가정 대기 오염 및 건강: 다국가 LPG 개입 시험 (HAPIN)
2026년 5월 7일 업데이트: Thomas Clasen, Emory University
이 연구는 4개국(인도, 과테말라, 페루 및 르완다)의 3,200가구에서 액화석유가스(LPG) 스토브 및 연료 분배에 대한 무작위 통제 시험입니다.
공통 프로토콜에 따라 각 개입 사이트는 800명의 임산부(18-34세, 9 - 임신 20주 미만)를 모집하고 가구의 절반을 무작위로 배정하여 LPG 스토브와 18개월분의 LPG 공급을 받게 됩니다.
대조군 가정은 주로 고체 바이오매스 연료로 요리를 계속할 것으로 예상되며 형성 연구를 기반으로 각 현장에 맞게 조정된 일련의 실험 전체 원칙에 따라 보상을 받게 됩니다.
아이가 1살이 될 때까지 엄마가 아이를 따라다닙니다.
연구자들은 가구의 15%에 두 번째, 임신하지 않은 노인 여성(40~80세 미만)이 있을 것으로 추산합니다. 이 여성도 기준선에서 등록되고 18개월의 후속 기간 동안 추적될 것입니다.
중재 사용을 최적화하기 위해 연구자들은 1년차의 이전 경험과 형성 연구에서 정보를 얻은 행동 변화 전략을 구현할 것입니다.
이 연구는 쿡스토브 사용을 평가하고, 가정 대기 오염에 대한 반복적인 개인 노출 평가를 수행하고, 바이오마커 분석 및 생체 표본 보관을 위해 마른 핏자국과 소변 샘플을 수집합니다.
주요 결과는 저체중 출생, 심각한 폐렴 발병률, 어린이 발육 부진, 노인 여성의 혈압입니다.
이차 결과에는 아이의 조산 및 발달, 임신 중 산모의 혈압, 내피 기능, 호흡 장애, 죽상경화증, 발암성 대사 물질, 노인 여성의 삶의 질이 포함됩니다.
연구 개요
상세 설명
전 세계적으로 약 30억 명의 사람들이 요리와 난방을 위해 고체 연료에 의존하고 있으며, 대다수는 저소득 및 중간 소득 국가(LMIC)에 있습니다. 그로 인한 가정 대기 오염(HAP)은 2010년 전 세계 질병 부담의 세 번째 주요 위험 요소이며, 주로 여성과 어린 아이들 사이에서 연간 약 430만 명이 사망합니다. 이전의 개입은 더 깨끗한 바이오매스 기반 쿡스토브를 제공했지만 의미 있는 건강 개선을 생성하는 수준으로 노출을 줄이는 데 실패했습니다. 액화 석유 가스(LPG) 쿡스토브를 사용한 대규모 현장 시험은 없었으며, 아마도 가장 깨끗하고 확장 가능한 개입일 것입니다.
이 연구의 목적은 4개의 LMIC(인도, 과테말라, 페루 및 르완다)의 3,200가구에서 LPG 스토브 및 연료 분배에 대한 무작위 통제 시험을 수행하여 수명에 걸쳐 잠재적인 건강상의 이점에 대한 엄격한 증거를 제공하는 것입니다. 각 개입 사이트는 800명의 임산부(18-34세, 9 - 임신 20주 미만)를 모집하고 가구의 절반을 무작위로 배정하여 LPG 스토브와 18개월분의 LPG 공급을 받게 됩니다. 대조군 가정은 주로 고체 바이오매스 연료로 요리를 계속할 것으로 예상되며 형성 연구를 기반으로 각 현장에 맞게 조정된 일련의 실험 전체 원칙에 따라 보상을 받게 됩니다. 아이가 1살이 될 때까지 엄마가 아이를 따라다닙니다. 임신하지 않은 두 번째 노인 여성(40세에서 80세 미만)이 있는 가정에서 연구원은 심폐, 대사 및 암 결과를 평가하기 위해 18개월 추적 기간 동안 그녀를 등록하고 추적할 것입니다. 중재 사용을 최적화하기 위해 연구자들은 행동 변화 전략을 구현할 것입니다. 이 연구는 쿡스토브 사용을 평가하고, HAP(PM2.5, 블랙 카본, 일산화탄소)에 대한 반복적인 개인 노출 평가를 수행하고, 여러 시점에서 모든 참가자의 바이오마커 분석 및 생체 표본 보관을 위해 마른 혈반 및 소변 샘플을 수집합니다. 주요 결과는 저체중 출생, 심각한 폐렴 발병률, 어린이 발육 부진, 노인 여성의 혈압입니다. 이차 결과에는 아이의 조산 및 발달, 임신 중 산모의 혈압, 내피 기능, 호흡 장애, 죽상경화증, 발암성 대사 물질, 노인 여성의 삶의 질이 포함됩니다.
이 연구는 다음과 같은 구체적인 목표를 다룰 것입니다. (1) 치료 의도 분석을 사용하여 공통 프로토콜을 사용하여 4개의 다양한 저소득층 인구에서 무작위 LPG 스토브 및 연료 개입이 건강에 미치는 영향을 결정합니다. (2) HAP 및 건강 결과에 대한 노출-반응 관계를 결정합니다. (3) LPG 개입과 노출/건강 영향의 표적 및 탐색 바이오마커 사이의 관계를 결정합니다.
이 연구는 비용 및 구현 전략을 포함한 증거를 제공하여 취약 계층의 LPG 스토브 확장에 대한 국가 및 글로벌 정책을 알리게 됩니다. 궁극적으로 이것은 정책 수준의 심도 있는 논의를 촉진하고 전 세계적으로 HAP 개입을 시작하고 유지하기 위한 요구 사항을 식별할 것입니다.
연구 유형
중재적
등록 (실제)
3640
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Departamento de Guatemala
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Guatemala City, Departamento de Guatemala, 과테말라, 01015
- Universidad del Valle de Guatemala
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Kigali, 르완다
- Rwanda Research Site, London School of Hygiene and Tropical Medicine, University of Liverpool
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Tamil Nadu
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Chennai, Tamil Nadu, 인도, 600116
- Sri Ramachandra Institute of Higher Education and Research
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Puno, 페루
- Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
임산부를 위한 포함 기준:
- 임신 확인(hCG 양성 혈액 또는 소변 검사)
- 18세 이상 35세 미만(자기 신고)
- 주로 바이오매스 스토브 사용
- 연구 지역에 거주
- 9 - 20주 미만 초음파로 확인된 임신
- 단태임신(태아 1명)
- 초음파 시 정상적인 태아 심박수(분당 120~180회)를 보이는 생존 가능한 태아
- 자가 보고에 의해 확인된 무작위 배정 시 임신 지속
- 정보에 입각한 동의를 받아 참여하기로 동의합니다.
임산부에 대한 제외 기준:
- 현재 담배 또는 기타 담배 제품을 피운다
- 향후 12개월 내에 연구 지역 밖으로 영구적으로 이동할 계획
- LPG 스토브를 주로 사용하거나 가까운 장래에 LPG를 주로 사용할 가능성이 있음
같은 가구에 있는 나이든 성인 여성에 대한 포함 기준:
- 40세 이상 80세 미만(자기 보고)
같은 가구에 있는 나이든 성인 여성에 대한 제외 기준:
- 현재 담배 또는 기타 담배 제품을 피운다
- 임신(자체 보고)
- 향후 12개월 내에 현재 가정에서 이사할 계획
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 액화석유가스 쿡스토브
무작위로 실험 부문에 배정된 참가자는 액화 석유 가스(LPG) 쿡스토브와 18개월 분량의 LPG를 받게 됩니다.
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The intervention consists of a high-quality locally available liquefied petroleum gas (LPG) stove having at least two burners, a continuous supply of LPG fuel for 18 months, and the promotion of stove use on an exclusive basis for cooking.
The intervention will be provided free of charge to all intervention households upon enrollment.
