<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/NCT04464720</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01-10615</org_study_id>
    <secondary_id>R21ES030173</secondary_id>
    <nct_id>NCT04464720</nct_id>
  </id_info>
  <brief_title>AIM to Improve Asthma: Airflow Improvements During Meal-Prep</brief_title>
  <acronym>AIM</acronym>
  <official_title>AIM to Improve Asthma: Airflow Improvements During Meal-Prep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Environmental Health Sciences (NIEHS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Berkeley</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 investigators propose a pilot trial of kitchen ventilation in the homes of children using&#xD;
      a youth engaged research strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this trial of children ages 6-12, children and their households will receive an intensive&#xD;
      home kitchen ventilation intervention after one week of baseline data collection. The&#xD;
      intervention includes education regarding improving ventilation in their homes during cooking&#xD;
      and replacement of their range hood if it has inadequate flow or an intolerable noise level.&#xD;
      During baseline data collection periods the households will be encouraged to continue their&#xD;
      regular cooking patterns. The investigators will measure home particulate matter &lt;2.5 microns&#xD;
      (PM2.5) and nitrogen dioxide (NO2) levels for one week at baseline, and a final week after&#xD;
      all remaining families receive the cooking ventilation intervention, to assess for changes&#xD;
      within each household. The investigators will also examine changes in airways inflammation&#xD;
      (as measured by the exhaled fraction of nitric oxide, FeNO), lung function (as measured by&#xD;
      spirometry), and reported symptoms after the baseline and intervention period. Members of the&#xD;
      research team have successfully conducted youth participatory action research in the&#xD;
      low-income, high asthma prevalence community of Richmond, California (CA) as well as&#xD;
      extensive youth participatory action research on other environmental health concerns in the&#xD;
      low income city of Salinas, CA; using a similar model, the investigators aim to teach&#xD;
      research methods to a new group of Richmond youth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 24, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a trial with a single group, where they receive the intervention following one week of baseline data collection.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention</measure>
    <time_frame>1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group</time_frame>
    <description>Home PM2.5 levels will measured in real-time using the Clarity air sensors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention</measure>
    <time_frame>2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group</time_frame>
    <description>Home PM2.5 levels will measured in real-time using the Clarity air sensors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention</measure>
    <time_frame>1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group</time_frame>
    <description>Home NO2 levels will measured in real-time using the Clarity air sensors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention</measure>
    <time_frame>2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group</time_frame>
    <description>Home NO2 levels will measured in real-time using the Clarity air sensors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spirometry- Forced Vital Capacity (FVC)</measure>
    <time_frame>measured at the second home visit, after one week of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry- Forced Expiratory Volume in One Second (FEV1)</measure>
    <time_frame>measured at the second home visit, after one week of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry- Forced Expiratory Flow (FEF)</measure>
    <time_frame>measured at the second home visit, after one week of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory flow measures the flow rate at different volumes of the forced exhalation maneuver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry-Forced Vital Capacity (FVC)</measure>
    <time_frame>measured at the third home visit, after two weeks of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry- Forced Expiratory Volume in One Second (FEV1)</measure>
    <time_frame>measured at the third home visit, after two weeks of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry- Forced Expiratory Flow (FEF)</measure>
    <time_frame>measured at the third home visit, after two weeks of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory flow measures the flow rate at different volumes of the forced exhalation maneuver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry-Forced Vital Capacity (FVC)</measure>
    <time_frame>measured at the fourth home visit, after three weeks of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry- Forced Expiratory Volume in One Second (FEV1)</measure>
    <time_frame>measured at the fourth home visit, after three weeks of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry- Forced Expiratory Flow (FEF)</measure>
    <time_frame>measured at the fourth home visit, after three weeks of the study</time_frame>
    <description>Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory flow measures the flow rate at different volumes of the forced exhalation maneuver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional Exhaled Nitric Oxide (FeNO)</measure>
    <time_frame>measured at the second home visit, after one week of the study</time_frame>
    <description>FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional Exhaled Nitric Oxide (FeNO)</measure>
    <time_frame>measured at the third home visit, after two weeks of the study</time_frame>
