Clinical trial NCT02994680: Cardiopulmonary Outcomes and Household Air Pollution Trial
Official title: Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Carotid Intima Media Thickness
Endothelial Function
Signs and Symptoms, Respiratory
Respiratory Function Tests
Keywords: Air Pollution
Liquefied Petroleum Gas
Cookstove
Behavioral Intervention
Propane Stove
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: University of Georgia
name: Emory University
name: Universidad Peruana Cayetano Heredia
name: Asociacion Benefica Prisma
First posted: 2016-12-16
Enrollment: 181
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility 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

Primary outcomes:
measure: Particulate matter of 2.5 μm in size (household air pollutant)
timeFrame: One year
measure: Carbon monoxide (household air pollutant)
timeFrame: One year
measure: Blood pressure (cardiovascular health endpoint)
timeFrame: One year
measure: Flow mediated dilation (cardiovascular health endpoint)
timeFrame: One year
measure: Carotid intima media thickness (cardiovascular health endpoint)
timeFrame: One year
measure: Respiratory symptoms (respiratory health endpoint)
timeFrame: One year
measure: Peak expiratory flow (respiratory health endpoint)
timeFrame: One year
measure: Forced expiratory volume at one second (respiratory health endpoint)
timeFrame: One year
Secondary outcomes:
measure: Quality-adjusted life years
timeFrame: One year
measure: Inflammatory metabolites
timeFrame: One year
measure: Compliance with stove use
timeFrame: One year
measure: Exhaled carbon monoxide
timeFrame: One year
measure: Diet
timeFrame: One year
measure: Urinary sodium
timeFrame: One year
measure: Percentage of households with sustained LPG stove use in intervention arm
timeFrame: One year
measure: Percentage of households who adopted LPG stove use in the control arm
timeFrame: One year
Other outcomes:
Locations:
city: Puno
country: Peru
facility: Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University
Study officials:
affiliation: Associate Professor
name: William N Checkley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: Fandino-Del-Rio M, Kephart JL, Williams KN, Shade T, Adekunle T, Steenland K, Naeher LP, Moulton LH, Gonzales GF, Chiang M, Hossen S, Chartier RT, Koehler K, Checkley W; Cardiopulmonary outcomes and Household Air Pollution (CHAP) Trial Investigators. Household Air Pollution Concentrations after Liquefied Petroleum Gas Interventions in Rural Peru: Findings from a One-Year Randomized Controlled Trial Followed by a One-Year Pragmatic Crossover Trial. Environ Health Perspect. 2022 May;130(5):57007. doi: 10.1289/EHP10054. Epub 2022 May 12.
citation: Checkley W, Williams KN, Kephart JL, Fandino-Del-Rio M, Steenland NK, Gonzales GF, Naeher LP, Harvey SA, Moulton LH, Davila-Roman VG, Goodman D, Tarazona-Meza C, Miele CH, Simkovich S, Chiang M, Chartier RT, Koehler K; CHAP Trial Investigators. Effects of a Household Air Pollution Intervention with Liquefied Petroleum Gas on Cardiopulmonary Outcomes in Peru. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2021 Jun 1;203(11):1386-1397. doi: 10.1164/rccm.202006-2319OC.