Clinical trial NCT02944682: Household Air Pollution and Health: A Multi-country LPG Intervention Trial
Official title: Household Air Pollution and Health: A Multi-country LPG Intervention Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant, Low Birth Weight
Keywords: Obstetrics
Pregnancy Outcomes
Pediatrics
Atherosclerosis
Cancer
Cardiovascular Disease
Public Health
Environmental Air Pollutants
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Bill and Melinda Gates Foundation
name: Berkeley Air Monitoring Group
name: Colorado State University
name: Global LPG Partnership
name: Harvard University
name: Johns Hopkins University
name: London School of Hygiene and Tropical Medicine
name: Asociacion Benefica Prisma
name: Sri Ramachandra University
name: Universidad del Valle, Guatemala
name: Universidad Peruana Cayetano Heredia
name: University of Georgia
name: Washington University School of Medicine
name: University of Rwanda
name: Eagle Research Center
name: University of Oxford
name: University of Liverpool
First posted: 2016-10-26
Enrollment: 3640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda). Following a common protocol, each intervention site will recruit 800 pregnant women (aged 18-34 years, 9 - \<20 weeks gestation), and will randomly assign half their households to receive LPG stoves and an 18-month supply of LPG. Control households are anticipated to continue to cook primarily with solid biomass fuels, and will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research. The mother will be followed along with her child until the child is 1 year old. The researchers estimate that 15% of households will have a second, non-pregnant older adult woman (aged 40 to \<80 years) who will also be enrolled at baseline and followed during the 18-month follow-up period. To optimize intervention use, the researchers will implement behavior change strategies informed by previous experiences and formative research in Year 1. This study will assess cookstove use, conduct repeated personal exposure assessments of household air pollution, and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage. The primary outcomes are low birth weight, severe pneumonia incidence, and stunting of the child, and blood pressure in the older adult woman. Secondary outcomes include preterm birth and development in the child, maternal blood pressure during pregnancy, and endothelial function, respiratory impairment, atherosclerosis, carcinogenic metabolites, and quality of life in the older adult woman. Participants in India, Guatemala and Rwanda will be followed until the child is 5 years old to assess the longer-term effects of the intervention.

Detailed description: Globally, nearly 3 billion people rely on solid fuels for cooking and heating, the vast majority in low- and middle-income countries (LMICs). The resulting household air pollution (HAP) is the third leading risk factor in the 2010 global burden of disease, accounting for an estimated 4.3 million deaths annually, largely among women and young children. Previous interventions have provided cleaner biomass-based cookstoves, but have failed to reduce exposure to levels that produce meaningful health improvements. There have been no large-scale field trials with liquefied petroleum gas (LPG) cookstoves, likely the cleanest scalable intervention.

The aim of this study is to conduct a randomized controlled trial of LPG stove and fuel distribution in 3,200 households in four LMICs (India, Guatemala, Peru, and Rwanda) to deliver rigorous evidence regarding potential health benefits across the lifespan. Each intervention site will recruit 800 pregnant women (aged 18-34 years, 9 - \<20 weeks gestation), and will randomly assign half their households to receive LPG stoves and an 18-month supply of LPG. Control households are anticipated to continue to cook primarily with solid biomass fuels, and will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research. The mother will be followed along with her child until the child is 1 year old. In households with a second, non-pregnant older adult woman (aged 40 to \<80 years) the researchers will also enroll and follow her during the 18-month follow-up period in order to assess cardiopulmonary, metabolic, and cancer outcomes. To optimize intervention use, the researchers will implement behavior change strategies. This study will assess cookstove use, conduct repeated personal exposure assessments to HAP (PM2.5, black carbon, carbon monoxide), and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage on all participants at multiple time points. The primary outcomes are low birth weight, severe pneumonia incidence, and stunting of the child, and blood pressure in the older adult woman. Secondary outcomes include preterm birth and development in the child, maternal blood pressure during pregnancy, and endothelial function, respiratory impairment, atherosclerosis, carcinogenic metabolites, and quality of life in the older adult woman.