    <description>FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional Exhaled Nitric Oxide (FeNO)</measure>
    <time_frame>measured at the fourth home visit, after three weeks of the study</time_frame>
    <description>FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control</measure>
    <time_frame>measured at the second home visit, after one week of the study</time_frame>
    <description>Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control</measure>
    <time_frame>measured at the third home visit, after two weeks of the study</time_frame>
    <description>Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control</measure>
    <time_frame>measured at the fourth home visit, after three weeks of the study</time_frame>
    <description>Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Asthma in Children</condition>
  <condition>Pollution; Exposure</condition>
  <arm_group>
    <arm_group_label>Intervention after One Week</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This arm will have baseline data on air pollutant levels, stove use and range hood use collected for one week prior to receiving an educational intervention aimed at increasing use of the range hood. Data following the intervention will be collected for an additional week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cooking Ventilation Intervention</intervention_name>
    <description>An educational video presentation for the families regarding the importance of ventilation use during and after cooking, and strategies for improving the ventilation during cooking, has been created by Dr. Holm, with input from Youth Research Assistants (YRAs) The youth involvement will help to ensure that the information is presented in a way that will resonate with the local community and will also provide the youth with exposure to developing health education tools. The educational video will be shown to families at the time of the intervention visit and they will receive printed reminder materials of what they have learned.</description>
    <arm_group_label>Intervention after One Week</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Household has a gas stove&#xD;
&#xD;
          -  Household has a range hood that vents to the outdoors&#xD;
&#xD;
          -  Household in Richmond or San Pablo&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child has other significant medical illnesses (e.g. prematurity, diabetes)&#xD;
&#xD;
          -  living with a smoker who smokes indoors&#xD;
&#xD;
          -  family knows they will not have stable housing for the period of the study&#xD;
&#xD;
          -  Parent is not fluent in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John R Balmes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Berkeley</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephanie Holm, MD PhD MPH</last_name>
    <phone>(510) 621-3250</phone>
    <email>RichmondAIMstudy@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California Berkeley</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94720</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie M Holm, MD MPH</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 18, 2019</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>November 9, 2021</last_update_submitted>
  <last_update_submitted_qc>November 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>pediatric</keyword>
  <keyword>indoor air pollution</keyword>
  <keyword>particulate matter</keyword>
  <keyword>nitrogen dioxide</keyword>
  <keyword>cooking</keyword>
  <keyword>ventilation</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>
    <ipd_description>There is no current plan to share data but the investigators would be willing to entertain requests from other researchers for sharing of de-identified data only. Subjects will be asked to give permission for release of photographs of them for future presentations and other outreach materials.</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/NCT04464720
org study id: 2018-01-10615
secondary id: R21ES030173
nct id: NCT04464720
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators propose a pilot trial of kitchen ventilation in the homes of children using
      a youth engaged research strategy.
In this trial of children ages 6-12, children and their households will receive an intensive
      home kitchen ventilation intervention after one week of baseline data collection. The
      intervention includes education regarding improving ventilation in their homes during cooking
      and replacement of their range hood if it has inadequate flow or an intolerable noise level.
      During baseline data collection periods the households will be encouraged to continue their
      regular cooking patterns. The investigators will measure home particulate matter <2.5 microns
      (PM2.5) and nitrogen dioxide (NO2) levels for one week at baseline, and a final week after
      all remaining families receive the cooking ventilation intervention, to assess for changes
      within each household. The investigators will also examine changes in airways inflammation
      (as measured by the exhaled fraction of nitric oxide, FeNO), lung function (as measured by
      spirometry), and reported symptoms after the baseline and intervention period. Members of the
      research team have successfully conducted youth participatory action research in the
      low-income, high asthma prevalence community of Richmond, California (CA) as well as
      extensive youth participatory action research on other environmental health concerns in the
      low income city of Salinas, CA; using a similar model, the investigators aim to teach
      research methods to a new group of Richmond youth.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a trial with a single group, where they receive the intervention following one week of baseline data collection.