On a weekly basis, study staff will examine stove condition, perform any necessary repairs, and measure and record weight of LPG tanks in order to anticipate need for refills.
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간섭 없음: 제어
통제 그룹의 참가자는 액화 석유 가스(LPG) 스토브를 받지 않고 계속해서 전통적인 요리 방법(직접 불 또는 전통 스토브) 또는 선택한 요리 방법을 사용합니다.
통제 가구는 형성 연구를 기반으로 각 사이트에 맞게 조정된 실험 전반에 걸친 균일한 원칙에 따라 보상을 받게 됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Birth weight
기간: Within 24 hours of birth (up to 5 months post-randomization of mother)
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Birth weight is assessed by a trained nurse or health worker within 24 hours of birth.
Infants are weighed naked or in a pre-weighed blanket.
Weight is measured to the nearest 10 g using a digital electronic scale, if performed by the study field staff; otherwise, hospital medical records are used.
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Within 24 hours of birth (up to 5 months post-randomization of mother)
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Incidence of HAPIN Defined Severe Pneumonia
기간: Up to 12 months after birth
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The number of times a child has severe pneumonia over their period of follow-up during the first year of life is assessed.
For this study pneumonia criteria are adapted from the WHO classification of childhood pneumonia (2014) and there are 3 algorithms for case criteria: 1) the presence of cough and/or difficult breathing and at least 1 general danger sign plus evidence of pneumonia on lung imaging (i.e., lung ultrasound or chest x-ray), or 2) the presence of cough and/or difficult breathing and hypoxemia (measured either via pulse oximetry (SpO2), or observing a child requiring advanced respiratory support (i.e., intubation and mechanical ventilation, non-invasive ventilation with continuous or bi-level positive airway pressure support, or high-flow nasal cannula oxygen), or 3) children who die prior to evaluation but their death is attributed to pneumonia by verbal autopsy.
Cases of pneumonia are recorded children present to HAPIN health facilities with respiratory symptoms.
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Up to 12 months after birth
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Length-for-age z-score 2 standard deviations below the standard
기간: 12 months after birth
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The primary outcome measured is stunting at one year of age, defined as a length-for-age z-score (LAZ) that is 2 standard deviations below the median of the growth standard.
Infant length is assessed at birth and quarterly thereafter, until the child is 12 months old.
Z-scores are calculated using the 2006 World Health Organization (WHO) Multi-Growth Reference Standard (MGRS).
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12 months after birth
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Systolic Blood Pressure Among Older Adult Women
기간: Baseline, 3, 6, 9, 12, and 18 months post-randomization
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Systolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline, 3, 6, 9, 12, and 18 months post-randomization
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Child Linear Growth During Extended Follow-up
기간: 24, 36, 48 and 60 months of age
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Linear growth of children is assessed in centimeters of height.
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24, 36, 48 and 60 months of age
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Caregiver Reported Early Childhood Development Instrument (CREDI) Score During Extended Follow-up
기간: 24 months of age
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Child development is assessed with the Caregiver Reported Early Childhood Development Instrument (CREDI).
The CREDI is a population-level measure of early childhood development (ECD) for children from 0-3 years of age.
The CREDI assesses 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) social-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence).
The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child.
Responses of "yes" are coded as 1 and "no" is coded as 0; certain items are reverse coded.
Both domain-specific and overall z-scores are calculated.
Total raw scores increase by age (with developmental progression), and higher scores indicate increased development.
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24 months of age
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Malawi Developmental Assessment Tool (MDAT) Score
기간: 36, 48 and 60 months of age
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The MDAT measures gross motor (39 items), fine motor (42 items), language/cognition (40 items) and social skills (36 items).
Originally developed and validated in rural Malawi, it has now been used in over 25 countries with more than 8,000 children as both a clinical and research tool.
The MDAT is a continuous test with start and stop rules.
Most items are administered directly to the child and items that are not easily observed (e.g., child speaks in full sentences; child understands sharing with others; child can dress self) are administered by parent report.
Children receive either a pass or fail for each item, and summed pass scores can produce a composite score as well as domain-specific scores.
Total scores range from 0 to 157 where higher scores indicate greater neurodevelopment.
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36, 48 and 60 months of age
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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조산
기간: 최대 5개월(생후 24시간 이내, 무작위 배정 후 3~5개월)
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조산은 임신 37주가 완료되기 전에 살아있는 영아를 분만하는 것으로 정의됩니다.
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최대 5개월(생후 24시간 이내, 무작위 배정 후 3~5개월)
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호흡기 질환으로 입원
기간: 생후 12개월까지
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생후 1년 동안 호흡기 질환으로 인한 입원 누적 발생률.
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생후 12개월까지
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WHO 경증 폐렴
기간: 생후 12개월까지
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생후 1년 동안 WHO 경증 폐렴(2014년 정의 및 2013년 정의)의 누적 발생률.
폐렴 사례는 어린이가 호흡기 증상으로 하핀 의료 시설을 방문할 때마다 기록됩니다.
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생후 12개월까지
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WHO 중증 폐렴
기간: 생후 12개월까지
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생후 1년 동안 WHO 경증 폐렴(2014년 정의 및 2013년 정의)의 누적 발생률.
폐렴 사례는 어린이가 호흡기 증상으로 하핀 의료 시설을 방문할 때마다 기록됩니다.
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생후 12개월까지
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WHO 포켓북 경증 폐렴
기간: 생후 12개월까지
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"Pocket book of hospital care for children"(2013) 제2판에 정의된 생후 1년 동안 WHO 중증이 아닌 폐렴의 누적 발생률.
폐렴 사례는 어린이가 호흡기 증상으로 하핀 의료 시설을 방문할 때마다 기록됩니다.
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생후 12개월까지
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WHO 포켓북 중증폐렴
기간: 생후 12개월까지
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"Pocket book of hospital care for children"(2013) 제2판에 정의된 생후 1년 동안 WHO 중증 폐렴의 누적 발생률.
폐렴 사례는 어린이가 호흡기 증상으로 하핀 의료 시설을 방문할 때마다 기록됩니다.
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생후 12개월까지
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저산소성 폐렴
기간: 생후 12개월까지
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생후 1년 동안 저산소혈증성 폐렴의 누적 발생률.
폐렴 사례는 어린이가 호흡기 증상으로 하핀 의료 시설을 방문할 때마다 기록됩니다.
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생후 12개월까지
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초음파 또는 방사선 사진 폐렴
기간: 생후 12개월까지
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생후 1년 동안 폐 초음파 또는 흉부 방사선 사진 폐렴의 누적 발생률.
폐렴 사례는 어린이가 호흡기 증상으로 하핀 의료 시설을 방문할 때마다 기록됩니다.
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생후 12개월까지
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Gestational Systolic Blood Pressure
기간: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Gestational Diastolic Blood Pressure
기간: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Systolic Blood Pressure in New Mothers
기간: 9, 12, and 18 months post-randomization
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Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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9, 12, and 18 months post-randomization
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Diastolic Blood Pressure in New Mothers
기간: 9, 12, and 18 months post-randomization
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Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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9, 12, and 18 months post-randomization
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Diastolic Blood Pressure Among Older Adult Women
기간: Baseline, 3, 6, 12 and 18 months post-randomization
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Diastolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline, 3, 6, 12 and 18 months post-randomization
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Mean arterial pressure
기간: Baseline, 3, 6, 12 and 18 months post-randomization
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Mean arterial pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
Mean arterial pressure is calculated as DBP+(SBP-DBP)/3, where SBP=systolic blood pressure and DBP=diastolic blood pressure.
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Baseline, 3, 6, 12 and 18 months post-randomization
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Pulse pressure
기간: Baseline, 3, 6, 12 and 18 months post-randomization
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Pulse pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
pressure.
Pulse pressure is the difference between systolic blood pressure and diastolic blood pressure.
