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Cardiopulmonary Outcomes and Household Air Pollution Trial (CHAP)

Primary Purpose

Blood Pressure, Carotid Intima Media Thickness, Endothelial Function

Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Three-burner LPG stove
Delivery of LPG tanks
Vouchers for LPG tanks
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure focused on measuring Air Pollution, Liquefied Petroleum Gas, Cookstove, Behavioral Intervention, Propane Stove

Eligibility Criteria

25 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Control arm

Arm Description

Will receive: Three-burner LPG stove (at enrollment) 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.

Will receive: Three-burner LPG stove (one year after enrollment) 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 28, 2016
Last Updated
October 12, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Washington University School of Medicine, University of Georgia, Emory University, Universidad Peruana Cayetano Heredia, Asociacion Benefica Prisma
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1. Study Identification

Unique Protocol Identification Number
NCT02994680
Brief Title
Cardiopulmonary Outcomes and Household Air Pollution Trial
Acronym
CHAP
Official Title
Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Washington University School of Medicine, University of Georgia, Emory University, Universidad Peruana Cayetano Heredia, Asociacion Benefica Prisma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Masking Description
The clinical team is masked in this study, and a portion of the investigators.
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Will receive: Three-burner LPG stove (at enrollment) 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.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Will receive: Three-burner LPG stove (one year after enrollment) 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.
Intervention Type
Device
Intervention Name(s)
Three-burner LPG stove
Other Intervention Name(s)
propane stove, SURGE three-burner liquefied petroleum gas stove
Intervention Description
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
Other
Intervention Name(s)
Delivery of LPG tanks
Other Intervention Name(s)
propane tank
Intervention Description
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
Intervention Name(s)
Vouchers for LPG tanks
Other Intervention Name(s)
coupon
Intervention Description
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)
Primary Outcome Measure Information:
Title
Particulate matter of 2.5 μm in size (household air pollutant)
Description
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.
Time Frame
One year
Title
Carbon monoxide (household air pollutant)
Description
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.
Time Frame
One year
Title
Blood pressure (cardiovascular health endpoint)
Description
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.
Time Frame
One year
Title
Flow mediated dilation (cardiovascular health endpoint)
Description
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.
Time Frame
One year
Title
Carotid intima media thickness (cardiovascular health endpoint)
Description
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.
Time Frame
One year
Title
Respiratory symptoms (respiratory health endpoint)
Description
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.
Time Frame
One year
Title
Peak expiratory flow (respiratory health endpoint)
Description
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.
Time Frame
One year
Title
Forced expiratory volume at one second (respiratory health endpoint)
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Quality-adjusted life years
Description
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.
Time Frame
One year
Title
Inflammatory metabolites
Description
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.
Time Frame
One year
Title
Compliance with stove use
Description
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.
Time Frame
One year
Title
Exhaled carbon monoxide
Description
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.
Time Frame
One year
Title
Diet
Description
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.
Time Frame
One year
Title
Urinary sodium
Description
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.
Time Frame
One year
Title
Percentage of households with sustained LPG stove use in intervention arm
Description
Hypothesis: Participants in the intervention arm will continue to use their LPG stoves without stove stacking in the year following the intervention.
Time Frame
One year
Title
Percentage of households who adopted LPG stove use in the control arm
Description
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.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William N Checkley, MD, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University
City
Puno
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual patient data (IPD).
Citations:
PubMed Identifier
29100550
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.
Results Reference
background
PubMed Identifier
35549716
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.
Results Reference
derived
PubMed Identifier
33306939
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.
Results Reference
derived

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Cardiopulmonary Outcomes and Household Air Pollution Trial

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