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Cardiopulmonary Outcomes and Household Air Pollution Trial (CHAP)

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ClinicalTrials.gov Identifier: NCT02994680
Recruitment Status : Active, not recruiting
First Posted : December 16, 2016
Last Update Posted : February 28, 2018
Sponsor:
Collaborators:
Washington University School of Medicine
University of Georgia
Emory University
Universidad Peruana Cayetano Heredia
Asociación Benéfica Prisma
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Pressure Carotid Intima Media Thickness Endothelial Function Signs and Symptoms, Respiratory Respiratory Function Tests Device: Three-burner LPG stove Other: Delivery of LPG tanks Other: Vouchers for LPG tanks Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: The clinical team is masked in this study, and a portion of the investigators.
Primary Purpose: Prevention
Official Title: Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention arm

Will receive:

  1. Three-burner LPG stove (at enrollment)
  2. 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.

Device: Three-burner LPG stove
The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.
Other Names:
  • propane stove
  • SURGE three-burner liquefied petroleum gas stove

Other: Delivery of LPG tanks
One year supply of LPG fuel, in the form of delivery of 20 kg tank that holds 10 kg of LPG. Delivered to homes.
Other Name: propane tank

Active Comparator: Control arm

Will receive:

  1. Three-burner LPG stove (one year after enrollment)
  2. 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.

Device: Three-burner LPG stove
The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.
Other Names:
  • propane stove
  • SURGE three-burner liquefied petroleum gas stove

Other: Vouchers for LPG tanks
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)
Other Name: coupon




Primary Outcome Measures :
  1. Particulate matter of 2.5 μm in size (household air pollutant) [ Time Frame: One year ]

    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.


  2. Carbon monoxide (household air pollutant) [ Time Frame: One year ]

    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.


  3. Blood pressure (cardiovascular health endpoint) [ Time Frame: One year ]

    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.


  4. Flow mediated dilation (cardiovascular health endpoint) [ Time Frame: One year ]

    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.


  5. Carotid intima media thickness (cardiovascular health endpoint) [ Time Frame: One year ]

    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.


  6. Respiratory symptoms (respiratory health endpoint) [ Time Frame: One year ]

    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.


  7. Peak expiratory flow (respiratory health endpoint) [ Time Frame: One year ]

    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.


  8. Forced expiratory volume at one second (respiratory health endpoint) [ Time Frame: One year ]

    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.



Secondary Outcome Measures :
  1. Quality-adjusted life years [ Time Frame: One year ]

    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.


  2. Inflammatory metabolites [ Time Frame: One year ]

    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.


  3. Compliance with stove use [ Time Frame: One year ]
    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.

  4. Exhaled carbon monoxide [ Time Frame: One year ]

    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.


  5. Diet [ Time Frame: One year ]

    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.


  6. Urinary sodium [ Time Frame: One year ]

    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.


  7. Percentage of households with sustained LPG stove use in intervention arm [ Time Frame: One year ]
    Hypothesis: Participants in the intervention arm will continue to use their LPG stoves without stove stacking in the year following the intervention.

  8. Percentage of households who adopted LPG stove use in the control arm [ Time Frame: One year ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Full-time resident ≥6 months in current location
  • Capable of understanding procedures
  • Capable of providing informed consent and responding to a questionnaire
  • Primary household cook
  • Currently using a traditional stove as primary stove for cooking
  • Cooking room/area separate from sleeping room/area to minimize probability of use of biomass fuel stoves for heating living space.

Exclusion Criteria:

  • Plans to move from the area within one year
  • Uncontrolled hypertension
  • Diagnosis of chronic obstructive pulmonary disease (COPD)
  • Pregnant or planning pregnancy in the next year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994680


Locations
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Peru
Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University
Puno, Peru
Sponsors and Collaborators
Johns Hopkins University
Washington University School of Medicine
University of Georgia
Emory University
Universidad Peruana Cayetano Heredia
Asociación Benéfica Prisma
Investigators
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Principal Investigator: William N Checkley, MD, PhD Associate Professor

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02994680     History of Changes
Other Study ID Numbers: IRB00007128
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual patient data (IPD).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Air Pollution
Liquefied Petroleum Gas
Cookstove
Behavioral Intervention
Propane Stove

Additional relevant MeSH terms:
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Signs and Symptoms
Signs and Symptoms, Respiratory