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Baseline, 3, 6, 12 and 18 months post-randomization
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Fetal Growth
기간: Baseline, Gestation Week 24-28 and Gestation Week 32-36
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Pregnant women have ultrasounds at Baseline and during gestation weeks 24-28 and gestation weeks 32-36 to measure fetal growth outcomes.
Specifically, the researchers evaluate head circumference (HC), abdominal circumference (AC), femur length (FL) and estimated fetal weight (EFW) during gestation.
The researchers are comparing (i) z-scores of individual fetal growth measurements (HC, AC, FL, EFW) at the 2 growth ultrasound visits between intervention and control participants (separately at 24-28 weeks gestation and 32-36 weeks gestation); (ii) differences in proportions of the 2.5th percentiles of each of these measurements evaluated separately at 24-28 and 32-36 weeks gestation; (iii) Z-score trajectories of HC, AC, FL and EFW as a function of gestational age and intervention; and (iv) prevalence of small for gestational age (SGA) during the fetal period through birth as measured by WHO INTERGROWTH 21st standards.
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Baseline, Gestation Week 24-28 and Gestation Week 32-36
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Gestational age at birth
기간: Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
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Gestational age at birth is measured in weeks, as continuous outcome, among all live births.
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Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
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Brachial artery reactivity testing (BART)
기간: Baseline, 18 months post-randomization
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Brachial artery reactivity testing (BART) measures endothelial function via flow-mediated dilatation to reactive hyperemia following the release of arm blood-flow occlusion.
In this test, baseline artery diameter is measured, then a blood pressure cuff is inflated to induce distal arm ischemia for 5 minutes and after releasing the pressure, the post-occlusion brachial artery diameter is measured.
The ratio of post- to pre-occlusion artery diameter represents endothelial function where lower values indicate worse endothelial function.
(Peru only)
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Baseline, 18 months post-randomization
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Carotid intima-media thickness (CIMT) Among Older Adult Women
기간: Baseline, 18 months post-randomization
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The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease.
The test measures the thickness of the inner two layers of the carotid artery and can detect plaque build up prior to physical symptoms being experienced.
The carotid ultrasound will be performed with a portable ultrasound by trained sonographers.
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Baseline, 18 months post-randomization
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St. George Respiratory Questionnaire (SGRQ) Score
기간: Baseline, 18 months post-randomization
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Adult respiratory health and well-being is assessed with the St. George Respiratory Questionnaire (SGRQ).
The SGRQ measures impaired health and perceived well-being among individuals with chronic airway disease.
The SGRQ has sections assessing symptoms, activities that cause breathlessness or are limited because of breathlessness, and the impacts of respiratory problems on employment, sense of control of health, panic, stigmatization, medication use, side effects of therapies, expectations for health and disturbances of daily life.
The questionnaire includes multiple choice, true/false and open-ended questions.
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Baseline, 18 months post-randomization
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Short Form 36 Survey (SF-36) Score Among Older Adult Women
기간: Baseline, 18 months post-randomization
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The Short Form 36 survey (SF-36) is a standardized, preference-based 36 item questionnaire evaluating quality of life.
The survey has 8 sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health).
Possible scores range from 0 (lowest quality of life) to 100 (highest quality of life).
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Baseline, 18 months post-randomization
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Weight
기간: 24, 36, 48 and 60 months of age of the child
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Weight is measured in kilograms (kg).
Weight in new mothers in Rwanda is measured when the child is 24 months old.
For new mothers in Guatemala weight is measured when the child is 24 and 36 months old.
In older adult women, weight is measured when the child is 24 months old.
Weight is measured in children at 24, 36, 48 and 60 months of age.
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24, 36, 48 and 60 months of age of the child
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Body Mass Index (BMI)
기간: 24, 36, 48 and 60 months of age of the child
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BMI is calculated as weight in kilograms divided by height in meters (m) squared (kg/m^2).
BMI in new mothers in Rwanda is calculated from height and weight measurements obtained when the child is 24 months old.
For new mothers in Guatemala BMI is calculated from height and weight measurements obtained when the child is 24 and 36 months old.
In older adult women, BMI is calculated from height and weight measurements obtained when the child is 24 months old.
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24, 36, 48 and 60 months of age of the child
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Height
기간: 24 and 36 months of age of the child
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Height is measured in meters.
Height in new mothers in Rwanda is measured when the child is 24 months old.
For new mothers in Guatemala height is measured when the child is 24 and 36 months old.
In older adult women, height is measured when the child is 24-months old.
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24 and 36 months of age of the child
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Child Blood Pressure
기간: 24 (Rwanda only) and 60 months of age
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Blood pressure is assessed in the children using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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24 (Rwanda only) and 60 months of age
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Child Linear Growth
기간: Birth (3-5 months post-randomization), and 3, 6, 9, and 12 months of age
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Linear growth of children is assessed in centimeters at birth and quarterly thereafter, until the child is 12 months old.
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Birth (3-5 months post-randomization), and 3, 6, 9, and 12 months of age
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Caregiver Reported Early Childhood Development Instrument (CREDI) Score
기간: 3 and 12 months of age
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Child development is assessed with the Caregiver Reported Early Childhood Development Instrument (CREDI).
The CREDI is a population-level measure of early childhood development (ECD) for children from 0-3 years of age.
The CREDI assesses 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) social-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence).
The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child.
Responses of "yes" are coded as 1 and "no" is coded as 0; certain items are reverse coded.
Both domain-specific and overall z-scores are calculated.
Total raw scores increase by age (with developmental progression), and higher scores indicate increased development.
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3 and 12 months of age
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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자연 유산
기간: 기준선에서 임신 20주까지
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19주 6일 전에 태아 사망.
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기준선에서 임신 20주까지
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조기 조산
기간: 출생
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모든 정상 출산 중에서 34주 미만의 출생은 임신을 완료했습니다.
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출생
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사산
기간: 출생까지
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임신 20주 또는 그 이후에 발생하거나 심각한 부작용 양식 또는 임산부 병력 양식 또는 구두 부검 양식에 표시된 모든 태아 사망.
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출생까지
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신생아 사망
기간: 출생 ~ 28일
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생후 28일 사이의 사망.
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출생 ~ 28일
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어린이 폐 기능
기간: 36, 48, 60개월
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폐 기능 측정은 일회용 마우스피스가 장착된 Tremoflo C-100 장치를 사용하여 강제 진동 기술(FOT)을 사용하여 수행됩니다.
FOT는 기도의 초기 변화를 식별할 수 있는 기술입니다.
FOT 장치는 외부에서 적용되는 압력파와 그에 따른 공기 흐름 사이의 관계를 측정하여 호흡 임피던스를 측정합니다.
높은 주파수에서 생성된 값은 근위 및 큰 기도에 해당하고, 낮은 주파수에서 생성된 값은 원위 및 작은 기도에 해당합니다.
이 측정은 과테말라의 어린이를 대상으로 실시됩니다.
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36, 48, 60개월
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비뇨기 바이오마커의 변화
기간: 기준선, 무작위 배정 후 3, 6, 9, 12, 18개월 및 아동 연령 24개월
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다중 노출 바이오마커가 측정됩니다: 3-OH 코티닌, 4-(메틸니트로스아미노)-1-(3-피리딜)-1-부탄올(NNAL), 레보글루코산, 8OH-데옥시구아노신(8OHdG) 및 휘발성 유기화학물질(VOC) 대사산물 .
노출 바이오마커(특히 소변이 제한될 수 있는 어린이의 경우)는 다환 방향족 탄화수소(PAH) 바이오마커, 레보글루코산, 휘발성 유기 화학물질(VOC) 바이오마커, 중금속 및 담배 관련 바이오마커와 같이 우선순위가 지정됩니다.
요로 바이오마커는 기준시점, 임신 24~28주, 임신 32~36주에 임산부, 그리고 아이가 24개월이 된 초산모에서 측정됩니다.
바이오마커는 기준선, 무작위화 후 3, 6, 9, 12 및 18개월에 노년층 여성에서 측정됩니다.
