<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/NCT02240069</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 218-12</org_study_id>
    <secondary_id>R01ES022583</secondary_id>
    <nct_id>NCT02240069</nct_id>
  </id_info>
  <brief_title>Wood Smoke Interventions in Native American Populations</brief_title>
  <acronym>EldersAIR</acronym>
  <official_title>Residential Wood Smoke Interventions Improving Health in Native American Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Montana</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 Montana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A critical need exists for efficient community-based interventions aimed at reduction of&#xD;
      environmental exposures relevant to health. Biomass smoke exposures due to residential wood&#xD;
      heating are common among rural Native American communities, and such exposures have been&#xD;
      associated with respiratory disease in susceptible populations. In many of these communities&#xD;
      wood stoves are the most economic and traditionally preferred method of residential heating,&#xD;
      but resource scarcity can result in burning of improper wood fuels and corresponding high&#xD;
      levels of indoor particulate matter. Community-based participatory research techniques will&#xD;
      be used to adapt intervention approaches to meet the cultural context of each participating&#xD;
      community. At the community level, investigators will facilitate local development of a&#xD;
      tribal agency-led wood bank program ensuring that elderly and/or persons with need have&#xD;
      access to dry wood for heating. At the household level, investigators will use a three arm&#xD;
      randomized placebo-controlled intervention trial to implement and assess education/outreach&#xD;
      on best burn practices (Tx1). The content and delivery strategies of the education&#xD;
      intervention will be adapted to each community according to stakeholder input. This&#xD;
      educational intervention will be evaluated against an indoor air filtration unit arm (Tx2),&#xD;
      as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the&#xD;
      other two treatment arms to evaluate the penetration and efficacy of the community-level wood&#xD;
      bank program. Outcomes will be evaluated with respect to changes in pulmonary function&#xD;
      measures and respiratory symptoms and conditions among household elders. The investigators&#xD;
      hypothesize that locally-designed education-based interventions at the community and&#xD;
      household levels will result in efficacious and sustainable strategies for reducing personal&#xD;
      exposures to indoor particulate matter, and lead to respiratory health improvements in&#xD;
      elderly Native populations. This study will advance knowledge of cost-effective environmental&#xD;
      interventions within two unique Native American communities, and inform sustainable&#xD;
      multi-level strategies in similar communities throughout the US to improve respiratory health&#xD;
      among at-risk populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rural Native American (NA) communities experience disproportionate disease burden compared to&#xD;
      other US populations, with poor indoor air quality resulting from in-home biomass smoke&#xD;
      exposures (residential wood stoves) a likely contributor to these health burden&#xD;
      discrepancies. Epidemiological studies support the etiological association between indoor&#xD;
      biomass smoke exposure and several domains of global disease burden, particularly with&#xD;
      respect to pediatric respiratory tract infections and adult chronic obstructive pulmonary&#xD;
      disease (COPD) and chronic bronchitis. Elderly populations are particularly susceptible to&#xD;
      chronic respiratory conditions, and declining pulmonary function is associated with increased&#xD;
      morbidity and mortality. Randomized trials in developing countries have demonstrated the&#xD;
      impact that improved cookstove technologies have in reducing biomass smoke exposures and&#xD;
      children's risk of acute respiratory infection. However limited knowledge is available&#xD;
      regarding the potential improvements in NA elderly populations following wood stove&#xD;
      interventions.&#xD;
&#xD;
      Today, a critical need exists for efficient community-based interventions aimed at promoting&#xD;
      healthy indoor environments in at-risk communities. Financial and logistical barriers that&#xD;
      currently exist in rural and economically disadvantaged NA communities prohibit the&#xD;
      implementation and sustainability of many environmental health interventions. Regarding wood&#xD;
      stoves, qualitative input from experts and Native communities underscores the need for&#xD;
      innovative low-cost, sustainable interventions targeting the reduction of in-home biomass&#xD;
      smoke exposures. In this proposal, investigators will test community-level and&#xD;
      education-based household-level strategies aimed at promoting and implementing best-burn&#xD;
      practices to improve air quality and respiratory health in at-risk elderly populations.&#xD;
&#xD;
      This proposal represents a multidisciplinary collaboration between university and tribal&#xD;
      stakeholders from two Native American Reservations to develop, adapt, implement, and evaluate&#xD;
      a two-level intervention to reduce exposure to indoor biomass smoke and improve respiratory&#xD;
      health among elderly tribal members. Community-based participatory research techniques will&#xD;
      be used to adapt intervention approaches to meet the cultural context of each participating&#xD;
      community. At the community level, investigators will facilitate local development of tribal&#xD;
      agency-led wood yard and distribution programs ensuring that elderly and/or persons with need&#xD;
      have access to dry wood for heating. With community advisory guidance, investigators will use&#xD;
      a three arm randomized placebo-controlled intervention trial to implement and assess&#xD;
      education on best burn practices (Tx1) at the household level. This educational intervention&#xD;
      will be evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm&#xD;
