<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/NCT03265665</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0466</org_study_id>
    <secondary_id>K01HL133370</secondary_id>
    <nct_id>NCT03265665</nct_id>
  </id_info>
  <brief_title>physicAl aCtiviTy In minOrity womeN With Asthma Intervention</brief_title>
  <acronym>ACTION</acronym>
  <official_title>ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle&#xD;
      physical activity intervention refined to be applicable for sedentary African American (AA)&#xD;
      women with asthma. The main outcome of this study is to test the feasibility, acceptability&#xD;
      and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80&#xD;
      AA women with asthma within a pragmatic community setting at 24-weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is a highly prevalent chronic disease that disproportionately impacts African American&#xD;
      (AA) women. AA women have poorer asthma-related quality of life and higher rates of asthma&#xD;
      exacerbations, healthcare utilization and mortality compared to Caucasian women. Further, AA&#xD;
      women are less physically active than any other subgroup of adults, which may help explain&#xD;
      the asthma health disparities, found between AA and Caucasian women. Physical inactivity&#xD;
      among individuals with asthma is associated with poor asthma control and respiratory&#xD;
      function, greater health care utilization, and poorer quality of life. Given the connection&#xD;
      between poor asthma outcomes and physical inactivity, addressing physical activity (PA) among&#xD;
      sedentary AA women with asthma is imperative. Physical activity demonstrated improvement in&#xD;
      asthma outcomes specifically asthma control, quality of life and healthcare utilization.&#xD;
      Despite these benefits, fewer than 25% of AA women with asthma engage in regular physical&#xD;
      activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a&#xD;
      lifestyle PA intervention refined to be applicable for sedentary AA women with asthma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 15, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Intervention-Recruitment</measure>
    <time_frame>24 weeks</time_frame>
    <description>The total number of participants recruited and consented in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Intervention-Withdrawals</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of participants that withdrew from the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Lifestyle PA Intervention</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of participants that completed 24-week outcomes assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Lifestyle PA Intervention</measure>
    <time_frame>24-weeks</time_frame>
    <description>Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Lifestyle PA Intervention-Qualitative Data</measure>
    <time_frame>24-weeks</time_frame>
    <description>Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Light Physical Activity Levels</measure>
    <time_frame>24 weeks</time_frame>
    <description>as measured by accelerometer and using proprietary Actilife software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Quality of Life Questionnaire (AQLQ)</measure>
    <time_frame>24 weeks</time_frame>
    <description>The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Questionnaire (ACQ-6)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Step Counts</measure>
    <time_frame>24 weeks</time_frame>
    <description>as measured by accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderate Physical Activity Levels</measure>
    <time_frame>24 weeks</time_frame>
    <description>as measured by accelerometer and using proprietary Actilife software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vigorous Physical Activity Levels</measure>
    <time_frame>24 weeks</time_frame>
    <description>as measured by accelerometer and using proprietary Actilife software</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>ACTION Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACTION Intervention</intervention_name>
    <description>The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
    <arm_group_label>ACTION Intervention</arm_group_label>
    <other_name>Group sessions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced usual care</intervention_name>
    <description>Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
    <arm_group_label>Enhanced usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identify as female and black or AA&#xD;
&#xD;
          -  Age 18-70&#xD;
&#xD;
          -  Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT &lt;20)&#xD;
&#xD;
          -  Wiling to enroll and provide written-informed consent&#xD;
&#xD;
          -  Willing to be randomly assigned to treatment or control group&#xD;
&#xD;
        Exclusion Criteria: • Plans to relocate outside of the Chicagoland area during the study&#xD;
        period.&#xD;
&#xD;
          -  Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)&#xD;
&#xD;
          -  History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)&#xD;
&#xD;
          -  Currently pregnant, planning to become pregnant over the next 3 months&#xD;
&#xD;
          -  Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of&#xD;
             doctor diagnosis or smoking history (&gt;20 pack years)&#xD;
&#xD;
          -  Poorly controlled high blood pressure (BP &gt;180/100 at baseline visit)&#xD;
&#xD;
          -  Family/household member of another study participant or staff member&#xD;
&#xD;
          -  Inability to speak, read or understand English;&#xD;
&#xD;
          -  Investigator discretion for safety or protocol adherence reasons&#xD;
&#xD;
          -  Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The focus population for this study is sedentary African-American (AA) women with asthma. All participants included in the study will self-identify themselves as female and AA. This study population was chosen as AA women are disproportionately impacted by physical inactivity and asthma compared to Caucasian men and women and AA men.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharmilee M Nyenhuis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois Hospital and Health Sciences System</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>December 18, 2021</results_first_submitted>
  <results_first_submitted_qc>February 18, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2022</results_first_posted>
  <last_update_submitted>February 18, 2022</last_update_submitted>
  <last_update_submitted_qc>February 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Sharmilee Nyenhuis</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>walking</keyword>
  <keyword>African American women</keyword>
