DATA COORDINATING CENTER FOR THE PRENATAL AND CHILDHOOD MECHANISMS OF HEALTH DISPARITIES: START-UP AND RECRUITMENT OF THE FIRST SUBCOHORT OF PREGNANT WOMEN AND THEIR PARTNERS

产前和儿童健康差异机制数据协调中心：第一个孕妇及其伴侣小组的启动和招募

• 批准号: 10261309
• 负责人: Seth Sherman
• 金额: $ 38.8万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-23 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10261309
• 关键词: Address; Affect; Age; Age-Months; Alcohol or Other Drugs use; Back; Beginning of Life; Behavior; Behavior assessment; Birth; Blood; Blood Pressure; Books; Breast Feeding; Characteristics; Child; Child Development; Child Rearing; Childhood; Clinical Research; Cohort Studies; Collaborations; Collection; Consent; Contracts; Data; Data Collection; Data Coordinating Center; Data Management Resources; Data Reporting; Development; Diagnostic; Discrimination; Disease; Documentation; Eating Behavior; Economically Deprived Population; Eligibility Determination; Enrollment; Ensure; Environment; Ethnic Origin; Etiology; Event; Family; Family Study; Fetal Development; First Pregnancy Trimester; Generations; Genotype; Gestational Age; Grant; Growth and Development function; Health; Health behavior; Height; Immune; Individual; Inequality; Infant; Infant Development; Infant Health; Intervention Studies; Interview; Knowledge; Lead; Life; Life Cycle Stages; Link; Literature; Maternal Health; Measurement; Measures; Mediating; Medical Records; Mental Health; Mental disorders; Metabolic Pathway; Moods; Mothers; National Institute of Child Health and Human Development; Neighborhoods; Neonatal; Neurosecretory Systems; Observational Study; Outcome; Parental Consent; Parents; Participant; Patient Recruitments; Patient Self-Report; Phase; Phenotype; Play; Population; Poverty; Pregnancy; Pregnancy Complications; Pregnant Women; Procedures; Psychiatric Diagnosis; Psychopathology; Race; Recording of previous events; Research; Research Design; Research Personnel; Risk Factors; Role; Saliva; Sampling; Second Pregnancy Trimester; Services; Ships; Site; Social support; Socioeconomic Status; Source; Strategic Planning; Structure; System; Testing; Time; United States; United States National Institutes of Health; Urine; Visit; Weight; Weight Gain; Woman; base; biobank; childhood adversity; clinical research site; cohort; data quality; design; ethnic diversity; experience; fetal; follow up assessment; follow-up; health disparity; improved; knowledge base; multiple data sources; neurodevelopment; nutrition; offspring; perceived stress; physical conditioning; population health; postnatal; prenatal; prepregnancy; prospective; protective factors; racial disparity; racial diversity; recruit; research study; social; social disadvantage; socioeconomics; theories; transmission process

BACKGROUND Health disparities in the United States have their origins as early as the prenatal period. Early life conditions including poverty and discrimination generate disparities in health over the life course that become further entrenched in the population through their transmission across generations. Parental mental health, which is strongly linked with social and economic disadvantage as well as child development, may play a key mediating role in the transmission of disparities across generation, but a persistent gap in the disparities literature is that both maternal and paternal psychopathology have not been fully considered as mechanisms nor measured using phenotypically validated approaches. As a result, though disparities in health are well documented, the developmental mechanisms that impact disparities at the very beginning of life are not, particularly those which lead to developmental deficits that emerge long before disease states. The National Institutes of Health (NIH) strategic plan (2016-2020) highlights the need for research to improve “understanding mechanisms that lead to disparities by race/ethnicity and socioeconomic status.” Such enhanced understanding is needed to clarify the etiology of disparities – particularly the specific exposures linked with social or economic disadvantage that impact early development. Advancing knowledge of the developmental mechanisms that generate disparities requires a more thorough understanding of how socioeconomic and race/ethnic status influence the determinants of development from gestation onward. To accomplish this, more in-depth measurement of potential causes of disparities is needed from more diverse samples starting earlier in the life course are needed than is currently available from existing studies. A. Study Research Aims The Division of Intramural Population Health Research (DIPHR) is examining evidence-and theory-based risk and protective factors for maternal health during pregnancy and child development that are expected