<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/NCT01686867</url>
  </required_header>
  <id_info>
    <org_study_id>COCINAS</org_study_id>
    <secondary_id>HHSN268200900033C</secondary_id>
    <nct_id>NCT01686867</nct_id>
  </id_info>
  <brief_title>Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries</brief_title>
  <official_title>Feasibility Intervention Trial of Two Types of Improved Cookstoves in Three Developing Countries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Moi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asociacion Benefica Prisma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nepal Nutrition Intervention Project Sarlahi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The underlying concept behind this feasibility trial is to achieve a reduction in indoor&#xD;
      smoke from biomass fuels and minimize changes in cooking practices such that it prompts one&#xD;
      of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel&#xD;
      sources used in developing countries include wood, dried dung, and agricultural waste. The&#xD;
      investigators propose to reduce indoor air pollution by replacing the household traditional&#xD;
      cookstove with an improved design that incorporates the following key elements:&#xD;
&#xD;
        -  Burner openings customized to the size and shape of the cooking vessels in the home.&#xD;
&#xD;
        -  Flue designed to draw air into the fire box under the cooking pots and pass it out&#xD;
           through a chimney.&#xD;
&#xD;
        -  A chimney with adequate height to create a draft and vented to the exterior.&#xD;
&#xD;
        -  An exterior port that has bidirectional openings to prevent backflow of smoke.&#xD;
&#xD;
        -  An access port for the chimney that permits cleaning of soot.&#xD;
&#xD;
      The investigators propose to use two types of improved cookstoves that meet these criteria.&#xD;
      As part of piloting activities, the investigators will test several different types of&#xD;
      commercially-available cookstoves with a chimney, and we may also want to test a locally-made&#xD;
      improved cookstove. The investigators want to evaluate those designs by comparing their&#xD;
      ability to reduce indoor air pollution, the reliability between cookstoves of the same type,&#xD;
      the functioning over time, the logistics of import/build locally, preferences and cultural&#xD;
      compatibility, and costs. The investigators will select two types of improved cookstoves to&#xD;
      use in the feasibility trial.&#xD;
&#xD;
      The study design will be a crossover intervention trial in which all patients will first have&#xD;
      a run-in observational period of 4 months with the traditional cookstove prior to&#xD;
      randomization. At baseline, the investigators will obtain sociodemographic information for&#xD;
      each household, respiratory outcomes and other health data for the participating women, and&#xD;
      cooking times and practices including the types of fuels used. All 40 patients at each site&#xD;
      will receive the two types of improved cookstoves, one after the other: 20 will be randomized&#xD;
      to receive the first type of cookstove with a chimney and the other 20 to first receive the&#xD;
      second type of improved cookstove with a chimney. The patients will be followed for 4 months&#xD;
      before the crossover. The investigators will assess cooking behavioral practices and&#xD;
      compliance with cookstove use monthly, and respiratory and environmental measures at the&#xD;
      mid-point of the 4 month period to minimize carry-over effects. At the end of second 4 month&#xD;
      period, the investigators will switch the order of the improved cookstoves and follow all&#xD;
      participants for another 4 months. The investigators will assess behavior, compliance,&#xD;
      respiratory and environmental measures as above. The study is expected to require 12 months&#xD;
      to complete.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exposure to biomass fuel combustion</measure>
    <time_frame>One year</time_frame>
    <description>Measure change in levels of particulate matter concentrations and carbon monoxide between traditional cookstoves and improved, ventilated cookstoves in households in three rural populations in which biomass fuels are used almost exclusively for cooking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Outcomes</measure>
    <time_frame>One year</time_frame>
    <description>Measure change in respiratory outcomes (spirometry for FEV1 and peak expiratory flow, carboxyhemoglobin and DLCO) in women aged 20 to 49 years in three rural populations between traditional cookstoves and the improved, ventilated cookstoves.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adoption process of improved cookstoves</measure>
    <time_frame>One year</time_frame>