  <keyword>lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_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>April 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03265665/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ACTION Intervention</title>
          <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
        </group>
        <group group_id="P2">
          <title>Enhanced Usual Care</title>
          <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>24-week Data Collection</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>36-week Data Collection</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23">Used the number of participants that did not withdraw from the study. If a participant did not complete the 24 week week data collection, they were still allowed to complete the 36-week data collection. Thus the number we started with for this period was the total number of participants in each group that did not withdraw from the study.</participants>
                <participants group_id="P2" count="26">Used the number of participants that did not withdraw from the study. If a participant did not complete the 24 week week data collection, they were still allowed to complete the 36-week data collection. Thus the number we started with for this period was the total number of participants in each group that did not withdraw from the study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ACTION Intervention</title>
          <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
        </group>
        <group group_id="B2">
          <title>Enhanced Usual Care</title>
          <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</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="25"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="53"/>
          </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="42.87" spread="11"/>
                    <measurement group_id="B2" value="43.84" spread="14"/>
                    <measurement group_id="B3" value="43.38" spread="12"/>
                  </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="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>More than one race</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>Unknown or Not Reported</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>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.97" spread="7"/>
                    <measurement group_id="B2" value="36.86" spread="12"/>
                    <measurement group_id="B3" value="36.44" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household Income (&lt;$30,000/year)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance status (medicare/medicaid/medical assistance)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital status (Single/divorced/widowed)</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="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced Expiratory Volume in 1 second</title>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.06" spread="0.68"/>
                    <measurement group_id="B2" value="2.04" spread="0.58"/>
                    <measurement group_id="B3" value="2.04" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced Expiratory Volume in 1 second % predicted</title>
          <units>% predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.64" spread="29"/>
                    <measurement group_id="B2" value="66.85" spread="24"/>
                    <measurement group_id="B3" value="62.74" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Unscheduled office visits in past 6 mo (Yes)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Emergency Department visit(s) in the past 6 mo (yes)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma control Questionnaire(ACQ-6)</title>
          <description>Asthma control questionnaire (ACQ): The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 7-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.</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="1.69" spread="0.98"/>
                    <measurement group_id="B2" value="1.83" spread="0.86"/>
                    <measurement group_id="B3" value="1.76" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma quality of life (AQLQ)</title>
          <description>The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. Total score is shown here as subdomains were not analyzed.</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="4.66" spread="1.2"/>
                    <measurement group_id="B2" value="4.6" spread="0.91"/>
                    <measurement group_id="B3" value="4.63" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daily steps</title>
          <units>steps/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4737.97" spread="1726.55"/>
                    <measurement group_id="B2" value="4958.94" spread="2241.91"/>
                    <measurement group_id="B3" value="4853.98" spread="1991.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Light Physical Activity</title>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="576.86" spread="59.92"/>
                    <measurement group_id="B2" value="272.77" spread="62.01"/>
                    <measurement group_id="B3" value="274.17" spread="70.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Moderate Physical Activity</title>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.78" spread="18.30"/>
                    <measurement group_id="B2" value="16.67" spread="16.56"/>
                    <measurement group_id="B3" value="16.23" spread="16.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vigorous Physical Activity</title>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.63" spread="2.48"/>
                    <measurement group_id="B2" value="0.19" spread="0.76"/>
                    <measurement group_id="B3" value="0.34" spread="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of Intervention-Recruitment</title>
        <description>The total number of participants recruited and consented in the study.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Screen Participants</title>
            <description>This is the number of participants that were screened for eligibility in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Intervention-Recruitment</title>
          <description>The total number of participants recruited and consented in the study.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of Intervention-Withdrawals</title>
        <description>Number of participants that withdrew from the study</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Intervention-Withdrawals</title>
          <description>Number of participants that withdrew from the study</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="25"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of Lifestyle PA Intervention</title>
        <description>Number of participants that completed 24-week outcomes assessment</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Lifestyle PA Intervention</title>
