<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/NCT02994680</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00007128</org_study_id>
    <nct_id>NCT02994680</nct_id>
  </id_info>
  <brief_title>Cardiopulmonary Outcomes and Household Air Pollution Trial</brief_title>
  <acronym>CHAP</acronym>
  <official_title>Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Georgia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asociacion Benefica Prisma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</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 purpose of this randomized controlled field trial is to determine whether a liquefied&#xD;
      petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen&#xD;
      exposure to household air pollutants and improves cardiopulmonary health outcomes when&#xD;
      compared to usual cooking practices with open-fire biomass-burning stoves in adult women aged&#xD;
      25-64 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, controlled field trial of an LPG stove and fuel distribution intervention&#xD;
      compared to standard cooking practices with open-fire biomass-burning stoves in the homes of&#xD;
      participating adult women aged 25-64 years. The aim is to determine whether provision of&#xD;
      cleaner fuels will result in important reductions in household air pollutants and&#xD;
      consequently in an improvement in cardiopulmonary health outcomes over a one-year period.&#xD;
      Participants randomly assigned to the intervention arm will receive a free LPG stove and fuel&#xD;
      delivered to their homes during the one-year intervention period. Participants randomly&#xD;
      assigned to the control arm will receive a free LPG stove and vouchers that can be used to&#xD;
      obtain free fuel for an entire year at LPG fuel distribution centers at the end of the&#xD;
      one-year intervention period. All participants will be followed for a second year to assess&#xD;
      patterns and impacts of sustained use (intervention arm) and initial adoption (control arm).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</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>Double (Care Provider, Investigator)</masking>
    <masking_description>The clinical team is masked in this study, and a portion of the investigators.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Particulate matter of 2.5 μm in size (household air pollutant)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate sustained reductions in personal and kitchen particulate matter concentrations after distribution of an LPG stove and fuel tanks twice monthly over a one-year period.&#xD;
Hypothesis: Use of LPG stoves for cooking by participants in the intervention arm will result in a sustained reduction in personal and kitchen air pollutant concentrations when compared to those with the control arm during the one year intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbon monoxide (household air pollutant)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate sustained reductions in personal and kitchen carbon monoxide concentrations after distribution of an LPG stove and fuel tanks twice monthly over a one-year period.&#xD;
Hypothesis: Use of LPG stoves for cooking by participants in the intervention arm will result in a sustained reduction in personal and kitchen carbon monoxide concentrations when compared to those with the control arm during the one year intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure (cardiovascular health endpoint)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate sustained reduction in blood pressure after LPG stove intervention.&#xD;
Hypothesis: Women in the intervention arm will have lower blood pressure when compared with those in the control arm during the one year intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flow mediated dilation (cardiovascular health endpoint)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate a sustained improvement in endothelial function after LPG stove intervention.&#xD;
Hypothesis: Women in the intervention arm will have better endothelial function as measured by flow mediated dilation when compared with those in the control arm during the one year intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carotid intima media thickness (cardiovascular health endpoint)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate lower progression in carotid intima media thickness after LPG stove intervention.&#xD;
Hypothesis: Women in the intervention arm will have a lower rate of atherosclerosis progression as measured by carotid artery ultrasound assessment of the carotid intima-media complex over a one-year period when compared with those in the control arm during the one year intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory symptoms (respiratory health endpoint)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate sustained reduction in respiratory symptoms after LPG stove intervention.&#xD;
Hypothesis: Women in the intervention arm will have fewer respiratory symptoms as measured by a lower St. Georges Respiratory Symptoms Questionnaire score when compared with those in the control arm during the one year intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak expiratory flow (respiratory health endpoint)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate sustained improvement in peak expiratory flow after LPG stove intervention.&#xD;
Hypothesis: Women in the intervention arm will have a higher peak expiratory flow as measured by spirometry when compared with those in the control arm during the one year intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced expiratory volume at one second (respiratory health endpoint)</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate higher forced expiratory volumes at one second after LPG stove intervention.&#xD;
Hypothesis: Women in the intervention arm will have higher height- and age-adjusted, pre- and post-bronchodilator forced expiratory volume at one second as measured by spirometry over a one-year period when compared with those in the control arm during the one year intervention period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality-adjusted life years</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate improvements in quality of life scores after LPG stove intervention, as calculated by the Short Form-36 questionnaire.&#xD;
Hypothesis: Women in the intervention arm will have better quality of life related score than those in the control arm at the end of the one year intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory metabolites</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate reductions in inflammatory metabolites measured in urine and dot blood samples after LPG stove intervention.&#xD;
Hypothesis: Women in the intervention arm will have lower concentrations of inflammatory metabolites in urine and dot blood samples when compared to those in the control arm during the one year intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with stove use</measure>
