Skip to main content
OpenTrials
Completed

NCT Number: NCT02994680

Cardiopulmonary Outcomes and Household Air Pollution Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Pressure Carotid Intima Media Thickness Endothelial Function Pathological Conditions, Signs and Symptoms Respiratory Function Tests Signs and Symptoms Signs and Symptoms, Respiratory

Age range

25 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University

Puno, Peru

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three-burner LPG stove

Device

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

Delivery of LPG tanks

Other

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 names: propane tank

Vouchers for LPG tanks

Other

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 names: coupon

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Asociacion Benefica Prisma
  • Emory University
  • Universidad Peruana Cayetano Heredia
  • University of Georgia
  • Washington University School of Medicine

Registry information

Official study title

Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru

Acronym: CHAP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2016
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.