Cardiopulmonary Outcomes and Household Air Pollution Trial

NCT ID: NCT02994680

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2019-02-15

Brief Summary

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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

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators
The clinical team is masked in this study, and a portion of the investigators.

Study Groups

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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.

Group Type EXPERIMENTAL

Three-burner LPG stove

Intervention Type DEVICE

The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.

Delivery of LPG tanks

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Three-burner LPG stove

Intervention Type DEVICE

The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.

Vouchers for LPG tanks

Intervention Type 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)

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type 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)

Intervention Type OTHER

Other Intervention Names

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propane stove SURGE three-burner liquefied petroleum gas stove propane tank coupon

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role collaborator

University of Georgia

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role collaborator

Asociacion Benefica Prisma

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William N Checkley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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

Puno, , Peru

Site Status

Countries

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Peru

References

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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.

Reference Type BACKGROUND
PMID: 29100550 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35549716 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33306939 (View on PubMed)

Other Identifiers

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IRB00007128

Identifier Type: -

Identifier Source: org_study_id

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