- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02994680
Cardiopulmonary Outcomes and Household Air Pollution Trial (CHAP)
Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Puno, Peru
- Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
Will receive:
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. |
The intervention arm will receive a three-burner LPG stove upon enrollment.
The control arm will receive the stove one year after enrollment.
Other Names:
One year supply of LPG fuel, in the form of delivery of 20 kg tank that holds 10 kg of LPG.
Delivered to homes.
Other Names:
|
Active Comparator: Control arm
Will receive:
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. |
The intervention arm will receive a three-burner LPG stove upon enrollment.
The control arm will receive the stove one year after enrollment.
Other Names:
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Particulate matter of 2.5 μm in size (household air pollutant)
Time Frame: One year
|
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)
Time Frame: One year
|
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)
Time Frame: One year
|
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)
Time Frame: One year
|
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)
Time Frame: One year
|
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)
Time Frame: One year
|
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)
Time Frame: One year
|
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)
Time Frame: One year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality-adjusted life years
Time Frame: One year
|
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
|
Inflammatory metabolites
Time Frame: One year
|
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
|
Compliance with stove use
Time Frame: One year
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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
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Exhaled carbon monoxide
Time Frame: One year
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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
|
Diet
Time Frame: One year
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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
|
Urinary sodium
Time Frame: One year
|
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
|
Percentage of households with sustained LPG stove use in intervention arm
Time Frame: One year
|
Hypothesis: Participants in the intervention arm will continue to use their LPG stoves without stove stacking in the year following the intervention.
|
One year
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Percentage of households who adopted LPG stove use in the control arm
Time Frame: One year
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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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: William N Checkley, MD, PhD, Associate Professor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00007128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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