바이오마커는 3, 6, 12, 24개월 어린이를 대상으로 측정됩니다.
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기준선, 무작위 배정 후 3, 6, 9, 12, 18개월 및 아동 연령 24개월
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건조혈반(DBS) 바이오마커의 변화
기간: 기준선, 무작위 배정 후 3, 6, 9, 12, 18개월 및 소아의 24개월
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건조혈반에서 측정되는 주요 바이오마커는 염증표지자, 심혈관질환의 내피표지자, 산화스트레스 표지자, Hb, HbA1C, 종양관련항원항체, 시토크롬 P450, p53 종양관련항원(TAA), 지질, 대사체학, MiRNA, 중금속.
DBS 바이오마커는 기준선, 임신 24~28주, 임신 32~36주에 임산부, 그리고 아이가 24개월이 된 초산모에서 측정됩니다.
DBS 바이오마커는 무작위화 후 기준선, 3, 6, 9, 12 및 18개월에 노인 여성에서 측정됩니다.
DBS 바이오마커는 3, 6, 12 및 24개월 어린이에게서 측정됩니다.
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기준선, 무작위 배정 후 3, 6, 9, 12, 18개월 및 소아의 24개월
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산모 인지 스트레스 척도(PSS)
기간: 무작위 배정 후 9~18개월(아동의 생후 3~12개월)
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10개 항목으로 구성된 Cohen의 인지된 스트레스 척도(PPS)는 개인이 자신의 생활 사건을 스트레스가 많은 것으로 평가하는 방식을 평가합니다(예: "지난 달에 극복할 수 없을 정도로 어려움이 너무 쌓여 있다고 느낀 적이 얼마나 자주 있었습니까?" ) (코헨, 1983).
리커트 수준 응답 범위는 0(전혀 그렇지 않음)부터 4(매우 자주)까지였으며, 이는 PPS 점수가 높을수록 인지된 스트레스 수준이 높다는 것을 의미합니다.
스페인어 PPS가 생성 및 테스트되었으며 유효하고 신뢰할 수 있는 것으로 확인되었습니다(Vallijo et al., 2018).
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무작위 배정 후 9~18개월(아동의 생후 3~12개월)
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조기 분만
기간: 출생
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조산과 사산도 포함됩니다.
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출생
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가정용 식량 불안
기간: 기준선, 무작위 배정 후 18개월
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가구의 식량 불안은 식량농업기구(FAO)가 개발하고 검증한 식량 불안 경험 척도(FIES)를 사용하여 측정됩니다.
FIES 모듈에는 가구의 적절한 식품 접근성에 대한 각각 예/아니요 응답 옵션이 있는 8개의 질문이 포함되어 있으며, 식품 불안의 세 가지 영역인 불확실성/불안, 식품 수량 및 식품 품질을 측정하기 위한 것입니다.
각 질문은 0/1의 값을 가지며, 이 값의 합은 0-8의 총점으로 계산됩니다.
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기준선, 무작위 배정 후 18개월
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식단의 다양성 - 여성
기간: 무작위 배정 후 18개월까지의 기준선
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여성의 식단 다양성은 FAO 및 FHI 360의 MDD-W(Minimum Dietary Diversity - Women) 설문지를 사용하여 측정됩니다. MDD-W는 공개 회상 형식을 사용하여 응답자가 전날 낮과 밤에 소비한 음식 및 음료에 대한 데이터를 수집합니다. .
응답은 10가지 식품군으로 분류되며, 10가지 식품군 중 5가지 이상을 섭취한다고 보고한 여성은 최소 식이 다양성을 달성한 것으로 분류됩니다.
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무작위 배정 후 18개월까지의 기준선
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헤모글로빈(Hb) 농도/빈혈 - 여성
기간: 기준선, 무작위 배정 후 3개월 및 5개월
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Hb는 HemoCue® Hb 201system(HemoCue® AB) 현장 진료 장치를 사용하여 손가락을 찔러 얻은 한 방울의 모세혈관 혈액에서 측정됩니다.
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기준선, 무작위 배정 후 3개월 및 5개월
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헤모글로빈(Hb) 농도/빈혈 - 영유아
기간: 무작위 배정 후 12개월 및 18개월(생후 6개월 및 12개월)
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Hb는 HemoCue® Hb 201system(HemoCue® AB) 현장 진료 장치를 사용하여 손가락을 찔러 얻은 한 방울의 모세혈관 혈액에서 측정됩니다.
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무작위 배정 후 12개월 및 18개월(생후 6개월 및 12개월)
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Change in fine particulate matter (PM2.5) exposure
기간: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Personal monitoring equipment is used to assess exposure to fine particulate matter (PM2.5) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children).
Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old.
Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age.
Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
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Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Change in Carbon monoxide (CO) exposure
기간: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Personal monitoring equipment is used to assess exposure to carbon monoxide (CO) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children).
Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old.
Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age.
Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
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Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Change in Black carbon (BC) exposure
기간: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Personal monitoring equipment is used to assess exposure to black carbon (BC) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children).
Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old.
Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age.
Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
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Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Messenger Ribonucleic Acid (mRNA) Expression and microRNA in Older Adult Women
기간: Baseline, 18 months post-randomization
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Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon.
Nasal turbinate brush samples can be collected using a soft cytobrush on each turbinate.
Collection is gentle and causes no discomfort to study participants.
Both samples will be processed in the laboratory according to procedures detailed in the protocol.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Microbiome Operational Taxonomic Units (OTUs) in Older Adult Women
기간: Baseline, 18 months post-randomization
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For the oral rinse, participants will vigorously rinse their mouth and the rinsates are collected in a centrifuge tube.
The tube is centrifuged and the pellet and supernatant are removed to separate cryovials, labeled and frozen.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Epigenetics (DNA methylation) in Older Adult Women
기간: Baseline, 18 months post-randomization
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Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon.
A 5-mL venous blood sample will be collected in an ethylenediaminetetraacetic acid (EDTA) vacutainer tube by standard clinical venipuncture of a cubital vein.
Both samples will be transported and processed in the laboratory according to procedures detailed in the protocol.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Metabolomics and MicroRNA in Older Adult Women
기간: Baseline, 18 months post-randomization
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A 5-mL venous blood sample will be collected in an EDTA vacutainer tube by standard clinical venipuncture of a cubital vein.
The sample will be transported and processed in the laboratory according to procedures detailed in the protocol.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Dietary diversity - infants
기간: 9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age)
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Minimum dietary diversity for children will be measured using the World Health Organization (WHO) infant and young child feeding questionnaire.
The questionnaire uses a combination of open and closed recall and asks caregivers to report on foods and beverages consumed by the infant or young child during the previous day and night.
Responses will be categorized into eight food groups and infants who consumed five or more out of ten eight food groups will be categorized as achieving minimum dietary diversity.
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9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age)
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Carotid intima-media thickness (CIMT) Among Older Adult Women During Extended Follow-up
기간: 24 months of age of the child
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The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease.
The test measures the thickness of the inner two layers of the carotid artery and can detect plaque build up prior to physical symptoms being experienced.
The carotid ultrasound will be performed with a portable ultrasound by trained sonographers.
This outcome is only assessed in Guatemala during the extended follow-up period (after the birth of the household child).
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24 months of age of the child
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Reported Diarrhea in Children
기간: Up to 12 months after birth
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Reported diarrhea will be extracted from the Monthly Child Health Status Visit case report form.
Each month, the child's caretaker will be administered a survey to obtain information on whether the child under 1 year of age (the HAPIN study index child) or any other child in the home under 5 has experienced WHO-defined diarrhea (defined as three or more loose stools that can take the shape of a container within a 24-hour period) in the past 7 days.
Persistent diarrhea will be defined as 14 or more continuous days of diarrhea.
The presence of blood in the stool will also be noted as an indicator of severity.
