Cardiopulmonary Outcomes and Household Air Pollution Trial

Blood Pressure Clinical Trial

— CHAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994680
• Other study ID #: IRB00007128
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2020
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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:
• 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.
• 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)

Locations

Country	Name	City	State
Peru	Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University	Puno

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Asociacion Benefica Prisma, Emory University, Universidad Peruana Cayetano Heredia, University of Georgia, Washington University School of Medicine

Country where clinical trial is conducted

Peru, 

References & Publications (1)

Fandiño-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Particulate matter of 2.5 µm in size (household air pollutant)	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.	One year
Primary	Carbon monoxide (household air pollutant)	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.	One year
Primary	Blood pressure (cardiovascular health endpoint)	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.	One year
Primary	Flow mediated dilation (cardiovascular health endpoint)	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.	One year
Primary	Carotid intima media thickness (cardiovascular health endpoint)	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.	One year
Primary	Respiratory symptoms (respiratory health endpoint)	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.	One year
Primary	Peak expiratory flow (respiratory health endpoint)	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.	One year
Primary	Forced expiratory volume at one second (respiratory health endpoint)	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.	One year
Secondary	Quality-adjusted life years	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.	One year
Secondary	Inflammatory metabolites	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.	One year
Secondary	Compliance with stove use	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.	One year
Secondary	Exhaled carbon monoxide	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.	One year
Secondary	Diet	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.	One year
Secondary	Urinary sodium	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.	One year
Secondary	Percentage of households with sustained LPG stove use in intervention arm	Hypothesis: Participants in the intervention arm will continue to use their LPG stoves without stove stacking in the year following the intervention.	One year
Secondary	Percentage of households who adopted LPG stove use in the control arm	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.	One year