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Blood PressureCHAPNCT02994680

Cardiopulmonary Outcomes and Household Air Pollution Trial

A study testing Three-burner LPG stove, Delivery of LPG tanks and Vouchers for LPG tanks in people with Blood Pressure and Carotid Intima Media Thickness, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 64 years, women onlyHealthy volunteers can take part
What is being tested?
Three-burner LPG stove, Delivery of LPG tanks and Vouchers for LPG tanks
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
1 sitePeru
Study dates
18 Jan 2017to 15 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 64 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Peru1 site
  • Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University

    Puno

Other trials in Peru

About this study

Official title: Effects of a Liquefied Petroleum Gas Stove and Fuel Distribution Intervention on Adult Cardiopulmonary Health Outcomes in Puno, Peru

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.

Read the 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).

Being tested
Three-burner LPG stove, Delivery of LPG tanks, Vouchers for LPG tanks
Keywords
Air Pollution, Liquefied Petroleum Gas, Cookstove, Behavioral Intervention, Propane Stove
Medical subject headings
Signs and Symptoms, Respiratory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Three-burner LPG stoveDevice

    Also called propane stove, SURGE three-burner liquefied petroleum gas stove

    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 tanksOther

    Also called propane tank

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

  • Vouchers for LPG tanksOther

    Also called coupon

    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)

Study groups in NCT02994680
Study groupRoleWhat they receive
Intervention armExperimentalWill 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.
Receives: Device: Three-burner LPG stove; Other: Delivery of LPG tanks
Control armActive comparatorWill 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.
Receives: Device: Three-burner LPG stove; Other: Vouchers for LPG tanks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One year

  2. 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.

    Measured: One year

  3. 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.

    Measured: One year

  4. 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.

    Measured: One year

  5. 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.

    Measured: One year

  6. 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.

    Measured: One year

  7. 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.

    Measured: One year

  8. 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.

    Measured: One year

Secondary outcomes (8)
  1. 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.

    Measured: One year

  2. 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.

    Measured: One year

  3. 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.

    Measured: One year

  4. 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.

    Measured: One year

  5. 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.

    Measured: One year

  6. 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.

    Measured: One year

  7. 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.

    Measured: One year

  8. 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.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2016 (estimated)
  2. Study start18 Jan 2017
  3. Primary completion15 Feb 2019
  4. Study completion15 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994680
Sponsor's protocol ID
IRB00007128
Acronym
CHAP
Status last verified
Jul 2020
First submitted
28 Nov 2016
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual patient data (IPD).

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.

    PubMed 29100550
  • 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.

    PubMed 35549716
  • 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.

    PubMed 33306939

Questions about this trial

What is this clinical trial studying?

A study testing Three-burner LPG stove, Delivery of LPG tanks and Vouchers for LPG tanks in people with Blood Pressure and Carotid Intima Media Thickness, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Particulate matter of 2.5 μm in size (household air pollutant) (time frame: One year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02994680, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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