    <description>Assess behaviors and attitudes in women 20-49 years of age in three rural populations regarding the adoption and continued use of improved cookstoves and evaluate the reasons for their preferred choice of cookstove at the end of the trial. Methodology includes: patient direct observations, in-depth interviews, semi-structured interviews and focus groups with study staff.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>One year</time_frame>
    <description>Measure change in blood pressure in women 20 to 49 years of age in three rural populations between traditional cookstoves and improved, ventilated cookstoves.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Poisoning by Carbon Monoxide From Domestic Fuels</condition>
  <condition>Respiratory Conditions Due to Other External Agents</condition>
  <arm_group>
    <arm_group_label>Commercially-made followed by locally-made improved cookstove</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. Four months later the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Locally-made followed by commercially-made improved cookstove</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. Four months later the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Improved, ventilated cookstove</intervention_name>
    <description>An improved, ventilated cookstove incorporates the following key elements: burner openings customized to the size and shape of the cooking utensils; a flue designed to draw air into the fire box and pass it out through a chimney; a chimney, vented to the exterior, of adequate height to create a draft; an exterior port that has bidirectional openings to prevent the backflow of smoke and an access port for the chimney that permits cleaning.&#xD;
The investigators piloted cookstoves prior to the trial and compared their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functionality over time, preferences and cultural compatibility, and cost. The investigators selected the the Envirofit G-3300/3355, a modified Stovetec cookstove with a chimney and a locally-made improved, ventilated cookstove for use in the trial.</description>
    <arm_group_label>Commercially-made followed by locally-made improved cookstove</arm_group_label>
    <arm_group_label>Locally-made followed by commercially-made improved cookstove</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have at least one woman aged 20 to 49 years who is the main cook.&#xD;
&#xD;
          -  Have a traditional (i.e., open-fire) cookstove indoors with at least 3 walls and a&#xD;
             roof.&#xD;
&#xD;
          -  Are willing to have us install an improved cookstove and be willing to use it.&#xD;
&#xD;
          -  Have household walls of mud, brick, cement, or wood.&#xD;
&#xD;
          -  Capable of providing informed consent and responding to a questionnaire&#xD;
&#xD;
          -  Full-time resident in the area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a new improved cookstove or a chimney in the household.&#xD;
&#xD;
          -  Have household walls of thatch or bamboo no covered in mud.&#xD;
&#xD;
          -  Plans to move from the area within one year.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Checkley, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Moi University</name>
      <address>
        <city>Eldoret</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nepal Nutrition Intervention Project - Sarlahi (NNIPS)</name>
      <address>
        <city>Kathmandu</city>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.B. Prisma</name>
      <address>
        <city>Ayacucho</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
    <country>Nepal</country>
    <country>Peru</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>April 1, 2015</last_update_submitted>
  <last_update_submitted_qc>April 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins Bloomberg School of Public Health</investigator_affiliation>
    <investigator_full_name>William Checkley</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>improved cookstove</keyword>
  <keyword>ventilated cookstove</keyword>
  <keyword>behavior change</keyword>
  <keyword>adoption</keyword>
  <keyword>indoor air pollution</keyword>
  <keyword>DLCO</keyword>
  <keyword>spirometry</keyword>
  <keyword>biomass fuel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
    <mesh_term>Carbon Monoxide Poisoning</mesh_term>
  </condition_browse>
  <!-- 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/NCT01686867
org study id: COCINAS
secondary id: HHSN268200900033C
nct id: NCT01686867
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The underlying concept behind this feasibility trial is to achieve a reduction in indoor
      smoke from biomass fuels and minimize changes in cooking practices such that it prompts one
      of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel
      sources used in developing countries include wood, dried dung, and agricultural waste. The
      investigators propose to reduce indoor air pollution by replacing the household traditional
      cookstove with an improved design that incorporates the following key elements:

        -  Burner openings customized to the size and shape of the cooking vessels in the home.

        -  Flue designed to draw air into the fire box under the cooking pots and pass it out
           through a chimney.

        -  A chimney with adequate height to create a draft and vented to the exterior.

        -  An exterior port that has bidirectional openings to prevent backflow of smoke.

        -  An access port for the chimney that permits cleaning of soot.

      The investigators propose to use two types of improved cookstoves that meet these criteria.
      As part of piloting activities, the investigators will test several different types of
      commercially-available cookstoves with a chimney, and we may also want to test a locally-made
      improved cookstove. The investigators want to evaluate those designs by comparing their
      ability to reduce indoor air pollution, the reliability between cookstoves of the same type,
      the functioning over time, the logistics of import/build locally, preferences and cultural
      compatibility, and costs. The investigators will select two types of improved cookstoves to
      use in the feasibility trial.

      The study design will be a crossover intervention trial in which all patients will first have
      a run-in observational period of 4 months with the traditional cookstove prior to
      randomization. At baseline, the investigators will obtain sociodemographic information for
      each household, respiratory outcomes and other health data for the participating women, and
      cooking times and practices including the types of fuels used. All 40 patients at each site
      will receive the two types of improved cookstoves, one after the other: 20 will be randomized
      to receive the first type of cookstove with a chimney and the other 20 to first receive the
      second type of improved cookstove with a chimney. The patients will be followed for 4 months
      before the crossover. The investigators will assess cooking behavioral practices and
      compliance with cookstove use monthly, and respiratory and environmental measures at the
      mid-point of the 4 month period to minimize carry-over effects. At the end of second 4 month
      period, the investigators will switch the order of the improved cookstoves and follow all
      participants for another 4 months. The investigators will assess behavior, compliance,
      respiratory and environmental measures as above. The study is expected to require 12 months
      to complete.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Exposure to biomass fuel combustion
time frame: One year
description: Measure change in levels of particulate matter concentrations and carbon monoxide between traditional cookstoves and improved, ventilated cookstoves in households in three rural populations in which biomass fuels are used almost exclusively for cooking.
measure: Respiratory Outcomes
time frame: One year
description: Measure change in respiratory outcomes (spirometry for FEV1 and peak expiratory flow, carboxyhemoglobin and DLCO) in women aged 20 to 49 years in three rural populations between traditional cookstoves and the improved, ventilated cookstoves.
measure: Adoption process of improved cookstoves
time frame: One year
description: Assess behaviors and attitudes in women 20-49 years of age in three rural populations regarding the adoption and continued use of improved cookstoves and evaluate the reasons for their preferred choice of cookstove at the end of the trial. Methodology includes: patient direct observations, in-depth interviews, semi-structured interviews and focus groups with study staff.
measure: Blood pressure
time frame: One year
description: Measure change in blood pressure in women 20 to 49 years of age in three rural populations between traditional cookstoves and improved, ventilated cookstoves.
arm group label: Commercially-made followed by locally-made improved cookstove
arm group type: Experimental
description: Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. Four months later the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.
arm group label: Locally-made followed by commercially-made improved cookstove
arm group type: Experimental
description: Following a four month run-in period using their traditional, open-fire cookstoves, the investigators will install a locally-made improved, ventilated cookstove in each patient's kitchen. Four months later the investigators will install a commercially-made improved, ventilated cookstove (Envirofit G-3300/G-3355) in each patient's kitchen. During each of the two periods, the investigators will request that the patient uses the improved, ventilated cookstove installed for that period.
intervention type: Device
intervention name: Improved, ventilated cookstove
description: An improved, ventilated cookstove incorporates the following key elements: burner openings customized to the size and shape of the cooking utensils; a flue designed to draw air into the fire box and pass it out through a chimney; a chimney, vented to the exterior, of adequate height to create a draft; an exterior port that has bidirectional openings to prevent the backflow of smoke and an access port for the chimney that permits cleaning.
The investigators piloted cookstoves prior to the trial and compared their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functionality over time, preferences and cultural compatibility, and cost. The investigators selected the the Envirofit G-3300/3355, a modified Stovetec cookstove with a chimney and a locally-made improved, ventilated cookstove for use in the trial.
arm group label: Commercially-made followed by locally-made improved cookstove
arm group label: Locally-made followed by commercially-made improved cookstove
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Checkley, MD, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
facility: 
facility: 
country: Kenya
country: Nepal
country: Peru
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins Bloomberg School of Public Health
investigator full name: William Checkley
investigator title: Assistant Professor
mesh term: Poisoning
mesh term: Carbon Monoxide Poisoning