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Up to 12 months after birth
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
수사관
- 수석 연구원: Thomas Clasen, PhD, Emory University
- 수석 연구원: Jennifer Peel, PhD, Colorado State University
- 수석 연구원: William Checkley, MD PhD, Johns Hopkins School of Medicine
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Kearns KA, Naeher LP, McCracken JP, Boyd Barr D, Saikawa E, Hengstermann M, Mollinedo E, Panuwet P, Yakimavets V, Lee GE, Thompson LM. Estimating personal exposures to household air pollution and plastic garbage burning among adolescent girls in Jalapa, Guatemala. Chemosphere. 2024 Jan;348:140705. doi: 10.1016/j.chemosphere.2023.140705. Epub 2023 Nov 17.
- Younger A, Ye W, Alkon A, Harknett K, Kirby MA, Elon L, Lovvorn AE, Wang J, Diaz-Artiga A, McCracken JP, Castanaza Gonzalez A, Alarcon LM, Mukeshimana A, Rosa G, Chiang M, Balakrishnan K, Garg SS, Pillarisetti A, Piedrahita R, Johnson MA, Craik R, Papageorghiou AT, Toenjes A, Williams KN, Underhill LJ, Hartinger SM, Nicolaou L, Chang HH, Naeher LP, Rosenthal J, Checkley W, Peel JL, Clasen TF, Thompson LM; Household Air Pollution Intervention Network (HAPIN) Investigators. Effects of a liquefied petroleum gas stove intervention on stillbirth, congenital anomalies and neonatal mortality: A multi-country household air pollution intervention network trial. Environ Pollut. 2024 Mar 15;345:123414. doi: 10.1016/j.envpol.2024.123414. Epub 2024 Jan 27.
- Pillarisetti A, Ye W, Balakrishnan K, Rosa G, Diaz-Artiga A, Underhill LJ, Steenland K, Peel JL, Kirby MA, McCracken J, Waller L, Chang H, Wang J, Dusabimana E, Ndagijimana F, Sambandam S, Mukhopadhyay K, Kearns KA, Campbell D, Kremer J, Rosenthal J, Ghosh A, Clark M, Checkley W, Clasen T, Naeher L, Piedrahita R, Johnson M. Post-birth exposure contrasts for children during the Household Air Pollution Intervention Network randomized controlled trial. medRxiv [Preprint]. 2023 Jul 6:2023.07.04.23292226. doi: 10.1101/2023.07.04.23292226.
- Simkovich SM, Hossen S, McCollum ED, Toenjes AK, McCracken JP, Thompson LM, Castanaza A, Diaz A, Rosa G, Kirby MA, Mukeshimana A, Myers R, Lenzen PM, Craik R, Jabbarzadeh S, Elon L, Garg SS, Balakrishnan K, Thangavel G, Peel JL, Clasen TF, Davila-Roman VG, Papageorghiou AT, de las Fuentes L, Checkley W; HAPIN Investigators. Lung Ultrasound Protocol and Quality Control of Image Interpretation Using an Adjudication Panel in the Household Air Pollution Intervention Network (HAPIN) Trial. Ultrasound Med Biol. 2023 May;49(5):1194-1201. doi: 10.1016/j.ultrasmedbio.2023.01.005. Epub 2023 Feb 19.
- Williams KN, Quinn A, North H, Wang J, Pillarisetti A, Thompson LM, Diaz-Artiga A, Balakrishnan K, Thangavel G, Rosa G, Ndagijimana F, Underhill LJ, Kirby MA, Puzzolo E, Hossen S, Waller LA, Peel JL, Rosenthal JP, Clasen TF, Harvey SA, Checkley W; HAPIN Investigators. Fidelity and adherence to a liquefied petroleum gas stove and fuel intervention: The multi-country Household Air Pollution Intervention Network (HAPIN) trial. Environ Int. 2023 Sep;179:108160. doi: 10.1016/j.envint.2023.108160. Epub 2023 Aug 19.
- Younger A, Alkon A, Harknett K, Kirby MA, Elon L, Lovvorn AE, Wang J, Ye W, Diaz-Artiga A, McCracken JP, Castanaza Gonzalez A, Monroy Alarcon L, Mukeshimana A, Rosa G, Chiang M, Balakrishnan K, Garg SS, Pillarisetti A, Piedrahita R, Johnson M, Craik R, Papageorghiou AT, Toenjes A, Quinn A, Williams KN, Underhill L, Chang HH, Naeher LP, Rosenthal J, Checkley W, Peel JL, Clasen TF, Thompson LM; HAPIN investigators. Effects of a LPG stove and fuel intervention on adverse maternal outcomes: A multi-country randomized controlled trial conducted by the Household Air Pollution Intervention Network (HAPIN). Environ Int. 2023 Aug;178:108059. doi: 10.1016/j.envint.2023.108059. Epub 2023 Jun 28.
- Checkley W, Hossen S, Rosa G, Thompson LM, McCracken JP, Diaz-Artiga A, Balakrishnan K, Simkovich SM, Underhill LJ, Nicolaou L, Hartinger SM, Davila-Roman VG, Kirby MA, Clasen TF, Rosenthal J, Peel JL, On Behalf Of Household Air Pollution Intervention Network Hapin Investigators. Facing the Realities of Pragmatic Design Choices in Environmental Health Studies: Experiences from the Household Air Pollution Intervention Network Trial. Int J Environ Res Public Health. 2022 Mar 23;19(7):3790. doi: 10.3390/ijerph19073790.
- Hennessee I, Kirby MA, Misago X, Mupfasoni J, Clasen T, Kitron U, Rosenthal JP, Hakizimana E. Assessing the Effects of Cooking Fuels on Anopheles Mosquito Behavior: An Experimental Study in Rural Rwanda. Am J Trop Med Hyg. 2022 Feb 21;106(4):1196-1208. doi: 10.4269/ajtmh.21-0997. Print 2022 Apr 6.
- Johnson M, Pillarisetti A, Piedrahita R, Balakrishnan K, Peel JL, Steenland K, Underhill LJ, Rosa G, Kirby MA, Diaz-Artiga A, McCracken J, Clark ML, Waller L, Chang HH, Wang J, Dusabimana E, Ndagijimana F, Sambandam S, Mukhopadhyay K, Kearns KA, Campbell D, Kremer J, Rosenthal JP, Checkley W, Clasen T, Naeher L; the Household Air Pollution Intervention Network (HAPIN) Trial Investigators. Exposure Contrasts of Pregnant Women during the Household Air Pollution Intervention Network Randomized Controlled Trial. Environ Health Perspect. 2022 Sep;130(9):97005. doi: 10.1289/EHP10295. Epub 2022 Sep 16.
- Kaufman JD. Invited Perspective: A Critical Part of a Real-World Environmental Health Trial Is to Demonstrate That the Intervention Reduced Exposure. Environ Health Perspect. 2022 Sep;130(9):91304. doi: 10.1289/EHP11697. Epub 2022 Sep 16. No abstract available.
- Rajamani KD, Sambandam S, Mukhopadhyay K, Puttaswamy N, Thangavel G, Natesan D, Ramasamy R, Sendhil S, Natarajan A, Aravindalochan V, Pillarisetti A, Johnson M, Rosenthal J, Steenland K, Piedhrahita R, Peel J, Clark ML, Boyd Barr D, Rajkumar S, Young B, Jabbarzadeh S, Rosa G, Kirby M, Underhill LJ, Diaz-Artiga A, Lovvorn A, Checkley W, Clasen T, Balakrishnan K. Visualizing Field Data Collection Procedures of Exposure and Biomarker Assessments for the Household Air Pollution Intervention Network Trial in India. J Vis Exp. 2022 Dec 23;(190). doi: 10.3791/64144.
- Ye W, Thangavel G, Pillarisetti A, Steenland K, Peel JL, Balakrishnan K, Jabbarzadeh S, Checkley W, Clasen T; HAPIN Investigators. Association between personal exposure to household air pollution and gestational blood pressure among women using solid cooking fuels in rural Tamil Nadu, India. Environ Res. 2022 May 15;208:112756. doi: 10.1016/j.envres.2022.112756. Epub 2022 Jan 20.
