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家庭空气污染与健康:多国液化石油气干预试验 (HAPIN)

2026年5月7日 更新者:Thomas Clasen、Emory University
本研究是一项针对四个国家(印度、危地马拉、秘鲁和卢旺达)3,200 户家庭的液化石油气 (LPG) 炉灶和燃料分配的随机对照试验。 按照共同的协议,每个干预点将招募 800 名孕妇(年龄 18-34 岁,妊娠 9 - <20 周),并随机分配其中一半的家庭使用液化石油气炉和 18 个月的液化石油气供应。 预计控制家庭将继续主要使用固体生物质燃料做饭,并将根据一套统一的试验范围原则获得补偿,这些原则根据形成性研究针对每个地点进行定制。 母亲将和她的孩子一起被跟随,直到孩子 1 岁。 研究人员估计,15% 的家庭将有第二名未怀孕的老年成年女性(40 岁至 <80 岁),她们也将在基线时登记并在 18 个月的随访期内接受随访。 为了优化干预措施的使用,研究人员将根据第一年的以往经验和形成性研究实施行为改变策略。 这项研究将评估炉灶的使用,对家庭空气污染进行反复的个人暴露评估,并收集干血点和尿液样本用于生物标记物分析和生物样本储存。 主要结果是低出生体重、严重肺炎发病率和儿童发育迟缓,以及老年妇女的血压。 次要结局包括儿童早产和发育、孕期母亲血压、内皮功能、呼吸损伤、动脉粥样硬化、致癌代谢物和老年妇女的生活质量。

研究概览

详细说明

在全球范围内,近 30 亿人依靠固体燃料做饭和取暖,其中绝大多数生活在低收入和中等收入国家 (LMIC)。 由此产生的家庭空气污染 (HAP) 是 2010 年全球疾病负担的第三大风险因素,估计每年造成 430 万人死亡,其中大部分是妇女和幼儿。 以前的干预措施提供了更清洁的生物质炉灶,但未能将暴露水平降低到产生有意义的健康改善的水平。 目前还没有对液化石油气 (LPG) 炉灶进行大规模现场试验,这可能是最清洁的可扩展干预措施。

本研究的目的是在四个中低收入国家(印度、危地马拉、秘鲁和卢旺达)的 3,200 户家庭中对 LPG 炉灶和燃料分配进行随机对照试验,以提供有关整个生命周期潜在健康益处的严格证据。 每个干预点将招募 800 名孕妇(年龄 18-34 岁,妊娠 9-<20 周),随机分配半数家庭使用液化石油气炉和 18 个月的液化石油气供应。 预计控制家庭将继续主要使用固体生物质燃料做饭,并将根据一套统一的试验范围原则获得补偿,这些原则根据形成性研究针对每个地点进行定制。 母亲将和她的孩子一起被跟随,直到孩子 1 岁。 在有第二名未怀孕的老年成年女性(40 岁至 <80 岁)的家庭中,研究人员还将在 18 个月的随访期内对她进行登记和跟踪,以评估心肺、代谢和癌症结果。 为了优化干预措施的使用,研究人员将实施行为改变策略。 本研究将评估炉灶的使用情况,对 HAP(PM2.5、黑碳、一氧化碳)进行重复的个人暴露评估,并在多个时间点收集所有参与者的干血斑和尿液样本,用于生物标志物分析和生物样本储存。 主要结果是低出生体重、严重肺炎发病率和儿童发育迟缓,以及老年妇女的血压。 次要结局包括儿童早产和发育、孕期母亲血压、内皮功能、呼吸损伤、动脉粥样硬化、致癌代谢物和老年妇女的生活质量。

本研究将针对以下具体目标:(1) 使用意向治疗分析,使用通用方案确定随机 LPG 炉灶和燃料干预对四个不同 LMIC 人群健康的影响; (2) 确定 HAP 和健康结果的暴露-反应关系; (3) 确定 LPG 干预与暴露/健康影响的目标和探索性生物标志物之间的关系。