This study will address the following specific aims: (1) using an intent-to-treat analysis, determine the effect of a randomized LPG stove and fuel intervention on health in four diverse LMIC populations using a common protocol; (2) determine the exposure-response relationships for HAP and health outcomes; and (3) determine relationships between LPG intervention and both targeted and exploratory biomarkers of exposure/health effects.

This study will provide evidence, including costs and implementation strategies, to inform national and global policies on scaling up LPG stoves among vulnerable populations. Ultimately, this will facilitate deeper policy-level discussions as well as identify requirements for initiating and sustaining HAP interventions globally.

The intervention delivery occurred until the child was one year of age. The researchers will continue to follow participants in India, Guatemala and Rwanda until the child is 5 years old to assess the longer-term effects of the intervention. Previous evidence suggests that the benefits of reduced exposure during the first, critical year of development will continue even if the intervention ends. The researchers will continue using methods employed during the HAPIN trial period. The HAPIN trial provides a unique context in which to address these questions, particularly given the successful intervention and exposure reduction. Participants are well-characterized and health and exposures to air pollution are being documented. Critically, because of its experimental design of the trial, continued follow-up of the cohort will provide rigorous causal inferences about the effects of this 500-day intervention over the most important period of early childhood development.

Eligibility criteria: Inclusion Criteria for Pregnant Women:

* Confirmed pregnancy (hCG positive blood or urine test)
* Aged 18 to \<35 years (via self-report)
* Uses biomass stove predominantly
* Lives in study area
* 9 - \<20 weeks gestation confirmed by ultrasound
* Singleton pregnancy (one fetus)
* Viable fetus with normal fetal heart rate (120-180 beats per minute) at time of ultrasound
* Continued pregnancy at the time of randomization confirmed by self-report
* Agrees to participate with informed consent

Exclusion Criteria for Pregnant Women:

* Currently smokes cigarettes or other tobacco products
* Plans to move permanently outside study area in the next 12 months
* Uses LPG stove predominantly, or is likely to use LPG predominantly in the near future

Inclusion Criteria for Older Adult Woman in the Same Household:

* Aged 40 to \<80 years (via self-report)

Exclusion Criteria for Older Adult Woman in the Same Household:

* Currently smokes cigarettes or other tobacco products
* Pregnant (by self-report)
* Plans to move out of her current household in the next 12 months