      (Tx3, sham air filters). Tx3 will be used in comparison with the other two treatment arms to&#xD;
      evaluate the penetration and efficacy of the community-level fuel program. Outcomes will be&#xD;
      evaluated with respect to changes in markers of respiratory health among elders and changes&#xD;
      in indoor air quality (PM2.5). The investigators hypothesize that locally-designed&#xD;
      education-based interventions, in the context of a community-based strategy focused on wood&#xD;
      fuels, will result in efficacious and sustainable strategies for reducing personal exposures&#xD;
      to indoor biomass smoke PM2.5 and lead to respiratory health improvements in elderly NA&#xD;
      populations.&#xD;
&#xD;
      Specific Aims are as follows:&#xD;
&#xD;
      Aim 1. Facilitate the tribally-centered development, adaption, implementation, and evaluation&#xD;
      of community-level wood yard and distribution programs for participating tribal households.&#xD;
&#xD;
      Aim 2. Facilitate the development, adaptation, implementation, and evaluation of&#xD;
      household-level education strategies targeting best-burn practices (Tx1) for each&#xD;
      participating tribal community.&#xD;
&#xD;
      Aim 3. Compare effectiveness, both within and between communities, of household-level&#xD;
      interventions among elderly adults participating in a three-arm randomized placebo-controlled&#xD;
      trial.&#xD;
&#xD;
      Aim 3a. Compare group changes in pulmonary function and respiratory symptoms and infections.&#xD;
&#xD;
      Aim 3b. Compare group changes in indoor and personal PM2.5 exposures.&#xD;
&#xD;
      Aim 4. Evaluate penetration, acceptance, and sustainability of community- and household-level&#xD;
      strategies using both qualitative and quantitative data generated in collaboration with&#xD;
      tribal community advisory boards and research participants.&#xD;
&#xD;
      Impact. The long-term goal of this project will be to reduce mortality and morbidity in NA&#xD;
      communities from exposures related to residential home heating. This study will advance&#xD;
      knowledge of effective interventions within two unique NA Reservations and describe&#xD;
      improvements in sub-clinical indicators of pulmonary health in susceptible elderly&#xD;
      populations. Reducing in-home wood smoke exposures through community level facilitation of&#xD;
      access to proper fuels and introduction of sustainable, culturally appropriate best-burn&#xD;
      practices will inform strategies for translation to other NA communities or similar rural and&#xD;
      underserved populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2015</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-intervention FEV1</measure>
    <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
    <description>Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-intervention FVC</measure>
    <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
    <description>Mean of up to two post-intervention measures of forced vital capacity (FVC), liters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-intervention FEV1/FVC Ratio</measure>
    <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
    <description>Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-intervention Systolic Blood Pressure</measure>
    <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
    <description>Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-intervention Diastolic Blood Pressure</measure>
    <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
    <description>Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-intervention Indoor Fine Particulate Matter (PM2.5)</measure>
    <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Indoor 48-hour PM2.5 average concentration was measured at two post-intervention visits separated by at least three weeks.</time_frame>
    <description>Post-intervention average Indoor fine particulate matter (PM2.5) concentration</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Respiratory; Disorder, Functional, Impaired</condition>
  <condition>Respiratory Infection Other</condition>
  <arm_group>
    <arm_group_label>Education (Tx1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Education on best burn practices</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air Filtration Unit Treatment (Tx2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Intervention (Tx3)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education (Tx1)</intervention_name>
    <description>Education on best burn practices</description>
    <arm_group_label>Education (Tx1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air Filtration Unit Treatment (Tx2)</intervention_name>
    <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
    <arm_group_label>Air Filtration Unit Treatment (Tx2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Intervention (Tx3)</intervention_name>
    <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
    <arm_group_label>Placebo Intervention (Tx3)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tribal member from one of the two study regions&#xD;
&#xD;
          -  Age 55 years or older.&#xD;
&#xD;
          -  Utilize a wood stove as the primary heating source.&#xD;
&#xD;
          -  Capable and willing to record symptom data and wood stove usage data, as well as&#xD;
             complete pulmonary function testing (i.e., spirometry).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Curtis W Noonan, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Montana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Annie Belcourt, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Montana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tony J Ward, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Montana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Montana</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>November 2, 2022</results_first_submitted>
  <results_first_submitted_qc>November 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 1, 2022</results_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Montana</investigator_affiliation>
    <investigator_full_name>Curtis Noonan</investigator_full_name>