这项研究将提供证据,包括成本和实施策略,为国家和全球政策提供信息,帮助他们在弱势人群中扩大液化石油气炉灶。 最终,这将促进更深入的政策层面讨论,并确定在全球范围内启动和维持 HAP 干预措施的要求。

研究类型

介入性

注册 (实际的)

3640

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Kigali、卢旺达
        • Rwanda Research Site, London School of Hygiene and Tropical Medicine, University of Liverpool
    • Tamil Nadu
      • Chennai、Tamil Nadu、印度、600116
        • Sri Ramachandra Institute of Higher Education and Research
    • Departamento de Guatemala
      • Guatemala City、Departamento de Guatemala、危地马拉、01015
        • Universidad del Valle de Guatemala
      • Puno、秘鲁
        • Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 79年 (成人、年长者)

接受健康志愿者

不

描述

孕妇纳入标准:

  • 确认怀孕(hCG 阳性血液或尿液检测)
  • 18 岁至 <35 岁(通过自我报告)
  • 主要使用生物质炉
  • 住在学习区
  • 9 - <20 周妊娠经超声证实
  • 单胎妊娠(一个胎儿)
  • 超声检查时胎儿心率正常(每分钟 120-180 次)的活胎儿
  • 通过自我报告确认在随机分组时继续怀孕
  • 同意在知情同意的情况下参与

孕妇排除标准:

  • 目前吸食香烟或其他烟草制品
  • 计划在未来 12 个月内永久迁出研究区域
  • 主要使用液化石油气炉,或在不久的将来可能主要使用液化石油气

同一家庭中老年妇女的纳入标准:

  • 40 至 <80 岁(通过自我报告)

同一家庭中年长成年妇女的排除标准:

  • 目前吸食香烟或其他烟草制品
  • 怀孕(自我报告)
  • 计划在未来 12 个月内搬出目前的住所

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:液化石油气灶具
随机分配到实验组的参与者将获得液化石油气 (LPG) 炉灶和 18 个月的液化石油气供应。
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.
无干预:控制
对照组的参与者将不会收到液化石油气 (LPG) 炉灶,并将继续使用传统烹饪方法(明火或传统炉灶)或他们选择的烹饪方法。 对照家庭将根据一套统一的试验范围原则获得补偿,并根据形成性研究为每个地点量身定制。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Birth weight
大体时间:Within 24 hours of birth (up to 5 months post-randomization of mother)
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.
Within 24 hours of birth (up to 5 months post-randomization of mother)
Incidence of HAPIN Defined Severe Pneumonia
大体时间:Up to 12 months after birth
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.
Up to 12 months after birth
Length-for-age z-score 2 standard deviations below the standard
大体时间:12 months after birth
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).
12 months after birth
Systolic Blood Pressure Among Older Adult Women
大体时间:Baseline, 3, 6, 9, 12, and 18 months post-randomization
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.
Baseline, 3, 6, 9, 12, and 18 months post-randomization
Child Linear Growth During Extended Follow-up
大体时间:24, 36, 48 and 60 months of age
Linear growth of children is assessed in centimeters of height.
24, 36, 48 and 60 months of age
Caregiver Reported Early Childhood Development Instrument (CREDI) Score During Extended Follow-up
大体时间:24 months of age
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.
24 months of age
Malawi Developmental Assessment Tool (MDAT) Score
大体时间:36, 48 and 60 months of age
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.
36, 48 and 60 months of age