          <description>Number of participants that completed 24-week outcomes assessment</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="23"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of Lifestyle PA Intervention</title>
        <description>Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.</description>
        <time_frame>24-weeks</time_frame>
        <population>Acceptability of the intervention was measured in only intervention participants</population>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of Lifestyle PA Intervention</title>
          <description>Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.</description>
          <population>Acceptability of the intervention was measured in only intervention participants</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.88" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of Lifestyle PA Intervention-Qualitative Data</title>
        <description>Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.</description>
        <time_frame>24-weeks</time_frame>
        <population>Intervention satisfaction was only collected in those randomized to intervention group.It is not possible to summarize the data collected from the open-ended questions in tabular form.</population>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of Lifestyle PA Intervention-Qualitative Data</title>
          <description>Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.</description>
          <population>Intervention satisfaction was only collected in those randomized to intervention group.It is not possible to summarize the data collected from the open-ended questions in tabular form.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Light Physical Activity Levels</title>
        <description>as measured by accelerometer and using proprietary Actilife software</description>
        <time_frame>24 weeks</time_frame>
        <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Light Physical Activity Levels</title>
          <description>as measured by accelerometer and using proprietary Actilife software</description>
          <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
          <units>minutes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="567.13" spread="79.99"/>
                    <measurement group_id="O2" value="278.66" spread="89.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma Quality of Life Questionnaire (AQLQ)</title>
        <description>The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Quality of Life Questionnaire (AQLQ)</title>
          <description>The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.24" spread="1.35"/>
                    <measurement group_id="O2" value="4.70" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma Control Questionnaire (ACQ-6)</title>
        <description>Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Control Questionnaire (ACQ-6)</title>
          <description>Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="1.03"/>
                    <measurement group_id="O2" value="1.87" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daily Step Counts</title>
        <description>as measured by accelerometer</description>
        <time_frame>24 weeks</time_frame>
        <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Step Counts</title>
          <description>as measured by accelerometer</description>
          <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
          <units>steps/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4372.73" spread="1884.90"/>
                    <measurement group_id="O2" value="5196.32" spread="1763.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Moderate Physical Activity Levels</title>
        <description>as measured by accelerometer and using proprietary Actilife software</description>
        <time_frame>24 weeks</time_frame>
        <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Moderate Physical Activity Levels</title>
          <description>as measured by accelerometer and using proprietary Actilife software</description>
          <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
          <units>minutes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.63" spread="23.67"/>
                    <measurement group_id="O2" value="18.07" spread="13.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vigorous Physical Activity Levels</title>
        <description>as measured by accelerometer and using proprietary Actilife software</description>
        <time_frame>24 weeks</time_frame>
        <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
        <group_list>
          <group group_id="O1">
            <title>ACTION Intervention</title>
            <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Usual Care</title>
            <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Vigorous Physical Activity Levels</title>
          <description>as measured by accelerometer and using proprietary Actilife software</description>
          <population>The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).</population>
          <units>minutes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="1.28"/>
                    <measurement group_id="O2" value="1.14" spread="3.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>36 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ACTION Intervention</title>
          <description>Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.&#xD;
ACTION Intervention: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</description>
        </group>
        <group group_id="E2">
          <title>Enhanced Usual Care</title>
          <description>Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.&#xD;
Enhanced usual care: Participants will attend 1 two hour asthma education/physical activity session. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants will receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.&#xD;
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>skin rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </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>Dr. Sharmilee Nyenhuis</name_or_title>
      <organization>University of Illinois at Chicago</organization>
      <phone>3124131655</phone>
      <email>snyenhui@uic.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/NCT03265665
org study id: 2016-0466
secondary id: K01HL133370
nct id: NCT03265665
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle
      physical activity intervention refined to be applicable for sedentary African American (AA)
      women with asthma. The main outcome of this study is to test the feasibility, acceptability
      and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80
      AA women with asthma within a pragmatic community setting at 24-weeks.