- Ye W, Steenland K, Quinn A, Liao J, Balakrishnan K, Rosa G, Ndagijimana F, Ntivuguruzwa JD, Thompson LM, McCracken JP, Diaz-Artiga A, Rosenthal JP, Papageorghiou A, Davila-Roman VG, Pillarisetti A, Johnson M, Wang J, Nicolaou L, Checkley W, Peel JL, Clasen TF; Household Air Pollution Intervention Network (HAPIN) trial Investigators. Effects of a Liquefied Petroleum Gas Stove Intervention on Gestational Blood Pressure: Intention-to-Treat and Exposure-Response Findings From the HAPIN Trial. Hypertension. 2022 Aug;79(8):1887-1898. doi: 10.1161/HYPERTENSIONAHA.122.19362. Epub 2022 Jun 16.
- Hengstermann M, Diaz-Artiga A, Otzoy-Sucuc R, Laura Maria Ruiz-Aguilar A, Thompson LM; HAPIN Investigators. Developing Visual Messages to Support Liquefied Petroleum Gas Use in Intervention Homes in the Household Air Pollution Intervention Network (HAPIN) Trial in Rural Guatemala. Health Educ Behav. 2021 Oct;48(5):651-669. doi: 10.1177/1090198121996280. Epub 2021 Mar 18.
- Liao J, Kirby MA, Pillarisetti A, Piedrahita R, Balakrishnan K, Sambandam S, Mukhopadhyay K, Ye W, Rosa G, Majorin F, Dusabimana E, Ndagijimana F, McCracken JP, Mollinedo E, de Leon O, Diaz-Artiga A, Thompson LM, Kearns KA, Naeher L, Rosenthal J, Clark ML, Steenland K, Waller LA, Checkley W, Peel JL, Clasen T, Johnson M; HAPIN Investigators. LPG stove and fuel intervention among pregnant women reduce fine particle air pollution exposures in three countries: Pilot results from the HAPIN trial. Environ Pollut. 2021 Dec 15;291:118198. doi: 10.1016/j.envpol.2021.118198. Epub 2021 Sep 21.
- Quinn AK, Williams KN, Thompson LM, Harvey SA, Piedrahita R, Wang J, Quinn C, Pillarisetti A, McCracken JP, Rosenthal JP, Kirby MA, Diaz Artiga A, Thangavel G, Rosa G, Miranda JJ, Checkley W, Peel JL, Clasen TF. Fidelity and Adherence to a Liquefied Petroleum Gas Stove and Fuel Intervention during Gestation: The Multi-Country Household Air Pollution Intervention Network (HAPIN) Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Nov 29;18(23):12592. doi: 10.3390/ijerph182312592.
- Simkovich SM, Underhill LJ, Kirby MA, Crocker ME, Goodman D, McCracken JP, Thompson LM, Diaz-Artiga A, Castanaza-Gonzalez A, Garg SS, Balakrishnan K, Thangavel G, Rosa G, Peel JL, Clasen TF, McCollum ED, Checkley W; HAPIN Investigators. Resources and Geographic Access to Care for Severe Pediatric Pneumonia in Four Resource-limited Settings. Am J Respir Crit Care Med. 2022 Jan 15;205(2):183-197. doi: 10.1164/rccm.202104-1013OC.
- Barr DB, Puttaswamy N, Jaacks LM, Steenland K, Rajkumar S, Gupton S, Ryan PB, Balakrishnan K, Peel JL, Checkley W, Clasen T, Clark ML; (HAPIN Investigative Team). Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial. Environ Health Perspect. 2020 Apr;128(4):47010. doi: 10.1289/EHP5751. Epub 2020 Apr 29.
- Burrowes VJ, Piedrahita R, Pillarisetti A, Underhill LJ, Fandino-Del-Rio M, Johnson M, Kephart JL, Hartinger SM, Steenland K, Naeher L, Kearns K, Peel JL, Clark ML, Checkley W; HAPIN Investigators. Comparison of next-generation portable pollution monitors to measure exposure to PM2.5 from household air pollution in Puno, Peru. Indoor Air. 2020 May;30(3):445-458. doi: 10.1111/ina.12638. Epub 2020 Jan 23.
- Clasen T, Checkley W, Peel JL, Balakrishnan K, McCracken JP, Rosa G, Thompson LM, Barr DB, Clark ML, Johnson MA, Waller LA, Jaacks LM, Steenland K, Miranda JJ, Chang HH, Kim DY, McCollum ED, Davila-Roman VG, Papageorghiou A, Rosenthal JP; HAPIN Investigators. Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution. Environ Health Perspect. 2020 Apr;128(4):47008. doi: 10.1289/EHP6407. Epub 2020 Apr 29.
- Crocker ME, Hossen S, Goodman D, Simkovich SM, Kirby M, Thompson LM, Rosa G, Garg SS, Thangavel G, McCollum ED, Peel J, Clasen T, Checkley W; HAPIN Investigators. Effects of high altitude on respiratory rate and oxygen saturation reference values in healthy infants and children younger than 2 years in four countries: a cross-sectional study. Lancet Glob Health. 2020 Mar;8(3):e362-e373. doi: 10.1016/S2214-109X(19)30543-1.
- Johnson MA, Steenland K, Piedrahita R, Clark ML, Pillarisetti A, Balakrishnan K, Peel JL, Naeher LP, Liao J, Wilson D, Sarnat J, Underhill LJ, Burrowes V, McCracken JP, Rosa G, Rosenthal J, Sambandam S, de Leon O, Kirby MA, Kearns K, Checkley W, Clasen T; HAPIN Investigators. Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial. Environ Health Perspect. 2020 Apr;128(4):47009. doi: 10.1289/EHP6422. Epub 2020 Apr 29.
- Puttaswamy N, Saidam S, Rajendran G, Arumugam K, Gupton S, Williams EW, Johnson CL, Panuwet P, Rajkumar S, Clark ML, Peel JL, Checkley W, Clasen T, Balakrishnan K, Barr DB. Cross-validation of biomonitoring methods for polycyclic aromatic hydrocarbon metabolites in human urine: Results from the formative phase of the Household Air Pollution Intervention Network (HAPIN) trial in India. J Chromatogr B Analyt Technol Biomed Life Sci. 2020 Oct 1;1154:122284. doi: 10.1016/j.jchromb.2020.122284. Epub 2020 Jul 29.
- Sambandam S, Mukhopadhyay K, Sendhil S, Ye W, Pillarisetti A, Thangavel G, Natesan D, Ramasamy R, Natarajan A, Aravindalochanan V, Vinayagamoorthi A, Sivavadivel S, Uma Maheswari R, Balakrishnan L, Gayatri S, Nargunanathan S, Madhavan S, Puttaswamy N, Garg SS, Quinn A, Rosenthal J, Johnson M, Liao J, Steenland K, Piedhrahita R, Peel J, Checkley W, Clasen T, Balakrishnan K. Exposure contrasts associated with a liquefied petroleum gas (LPG) intervention at potential field sites for the multi-country household air pollution intervention network (HAPIN) trial in India: results from pilot phase activities in rural Tamil Nadu. BMC Public Health. 2020 Nov 26;20(1):1799. doi: 10.1186/s12889-020-09865-1.
- Simkovich SM, Underhill LJ, Kirby MA, Goodman D, Crocker ME, Hossen S, McCracken JP, de Leon O, Thompson LM, Garg SS, Balakrishnan K, Thangavel G, Rosa G, Peel JL, Clasen TF, McCollum ED, Checkley W. Design and conduct of facility-based surveillance for severe childhood pneumonia in the Household Air Pollution Intervention Network (HAPIN) trial. ERJ Open Res. 2020 Mar 23;6(1):00308-2019. doi: 10.1183/23120541.00308-2019. eCollection 2020 Jan.
