April 2009
What is the National Children's Study?
The National Children’s Study is the largest, long-term study of environmental and genetic influences on children’s health ever conducted in the United States. By following 100,000 children from before birth to age 21, Study researchers hope to better understand how children’s genes and their environments interact to affect their health and development. In the Study, “environment” includes factors such as: air, water, and house dust; what children eat; how they are cared for; the safety of their neighborhoods; how often they see a doctor; and other factors.
What are the Study’s overarching goals?
The National Children’s Study will reaffirm the government’s commitment to the health and well-being of children by drawing together the nation’s top experts on child health and the environment in an unprecedented collaboration. Multiple federal agencies, national non-profit groups, community health care providers, and the participating families will stand together to help child health move forward in the 21st Century. The goals of the Study complement government efforts to challenge individuals, communities, and professionals to take action to ensure that good health and long life are enjoyed by all.
Who designed the Study, and how was it developed?
The National Children’s Study is led by a consortium of federal partners: the U.S. Department of Health and Human Services (including the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Environmental Health Sciences of the National Institutes of Health and the Centers for Disease Control and Prevention), and the U.S. Environmental Protection Agency. Members of the National Children’s Study Federal Advisory Committee—including its working groups of more than 2,400 obstetric, pediatric, and environmental health researchers from federal agencies, the private sector, and non-governmental organizations—completed the planning and groundwork that helped the lead federal agencies design and develop the Study.
The Study will examine important health issues, including birth defects and pregnancy-related problems; injuries; asthma; obesity; diabetes; and behavior, learning, and mental health disorders, to establish links between children’s environments and their health. By tracking children’s development through infancy, childhood, and early adulthood, the Study hopes to determine the root causes of many childhood and adult diseases. Findings from the Study will benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments and cures for disease.
How will the Study be conducted?
The National Children’s Study is an observational research Study. A participant is not asked to change what they normally do nor will they or their child be asked to take any medicines or drugs. The Study staff will visit with the mother and child at home, at other places where the child spends a lot of time, and at the local Study Center. Study staff will ask questions about the participant and their environment, and will collect samples of things from the participant and their environment. The Study is not a clinical trial. A clinical trial is an interventional research study in which participants are assigned to a treatment or other intervention, and their different outcomes are measured.
The Study will be conducted in 105 locations (counties or in rural areas, groups of counties) across the United States. All locations were selected using a probability-based method to ensure that children and families across the nation—from diverse ethnic, racial, economic, religious, geographic, and social groups—are fairly represented. In these locations, Study teams will work with health care professionals and community leaders to recruit women who are pregnant, or are likely to become pregnant in the near future, for participation in the Study. Most families will be recruited through contact at their home. Others will join through their local physicians’ offices, health clinics, and hospitals.
Initially, researchers will collect information on women’s pregnancies, including their diets, environments, chemical exposures, and emotional stress. When their children are born, and periodically thereafter, researchers will collect biologic samples and environmental samples like air, water, and dust from their environments. Researchers will meet with families in both their homes and in clinical settings, and data also will be collected remotely via telephone, computer, or mail-in questionnaires.
What is the difference between a Study Center and a Study location?
It is important to distinguish between Study Centers and locations. Study Centers are organizations such as universities or hospitals—often working in collaboration with each other—that are engaged through a federal contract to conduct the Study. Study locations are designated geographic areas, or counties, where the Study will be conducted and where eligible participants reside. A map and list of all Study Centers and their locations can be found at http://www.nationalchildrensstudy.gov/studylocations/.
What is the difference between a Vanguard Center and a Study Center?
The Vanguard Centers are the first seven universities and hospitals that were awarded contracts in September 2005. An additional 17 Study Centers were established in 2007, and another 12 joined them in 2008, for a total of 36 Study Centers awarded to date. Study Centers refer to all established Centers, including the Vanguard Centers.
