<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/NCT02981160</url>
  </required_header>
  <id_info>
    <org_study_id>Breezing Study</org_study_id>
    <nct_id>NCT02981160</nct_id>
  </id_info>
  <brief_title>Validation of a Personal Breath Analyzer for Diet and Energy Expenditure Assessment and Management</brief_title>
  <acronym>Breezing</acronym>
  <official_title>Validation of a Personal Breath Analyzer for Diet and Energy Expenditure Assessment and Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Banner Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Banner Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the research is to determine energy expenditure rates and diet and/ physical&#xD;
      activity metabolic features of an individual using current state technologies and a new&#xD;
      technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot&#xD;
      study which intent is to validate this device for use in the weight loss patient population.&#xD;
&#xD;
      This study will involve research of metabolic physiological parameters that are measured&#xD;
      through the breath of the individuals, together with other physical parameters (weight,&#xD;
      height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood&#xD;
      pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary&#xD;
      physical activities. The study will involve withdrawn of breath samples at resting&#xD;
      conditions, and under diets or physical activities regimes.&#xD;
&#xD;
      This instrument will assist our patients in terms of tailoring their diet/nutrition through&#xD;
      their weight loss journey prior and after surgery. As a new technology, it will be an&#xD;
      excellent tool for compliance assessment and engagement with the Weight Loss Program as well&#xD;
      as for long term follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Breezing® device is a new technology locally invented in the state of Arizona that uses a&#xD;
      sensor cartridge and a flow meter to determine the rate of consumed oxygen and produced&#xD;
      carbon dioxide in the breath. The sensing technology of the new indirect calorimeter, which&#xD;
      used a cell-phone camera as the optical detector. The current Breezing® device uses a code to&#xD;
      carry calibration parameters of a single-use sensor cartridge, which can be scanned and&#xD;
      recognized by the mobile application (app). The device is 6.0 oz. (170 g), and 1.8 in × 2.1&#xD;
      in × 4.8 in (4.7 cm × 5.4 cm × 12.3 cm), and connects wirelessly to an iOS mobile device,&#xD;
      using Bluetooth 4.0 technology.&#xD;
&#xD;
      The mobile device (phone or tablet) receives data from the device, processes information, and&#xD;
      then provides test results and summaries through a graphic user interface. It determines the&#xD;
      energy expenditure from the measurement of VO2 and VCO2 according to the Weir equation, along&#xD;
      with RQ. In addition to the sensor cartridge, the Breezing® device is used with a&#xD;
      non-rebreathing 2-valvesmouthpiece.&#xD;
&#xD;
      This new device will provide a more precise information regarding metabolic rate in our&#xD;
      Bariatric Patients to better tailor their preoperative diet and monitor their weight loss.&#xD;
&#xD;
      Up to date, this device was never used or validated before in the Bariatric population under&#xD;
      this setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Pending Organization approval&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improve weight loss measures</measure>
    <time_frame>12 months</time_frame>
    <description>Improve weight loss from a standard weight loss program from a mobile breath analyzer device. The device may provide more precise information regarding the metabolic rate in bariatric patients, this device may better tailor patients preoperative diet and assist in monitoring their weight loss.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Standard Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants assigned to this group will follow a standard weight loss program for 12-months. This patients will be instructed by the Weight loss program registered dietitian/diet tech in clinic in terms of nutrition regimen, daily intake and calories.Patients will be followed up monthly as per clinic protocol. All visits will include physical measurements including body mass index (BMI) based on height and weight, blood pressure, and body composition (fat percentage). Body composition will be assessed during clinic visits by bio-impedance. Waist circumference (cm) will be measured at the umbilicus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile Device Assistant Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will follow the same weight loss protocol, monitoring, and clinic visits as the standard weight loss group described above, but will also use the mobile health tool (Breezing) to track REE every visit. This data will be loaded onto an accompanying electronic pad using the Breezing &quot;app&quot; and will be transmitted electronically to the study investigators who will use the information to adjust dietary and physical activity recommendations and targets. The test will be performed at initial visit, 2 weeks, 1, 3, 6 and 12 months after started.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary</intervention_name>
    <description>The REE testing will be done with the Breezing device, a breath analyzer developed at Arizona State University. The Breezing device is an indirect calorimetry analyzer that measures the rate of oxygen consumption and carbon dioxide production, and determines how much energy the body is burning (REE), and the type of nutrients the body uses to produce energy (energy source). The Breezing device is a cellphone-size, battery-operated, portable technology that syncs with smartphones and electronic pads. The patients will be asked to breathe into a mouthpiece connected to the Breezing device; the data will be then beamed wirelessly to the device. The breath analysis data will displayed on the screen in conjunction with an estimate of total calories burned each day (total energy expenditure, TEE).</description>
    <arm_group_label>Mobile Device Assistant Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females or Males between 18 and 50 yo&#xD;
&#xD;
          -  Class II and Class III Obesity (BMI 35 and above)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - No Obesity. Patients with normal BMI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Banner Gateway Medical Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner Estrella Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Banner Health</investigator_affiliation>
    <investigator_full_name>Flavia Soto</investigator_full_name>
    <investigator_title>Bariatric Surgeon</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Baseline and demographic characteristics will be summarized by standard descriptive summaries (e.g. means and standard deviations for continuous variables such as age and percentages for categorical variables such as gender). We will measure differences in weight loss in the two groups using the Mann-Whitney U test</ipd_description>
  </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/NCT02981160
org study id: Breezing Study
nct id: NCT02981160
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the research is to determine energy expenditure rates and diet and/ physical
      activity metabolic features of an individual using current state technologies and a new
      technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot
      study which intent is to validate this device for use in the weight loss patient population.