- Williams KN, Thompson LM, Sakas Z, Hengstermann M, Quinn A, Diaz-Artiga A, Thangavel G, Puzzolo E, Rosa G, Balakrishnan K, Peel J, Checkley W, Clasen TF, Miranda JJ, Rosenthal JP, Harvey SA; Household Air Pollution Intervention Network (HAPIN) trial Investigators; HAPIN Investigators. Designing a comprehensive behaviour change intervention to promote and monitor exclusive use of liquefied petroleum gas stoves for the Household Air Pollution Intervention Network (HAPIN) trial. BMJ Open. 2020 Sep 29;10(9):e037761. doi: 10.1136/bmjopen-2020-037761.
- Wilson DL, Williams KN, Pillarisetti A. 2020. An Integrated Sensor Data Logging, Survey, and Analytics Platform for Field Research and Its Application in HAPIN, a Multi-Center Household Energy Intervention Trial. Sustainability. 2020; 12 (5): 1805. doi:10.3390/su12051805.
- Goodman D, Crocker ME, Pervaiz F, McCollum ED, Steenland K, Simkovich SM, Miele CH, Hammitt LL, Herrera P, Zar HJ, Campbell H, Lanata CF, McCracken JP, Thompson LM, Rosa G, Kirby MA, Garg S, Thangavel G, Thanasekaraan V, Balakrishnan K, King C, Clasen T, Checkley W; HAPIN Investigators. Challenges in the diagnosis of paediatric pneumonia in intervention field trials: recommendations from a pneumonia field trial working group. Lancet Respir Med. 2019 Dec;7(12):1068-1083. doi: 10.1016/S2213-2600(19)30249-8. Epub 2019 Oct 4.
- Quinn AK, Williams K, Thompson LM, Rosa G, Diaz-Artiga A, Thangavel G, Balakrishnan K, Miranda JJ, Rosenthal JP, Clasen TF, Harvey SA; HAPIN Investigators. Compensating control participants when the intervention is of significant value: experience in Guatemala, India, Peru and Rwanda. BMJ Glob Health. 2019 Aug 21;4(4):e001567. doi: 10.1136/bmjgh-2019-001567. eCollection 2019.
- Steenland K, Pillarisetti A, Kirby M, Peel J, Clark M, Checkley W, Chang HH, Clasen T. Modeling the potential health benefits of lower household air pollution after a hypothetical liquified petroleum gas (LPG) cookstove intervention. Environ Int. 2018 Feb;111:71-79. doi: 10.1016/j.envint.2017.11.018. Epub 2017 Nov 26.
- Checkley W, Thompson LM, Sinharoy SS, Hossen S, Moulton LH, Chang HH, Waller L, Steenland K, Rosa G, Mukeshimana A, Ndagijimana F, McCracken JP, Diaz-Artiga A, Balakrishnan K, Garg SS, Thangavel G, Aravindalochanan V, Hartinger SM, Chiang M, Kirby MA, Papageorghiou AT, Ramakrishnan U, Williams KN, Nicolaou L, Johnson M, Pillarisetti A, Rosenthal J, Underhill LJ, Wang J, Jabbarzadeh S, Chen Y, Davila-Roman VG, Naeher LP, McCollum ED, Peel JL, Clasen TF; HAPIN Investigators. Effects of Cooking with Liquefied Petroleum Gas or Biomass on Stunting in Infants. N Engl J Med. 2024 Jan 4;390(1):44-54. doi: 10.1056/NEJMoa2302687.
- McCollum ED, McCracken JP, Kirby MA, Grajeda LM, Hossen S, Moulton LH, Simkovich SM, Goodman-Palmer D, Rosa G, Mukeshimana A, Balakrishnan K, Thangavel G, Garg SS, Castanaza A, Thompson LM, Diaz-Artiga A, Papageorghiou AT, Davila-Roman VG, Underhill LJ, Hartinger SM, Williams KN, Nicolaou L, Chang HH, Lovvorn AE, Rosenthal JP, Pillarisetti A, Ye W, Naeher LP, Johnson MA, Waller LA, Jabbarzadeh S, Wang J, Chen Y, Steenland K, Clasen TF, Peel JL, Checkley W; HAPIN Investigators. Liquefied Petroleum Gas or Biomass Cooking and Severe Infant Pneumonia. N Engl J Med. 2024 Jan 4;390(1):32-43. doi: 10.1056/NEJMoa2305681.
- Balakrishnan K, Steenland K, Clasen T, Chang H, Johnson M, Pillarisetti A, Ye W, Naeher LP, Diaz-Artiga A, McCracken JP, Thompson LM, Rosa G, Kirby MA, Thangavel G, Sambandam S, Mukhopadhyay K, Puttaswamy N, Aravindalochanan V, Garg S, Ndagijimana F, Hartinger S, Underhill LJ, Kearns KA, Campbell D, Kremer J, Waller L, Jabbarzadeh S, Wang J, Chen Y, Rosenthal J, Quinn A, Papageorghiou AT, Ramakrishnan U, Howards PP, Checkley W, Peel JL; HAPIN Investigators. Exposure-response relationships for personal exposure to fine particulate matter (PM2.5), carbon monoxide, and black carbon and birthweight: an observational analysis of the multicountry Household Air Pollution Intervention Network (HAPIN) trial. Lancet Planet Health. 2023 May;7(5):e387-e396. doi: 10.1016/S2542-5196(23)00052-9.
- Clasen TF, Chang HH, Thompson LM, Kirby MA, Balakrishnan K, Diaz-Artiga A, McCracken JP, Rosa G, Steenland K, Younger A, Aravindalochanan V, Barr DB, Castanaza A, Chen Y, Chiang M, Clark ML, Garg S, Hartinger S, Jabbarzadeh S, Johnson MA, Kim DY, Lovvorn AE, McCollum ED, Monroy L, Moulton LH, Mukeshimana A, Mukhopadhyay K, Naeher LP, Ndagijimana F, Papageorghiou A, Piedrahita R, Pillarisetti A, Puttaswamy N, Quinn A, Ramakrishnan U, Sambandam S, Sinharoy SS, Thangavel G, Underhill LJ, Waller LA, Wang J, Williams KN, Rosenthal JP, Checkley W, Peel JL; HAPIN Investigators. Liquefied Petroleum Gas or Biomass for Cooking and Effects on Birth Weight. N Engl J Med. 2022 Nov 10;387(19):1735-1746. doi: 10.1056/NEJMoa2206734. Epub 2022 Oct 10.
- Simkovich SM, Thompson LM, Clark M, Balakrishnan K, Bussalleu A, Checkley W, Clasen T, Davila-Roman V, Diaz-Artiga A, de las Fuentes L, Harvey S, Kirby M, Lovvorn A, McCollum E, Peel J, Quinn A, Rosa G, Underhill L, Williams K, Young B, Rosenthal J. A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic. Res Sq [Preprint]. 2020 Nov 12:rs.3.rs-103997. doi: 10.21203/rs.3.rs-103997/v1.
- Nicolaou L, Underhill L, Hossen S, Simkovich S, Thangavel G, Rosa G, McCracken JP, Davila-Roman V, de las Fuentes L, Quinn AK, Clark M, Diaz A, Pillarisetti A, Steenland K, Waller LA, Jabbarzadeh S, Peel JL, Checkley W; HAPIN Investigators. Cross-sectional analysis of the association between personal exposure to household air pollution and blood pressure in adult women: Evidence from the multi-country Household Air Pollution Intervention Network (HAPIN) trial. Environ Res. 2022 Nov;214(Pt 4):114121. doi: 10.1016/j.envres.2022.114121. Epub 2022 Aug 24.
- Davila-Roman VG, Toenjes AK, Meyers RM, Lenzen PM, Simkovich SM, Herrera P, Fung E, Papageorghiou AT, Craik R, McCracken JP, Thompson LM, Balakrishnan K, Rosa G, Peel J, Clasen TF, Hossen S, Checkley W, de las Fuentes L; HAPIN Investigators. Ultrasound Core Laboratory for the Household Air Pollution Intervention Network Trial: Standardized Training and Image Management for Field Studies Using Portable Ultrasound in Fetal, Lung, and Vascular Evaluations. Ultrasound Med Biol. 2021 Jun;47(6):1506-1513. doi: 10.1016/j.ultrasmedbio.2021.02.015. Epub 2021 Apr 1.