to be affected by inequalities at the individual, family, and neighborhood levels. The results of this study will expand the knowledge base concerning the impacts of disparities on parental health and early child development that may account for the establishment of life-long disparities in health. This knowledge base will, in turn, inform interventional research on effective approaches to the alleviation of disparities. Accordingly, this prospective observational cohort study will enroll a socioeconomically and racially and ethnically diverse cohort totaling approximately 2,000 women and their partners during the first trimester of pregnancy and conduct follow-up assessments through pregnancy, delivery and the first year of their offspring’s life. The specific aims of the overall study are the following: (1) To investigate disparities in parents’ health and behaviors during pregnancy (2) To investigate the mechanisms generating disparities in birth outcomes and child development during the first year of life. B. Study Design The clinical site(s) will enroll a socioeconomically and racially and ethnically diverse sample totaling approximately 2,000 pregnant women and their partners at 12 or fewer gestational weeks. In addition to gestational age, eligibility requirements for participants are that they be noninstitutionalized, able to grant consent (or, if under the age of majority, to obtain parental consent), and able to speak either English or Spanish. The study will include serial collection of quantitative data from multiple sources including structured diagnostic interviews for psychiatric disorders. In addition, anthropometric assessments and biomedical measurements such as weight, height, and blood pressure will be obtained. At baseline, detailed assessments of maternal and paternal prepregnancy physical and mental health and social histories, familial and neighborhood-level risk and protective factors for fetal development will be conducted utilizing structured interviews. Specific domains to be assessed include psychiatric diagnoses, childhood adversities, traumatic and stressful life events, perceived stress and social support, substance use, and eating behavior, as well as intentions to breastfeed and perceived partner support for breastfeeding. Further, participant addresses will be geocoded to enable data on neighborhood-level characteristics to be obtained from public sources. Biospecimens (blood, urine, saliva) will be collected from mothers serially for genotyping and to measure neuroendocrine-immune and metabolic pathways through pregnancy; in addition, blood for genotyping will be collected partners/co-parents at baseline. Maternal biospecimens will be collected and infants’ physical health and neurodevelopment assessed at delivery. Prenatal, labor and delivery, and neonatal medical record abstractions at the end of pregnancy will provide additional data on maternal and fetal conditions during pregnancy and complications during delivery. Follow-up assessments of infants at 6 months and 12 months of age will encompass physical health and neurodevelopment; parenting behaviors and family and neighborhood environments will also be assessed. Between postdelivery study visits, parents will complete interim Real-time assessment of Pregnancy and Parenting Environment for Research, known as RAPPER-based assessments of behaviors, moods, parenting experiences, and children’s growth and development during the first postnatal year. Part of the RAPPER platform will be used to construct an electronic pregnancy/baby “book” that will give back to participants to recognize their families’ study participation. After the 12-month follow-up, pediatric record abstraction will provide additional data on infant health and development. SCOPE The purpose of this task order is to provide services of a Data Coordinating Center for the completion of the start-up, initial recruitment phase, and the beginning of second trimester follow-up assessments in the Prenatal and Childhood Mechanisms of Health Disparities observational study. In collaboration with the clinical study site(s) and DIPHR investigators, theData Coordinating Center is responsible for designing and implementing a system to track participant recruitment, retention, and follow-up over multiple waves of assessment across up to 4 study sites; designing and implementing the data collection platforms for the study; developing and implementing a system to track the ascertainment, shipment, and storage of biospecimens in the NICHD biorepository; developing and implementing a system to ensure data quality and completeness; and providing those data collection and management systems and documentation of study procedures to the Contracting Officer’s Representative (COR).