Primary outcomes:
measure: Birth weight
timeFrame: Within 24 hours of birth (up to 5 months post-randomization of mother)
measure: Incidence of HAPIN Defined Severe Pneumonia
timeFrame: Up to 12 months after birth
measure: Length-for-age z-score 2 standard deviations below the standard
timeFrame: 12 months after birth
measure: Change in Systolic Blood Pressure
timeFrame: Baseline, 3, 5, 9, 12, and 18 months post-randomization (24, 36, 48, and 60 months of age)
measure: Change in Child Linear Growth
timeFrame: Birth (3-5 months post-randomization), and 3, 6, 9, 12, 24, 36, 48 and 60 months of age
measure: Change in Caregiver Reported Early Childhood Development Instrument (CREDI) Score
timeFrame: 3 months of age to 24 months of age
measure: Change in Malawi Developmental Assessment Tool (MDAT) Score
timeFrame: 36, 48 and 60 months of age
Secondary outcomes:
measure: Change in Maternal Blood Pressure
timeFrame: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation, and at 24, 36, 48 and 60 months of age of the child
measure: Change in Diastolic blood pressure
timeFrame: Baseline, 3, 6, 12 and 18 months post-randomization, and at 24, 36, 48, and 60 months of age of the child
measure: Mean arterial pressure
timeFrame: Baseline, 3, 6, 12 and 18 months post-randomization, and at 24, 36, 48, and 60 months of age of the child
measure: Pulse pressure
timeFrame: Baseline, 3, 6, 12 and 18 months post-randomization, and at 24, 36, 48, and 60 months of age of the chld
measure: Fetal Growth
timeFrame: Baseline, Gestation Week 24-28 and Gestation Week 32-36
measure: Gestational age at birth
timeFrame: Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
measure: Preterm birth
timeFrame: Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
measure: WHO Non-severe Pneumonia
timeFrame: Up to 12 months after birth
measure: WHO Severe Pneumonia
timeFrame: Up to 12 months after birth
measure: Hospitalization for respiratory illness
timeFrame: Up to 12 months after birth
measure: WHO Pocket Book Non-severe Pneumonia
timeFrame: Up to 12 months after birth
measure: WHO Pocket Book Severe Pneumonia
timeFrame: Up to 12 months after birth
measure: Hypoxemic Pneumonia
timeFrame: Up to 12 months after birth
measure: Ultrasound or Radiograph Pneumonia
timeFrame: Up to 12 months after birth
measure: Change in Brachial artery reactivity testing (BART)
timeFrame: Baseline, 18 months post-randomization
measure: Change in Carotid intima-media thickness (CIMT)
timeFrame: Baseline, 18 months post-randomization, and when child is 24 months of age
measure: Change in St. George Respiratory Questionnaire (SGRQ) Score
timeFrame: Baseline, 18 months post-randomization
measure: Change in Short Form 36 Survey (SF-36) Score
timeFrame: Baseline, 18 months post-randomization
measure: Change in Weight
timeFrame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48 and 60 months of age of the child
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48 and 60 months of age of the child
measure: Change in Height
timeFrame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24 months of age of the child
measure: Change in Urinary Biomarkers
timeFrame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and 24 months of age of the child
measure: Change in Dried Blood Spot (DBS) Biomarkers
timeFrame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24 months of age of the child
measure: Child Lung Function
timeFrame: 36, 48 and 60 months of age
measure: Death
timeFrame: Up to Study Exit (up to 60 months of age of child)
Other outcomes:
measure: Change in fine particulate matter (PM2.5) exposure
timeFrame: Baseline, 3, 5, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
measure: Change in Carbon monoxide (CO) exposure
timeFrame: Baseline, 3, 5, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
measure: Change in Black carbon (BC) exposure
timeFrame: Baseline, 3, 5, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
measure: Maternal Perceived Stress Scale (PSS)
timeFrame: 9 to 18 months post-randomization (3 to 12 months of age of the child)
measure: Maternal death
timeFrame: Pregnancy through 42 days post-partum
measure: Spontaneous abortion
timeFrame: Baseline through 20 weeks gestation
measure: Early preterm birth
timeFrame: Birth
measure: Preterm delivery
timeFrame: Birth
measure: Stillbirth
timeFrame: Up to birth
measure: Neonatal death
timeFrame: Birth through 28 days
measure: Change in Child Blood Pressure
timeFrame: 48 and 60 months of age
measure: Change in Messenger Ribonucleic Acid (mRNA) Expression and microRNA in Older Adult Women
timeFrame: Baseline, 18 months post-randomization
measure: Change in Microbiome Operational Taxonomic Units (OTUs) in Older Adult Women
timeFrame: Baseline, 18 months post-randomization
measure: Change in Epigenetics (DNA methylation) in Older Adult Women
timeFrame: Baseline, 18 months post-randomization
measure: Change in Metabolomics and MicroRNA in Older Adult Women
timeFrame: Baseline, 18 months post-randomization
measure: Household food insecurity
timeFrame: Baseline, 18 months post-randomization
measure: Dietary diversity - women
timeFrame: Baseline to 18 months post-randomization
measure: Dietary diversity - infants
timeFrame: 9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age), and 24, 36, 48 and 60 months of age
measure: Hemoglobin (Hb) concentration / anemia - women
timeFrame: Baseline, 3 and 5 months post-randomization
measure: Hemoglobin (Hb) concentration / anemia - infants
timeFrame: 12 and 18 months post-randomization (6 and 12 months of age)
Locations:
city: Guatemala
country: Guatemala
facility: Universidad del Valle de Guatemala
city: Chennai
country: India
facility: Sri Ramachandra Institute of Higher Education and Research
state: Tamil Nadu
city: Puno
country: Peru
facility: Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University
city: Kigali
country: Rwanda
facility: Rwanda Research Site, London School of Hygiene and Tropical Medicine
Study officials:
affiliation: Emory University
name: Thomas Clasen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado State University
name: Jennifer Peel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: William Checkley, MD PhD
role: PRINCIPAL_INVESTIGATOR
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