Asthma is a highly prevalent chronic disease that disproportionately impacts African American
      (AA) women. AA women have poorer asthma-related quality of life and higher rates of asthma
      exacerbations, healthcare utilization and mortality compared to Caucasian women. Further, AA
      women are less physically active than any other subgroup of adults, which may help explain
      the asthma health disparities, found between AA and Caucasian women. Physical inactivity
      among individuals with asthma is associated with poor asthma control and respiratory
      function, greater health care utilization, and poorer quality of life. Given the connection
      between poor asthma outcomes and physical inactivity, addressing physical activity (PA) among
      sedentary AA women with asthma is imperative. Physical activity demonstrated improvement in
      asthma outcomes specifically asthma control, quality of life and healthcare utilization.
      Despite these benefits, fewer than 25% of AA women with asthma engage in regular physical
      activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a
      lifestyle PA intervention refined to be applicable for sedentary AA women with asthma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Feasibility of Intervention-Recruitment
time frame: 24 weeks
description: The total number of participants recruited and consented in the study.
measure: Feasibility of Intervention-Withdrawals
time frame: 24 weeks
description: Number of participants that withdrew from the study
measure: Feasibility of Lifestyle PA Intervention
time frame: 24 weeks
description: Number of participants that completed 24-week outcomes assessment
measure: Acceptability of Lifestyle PA Intervention
time frame: 24-weeks
description: Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.
measure: Acceptability of Lifestyle PA Intervention-Qualitative Data
time frame: 24-weeks
description: Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.
measure: Light Physical Activity Levels
time frame: 24 weeks
description: as measured by accelerometer and using proprietary Actilife software
measure: Asthma Quality of Life Questionnaire (AQLQ)
time frame: 24 weeks
description: The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.
measure: Asthma Control Questionnaire (ACQ-6)
time frame: 24 weeks
description: Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.
measure: Daily Step Counts
time frame: 24 weeks
description: as measured by accelerometer
measure: Moderate Physical Activity Levels
time frame: 24 weeks
description: as measured by accelerometer and using proprietary Actilife software
measure: Vigorous Physical Activity Levels
time frame: 24 weeks
description: as measured by accelerometer and using proprietary Actilife software
arm group label: ACTION Intervention
arm group type: Experimental
description: Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.
arm group label: Enhanced usual care
arm group type: Other
description: Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.
intervention type: Behavioral
intervention name: ACTION Intervention
description: The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.
arm group label: ACTION Intervention
other name: Group sessions
intervention type: Other
intervention name: Enhanced usual care
description: Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.
arm group label: Enhanced usual care
criteria: 
gender: Female
gender based: Yes
gender description: The focus population for this study is sedentary African-American (AA) women with asthma. All participants included in the study will self-identify themselves as female and AA. This study population was chosen as AA women are disproportionately impacted by physical inactivity and asthma compared to Caucasian men and women and AA men.
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sharmilee M Nyenhuis, MD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Sharmilee Nyenhuis
investigator title: Associate Professor of Medicine
mesh term: Asthma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 