次要结果测量

结果测量
措施说明
大体时间
早产
大体时间:最多 5 个月(出生后 24 小时内,随机分组后 3-5 个月)
早产定义为在妊娠满 37 周之前分娩活婴儿。
最多 5 个月(出生后 24 小时内,随机分组后 3-5 个月)
呼吸系统疾病住院
大体时间:出生后 12 个月内
出生后第一年因呼吸系统疾病住院的累积发生率。
出生后 12 个月内
世界卫生组织 非重症肺炎
大体时间:出生后 12 个月内
出生后第一年 WHO 非重症肺炎(2014 年定义和 2013 年定义)的累积发病率。 每当有呼吸道症状的儿童出现在 HAPIN 卫生机构时​​,就会记录肺炎病例。
出生后 12 个月内
世界卫生组织 严重肺炎
大体时间:出生后 12 个月内
出生后第一年 WHO 非重症肺炎(2014 年定义和 2013 年定义)的累积发病率。 每当有呼吸道症状的儿童出现在 HAPIN 卫生机构时​​,就会记录肺炎病例。
出生后 12 个月内
世界卫生组织袖珍书非重症肺炎
大体时间:出生后 12 个月内
根据“儿童医院护理袖珍手册”(2013 年)第二版中的定义,世卫组织出生后第一年非重症肺炎的累积发病率。 每当有呼吸道症状的儿童出现在 HAPIN 卫生机构时​​,就会记录肺炎病例。
出生后 12 个月内
世界卫生组织袖珍书严重肺炎
大体时间:出生后 12 个月内
根据“儿童医院护理袖珍手册”(2013 年)第二版中的定义,世卫组织出生后第一年严重肺炎的累积发病率。 每当有呼吸道症状的儿童出现在 HAPIN 卫生机构时​​,就会记录肺炎病例。
出生后 12 个月内
低氧性肺炎
大体时间:出生后 12 个月内
出生后第一年低氧性肺炎的累积发病率。 每当有呼吸道症状的儿童出现在 HAPIN 卫生机构时​​,就会记录肺炎病例。
出生后 12 个月内
超声波或射线照相肺炎
大体时间:出生后 12 个月内
出生后第一年肺部超声或胸片肺炎的累积发生率。 每当有呼吸道症状的儿童出现在 HAPIN 卫生机构时​​,就会记录肺炎病例。
出生后 12 个月内
Gestational Systolic Blood Pressure
大体时间:Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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.
Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
Gestational Diastolic Blood Pressure
大体时间:Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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.
Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
Systolic Blood Pressure in New Mothers
大体时间:9, 12, and 18 months post-randomization
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.
9, 12, and 18 months post-randomization
Diastolic Blood Pressure in New Mothers
大体时间:9, 12, and 18 months post-randomization
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.
9, 12, and 18 months post-randomization
Diastolic Blood Pressure Among Older Adult Women
大体时间:Baseline, 3, 6, 12 and 18 months post-randomization
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.
Baseline, 3, 6, 12 and 18 months post-randomization
Mean arterial pressure
大体时间:Baseline, 3, 6, 12 and 18 months post-randomization
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.
Baseline, 3, 6, 12 and 18 months post-randomization
Pulse pressure
大体时间:Baseline, 3, 6, 12 and 18 months post-randomization
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.
Baseline, 3, 6, 12 and 18 months post-randomization
Fetal Growth
大体时间:Baseline, Gestation Week 24-28 and Gestation Week 32-36
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.
Baseline, Gestation Week 24-28 and Gestation Week 32-36
Gestational age at birth
大体时间:Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
Gestational age at birth is measured in weeks, as continuous outcome, among all live births.
Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
Brachial artery reactivity testing (BART)
大体时间:Baseline, 18 months post-randomization
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)
Baseline, 18 months post-randomization
Carotid intima-media thickness (CIMT) Among Older Adult Women
大体时间:Baseline, 18 months post-randomization
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.
Baseline, 18 months post-randomization
St. George Respiratory Questionnaire (SGRQ) Score
大体时间:Baseline, 18 months post-randomization
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.
Baseline, 18 months post-randomization
Short Form 36 Survey (SF-36) Score Among Older Adult Women
大体时间:Baseline, 18 months post-randomization
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).
Baseline, 18 months post-randomization
Weight
大体时间:24, 36, 48 and 60 months of age of the child
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.
24, 36, 48 and 60 months of age of the child
Body Mass Index (BMI)
大体时间:24, 36, 48 and 60 months of age of the child
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.
24, 36, 48 and 60 months of age of the child
Height
大体时间:24 and 36 months of age of the child
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.
24 and 36 months of age of the child
Child Blood Pressure
大体时间:24 (Rwanda only) and 60 months of age
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.
24 (Rwanda only) and 60 months of age
Child Linear Growth
大体时间:Birth (3-5 months post-randomization), and 3, 6, 9, and 12 months of age
Linear growth of children is assessed in centimeters at birth and quarterly thereafter, until the child is 12 months old.
Birth (3-5 months post-randomization), and 3, 6, 9, and 12 months of age
Caregiver Reported Early Childhood Development Instrument (CREDI) Score
大体时间:3 and 12 months of age
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.
3 and 12 months of age