primary purpose: Prevention
masking: None (Open Label)
measure: Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention
time frame: 1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group
description: Home PM2.5 levels will measured in real-time using the Clarity air sensors.
measure: Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention
time frame: 2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group
description: Home PM2.5 levels will measured in real-time using the Clarity air sensors.
measure: Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention
time frame: 1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group
description: Home NO2 levels will measured in real-time using the Clarity air sensors.
measure: Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention
time frame: 2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group
description: Home NO2 levels will measured in real-time using the Clarity air sensors.
measure: Spirometry- Forced Vital Capacity (FVC)
time frame: measured at the second home visit, after one week of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out.
measure: Spirometry- Forced Expiratory Volume in One Second (FEV1)
time frame: measured at the second home visit, after one week of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath.
measure: Spirometry- Forced Expiratory Flow (FEF)
time frame: measured at the second home visit, after one week of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory flow measures the flow rate at different volumes of the forced exhalation maneuver.
measure: Spirometry-Forced Vital Capacity (FVC)
time frame: measured at the third home visit, after two weeks of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out.
measure: Spirometry- Forced Expiratory Volume in One Second (FEV1)
time frame: measured at the third home visit, after two weeks of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath.
measure: Spirometry- Forced Expiratory Flow (FEF)
time frame: measured at the third home visit, after two weeks of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory flow measures the flow rate at different volumes of the forced exhalation maneuver.
measure: Spirometry-Forced Vital Capacity (FVC)
time frame: measured at the fourth home visit, after three weeks of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out.
measure: Spirometry- Forced Expiratory Volume in One Second (FEV1)
time frame: measured at the fourth home visit, after three weeks of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath.
measure: Spirometry- Forced Expiratory Flow (FEF)
time frame: measured at the fourth home visit, after three weeks of the study
description: Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory flow measures the flow rate at different volumes of the forced exhalation maneuver.
measure: Fractional Exhaled Nitric Oxide (FeNO)
time frame: measured at the second home visit, after one week of the study
description: FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
measure: Fractional Exhaled Nitric Oxide (FeNO)
time frame: measured at the third home visit, after two weeks of the study
description: FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
measure: Fractional Exhaled Nitric Oxide (FeNO)
time frame: measured at the fourth home visit, after three weeks of the study
description: FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
measure: Asthma Control
time frame: measured at the second home visit, after one week of the study
description: Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
measure: Asthma Control
time frame: measured at the third home visit, after two weeks of the study
description: Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
measure: Asthma Control
time frame: measured at the fourth home visit, after three weeks of the study
description: Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
arm group label: Intervention after One Week
arm group type: Other
description: This arm will have baseline data on air pollutant levels, stove use and range hood use collected for one week prior to receiving an educational intervention aimed at increasing use of the range hood. Data following the intervention will be collected for an additional week.
intervention type: Behavioral
intervention name: Cooking Ventilation Intervention
description: An educational video presentation for the families regarding the importance of ventilation use during and after cooking, and strategies for improving the ventilation during cooking, has been created by Dr. Holm, with input from Youth Research Assistants (YRAs) The youth involvement will help to ensure that the information is presented in a way that will resonate with the local community and will also provide the youth with exposure to developing health education tools. The educational video will be shown to families at the time of the intervention visit and they will receive printed reminder materials of what they have learned.
arm group label: Intervention after One Week
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: John R Balmes, MD
role: Principal Investigator
affiliation: University of California, Berkeley
last name: Stephanie Holm, MD PhD MPH
phone: (510) 621-3250
email: RichmondAIMstudy@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
ipd description: There is no current plan to share data but the investigators would be willing to entertain requests from other researchers for sharing of de-identified data only. Subjects will be asked to give permission for release of photographs of them for future presentations and other outreach materials.