    <time_frame>One year</time_frame>
    <description>Hypothesis: Stove use monitors will demonstrate &gt;90% compliance with LPG stove use during the one-year intervention period in the LPG stoves of participants in the intervention arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exhaled carbon monoxide</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Demonstrate sustained lower exhaled carbon monoxide concentrations during the one-year intervention period.&#xD;
Hypothesis: Personal exhaled carbon monoxide concentrations will be lower in participants in the intervention arm when compared to those in the control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Document changes in diet after LPG stove intervention, as measured by 24-hour recalls.&#xD;
Hypothesis: Women in the intervention arm will have a better diet than those in the control arm during the one year intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary sodium</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Document changes in salt intake after LPG stove intervention, as measured by 24-hour recalls.&#xD;
Hypothesis: Women in the intervention arm will have lower urinary sodium than those in the control arm after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of households with sustained LPG stove use in intervention arm</measure>
    <time_frame>One year</time_frame>
    <description>Hypothesis: Participants in the intervention arm will continue to use their LPG stoves without stove stacking in the year following the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of households who adopted LPG stove use in the control arm</measure>
    <time_frame>One year</time_frame>
    <description>Specific Aim: Characterize the percentage of participants in control arm who decided to adopt LPG stove use one year after the intervention.&#xD;
Hypothesis: Participants in the control arm will adopt LPG stoves without stove stacking in the year following the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Carotid Intima Media Thickness</condition>
  <condition>Endothelial Function</condition>
  <condition>Signs and Symptoms, Respiratory</condition>
  <condition>Respiratory Function Tests</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive:&#xD;
Three-burner LPG stove (at enrollment)&#xD;
Delivery of LPG tanks (beginning at enrollment for one year)&#xD;
The study will be conducted over three years, with staggered enrollment over one year, one year of observations during the intervention period, and one year of follow-up observations after the intervention period for each participant.&#xD;
Participants in the intervention arm will receive an LPG stove upon enrollment and the research team will deliver fuel twice monthly to their homes during the first year. Participants in the intervention arm will not receive fuel during the second year, but researchers will encourage these participants to continue using LPG fuel for cooking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive:&#xD;
Three-burner LPG stove (one year after enrollment)&#xD;
Vouchers for LPG tanks (one year after enrollment)&#xD;
Participants in the control arm but will not receive an LPG stove or fuel during the first year. Instead, participants will receive an LPG stove at the end of the first year and vouchers to obtain free fuel at distribution centers during the course of the second year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Three-burner LPG stove</intervention_name>
    <description>The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.</description>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_label>Intervention arm</arm_group_label>
    <other_name>propane stove</other_name>
    <other_name>SURGE three-burner liquefied petroleum gas stove</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Delivery of LPG tanks</intervention_name>
    <description>One year supply of LPG fuel, in the form of delivery of 20 kg tank that holds 10 kg of LPG. Delivered to homes.</description>
    <arm_group_label>Intervention arm</arm_group_label>
    <other_name>propane tank</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vouchers for LPG tanks</intervention_name>
    <description>One year supply of LPG, in the form of vouchers to obtain a free LPG tanks from a distribution center. (Beginning one year after enrollment, for one year)</description>
    <arm_group_label>Control arm</arm_group_label>
    <other_name>coupon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Full-time resident ≥6 months in current location&#xD;
&#xD;
          -  Capable of understanding procedures&#xD;
&#xD;
          -  Capable of providing informed consent and responding to a questionnaire&#xD;
&#xD;
          -  Primary household cook&#xD;
&#xD;
          -  Currently using a traditional stove as primary stove for cooking&#xD;
&#xD;
          -  Cooking room/area separate from sleeping room/area to minimize probability of use of&#xD;
             biomass fuel stoves for heating living space.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Plans to move from the area within one year&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Diagnosis of chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Pregnant or planning pregnancy in the next year&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William N Checkley, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University</name>
      <address>
        <city>Puno</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <reference>
    <citation>Fandino-Del-Rio M, Goodman D, Kephart JL, Miele CH, Williams KN, Moazzami M, Fung EC, Koehler K, Davila-Roman VG, Lee KA, Nangia S, Harvey SA, Steenland K, Gonzales GF, Checkley W; Cardiopulmonary outcomes and Household Air Pollution trial (CHAP) Trial Investigators. Effects of a liquefied petroleum gas stove intervention on pollutant exposure and adult cardiopulmonary outcomes (CHAP): study protocol for a randomized controlled trial. Trials. 2017 Nov 3;18(1):518. doi: 10.1186/s13063-017-2179-x.</citation>
    <PMID>29100550</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Air Pollution</keyword>
  <keyword>Liquefied Petroleum Gas</keyword>
  <keyword>Cookstove</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Propane Stove</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Signs and Symptoms, Respiratory</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual patient data (IPD).</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/NCT02994680
org study id: IRB00007128
nct id: NCT02994680
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized controlled field trial is to determine whether a liquefied
      petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen
      exposure to household air pollutants and improves cardiopulmonary health outcomes when
      compared to usual cooking practices with open-fire biomass-burning stoves in adult women aged
      25-64 years.
