Overview of National Children’s Study -Goals, Study Design, Progress

1. Overview of National Children’s Study -Goals, Study Design, Progress Dean Baker, MD, MPH Mary Coggins University of California, Irvine November 19, 2009 Orange County Vanguard Center

2. Topics • National Children’s Study overview • Rationale and key concepts • Priority exposures and outcomes • Benefits of the NCS • Study design and data collection • Neighborhood (segment) sampling in Orange County • Data collection milestones • Community Outreach and Engagement

3. Facts about the NCS • National in scope; the study group will be representative of all US families • 100,000 children & parents from 105 US counties • Families followed from before conception or in early pregnancy until child is age 21 years • Comprehensive study with priority exposures and outcomes • Specimens (e.g., household dust, mother’s blood) will be stored, to answer questions in the future

4. Rationale for the National Children’s Study President’s Task Force on Environmental Health and Safety Risks to Children, 2000 • Compared to adults, children may be especially vulnerable to environmental exposures – metabolism, behavior • Exposures to some agents demonstrate potential for serious developmental effects – lead, prenatal alcohol • Known exposures of high frequency: pesticides, violence, media • Numerous high burden conditions with suspected environmental contribution – learning disabilities, autism, diabetes, asthma, birth defects, premature birth • Existing research too limited in size and scope to answer these questions • Life-course (longitudinal) design needed to correctly link multiple exposures and multiple outcomes

5. PL 106-310: Children’s Health Act of 2000 (a) PURPOSE — … to authorize NICHD to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children's health and development. (b) The Director of NICHD shall establish a consortium of representatives from appropriate Federal agencies to: (1) plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of both chronic and intermittent exposures on child health and human development; and (2) investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes…

6. Study Concepts • Study high priority and burdensome conditions • Large study population to address complex causation of important conditions (n~100,000) • Hypothesis driven • Exposure period begins with pregnancy • Study environment and genetic interactions • State-of-the-art technology • National resource for future studies

7. Exposures Mediator Examples Outcomes Chemical Exposures Pregnancy Outcomes Physical Exposures Neurodevelopment and Behavior Gene Expression Psychosocial Exposures Asthma Biological Exposures Obesity and Growth Health Care Genetics Child Health and Development Injury Reproductive Development Conceptual Model: Exposures, Interactions, Mediators, and Outcomes

8. Priority Exposures and Health Outcomes

9. Potential Impact of NCS on Our Children’s Well-Being • Identify social and environmental factors which cause or contribute to health, development, and behavior problems • Understand the biology and genetics of health, development, and behavior • Information on which to base decisions about policies regarding children’s health • Economic benefits: cost avoidance • Resource for future research

10. Potential Cost-Benefit Impact of NCS on Selected Health Outcomes • Estimated annual disease burden from 10 health outcomes is approximately $395 billion • Includes direct medical spending and indirect costs from reduced productivity • Estimated annual reduction of $4.0–9.7 billion (1.0 –2.5%) attributable to the NCS • Estimated annual cost of study: $0.1 billion - represents a 40:1 to 97:1 return on investment Pivetz T et al., Battelle, April 2004

11. National Children’s Study - Sample Design ~4 million births in 3,141 counties All Births in the Nation Sample of Study Locations 105 Locations(counties) Sample of Study Segments Selection of neighborhoods All or a sample of households within neighborhoods Sample of Study Households All eligible women in the household Sample of Study Women

12. NCS Study Locations Orange County

13. Selection of Segments in County • Orange County has 45,000 births per year. The target enrollment is 250 births per year. • Multi-stage sampling plan: • Strata: 15 geographical strata with equal number of births • Segment: 1,850 segments with ~ 25 births/year each • Segments consist of contiguous US census blocks that are aggregated to have equal number of births • The NCS Coordinating Center randomly selected one segment from each Strata

14. Orange County – Strata

15. Orange County – Sampled Segments

17. Single family and multi-household dwellings – some behind gates

18. Dense apartments – many with gates

19. Household Screening and Recruitment (EPSC) • Door-to-door recruitment in segments • Contact ~ 10,500 households • Enroll women 18 to 49 years of age (~ 7,000) • Follow-up of women for 5 years for pregnancy • Intensity of follow-up depends on likelihood of pregnancy • Women in sampled neighborhoods who become pregnant will be enrolled in study • Household recruitment will be supplemented: • Prenatal care providers

20. Schedule of Participant Visits • 14 face-to-face contacts over 21 year study period • Contacts most frequent early in the study • Between visits: ongoing data collection by phone, PDA, etc. White = home Blue = clinic Red = hospital

21. Data Collection • Questionnaires and Interviews • Face to face • Remote (computer, telephone, mail) • Diaries • Examinations • Clinical and behavioral assessments • Biologic samples • blood, urine, cord blood, placenta, breast milk • Environmental samples and observations • Air, dust, soil, water, home observations

22. T1 Home Visit – Data Collection Equipment and Supplies

23. Birth Visit – Data Collection at Birthing Hospitals > 3,000 births/yr

24. OCVC Milestones - EPSC • Enumeration – 10,503 dwelling units • Completed enumeration – 8,524 (82%) • Refusal/ineligible DU – 174 • With eligible female – 3,654 (37%) of DU • Pregnancy Screen - 4,449 eligible females • Completed pregnancy screen – 3,946 • Refusal/ineligible females – 226 • Eligible non-pregnant females – 2,931 • Eligible Pregnant females – 70 • Pregnant Women Informed Consent • Refused – 6 • Agreed to Participate – 48

25. OCVC Milestones – Data Collection • T1/T2/T3 Pregnancy Visits • 27 completed & partially completed T1 visits • 4 T2 ultrasounds • 6 completed & partially completed T3 visits • Father Visits • Beginning November 2009 • Birth Visits • First birth - September 17, 2009 • More in October and November

26. Orange County – Special Characteristics for Recruitment • Highly populous county with many births • 45,000 births per year with NCS target of 250/year • Births in segments are < 0.5% of births in county • Highly diverse population with multiple primary languages and cultures • English, Spanish, Chinese, Korean, Vietnamese, Persian • Many restricted access communities • Home owner associations, gated communities,locked apartment buildings

27. Community Outreach & Engagement Strategies • Multi-prong approach • Multi-level media outreach • Neighborhood Advisory Committee (NAC) for each segment • Community group representatives and residents in segments • Formed or facilitated additional support groups • e.g., Korean Leadership Forum • Monthly newsletter distributed via e-mail

28. Multi-Pronged Outreach Strategy

29. Multi-level Media Outreach

30. Events

32. Neighborhood Advisory Committees (NAC’s) • gather unique segment characteristics • share segment contacts • tap into existing community networks • help to identify key segment informants • support continuous segment surveillance throughout recruitment

33. NAC - Breakfast of Champions