    <investigator_title>Principal Investigator, Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <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>November 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02240069/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>For this pre/post study recruited and consented participants completed baseline measures during a pre-intervention period (n=149). Randomization to arms occurred after the first (baseline) period and before the second (post-intervention) period. Six participants dropped out of the study before the randomization process. Thus, only 143 participants were randomized to a treatment arm.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Education (Tx1)</title>
          <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
        </group>
        <group group_id="P2">
          <title>Air Filtration Unit Treatment (Tx2)</title>
          <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
        </group>
        <group group_id="P3">
          <title>Placebo Intervention (Tx3)</title>
          <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Education (Tx1)</title>
          <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
        </group>
        <group group_id="B2">
          <title>Air Filtration Unit Treatment (Tx2)</title>
          <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
        </group>
        <group group_id="B3">
          <title>Placebo Intervention (Tx3)</title>
          <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="47"/>
            <count group_id="B4" value="143"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Specific age for one participant not disclosed; all participants 55 years or older</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="46"/>
                    <count group_id="B4" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.8" spread="9.3"/>
                    <measurement group_id="B2" value="69.8" spread="9.5"/>
                    <measurement group_id="B3" value="68.9" spread="8.7"/>
                    <measurement group_id="B4" value="69.6" spread="9.2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="47"/>
                    <count group_id="B4" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="43"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="47"/>
                    <count group_id="B4" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="47"/>
                    <count group_id="B4" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced expiratory volume in 1 second (FEV1)</title>
          <population>Valid spirometry measures captured for 133 of 143 participants</population>
          <units>liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="44"/>
                    <count group_id="B4" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.1" spread="0.7"/>
                    <measurement group_id="B2" value="2.1" spread="0.6"/>
                    <measurement group_id="B3" value="2.0" spread="0.8"/>
                    <measurement group_id="B4" value="2.0" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced vital capacity (FVC)</title>
          <population>Valid spirometry measures captured for 133 of 143 participants</population>
          <units>liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="44"/>
                    <count group_id="B4" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.6" spread="0.8"/>
                    <measurement group_id="B2" value="2.6" spread="0.7"/>
                    <measurement group_id="B3" value="2.5" spread="0.9"/>
                    <measurement group_id="B4" value="2.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FEV1/FVC</title>
          <population>Valid spirometry measures captured for 133 of 143 participants</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="44"/>
                    <count group_id="B4" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.79" spread="0.08"/>
                    <measurement group_id="B2" value="0.80" spread="0.07"/>
                    <measurement group_id="B3" value="0.79" spread="0.08"/>
                    <measurement group_id="B4" value="0.79" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic blood pressure</title>
          <population>Valid blood pressure measures captured for 130 of 143 participants</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="132" spread="18"/>
                    <measurement group_id="B2" value="143" spread="19"/>
                    <measurement group_id="B3" value="137" spread="20"/>
                    <measurement group_id="B4" value="137" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic blood pressure</title>
          <population>Valid blood pressure measures captured for 130 of 143 participants</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74" spread="11"/>
                    <measurement group_id="B2" value="79" spread="10"/>
                    <measurement group_id="B3" value="77" spread="14"/>
                    <measurement group_id="B4" value="77" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-intervention FEV1</title>
        <description>Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters</description>
        <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
        <population>Valid post-intervention spirometry measures captured for 127 of 143 participants</population>
        <group_list>
          <group group_id="O1">
            <title>Education (Tx1)</title>
            <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-intervention FEV1</title>
          <description>Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters</description>
          <population>Valid post-intervention spirometry measures captured for 127 of 143 participants</population>
          <units>liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.7"/>
                    <measurement group_id="O2" value="2.1" spread="0.6"/>
                    <measurement group_id="O3" value="2.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in FEV1 for Education group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.10</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in FEV1 for Filtration group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.90</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-intervention FVC</title>
        <description>Mean of up to two post-intervention measures of forced vital capacity (FVC), liters</description>
        <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
        <population>Valid post-intervention spirometry measures captured for 127 of 143 participants</population>
        <group_list>
          <group group_id="O1">
            <title>Education (Tx1)</title>
            <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-intervention FVC</title>
          <description>Mean of up to two post-intervention measures of forced vital capacity (FVC), liters</description>
          <population>Valid post-intervention spirometry measures captured for 127 of 143 participants</population>
          <units>liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.7"/>
                    <measurement group_id="O2" value="2.7" spread="0.7"/>
                    <measurement group_id="O3" value="2.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in FVC for Education group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.28</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in FVC for Filter group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.89</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-intervention FEV1/FVC Ratio</title>
        <description>Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)</description>
        <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
        <population>Valid post-intervention spirometry measures captured for 127 of 143 participants</population>
        <group_list>
          <group group_id="O1">
            <title>Education (Tx1)</title>
            <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-intervention FEV1/FVC Ratio</title>
          <description>Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)</description>
          <population>Valid post-intervention spirometry measures captured for 127 of 143 participants</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="0.08"/>
                    <measurement group_id="O2" value="0.79" spread="0.08"/>
                    <measurement group_id="O3" value="0.80" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in FEV1/FVC for Education group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.06</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in FEV1/FVC for Filter group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.71</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-intervention Systolic Blood Pressure</title>
        <description>Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)</description>
        <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
        <population>Valid post-intervention blood pressure measures captured for 128 of 143 participants</population>
        <group_list>
          <group group_id="O1">
            <title>Education (Tx1)</title>
            <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-intervention Systolic Blood Pressure</title>
          <description>Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)</description>
          <population>Valid post-intervention blood pressure measures captured for 128 of 143 participants</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132" spread="16"/>
                    <measurement group_id="O2" value="139" spread="17"/>
                    <measurement group_id="O3" value="136" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in systolic blood pressure for Education group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.39</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-3.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.45</ci_lower_limit>
            <ci_upper_limit>4.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in systolic blood pressure for Filter group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.95</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.73</ci_lower_limit>
            <ci_upper_limit>8.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-intervention Diastolic Blood Pressure</title>
        <description>Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)</description>
        <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.</time_frame>
        <population>Valid post-intervention blood pressure measures captured for 128 of 143 participants</population>
        <group_list>
          <group group_id="O1">
            <title>Education (Tx1)</title>
            <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-intervention Diastolic Blood Pressure</title>
          <description>Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)</description>
          <population>Valid post-intervention blood pressure measures captured for 128 of 143 participants</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="11"/>
                    <measurement group_id="O2" value="78" spread="11"/>
                    <measurement group_id="O3" value="76" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in diastolic blood pressure for Education group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.65</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.42</ci_lower_limit>
            <ci_upper_limit>3.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in diastolic blood pressure for Filter group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.79</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.97</ci_lower_limit>
            <ci_upper_limit>3.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-intervention Indoor Fine Particulate Matter (PM2.5)</title>
        <description>Post-intervention average Indoor fine particulate matter (PM2.5) concentration</description>
        <time_frame>Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Indoor 48-hour PM2.5 average concentration was measured at two post-intervention visits separated by at least three weeks.</time_frame>
        <population>Valid post-intervention PM2.5 measures captured for 123 of 143 households</population>
        <group_list>
          <group group_id="O1">
            <title>Education (Tx1)</title>
            <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-intervention Indoor Fine Particulate Matter (PM2.5)</title>
          <description>Post-intervention average Indoor fine particulate matter (PM2.5) concentration</description>
          <population>Valid post-intervention PM2.5 measures captured for 123 of 143 households</population>
          <units>microgram/cubic meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Household</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Household</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8" spread="33.9"/>
                    <measurement group_id="O2" value="30.5" spread="51.5"/>
                    <measurement group_id="O3" value="41.6" spread="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in indoor PM2.5 concentration for Education group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.88</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.6</ci_lower_limit>
            <ci_upper_limit>42.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pre- to post-intervention change in indoor PM2.5 concentration for Filter group relative to Placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-50.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-66.1</ci_lower_limit>
            <ci_upper_limit>-27.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Two consecutive winter periods, approximately 16 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Education (Tx1)</title>
          <description>Education on best burn practices&#xD;
Education (Tx1): Education on best burn practices</description>
        </group>
        <group group_id="E2">
          <title>Air Filtration Unit Treatment (Tx2)</title>
          <description>A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove</description>
        </group>
        <group group_id="E3">
          <title>Placebo Intervention (Tx3)</title>
          <description>A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): A 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
              </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>Curtis Noonan</name_or_title>
      <organization>University of Montana</organization>
      <phone>406-243-4957</phone>
      <email>curtis.noonan@umontana.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/NCT02240069
org study id: IRB 218-12
secondary id: R01ES022583
nct id: NCT02240069
lead sponsor: 
collaborator: 
has dmc: No
A critical need exists for efficient community-based interventions aimed at reduction of
      environmental exposures relevant to health. Biomass smoke exposures due to residential wood
      heating are common among rural Native American communities, and such exposures have been
      associated with respiratory disease in susceptible populations. In many of these communities
      wood stoves are the most economic and traditionally preferred method of residential heating,
      but resource scarcity can result in burning of improper wood fuels and corresponding high
      levels of indoor particulate matter. Community-based participatory research techniques will
      be used to adapt intervention approaches to meet the cultural context of each participating
      community. At the community level, investigators will facilitate local development of a
      tribal agency-led wood bank program ensuring that elderly and/or persons with need have
      access to dry wood for heating. At the household level, investigators will use a three arm
      randomized placebo-controlled intervention trial to implement and assess education/outreach
      on best burn practices (Tx1). The content and delivery strategies of the education
      intervention will be adapted to each community according to stakeholder input. This
      educational intervention will be evaluated against an indoor air filtration unit arm (Tx2),
      as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the
      other two treatment arms to evaluate the penetration and efficacy of the community-level wood
      bank program. Outcomes will be evaluated with respect to changes in pulmonary function
      measures and respiratory symptoms and conditions among household elders. The investigators
      hypothesize that locally-designed education-based interventions at the community and
      household levels will result in efficacious and sustainable strategies for reducing personal
      exposures to indoor particulate matter, and lead to respiratory health improvements in
      elderly Native populations. This study will advance knowledge of cost-effective environmental
      interventions within two unique Native American communities, and inform sustainable
      multi-level strategies in similar communities throughout the US to improve respiratory health
      among at-risk populations.
Rural Native American (NA) communities experience disproportionate disease burden compared to
      other US populations, with poor indoor air quality resulting from in-home biomass smoke
      exposures (residential wood stoves) a likely contributor to these health burden
      discrepancies. Epidemiological studies support the etiological association between indoor
      biomass smoke exposure and several domains of global disease burden, particularly with
      respect to pediatric respiratory tract infections and adult chronic obstructive pulmonary
      disease (COPD) and chronic bronchitis. Elderly populations are particularly susceptible to
      chronic respiratory conditions, and declining pulmonary function is associated with increased
      morbidity and mortality. Randomized trials in developing countries have demonstrated the
      impact that improved cookstove technologies have in reducing biomass smoke exposures and
      children's risk of acute respiratory infection. However limited knowledge is available
      regarding the potential improvements in NA elderly populations following wood stove
      interventions.

      Today, a critical need exists for efficient community-based interventions aimed at promoting
      healthy indoor environments in at-risk communities. Financial and logistical barriers that
      currently exist in rural and economically disadvantaged NA communities prohibit the
      implementation and sustainability of many environmental health interventions. Regarding wood
      stoves, qualitative input from experts and Native communities underscores the need for
      innovative low-cost, sustainable interventions targeting the reduction of in-home biomass
      smoke exposures. In this proposal, investigators will test community-level and
      education-based household-level strategies aimed at promoting and implementing best-burn
      practices to improve air quality and respiratory health in at-risk elderly populations.

      This proposal represents a multidisciplinary collaboration between university and tribal
      stakeholders from two Native American Reservations to develop, adapt, implement, and evaluate
      a two-level intervention to reduce exposure to indoor biomass smoke and improve respiratory
      health among elderly tribal members. Community-based participatory research techniques will
      be used to adapt intervention approaches to meet the cultural context of each participating
      community. At the community level, investigators will facilitate local development of tribal
      agency-led wood yard and distribution programs ensuring that elderly and/or persons with need
      have access to dry wood for heating. With community advisory guidance, investigators will use
      a three arm randomized placebo-controlled intervention trial to implement and assess
      education on best burn practices (Tx1) at the household level. This educational intervention
      will be evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm
      (Tx3, sham air filters). Tx3 will be used in comparison with the other two treatment arms to
      evaluate the penetration and efficacy of the community-level fuel program. Outcomes will be
      evaluated with respect to changes in markers of respiratory health among elders and changes
      in indoor air quality (PM2.5). The investigators hypothesize that locally-designed
      education-based interventions, in the context of a community-based strategy focused on wood
      fuels, will result in efficacious and sustainable strategies for reducing personal exposures
      to indoor biomass smoke PM2.5 and lead to respiratory health improvements in elderly NA
      populations.

      Specific Aims are as follows:

      Aim 1. Facilitate the tribally-centered development, adaption, implementation, and evaluation
      of community-level wood yard and distribution programs for participating tribal households.

      Aim 2. Facilitate the development, adaptation, implementation, and evaluation of
      household-level education strategies targeting best-burn practices (Tx1) for each
      participating tribal community.

      Aim 3. Compare effectiveness, both within and between communities, of household-level
      interventions among elderly adults participating in a three-arm randomized placebo-controlled
      trial.

      Aim 3a. Compare group changes in pulmonary function and respiratory symptoms and infections.

      Aim 3b. Compare group changes in indoor and personal PM2.5 exposures.

      Aim 4. Evaluate penetration, acceptance, and sustainability of community- and household-level
      strategies using both qualitative and quantitative data generated in collaboration with
      tribal community advisory boards and research participants.

      Impact. The long-term goal of this project will be to reduce mortality and morbidity in NA
      communities from exposures related to residential home heating. This study will advance
      knowledge of effective interventions within two unique NA Reservations and describe
      improvements in sub-clinical indicators of pulmonary health in susceptible elderly
      populations. Reducing in-home wood smoke exposures through community level facilitation of
      access to proper fuels and introduction of sustainable, culturally appropriate best-burn
      practices will inform strategies for translation to other NA communities or similar rural and
      underserved populations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Post-intervention FEV1
time frame: Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
description: Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters
measure: Post-intervention FVC
time frame: Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
description: Mean of up to two post-intervention measures of forced vital capacity (FVC), liters
measure: Post-intervention FEV1/FVC Ratio
time frame: Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
description: Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)
measure: Post-intervention Systolic Blood Pressure
time frame: Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
description: Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)
measure: Post-intervention Diastolic Blood Pressure
time frame: Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
description: Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)
measure: Post-intervention Indoor Fine Particulate Matter (PM2.5)
time frame: Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Indoor 48-hour PM2.5 average concentration was measured at two post-intervention visits separated by at least three weeks.
description: Post-intervention average Indoor fine particulate matter (PM2.5) concentration
arm group label: Education (Tx1)
arm group type: Experimental
description: Education on best burn practices
arm group label: Air Filtration Unit Treatment (Tx2)
arm group type: Active Comparator
description: A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.
arm group label: Placebo Intervention (Tx3)
arm group type: Sham Comparator
description: A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.
intervention type: Behavioral
intervention name: Education (Tx1)
description: Education on best burn practices
arm group label: Education (Tx1)
intervention type: Device
intervention name: Air Filtration Unit Treatment (Tx2)
description: A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove
arm group label: Air Filtration Unit Treatment (Tx2)
intervention type: Device
intervention name: Placebo Intervention (Tx3)
description: A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.
arm group label: Placebo Intervention (Tx3)
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Curtis W Noonan, Ph.D.
role: Principal Investigator
affiliation: University of Montana
last name: Annie Belcourt, Ph.D.
role: Principal Investigator
affiliation: University of Montana
last name: Tony J Ward, Ph.D.
role: Principal Investigator
affiliation: University of Montana
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Montana
investigator full name: Curtis Noonan
investigator title: Principal Investigator, Professor
mesh term: Respiratory Tract Infections
mesh term: Respiration Disorders
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 