- Simkovich SM, Thompson LM, Clark ML, Balakrishnan K, Bussalleu A, Checkley W, Clasen T, Davila-Roman VG, Diaz-Artiga A, Dusabimana E, de las Fuentes L, Harvey S, Kirby MA, Lovvorn A, McCollum ED, Mollinedo EE, Peel JL, Quinn A, Rosa G, Underhill LJ, Williams KN, Young BN, Rosenthal J; HAPIN Investigators. A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings. BMC Med Res Methodol. 2021 Apr 12;21(1):68. doi: 10.1186/s12874-021-01232-x.
- Liao J, McCracken JP, Piedrahita R, Thompson L, Mollinedo E, Canuz E, De Leon O, Diaz-Artiga A, Johnson M, Clark M, Pillarisetti A, Kearns K, Naeher L, Steenland K, Checkley W, Peel J, Clasen TF; HAPIN investigators. The use of bluetooth low energy Beacon systems to estimate indirect personal exposure to household air pollution. J Expo Sci Environ Epidemiol. 2020 Nov;30(6):990-1000. doi: 10.1038/s41370-019-0172-z. Epub 2019 Sep 26.
- Pillarisetti A, Ye W, Peel JL, Chang H, Underhill LJ, Balakrishnan K, Diaz-Artiga A, McCracken JP, Rosa G, Thompson LM, Aravindalochanan V, Boyd Barr D, Chen Y, Chiang M, Clark ML, Davila-Roman V, Jabbarzadeh S, Johnson MA, Kirby MA, Lovvorn AE, Naeher LP, Ndagijimana F, Piedrahita R, Puttaswamy N, Waller LA, Wang J, Williams KN, Nicolaou L, Checkley W, Clasen TF, Rosenthal JP, Steenland K; HAPIN Investigators. Household air pollution and blood pressure among adult women participants of the Household Air Pollution Intervention Network Trial: An exposure-response analysis. Environ Res. 2025 Nov 15;285(Pt 5):122570. doi: 10.1016/j.envres.2025.122570. Epub 2025 Aug 12.
- Sivalogan K, Stein AD, Thompson LM, Wang J, Diaz-Artiga A, Aravindalochanan V, Jabbarzadeh S, Nicolaou L, Williams KN, Balakrishnan K, Peel JL, Checkley W, Clasen T, Sinharoy SS; HAPIN investigators. Provision of a liquefied petroleum gas cookstove and fuel during pregnancy and infancy and linear growth trajectories between birth and 12 months: evidence from the multi-center Household Air Pollution Intervention Network (HAPIN) trial. medRxiv [Preprint]. 2025 Jun 6:2025.06.05.25329099. doi: 10.1101/2025.06.05.25329099.
- Quinn A, Hengstermann M, Diaz-Artiga A, Pillarisetti A, Clark M, Ruiz-Aguilar L, Ndagijimana F, McCracken JP, Rosa G, Checkley W, Peel J, Clasen TF, Thompson L; HAPIN Investigators. Development of personal air pollution exposure report-back materials to Household Air Pollution Intervention Network (HAPIN) trial participants in Guatemala and Rwanda: a qualitative study. BMJ Glob Health. 2025 May 15;10(5):e017672. doi: 10.1136/bmjgh-2024-017672.
- Raheel H, Sinharoy S, Diaz-Artiga A, Garg SS, Pillarisetti A, Balakrishnan K, Chiang M, Lovvorn A, Kirby M, Ramakrishnan U, Jabbarzadeh S, Mukeshimana A, Johnson M, McCracken JP, Naeher LP, Rosa G, Wang J, Rosenthal J, Checkley W, Clasen TF, Peel JL, Thompson LM; Household Air Pollution Intervention Network (HAPIN) investigators. Effects of a liquefied petroleum gas stove and fuel intervention on head circumference and length at birth: A multi-country household air pollution intervention network (HAPIN) trial. Environ Int. 2025 Jan;195:109211. doi: 10.1016/j.envint.2024.109211. Epub 2024 Dec 24.
- Patil SS, Puttaswamy N, Cardenas A, Barr DB, Ghosh S, Balakrishnan K. Protocol for CARES-HAPIN: an ambidirectional cohort study on exposure to environmental tobacco smoke and risk of early childhood caries. BMJ Open. 2024 May 15;14(5):e083874. doi: 10.1136/bmjopen-2024-083874.
- Sivalogan K, Liang D, Accardi C, Diaz-Artiga A, Hu X, Mollinedo E, Ramakrishnan U, Teeny SN, Tran V, Clasen TF, Thompson LM, Sinharoy SS. Human Milk Composition Is Associated with Maternal Body Mass Index in a Cross-Sectional, Untargeted Metabolomics Analysis of Human Milk from Guatemalan Mothers. Curr Dev Nutr. 2024 Apr 10;8(5):102144. doi: 10.1016/j.cdnut.2024.102144. eCollection 2024 May.
- Checkley W, Thompson LM, Hossen S, Nicolaou L, Williams KN, Hartinger SM, Chiang M, Balakrishnan K, Garg SS, Thangavel G, Aravindalochanan V, Rosa G, Mukeshimana A, Ndagijimana F, McCracken JP, Diaz-Artiga A, Sinharoy SS, Waller L, Wang J, Jabbarzadeh S, Chen Y, Steenland K, Kirby MA, Ramakrishnan U, Johnson M, Pillarisetti A, McCollum ED, Craik R, Ohuma EO, Davila-Roman VG, de las Fuentes L, Simkovich SM, Peel JL, Clasen TF, Papageorghiou AT; Household Air Pollution Intervention Network (HAPIN) Investigators. Cooking with liquefied petroleum gas or biomass and fetal growth outcomes: a multi-country randomised controlled trial. Lancet Glob Health. 2024 May;12(5):e815-e825. doi: 10.1016/S2214-109X(24)00033-0.
- Mollinedo E, McCracken JP, Johnson M, Piedrahita R, Pillarisetti A, Waller LA, Wang J, Thompson LM, Diaz-Artiga A, de Leon O, Ramirez A, Polanco A, Campbell D, Kearns KA, Kremer J, Nicolaou L, Clark ML, Balakrishnan K, Rosa G, Peel JL, Checkley W, Clasen TF, Naeher LP. Comparing Performance and Reliability of Collocated Enhanced Children's MicroPEM (ECM) on Gravimetric and Nephelometric PM2.5 Personal Exposure Samples in Field Measurements in Rural Guatemala. Indoor Air. 2025;2025:8812602. doi: 10.1155/ina/8812602. Epub 2025 Jan 2.
- Sivalogan K, Stein AD, Thompson LM, Wang J, Diaz-Artiga A, Aravindalochanan V, Jabbarzadeh S, Lovvorn AE, Ndagijimana F, Nicolaou L, Williams KN, Balakrishnan K, Peel JL, Checkley W, Clasen T, Sinharoy SS; HAPIN investigators paragraph sign. Provision of a liquefied petroleum gas cookstove and fuel during pregnancy and infancy and linear growth trajectories between birth and 12 months: Evidence from the multi-center Household Air Pollution Intervention Network (HAPIN) trial. PLOS Glob Public Health. 2025 Dec 31;5(12):e0004831. doi: 10.1371/journal.pgph.0004831. eCollection 2025.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 9월 1일
기본 완료 (실제)
2025년 6월 30일
연구 완료 (실제)
2025년 6월 30일
연구 등록 날짜
최초 제출
2016년 10월 17일
QC 기준을 충족하는 최초 제출
2016년 10월 24일
처음 게시됨 (추정된)
2016년 10월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 7일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .