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起源于其起源。早期的生活条件在内，包括贫困和歧视在整个生活过程中产生了健康的分布，这些分布通过世代相传的传播在人群中进一步根深蒂固。父母的心理健康与社会和经济灾难以及儿童发展密切相关，可能在跨几代人的差异传播中起关键的中介作用，但是分布文献的持续差距是，孕产妇和父亲心理病理学都没有被完全视为使用机制 表型验证的方法。 结果，尽管健康差异有充分的记录，但影响生命开始时差异的发育机制并非如此，尤其是那些导致发育的人定义了早在疾病状态之前出现的。美国国家卫生研究院（NIH）战略计划（2016-2020）强调了研究的必要性，以提高“理解因种族/民族和社会经济地位导致差异的机制”。需要这种增强的理解来阐明分布的病因，尤其是与影响早期发展的社会或经济灾难相关的特定暴露。促进对产生分布的发展机制的了解需要更彻底地了解社会经济和种族/种族地位如何影响妊娠的发展。为此，比现有研究中目前可以从生命过程中开始使用的更深入的分布原因，需要对潜在的分布原因进行更深入的测量。 A.研究研究目的 壁内人群健康研究（DIPHR）的划分正在研究妊娠和儿童发育期间孕产妇健康的基于证据和理论的风险，这些因素有望受到个人，家庭和邻里水平的不平等影响。这项研究的结果将扩大有关差距对父母健康和早期儿童发展的影响的知识基础，这可能解释了终身健康差异。反过 缓解分布。 根据此，这项前瞻性观察队列研究将在妊娠的第一个中期在社会经济，粗略和种族多样化的队列中招收，总计约2,000名妇女及其伴侣，并通过怀孕，分娩和后代的第一年进行随访评估。具体目标 总体研究中有以下内容： （1）调查怀孕期间父母健康和行为的分布 （2）调查生命第一年的出生结果和儿童发育差异的机制。 B.研究设计 临床部位将在12岁或更少的妊娠周上大约2,000名孕妇及其伴侣的社会经济，大致和种族多样化的样本招收。除胎龄外，参与者的资格要求是，他们是非机构化的，能够批准同意（或者，如果在多数年龄段以下，获得父母同意），并且能够说英语或西班牙语。 该研究将包括来自多个来源的定量数据的连续收集，包括针对精神疾病的结构化诊断访谈。另外，将获得人体测量评估和生物医学测量值，例如体重，身高和血压。在基准时，将使用结构化访谈对母亲和父亲的身体和心理健康以及社会水平的风险以及胎儿发育的保护因素进行详细评估。要评估的特定领域包括精神病诊断，儿童逆境，创伤性和压力性的生活事件，感知到的压力和 社会支持，吸毒和饮食行为，以及母乳喂养和感知伴侣对母乳喂养的支持。此外，将对参与者的地址进行地理编码，以启用有关邻里级特征的数据。生物菌（血液，尿液，唾液）将从母亲串行收集基因分型，并通过妊娠测量神经内分泌免疫和代谢途径；此外，基线的伴侣/共同父母将收集基因分型的血液。 将收集孕产妇的生物测量，并在分娩时评估婴儿的身体健康和神经发育。妊娠结束时的产前，劳动和分娩以及新生儿病历抽象将提供有关怀孕期间物物和胎儿状况以及分娩过程中并发症的其他数据。在6个月零12个月大时对婴儿的随访评估将包括身体健康和神经发育；还将评估育儿行为以及家庭和邻里环境。在寄托后的研究访问之间，父母将完成对怀孕和育儿环境的临时实时评估 研究后第一年被称为基于说唱​​歌手的行为，情绪，育儿经历以及儿童成长和发展的评估。说唱歌手平台的一部分将用于构建电子怀孕/婴儿“书”，这将回馈参与者以认识他们的家人的学习参与。在进行了12个月的随访之后，小儿记录抽象将提供有关婴儿健康和发育的其他数据。 范围 该任务订单的目的是为启动，初始招聘阶段的完成以及在健康差异观察研究的产前和儿童期机制中提供数据协调中心的服务。与临床研究地点和DIPHR研究人员合作，Thedata协调中心负责设计和实施一个系统，以跟踪参与者的招聘，保留和跟进，并在多达4个研究地点进行多个评估浪潮；为研究设计和实施数据收集平台；开发和实施一个系统，以跟踪NICHD生物验证中生物测量的确定，发货和存储；开发和实施系统以确保数据质量和完整性；并将这些数据收集和管理系统以及研究程序的文档提供给承包官的代表（COR）。