      This study will involve research of metabolic physiological parameters that are measured
      through the breath of the individuals, together with other physical parameters (weight,
      height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood
      pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary
      physical activities. The study will involve withdrawn of breath samples at resting
      conditions, and under diets or physical activities regimes.

      This instrument will assist our patients in terms of tailoring their diet/nutrition through
      their weight loss journey prior and after surgery. As a new technology, it will be an
      excellent tool for compliance assessment and engagement with the Weight Loss Program as well
      as for long term follow up.
The Breezing® device is a new technology locally invented in the state of Arizona that uses a
      sensor cartridge and a flow meter to determine the rate of consumed oxygen and produced
      carbon dioxide in the breath. The sensing technology of the new indirect calorimeter, which
      used a cell-phone camera as the optical detector. The current Breezing® device uses a code to
      carry calibration parameters of a single-use sensor cartridge, which can be scanned and
      recognized by the mobile application (app). The device is 6.0 oz. (170 g), and 1.8 in × 2.1
      in × 4.8 in (4.7 cm × 5.4 cm × 12.3 cm), and connects wirelessly to an iOS mobile device,
      using Bluetooth 4.0 technology.

      The mobile device (phone or tablet) receives data from the device, processes information, and
      then provides test results and summaries through a graphic user interface. It determines the
      energy expenditure from the measurement of VO2 and VCO2 according to the Weir equation, along
      with RQ. In addition to the sensor cartridge, the Breezing® device is used with a
      non-rebreathing 2-valvesmouthpiece.

      This new device will provide a more precise information regarding metabolic rate in our
      Bariatric Patients to better tailor their preoperative diet and monitor their weight loss.

      Up to date, this device was never used or validated before in the Bariatric population under
      this setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Improve weight loss measures
time frame: 12 months
description: Improve weight loss from a standard weight loss program from a mobile breath analyzer device. The device may provide more precise information regarding the metabolic rate in bariatric patients, this device may better tailor patients preoperative diet and assist in monitoring their weight loss.
arm group label: Standard Care Group
arm group type: No Intervention
description: The participants assigned to this group will follow a standard weight loss program for 12-months. This patients will be instructed by the Weight loss program registered dietitian/diet tech in clinic in terms of nutrition regimen, daily intake and calories.Patients will be followed up monthly as per clinic protocol. All visits will include physical measurements including body mass index (BMI) based on height and weight, blood pressure, and body composition (fat percentage). Body composition will be assessed during clinic visits by bio-impedance. Waist circumference (cm) will be measured at the umbilicus.
arm group label: Mobile Device Assistant Group
arm group type: Experimental
description: This group will follow the same weight loss protocol, monitoring, and clinic visits as the standard weight loss group described above, but will also use the mobile health tool (Breezing) to track REE every visit. This data will be loaded onto an accompanying electronic pad using the Breezing "app" and will be transmitted electronically to the study investigators who will use the information to adjust dietary and physical activity recommendations and targets. The test will be performed at initial visit, 2 weeks, 1, 3, 6 and 12 months after started.
intervention type: Other
intervention name: Dietary
description: The REE testing will be done with the Breezing device, a breath analyzer developed at Arizona State University. The Breezing device is an indirect calorimetry analyzer that measures the rate of oxygen consumption and carbon dioxide production, and determines how much energy the body is burning (REE), and the type of nutrients the body uses to produce energy (energy source). The Breezing device is a cellphone-size, battery-operated, portable technology that syncs with smartphones and electronic pads. The patients will be asked to breathe into a mouthpiece connected to the Breezing device; the data will be then beamed wirelessly to the device. The breath analysis data will displayed on the screen in conjunction with an estimate of total calories burned each day (total energy expenditure, TEE).
arm group label: Mobile Device Assistant Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Banner Health
investigator full name: Flavia Soto
investigator title: Bariatric Surgeon
sharing ipd: Yes
ipd description: Baseline and demographic characteristics will be summarized by standard descriptive summaries (e.g. means and standard deviations for continuous variables such as age and percentages for categorical variables such as gender). We will measure differences in weight loss in the two groups using the Mann-Whitney U test