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

The Emmes Company, Llc, Rockville MD

Investigators

Abstract

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).