<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/NCT03291808</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00141509</org_study_id>
    <secondary_id>R34HL136755</secondary_id>
    <nct_id>NCT03291808</nct_id>
  </id_info>
  <brief_title>Pilot of Lifestyle and Asthma Intervention</brief_title>
  <acronym>PLAN</acronym>
  <official_title>Pilot of Lifestyle and Asthma Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Lung Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is to pilot test a weight loss intervention in obese patients with poorly controlled&#xD;
      asthma.&#xD;
&#xD;
      Obesity is a risk factor for the development of asthma (approximately 250,000 cases per year&#xD;
      of asthma in the U.S. are related to obesity).&#xD;
&#xD;
      Investigators' ultimate purpose is to test the hypothesis that weight loss through an&#xD;
      intensive life style intervention will improve asthma control. But investigators first need&#xD;
      to establish whether the weight loss intervention is effective in patients with asthma.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        1. The primary objective of this study is to determine the effectiveness of an&#xD;
           internet-based weight loss intervention in producing weight loss in obese patients with&#xD;
           poorly controlled asthma.&#xD;
&#xD;
        2. The ultimate purpose is to implement a multi-center weight loss intervention trial for&#xD;
           obese patients with poorly controlled asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a pilot study of a weight loss intervention at two centers, the University of&#xD;
      Arizona and the University of Vermont. The primary outcome of interest will be the percent of&#xD;
      participants achieving a 5% weight loss, which is the amount of weight loss that prior&#xD;
      studies suggest is required to improve asthma control.&#xD;
&#xD;
      This will be a single arm-phase II futility trial; the &quot;futility&quot; to be assessed is the&#xD;
      ability to produce weight loss. Such designs are widely used in efficiently informing&#xD;
      decisions to proceed to Phase III clinical trials. This trial design is appropriate when the&#xD;
      effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to&#xD;
      0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to&#xD;
      weight loss). This is a 6-month study of 40 participants (20 at each site). All participants&#xD;
      will be assigned to the weight loss intervention, which is described in detail below&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Weight loss intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss).18 Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight loss intervention</intervention_name>
    <description>This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly &quot;group meetings&quot; in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.</description>
    <arm_group_label>Weight loss intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physician diagnosis of asthma on regular prescribed controller therapy for at least 3&#xD;
             months&#xD;
&#xD;
          -  Age: ≥18 years of age&#xD;
&#xD;
          -  Obese: BMI &gt; 30 kg/m2&#xD;
&#xD;
          -  Poorly controlled asthma&#xD;
&#xD;
               -  Asthma Control Test Score &lt; 19,19,20 or&#xD;
&#xD;
               -  Use of rescue inhaler, on average, &gt; 2 uses/week for preceding month, or&#xD;
&#xD;
               -  Nocturnal asthma awakening, on average,1 or more times / week in preceding month,&#xD;
                  or&#xD;
&#xD;
               -  Emergency Department (ED)/hospital visit or prednisone course for asthma in past&#xD;
                  six months&#xD;
&#xD;
          -  Ability and willingness to provide informed consent&#xD;
&#xD;
          -  Ability to access internet weight loss program for trial period&#xD;
&#xD;
          -  Completion of asthma diary cards and weight loss diary cards for same 3 consecutive&#xD;
             days at visit 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of bariatric surgery&#xD;
&#xD;
          -  Any condition that puts the participant at risk from participation in a weight loss&#xD;
             study or a condition that precludes participation in regular exercise as judged by the&#xD;
             site physician.&#xD;
&#xD;
          -  Pregnancy (by patient self-report)&#xD;
&#xD;
          -  Participation in another weight loss intervention within the last month&#xD;
&#xD;
          -  Weight loss of ≥ 10 pounds in the last 6 months by self-report&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Dixon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Wise, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janet Holbrook, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://medlineplus.gov/asthma.html</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>May 12, 2022</results_first_submitted>
  <results_first_submitted_qc>August 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2022</results_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Asthma</keyword>
  <keyword>Weight loss</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>March 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03291808/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03291808/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Forty-three were enrolled in the weight loss intervention in five cohorts, four English speaking and one Spanish speaking. Ten subjects dropped out before study completion, four reported this was related to research burden and six were lost to follow up: 33 participants completed the 6-month study. Recruitment was conducted at University of Vermont and University of Arizona.</recruitment_details>
      <pre_assignment_details>Forty-eight participants were screened for the study intervention and entered a 4-week run-in period; five were excluded from enrolling into the weight loss intervention because they did not complete three consecutive days recording food intake, physical activity, weight and asthma symptoms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Weight Loss Intervention</title>
          <description>This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials.&#xD;
Weight loss intervention: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly &quot;group meetings&quot; in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Research burden</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>People with poorly controlled asthma with a BMI of greater than 30</population>
      <group_list>
        <group group_id="B1">
          <title>Weight Loss Intervention</title>
          <description>This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials.&#xD;
Weight loss intervention: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly &quot;group meetings&quot; in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48" lower_limit="41" upper_limit="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced Expiratory Vital Capacity %</title>
          <units>Percent predicted</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80" lower_limit="69" upper_limit="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced Vital Capacity %</title>
          <units>Percent predicted</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85" lower_limit="77" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced Expiratory Vital Capacity/Forced vital capacity</title>
          <units>Percent predicted</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79" lower_limit="71" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma Control Test (ACT)</title>
          <description>range 5-25, higher score indicative of better health</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14" lower_limit="12" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma Symptom Utility Index, ASUI</title>
          <description>range 0-1, higher score is indicative of better health</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".6" lower_limit=".5" upper_limit=".8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marks Asthma Quality of Life Questionnaire</title>
          <description>Range, 1-80, lower score is indicative of better health</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" lower_limit="18" upper_limit="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Standard Brief activity survey (SBAS)</title>
          <description>SBAS is used to categorize patients based on activity level into:&#xD;
Inactive&#xD;
Light Intensity&#xD;
Moderate Intensity&#xD;
Hard Intensity&#xD;
Very Hard Intensity</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Inactive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Light intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hard Intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Hard intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SF-36 Short forrm Survey Instrument</title>
          <description>Range 0-100, higher score is indicative of better health</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="43" upper_limit="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Impact of Weight on Quality of Life-Lite</title>
          <description>Range 0-100, higher score is indicative of better health</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" lower_limit="35" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Treatment Motivation and Readiness (TRE-MORE)</title>
          <description>range 0-5, higher score is indicative of better health</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" lower_limit="3" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systemic corticosteroids</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Weight Loss</title>
        <description>The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Weight Loss Intervention</title>
            <description>This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials.&#xD;
Weight loss intervention: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly &quot;group meetings&quot; in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Loss</title>
          <description>The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.35</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Weight Loss Intervention</title>
          <description>Weight loss intervention: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly &quot;group meetings&quot; in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain with other symptoms</sub_title>
                <counts group_id="E1" events="6" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small bowel obstruction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Emergency Department visit</sub_title>
                <counts group_id="E1" events="11" subjects_affected="4" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Knee pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma Exacerbations</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="6" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain with other symptoms</sub_title>
                <description>Other symptoms such as fall, hypertension, allergic reaction, knee pain, unknown</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="43"/>
              </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>Gem Roy</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>4432875796</phone>
      <email>groy2@jhu.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/NCT03291808
org study id: IRB00141509
secondary id: R34HL136755
nct id: NCT03291808
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is to pilot test a weight loss intervention in obese patients with poorly controlled
      asthma.