其他结果措施

结果测量
措施说明
大体时间
自然流产
大体时间:基线至妊娠 20 周
胎死于19周前6天。
基线至妊娠 20 周
早期早产
大体时间:出生
在所有活产中,不足 34 周的出生完成妊娠。
出生
死胎
大体时间:直到出生
在妊娠 20 周或之后发生的任何胎儿死亡,或在严重不良事件表或孕妇病史表或口头尸检表上表明。
直到出生
新生儿死亡
大体时间:出生到 28 天
出生至 28 天之间死亡。
出生到 28 天
儿童肺功能
大体时间:36、48 和 60 个月大
肺功能测量将使用带有一次性吸嘴的 Tremoflo C-100 装置的受迫振荡技术 (FOT) 进行。 FOT 是一种可以识别气道早期变化的技术。 FOT 设备测量外部施加的压力波与产生的气流之间的关系,以测量呼吸阻抗。 高频产生的值对应于近端气道和大气道,​​低频产生的值对应于远端气道和小气道。 这项测量将在危地马拉的儿童中进行。
36、48 和 60 个月大
尿液生物标志物的变化
大体时间:基线、随机分组后 3、6、9、12 和 18 个月以及儿童 24 个月龄
将测量多次暴露生物标志物:3-OH 可替宁、4-(甲基亚硝基氨基)-1-(3-吡啶基)-1-丁醇 (NNAL)、左旋葡聚糖、8OH-脱氧鸟苷 (8OHdG) 和挥发性有机化学品 (VOC) 代谢物。 暴露生物标志物(尤其是尿液可能受限的儿童)将优先考虑如下:多环芳烃(PAH)生物标志物、左旋葡聚糖、挥发性有机化学品(VOC)生物标志物、重金属和烟草相关生物标志物。 将在基线、妊娠 24-28 周和妊娠 32-36 周的孕妇以及孩子 24 个月大时测量新妈妈的尿液生物标志物。 将在基线、随机分组后 3、6、9、12 和 18 个月时测量老年女性的生物标志物。 将对 3、6、12 和 24 个月大的儿童进行生物标志物测量。
基线、随机分组后 3、6、9、12 和 18 个月以及儿童 24 个月龄
干血斑 (DBS) 生物标志物的变化
大体时间:基线、随机分组后 3、6、9、12 和 18 个月以及儿童 24 个月大时
从干血斑中测量的主要生物标志物有:炎症标志物、心血管疾病内皮标志物、氧化应激标志物、Hb、HbA1C、肿瘤相关抗原抗体、细胞色素P450、p53肿瘤相关抗原(TAA)、脂质、代谢组学、miRNA、重金属。 DBS 生物标志物将在基线、妊娠 24-28 周和妊娠 32-36 周的孕妇以及孩子 24 个月大时的新妈妈中进行测量。 DBS 生物标志物将在基线、随机分组后 3、6、9、12 和 18 个月时对老年女性进行测量。 DBS 生物标志物将在 3、6、12 和 24 个月大的儿童中进行测量。
基线、随机分组后 3、6、9、12 和 18 个月以及儿童 24 个月大时
母亲感知压力量表 (PSS)
大体时间:随机分组后 9 至 18 个月(儿童 3 至 12 个月大)
科恩感知压力量表 (PPS) 包含 10 个项目,用于评估个人如何评价其生活事件带来的压力(例如,“在过去的一个月中,您有多少次感到困难堆积如山,以至于无法克服?” )(科恩,1983)。 Likert 水平反应范围从 0(从不)到 4(经常),这意味着高 PPS 分数将导致高水平的感知压力。 创建并测试了西班牙语 PPS,结果发现其有效且可靠(Vallijo 等人,2018)。
随机分组后 9 至 18 个月(儿童 3 至 12 个月大)
早产
大体时间:出生
包括早产和死产。
出生
家庭粮食不安全
大体时间:基线,随机化后 18 个月
家庭粮食不安全将使用粮食不安全经验量表(FIES)进行衡量,该量表由粮食及农业组织(FAO)开发和验证。 FIES 模块包括关于家庭是否获得充足食物的八个问题,每个问题都有是/否回答选项,旨在衡量粮食不安全的三个领域:不确定性/焦虑、粮食数量和粮食质量。 每个问题的得分为 0/1,将其相加得出可能的总分 0-8。
基线,随机化后 18 个月
饮食多样性——女性
大体时间:随机化后 18 个月的基线
女性的饮食多样性将使用粮农组织和 FHI 360 的最低饮食多样性 - 女性 (MDD-W) 调查问卷进行衡量,该调查问卷使用开放回忆格式来收集受访者在前一天和晚上消耗的食物和饮料的数据。 答复将被分为十个食物组,报告食用十个食物组中的五个或更多食物组的女性将被归类为实现最低饮食多样性。
随机化后 18 个月的基线
血红蛋白 (Hb) 浓度/贫血 - 女性
大体时间:基线、随机化后 3 个月和 5 个月
使用 HemoCue® Hb 201 系统 (HemoCue® AB) 护理点设备,通过刺破手指获得的一滴毛细血管血来测量 Hb
基线、随机化后 3 个月和 5 个月
血红蛋白 (Hb) 浓度/贫血 - 婴儿
大体时间:随机分组后 12 个月和 18 个月(6 个月和 12 个月大)
使用 HemoCue® Hb 201 系统 (HemoCue® AB) 护理点设备,通过刺破手指获得的一滴毛细血管血来测量 Hb
随机分组后 12 个月和 18 个月(6 个月和 12 个月大)
Change in fine particulate matter (PM2.5) exposure
大体时间:Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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.
Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
Change in Carbon monoxide (CO) exposure
大体时间:Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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.
Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
Change in Black carbon (BC) exposure
大体时间:Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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.
Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
Messenger Ribonucleic Acid (mRNA) Expression and microRNA in Older Adult Women
大体时间:Baseline, 18 months post-randomization
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.
Baseline, 18 months post-randomization
Microbiome Operational Taxonomic Units (OTUs) in Older Adult Women
大体时间:Baseline, 18 months post-randomization
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.
Baseline, 18 months post-randomization
Epigenetics (DNA methylation) in Older Adult Women
大体时间:Baseline, 18 months post-randomization
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.
Baseline, 18 months post-randomization
Metabolomics and MicroRNA in Older Adult Women
大体时间:Baseline, 18 months post-randomization
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.
Baseline, 18 months post-randomization
Dietary diversity - infants
大体时间:9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age)
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.
9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age)
Carotid intima-media thickness (CIMT) Among Older Adult Women During Extended Follow-up
大体时间:24 months of age of the child
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).
24 months of age of the child
Reported Diarrhea in Children
大体时间:Up to 12 months after birth
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.
Up to 12 months after birth

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年9月1日

初级完成 (实际的)

2025年6月30日

研究完成 (实际的)

2025年6月30日

研究注册日期

首次提交

2016年10月17日

首先提交符合 QC 标准的

2016年10月24日

首次发布 (估计的)

2016年10月26日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月7日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB00089799
  • 1UM1HL134590-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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