Randomized, controlled field trial of an LPG stove and fuel distribution intervention
      compared to standard cooking practices with open-fire biomass-burning stoves in the homes of
      participating adult women aged 25-64 years. The aim is to determine whether provision of
      cleaner fuels will result in important reductions in household air pollutants and
      consequently in an improvement in cardiopulmonary health outcomes over a one-year period.
      Participants randomly assigned to the intervention arm will receive a free LPG stove and fuel
      delivered to their homes during the one-year intervention period. Participants randomly
      assigned to the control arm will receive a free LPG stove and vouchers that can be used to
      obtain free fuel for an entire year at LPG fuel distribution centers at the end of the
      one-year intervention period. All participants will be followed for a second year to assess
      patterns and impacts of sustained use (intervention arm) and initial adoption (control arm).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Care Provider, Investigator)
masking description: The clinical team is masked in this study, and a portion of the investigators.
measure: Particulate matter of 2.5 μm in size (household air pollutant)
time frame: One year
description: Specific Aim: Demonstrate sustained reductions in personal and kitchen particulate matter concentrations after distribution of an LPG stove and fuel tanks twice monthly over a one-year period.
Hypothesis: Use of LPG stoves for cooking by participants in the intervention arm will result in a sustained reduction in personal and kitchen air pollutant concentrations when compared to those with the control arm during the one year intervention period.
measure: Carbon monoxide (household air pollutant)
time frame: One year
description: Specific Aim: Demonstrate sustained reductions in personal and kitchen carbon monoxide concentrations after distribution of an LPG stove and fuel tanks twice monthly over a one-year period.
Hypothesis: Use of LPG stoves for cooking by participants in the intervention arm will result in a sustained reduction in personal and kitchen carbon monoxide concentrations when compared to those with the control arm during the one year intervention period.
measure: Blood pressure (cardiovascular health endpoint)
time frame: One year
description: Specific Aim: Demonstrate sustained reduction in blood pressure after LPG stove intervention.
Hypothesis: Women in the intervention arm will have lower blood pressure when compared with those in the control arm during the one year intervention period.
measure: Flow mediated dilation (cardiovascular health endpoint)
time frame: One year
description: Specific Aim: Demonstrate a sustained improvement in endothelial function after LPG stove intervention.
Hypothesis: Women in the intervention arm will have better endothelial function as measured by flow mediated dilation when compared with those in the control arm during the one year intervention period.
measure: Carotid intima media thickness (cardiovascular health endpoint)
time frame: One year
description: Specific Aim: Demonstrate lower progression in carotid intima media thickness after LPG stove intervention.
Hypothesis: Women in the intervention arm will have a lower rate of atherosclerosis progression as measured by carotid artery ultrasound assessment of the carotid intima-media complex over a one-year period when compared with those in the control arm during the one year intervention period.
measure: Respiratory symptoms (respiratory health endpoint)
time frame: One year
description: Specific Aim: Demonstrate sustained reduction in respiratory symptoms after LPG stove intervention.
Hypothesis: Women in the intervention arm will have fewer respiratory symptoms as measured by a lower St. Georges Respiratory Symptoms Questionnaire score when compared with those in the control arm during the one year intervention period.
measure: Peak expiratory flow (respiratory health endpoint)
time frame: One year
description: Specific Aim: Demonstrate sustained improvement in peak expiratory flow after LPG stove intervention.
Hypothesis: Women in the intervention arm will have a higher peak expiratory flow as measured by spirometry when compared with those in the control arm during the one year intervention period.
measure: Forced expiratory volume at one second (respiratory health endpoint)
time frame: One year
description: Specific Aim: Demonstrate higher forced expiratory volumes at one second after LPG stove intervention.
Hypothesis: Women in the intervention arm will have higher height- and age-adjusted, pre- and post-bronchodilator forced expiratory volume at one second as measured by spirometry over a one-year period when compared with those in the control arm during the one year intervention period.
measure: Quality-adjusted life years
time frame: One year
description: Specific Aim: Demonstrate improvements in quality of life scores after LPG stove intervention, as calculated by the Short Form-36 questionnaire.
