<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/NCT03836547</url>
  </required_header>
  <id_info>
    <org_study_id>18-001832</org_study_id>
    <nct_id>NCT03836547</nct_id>
  </id_info>
  <brief_title>Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity</brief_title>
  <official_title>Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Researchers are trying to test the effectiveness and feasibility of a multicomponent&#xD;
      lifestyle intervention to support weight loss decreases dyspnea in obese people with chronic&#xD;
      lung disease and clinically significant breathlessness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient will be randomized to a 12-week intervention that uses the Weight watchers lifestyle&#xD;
      program online, a Garmin Fitness Tracker, blue tooth scale and receive health coaching vs a&#xD;
      wait-list control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2019</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</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>
    <intervention_model_description>Patients with lung disease and a BMI of 35 or greater with significant shortness of breath will be randomized to a multicomponent intervention vs a wait-list control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breathlessness</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Chronic Respiratory Questionnaire Dyspnea</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lean Body Mass (lbs.)using InBody 770 Scale</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>InBody770 analyzer to define Lean Body Mass (total body weight minus weight of fat). This measure includes organs, skin, bones, water and muscle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal Muscle Mass (lbs.) using InBody 770 Scale</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>InBody770 analyzer to define skeletal muscle mass (total weight of muscle)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Body Fat using InBody 770 Scale</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>InBody770 analyzer to define percent body fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight using InBody 770 Scale</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>InBody770 analyzer to define weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index using InBody 770 Scale</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>InBody770 analyzer to define Body Mass Index (BMI) is weight in kilograms divided by height in meters squared. A BMI of 25 or below is considered healthy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Eating</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Mindful Eating Questionnaire- 28 item instrument with a score range of 1-4. Higher scores are associated with lower body mass indexes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Steps</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Number of steps participant takes in a day recorded by Actigraph Activity tracker.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Sedentary Time</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Physical Activity</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Actigraph Activity Tracker to define the amount of time spent in mild to moderate and vigorous physical activity define by METs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Capacity</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Six-Minute Walking Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Time Measures</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Actigraph to measure total sleep time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Efficiency</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Time sleeping/ Time reclined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease specific quality of life</measure>
    <time_frame>baseline to 12 weeks</time_frame>
    <description>Chronic Respiratory Questionnaire measures Fatigue , Emotions and Mastery and is a 20 item questionnaire with a range of 1-7. A higher score is best.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>COPD</condition>
  <condition>Emphysema</condition>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>Multicomponent Intervention for weight loss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coaching and Weight Loss for patients with dyspnea</intervention_name>
    <description>Patients with lung disease and a BMI of 35 or greater who suffer from shortness of breath will be invited to participate in a study involving a commercial weight loss application with health coaching. The patients will subscribe on their own to the weight loss application. The patients will be provided with a blue tooth scale so that they may weigh themselves weekly. A health coach will call them weekly for 8 weeks.</description>
    <arm_group_label>Multicomponent Intervention for weight loss</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Control</intervention_name>
    <description>Participants will receive usual care for 12 weeks followed by the active intervention.</description>
    <arm_group_label>Wait-list Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  BMI &gt;=35&#xD;
&#xD;
          -  Dyspnea MRC class II or greater&#xD;
&#xD;
          -  Diagnosis of lung disease&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  BMI &lt;35&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Recent respiratory illness (within the last 6 weeks)&#xD;
&#xD;
          -  Recent exacerbation of chronic lung disease (within the last 6 weeks)&#xD;
&#xD;
          -  Already participating in a structured diet and/or exercise program&#xD;
&#xD;
          -  Medical contraindication to weight loss (cancer)&#xD;
&#xD;
          -  Medical contraindication to unsupervised exercise (unstable angina)&#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>Roberto P Benzo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Roberto P. Benzo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03836547
org study id: 18-001832
nct id: NCT03836547
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Researchers are trying to test the effectiveness and feasibility of a multicomponent
      lifestyle intervention to support weight loss decreases dyspnea in obese people with chronic
      lung disease and clinically significant breathlessness.
Patient will be randomized to a 12-week intervention that uses the Weight watchers lifestyle
      program online, a Garmin Fitness Tracker, blue tooth scale and receive health coaching vs a
      wait-list control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients with lung disease and a BMI of 35 or greater with significant shortness of breath will be randomized to a multicomponent intervention vs a wait-list control group.
primary purpose: Treatment
masking: None (Open Label)
measure: Breathlessness
time frame: baseline to 12 weeks
description: Chronic Respiratory Questionnaire Dyspnea
measure: Lean Body Mass (lbs.)using InBody 770 Scale
time frame: baseline to 12 weeks
description: InBody770 analyzer to define Lean Body Mass (total body weight minus weight of fat). This measure includes organs, skin, bones, water and muscle.
measure: Skeletal Muscle Mass (lbs.) using InBody 770 Scale
time frame: baseline to 12 weeks
description: InBody770 analyzer to define skeletal muscle mass (total weight of muscle)
measure: Percent Body Fat using InBody 770 Scale
time frame: baseline to 12 weeks
description: InBody770 analyzer to define percent body fat
measure: Weight using InBody 770 Scale
time frame: baseline to 12 weeks
description: InBody770 analyzer to define weight
measure: Body Mass Index using InBody 770 Scale
time frame: baseline to 12 weeks
description: InBody770 analyzer to define Body Mass Index (BMI) is weight in kilograms divided by height in meters squared. A BMI of 25 or below is considered healthy.
measure: Mindful Eating
time frame: baseline to 12 weeks
description: Mindful Eating Questionnaire- 28 item instrument with a score range of 1-4. Higher scores are associated with lower body mass indexes.
measure: Daily Steps
time frame: baseline to 12 weeks
description: Number of steps participant takes in a day recorded by Actigraph Activity tracker.
measure: Daily Sedentary Time
time frame: baseline to 12 weeks
description: Actigraph Activity Tracker to determine the amount of time (minutes) spend sedentary status
measure: Daily Physical Activity
time frame: baseline to 12 weeks
description: Actigraph Activity Tracker to define the amount of time spent in mild to moderate and vigorous physical activity define by METs
measure: Exercise Capacity
time frame: baseline to 12 weeks
description: Six-Minute Walking Test
measure: Sleep Time Measures
time frame: baseline to 12 weeks
description: Actigraph to measure total sleep time
measure: Sleep Efficiency
time frame: baseline to 12 weeks
description: Time sleeping/ Time reclined
measure: Disease specific quality of life
time frame: baseline to 12 weeks
description: Chronic Respiratory Questionnaire measures Fatigue , Emotions and Mastery and is a 20 item questionnaire with a range of 1-7. A higher score is best.
arm group label: Multicomponent Intervention for weight loss
arm group type: Experimental
description: 12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.
arm group label: Wait-list Control
arm group type: Active Comparator
description: The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.
intervention type: Behavioral
intervention name: Coaching and Weight Loss for patients with dyspnea
description: Patients with lung disease and a BMI of 35 or greater who suffer from shortness of breath will be invited to participate in a study involving a commercial weight loss application with health coaching. The patients will subscribe on their own to the weight loss application. The patients will be provided with a blue tooth scale so that they may weigh themselves weekly. A health coach will call them weekly for 8 weeks.
arm group label: Multicomponent Intervention for weight loss
intervention type: Behavioral
intervention name: Active Control
description: Participants will receive usual care for 12 weeks followed by the active intervention.
arm group label: Wait-list Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto P Benzo
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Roberto P. Benzo
investigator title: Principal Investigator
mesh term: Lung Diseases
mesh term: Dyspnea
mesh term: Emphysema
sharing ipd: No