        <group group_id="E2">
          <title>Office Contingency Management</title>
          <description>The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™.&#xD;
Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.&#xD;
Control participants will not have access to the MoMba Live Long app.</description>
        </group>
      </group_list>
      <serious_events>
        <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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Megan Smith</name_or_title>
      <organization>Yale School of Medicine</organization>
      <phone>(203) 764-8655</phone>
      <email>megan.smith@yale.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/NCT02237898
org study id: 1407014326
secondary id: 5R01CA195654
nct id: NCT02237898
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Through a smartphone platform, financial incentives for smoking abstinence in postpartum
      women can be delivered remotely, thus minimizing the need for participants to come to the
      office to receive traditional contingency management.
The specific aims of the proposal are:

        1. To develop through a 15-month pilot study, a novel smartphone-based system, Momba
           Smoking, that can be used in further relapse prevention trials for postpartum smokers.

        2. To determine, through a pilot randomized controlled trial, the potential feasibility,
           acceptability, and methodological parameters that are necessary to design a subsequent,
           appropriately powered, randomized controlled trial of the Momba Smoking smartphone-based
           system.

        3. To advance discovery and understanding on the use of technology to translate smoking
           cessation interventions from clinical to community settings through the training of the
           next generation of scientists.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability
time frame: 3 and 9 months
description: Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend.
Question: "How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?"
measure: Enrollment Rate
time frame: 15 months
description: Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of > 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake.
measure: Remote Detection
time frame: 15 months
description: Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments.
measure: Retention: Number of Participants Remaining in Study at 12 Weeks
time frame: 15 months
description: Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks).
measure: Visit Attendance / Challenge Completion
time frame: 15 months
description: Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance.
MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks.
Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks.
measure: Number of Participants With Short Term Abstinence From Smoking
time frame: 3 months
description: Secondary outcome - Short term abstinence from smoking. Immediate smoking prevalence as determined by # of negative breath tests and self-reports; the pilot will also utilize urine tests to measure negative cotinine levels.
measure: Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up
time frame: 9 months
description: Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.
measure: Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up
time frame: 15 months
description: Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back.
arm group label: MoMba Contingency Management
arm group type: Experimental
description: Study will provide access to the web-based MoMba Live Long application & Sensodrone™ carbon-monoxide sensor for purposes of researching the acceptability of the smartphone application, operating and functioning of it, and providing remote contingency management for smoking cessation to postpartum women.
arm group label: Office contingency management
arm group type: Active Comparator
description: Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women
intervention type: Behavioral
intervention name: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor
description: MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely
arm group label: MoMba Contingency Management
intervention type: Behavioral
intervention name: Office contingency management
description: A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.
arm group label: Office contingency management
intervention type: Device
intervention name: Sensordrone™ carbon-monoxide sensor
description: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.
arm group label: MoMba Contingency Management
arm group label: Office contingency management
intervention type: Device
intervention name: MoMba Live Long Smartphone application
description: The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.
arm group label: MoMba Contingency Management
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Megan V Smith, DrPH
role: Principal Investigator
affiliation: Yale School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carbon Monoxide
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 