NCT02994680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 18, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

October 14, 2022

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

November 28, 2016

Last Update Submit

October 12, 2022

Conditions

Blood PressureCarotid Intima Media ThicknessEndothelial FunctionSigns and Symptoms, RespiratoryRespiratory Function Tests

Keywords

Air PollutionLiquefied Petroleum GasCookstoveBehavioral InterventionPropane Stove

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (8)

  • Quality-adjusted life years

    One year

  • Inflammatory metabolites

    One year

  • Compliance with stove use

    One year

  • Exhaled carbon monoxide

    One year

  • Diet

    One year

  • +3 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

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 stoveOther: Delivery of LPG tanks

Control arm

ACTIVE COMPARATOR

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 stoveOther: Vouchers for LPG tanks

Interventions

Three-burner LPG stoveDEVICE

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

Also known as: propane stove, SURGE three-burner liquefied petroleum gas stove
Control armIntervention arm
Delivery of LPG tanksOTHER

One year supply of LPG fuel, in the form of delivery of 20 kg tank that holds 10 kg of LPG. Delivered to homes.

Also known as: propane tank
Intervention arm
Vouchers for LPG tanksOTHER

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)

Also known as: coupon
Control arm

Eligibility Criteria

Age25 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Puno, Peru

Location

Related Publications (3)

  • 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.

    PMID: 29100550BACKGROUND

  • 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.

    PMID: 35549716DERIVED

  • 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.

    PMID: 33306939DERIVED

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William N Checkley, MD, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
The clinical team is masked in this study, and a portion of the investigators.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 16, 2016

Study Start

January 18, 2017

Primary Completion

February 15, 2019

Study Completion

February 15, 2019

Last Updated

October 14, 2022

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual patient data (IPD).

Locations

PE(1)