Hypothesis: Women in the intervention arm will have better quality of life related score than those in the control arm at the end of the one year intervention period.
measure: Inflammatory metabolites
time frame: One year
description: Specific Aim: Demonstrate reductions in inflammatory metabolites measured in urine and dot blood samples after LPG stove intervention.
Hypothesis: Women in the intervention arm will have lower concentrations of inflammatory metabolites in urine and dot blood samples when compared to those in the control arm during the one year intervention period.
measure: Compliance with stove use
time frame: One year
description: Hypothesis: Stove use monitors will demonstrate >90% compliance with LPG stove use during the one-year intervention period in the LPG stoves of participants in the intervention arm.
measure: Exhaled carbon monoxide
time frame: One year
description: Specific Aim: Demonstrate sustained lower exhaled carbon monoxide concentrations during the one-year intervention period.
Hypothesis: Personal exhaled carbon monoxide concentrations will be lower in participants in the intervention arm when compared to those in the control arm.
measure: Diet
time frame: One year
description: Specific Aim: Document changes in diet after LPG stove intervention, as measured by 24-hour recalls.
Hypothesis: Women in the intervention arm will have a better diet than those in the control arm during the one year intervention period.
measure: Urinary sodium
time frame: One year
description: Specific Aim: Document changes in salt intake after LPG stove intervention, as measured by 24-hour recalls.
Hypothesis: Women in the intervention arm will have lower urinary sodium than those in the control arm after the intervention.
measure: Percentage of households with sustained LPG stove use in intervention arm
time frame: One year
description: Hypothesis: Participants in the intervention arm will continue to use their LPG stoves without stove stacking in the year following the intervention.
measure: Percentage of households who adopted LPG stove use in the control arm
time frame: One year
description: Specific Aim: Characterize the percentage of participants in control arm who decided to adopt LPG stove use one year after the intervention.
Hypothesis: Participants in the control arm will adopt LPG stoves without stove stacking in the year following the intervention.
arm group label: Intervention arm
arm group type: Experimental
description: Will receive:
Three-burner LPG stove (at enrollment)
Delivery of LPG tanks (beginning at enrollment for one year)
The study will be conducted over three years, with staggered enrollment over one year, one year of observations during the intervention period, and one year of follow-up observations after the intervention period for each participant.
Participants in the intervention arm will receive an LPG stove upon enrollment and the research team will deliver fuel twice monthly to their homes during the first year. Participants in the intervention arm will not receive fuel during the second year, but researchers will encourage these participants to continue using LPG fuel for cooking.
arm group label: Control arm
arm group type: Active Comparator
description: Will receive:
Three-burner LPG stove (one year after enrollment)
Vouchers for LPG tanks (one year after enrollment)
Participants in the control arm but will not receive an LPG stove or fuel during the first year. Instead, participants will receive an LPG stove at the end of the first year and vouchers to obtain free fuel at distribution centers during the course of the second year.
intervention type: Device
intervention name: Three-burner LPG stove
description: The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.
arm group label: Control arm
arm group label: Intervention arm
other name: propane stove
other name: SURGE three-burner liquefied petroleum gas stove
intervention type: Other
intervention name: Delivery of LPG tanks
description: One year supply of LPG fuel, in the form of delivery of 20 kg tank that holds 10 kg of LPG. Delivered to homes.
arm group label: Intervention arm
other name: propane tank
intervention type: Other
intervention name: Vouchers for LPG tanks
description: One year supply of LPG, in the form of vouchers to obtain a free LPG tanks from a distribution center. (Beginning one year after enrollment, for one year)
arm group label: Control arm
other name: coupon
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William N Checkley, MD, PhD
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: Peru
citation: Fandino-Del-Rio M, Goodman D, Kephart JL, Miele CH, Williams KN, Moazzami M, Fung EC, Koehler K, Davila-Roman VG, Lee KA, Nangia S, Harvey SA, Steenland K, Gonzales GF, Checkley W; Cardiopulmonary outcomes and Household Air Pollution trial (CHAP) Trial Investigators. Effects of a liquefied petroleum gas stove intervention on pollutant exposure and adult cardiopulmonary outcomes (CHAP): study protocol for a randomized controlled trial. Trials. 2017 Nov 3;18(1):518. doi: 10.1186/s13063-017-2179-x.
PMID: 29100550
responsible party type: Sponsor
mesh term: Signs and Symptoms, Respiratory
sharing ipd: No
ipd description: There is no plan to share individual patient data (IPD).