      Obesity is a risk factor for the development of asthma (approximately 250,000 cases per year
      of asthma in the U.S. are related to obesity).

      Investigators' ultimate purpose is to test the hypothesis that weight loss through an
      intensive life style intervention will improve asthma control. But investigators first need
      to establish whether the weight loss intervention is effective in patients with asthma.

      Objectives

        1. The primary objective of this study is to determine the effectiveness of an
           internet-based weight loss intervention in producing weight loss in obese patients with
           poorly controlled asthma.

        2. The ultimate purpose is to implement a multi-center weight loss intervention trial for
           obese patients with poorly controlled asthma.
This will be a pilot study of a weight loss intervention at two centers, the University of
      Arizona and the University of Vermont. The primary outcome of interest will be the percent of
      participants achieving a 5% weight loss, which is the amount of weight loss that prior
      studies suggest is required to improve asthma control.

      This will be a single arm-phase II futility trial; the "futility" to be assessed is the
      ability to produce weight loss. Such designs are widely used in efficiently informing
      decisions to proceed to Phase III clinical trials. This trial design is appropriate when the
      effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to
      0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to
      weight loss). This is a 6-month study of 40 participants (20 at each site). All participants
      will be assigned to the weight loss intervention, which is described in detail below
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Weight Loss
time frame: 6 months
description: The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.
arm group label: Weight loss intervention
arm group type: Experimental
description: Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss).18 Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention.
intervention type: Behavioral
intervention name: Weight loss intervention
description: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly "group meetings" in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.
arm group label: Weight loss intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne Dixon, MD
role: Principal Investigator
affiliation: University of Vermont
last name: Robert Wise, MD
role: Principal Investigator
affiliation: Johns Hopkins School of Medicine
last name: Janet Holbrook, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
facility: 
country: United States
url: http://medlineplus.gov/asthma.html
description: Related Info
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 