背景 美国的健康差异早在产前时期就有其根源。包括贫困和歧视在内的早期生活条件造成了生命历程中的健康差异，这种差异通过代代相传而在人口中进一步根深蒂固。父母的心理健康与社会和经济劣势以及儿童发展密切相关，可能在代际传播差异中发挥关键的中介作用，但差异文献中持续存在的差距是，母亲和父亲的精神病理学都没有被充分视为机制，也没有使用 表型验证的方法。 因此，尽管健康方面的差异有据可查，但在生命之初影响差异的发育机制却没有，特别是那些导致早在疾病状态之前就出现的发育缺陷的机制。美国国立卫生研究院 (NIH) 战略计划（2016-2020）强调需要进行研究以改善“对导致种族/族裔和社会经济地位差异的理解机制”。需要这种加强的理解来澄清差异的根源，特别是与影响早期发展的社会或经济劣势相关的特定风险。增进对产生差异的发育机制的了解需要更透彻地了解社会经济和种族/族裔地位如何影响从妊娠开始的发育决定因素。为了实现这一目标，需要从生命历程早期开始的更多样化的样本中比目前现有研究中提供的样本更深入地测量差异的潜在原因。 A. 研究目的 校内人口健康研究部 (DIPHR) 正在研究基于证据和理论的孕产妇健康风险和保护因素，这些因素预计会受到个人、家庭和社区层面不平等的影响。这项研究的结果将扩大关于父母健康和早期儿童发育差异影响的知识库，这可能是造成终生健康差异的原因。该知识库反过来将为干预研究提供有效方法 缩小差距。 因此，这项前瞻性观察队列研究将在怀孕的前三个月招募一个社会经济、种族和民族多样化的队列，总计约 2,000 名女性及其伴侣，并在怀孕、分娩和后代生命的第一年进行后续评估。具体目标 总体研究内容如下： (1) 调查父母在怀孕期间的健康和行为差异 (2) 调查出生结果和儿童第一年发育差异的机制。 B. 研究设计 临床中心将招募社会经济、种族和民族多样化的样本，总计约 2,000 名妊娠 12 周或以下的孕妇及其伴侣。除了胎龄之外，参与者的资格要求是他们没有被送入机构，能够给予同意（或者，如果未达到法定年龄，则获得父母同意），并且能够说英语或西班牙语。 该研究将包括从多个来源连续收集定量数据，包括精神疾病的结构化诊断访谈。此外，还将获得人体测量评估和生物医学测量结果，例如体重、身高和血压。在基线时，将利用结构化访谈对母亲和父亲孕前的身心健康和社会历史、家庭和社区层面的风险以及胎儿发育的保护因素进行详细评估。需要评估的具体领域包括精神病学诊断、童年逆境、创伤性和压力性生活事件、感知压力和 社会支持、物质使用和饮食行为，以及母乳喂养的意图和感知到的伴侣对母乳喂养的支持。此外，参与者地址将被地理编码，以便能够从公共来源获得有关社区级别特征的数据。将从母亲身上连续收集生物样本（血液、尿液、唾液）用于基因分型并测量整个怀孕期间的神经内分泌免疫和代谢途径；此外，将在基线时收集伴侣/共同父母的血液用于基因分型。 将收集母亲的生物样本，并在分娩时评估婴儿的身体健康和神经发育。产前、临产和分娩以及妊娠结束时的新生儿病历摘要将提供有关妊娠期间母婴状况以及分娩期间并发症的额外数据。对 6 个月和 12 个月大的婴儿进行的后续评估将包括身体健康和神经发育；养育行为以及家庭和邻里环境也将受到评估。在产后研究访问之间，父母将完成怀孕和育儿环境的临时实时评估 研究，即基于 RAPPER 的行为、情绪、养育经历以及儿童出生后第一年的成长和发展的评估。 RAPPER平台的一部分将用于构建电子怀孕/婴儿“书”，以回馈参与者以表彰其家庭的研究参与。 12 个月的随访后，儿科记录摘要将提供有关婴儿健康和发育的额外数据。 范围 该任务订单的目的是提供数据协调中心的服务，以完成产前和儿童健康差异机制观察性研究的启动、初始招募阶段以及中期妊娠后续评估的开始。数据协调中心与临床研究中心和 DIPHR 研究人员合作，负责设计和实施一个系统，以跟踪参与者的招募、保留和对最多 4 个研究中心的多轮评估的跟踪；设计和实施研究的数据收集平台；开发和实施一个系统来跟踪 NICHD 生物样本库中生物样本的确定、运输和存储；开发和实施一个系统以确保数据质量和完整性；向合同官员代表 (COR) 提供这些数据收集和管理系统以及研究程序文件。