The Vanguard Centers are undertaking what is considered the Study’s pilot or beginning phase of the Study, which kicked off in January 2009. Initial Study recruitment and data collection will start with the seven Vanguard Centers, and their ensuing results will inform the Study’s long-term recruitment and sampling methodology. Protocol refinements will be made as needed in preparation for participant recruitment by the other Study Centers, after the 18-month Vanguard cohort phase.
Study Centers were selected from a pool of applicants assessed through a competitive process. They successfully demonstrated the ability to carry out the Study, including collecting and managing biologic and environmental specimens; identifying community networks for recruiting and retaining eligible mothers and infants; and protecting the privacy of participant data.
How will Study Centers support the Study?
The Study Centers will work within their assigned Study locations to recruit participants and collect and process data. Study Centers are responsible for reporting to the Study’s Program Office. Some will conduct the Study in more than one Study location.
How many Study Centers and locations will there be, and when will recruitment begin?
Of the 36 Study Centers that are operational, the 7 Vanguard Centers were the first to begin recruitment efforts and data collection in January and April 2009 as part of the Study’s 18-month Vanguard cohort phase. Findings from this phase will inform the Study’s long-term recruitment and sampling methodology. Protocol refinements will be made as needed in preparation for participant recruitment by the remaining Study Centers over the next few years.
Vanguard Centers and their locations that launched recruitment in January 2009:
Vanguard Centers and their locations that launched recruitment in April 2009:
- Children’s Hospital of Philadelphia - Montgomery County, PA
- South Dakota State University - Brookings County, SD and Lincoln, Pipestone, and Yellow Medicine Counties, MN
- University of California, Irvine - Orange County, CA
- University of Utah School of Medicine, Department of Pediatrics - Salt Lake County, UT
- University of Wisconsin, Madison and Medical College of Wisconsin - Waukesha County, WI
There are Study locations throughout the United States, in urban, suburban, and rural areas. Visit http://www.nationalchildrensstudy.gov/studylocations/ for a printable map and list of all Study locations.
What types of activities are planned to launch recruitment at the Vanguard Centers?
Each of the seven Vanguard Centers had media events and community kick-off activities specific to their areas to announce the beginning of recruitment. These activities were preceded by months of community outreach efforts, which included meeting with local community leaders and local hospitals and birthing centers; holding town hall meetings and Community Advisory Board meetings; and explaining the Study to local media and other key interest groups. The success of the Study depends on the participation of families and communities, and recruitment launch activities that meet the needs of local communities will help facilitate this.
What is the source of funding for the National Children’s Study, and does funding the Study mean that other NIH research funds will be reduced?
The early development and initial implementation years of the Study (fiscal years 2000–2006) were funded by the lead supporting agencies: the U.S. Department of Health and Human Services—through the National Institutes of Health and the Centers for Disease Control and Prevention—and the U.S. Environmental Protection Agency. In fiscal year 2007, Congress authorized $69 million specifically for the National Children’s Study, to support funding Study Centers in additional locations across the country and to allow the Vanguard Centers to begin participant recruitment. This funding was provided separately from other Congressional funds for the NIH. For fiscal year 2008, Congress appropriated $110.9 million in new funding, specifically for carrying out research activities related to the National Children’s Study. Again, funding for other NIH research activities was not affected. Fiscal year 2009 funding for the National Children’s Study included up to $192 million.
Who will participate in the Study, and how will participants be encouraged to continue in the Study?
Families who participate in the National Children’s Study will come from 105 previously designated locations (which include U.S. counties, or in rural areas, groups of counties) from across the country and will be from many different racial, ethnic, and socioeconomic groups. Recruitment efforts for the Study will include community based grassroots campaigns to promote the formation of community partnerships; to build relationships with area obstetricians and other health care providers; and to direct outreach to parenting, religious, and community groups, as well as other organizations offering health information and support to families.
The National Children’s Study will seek to keep participants involved by maintaining strong relationships between Study staff and the children and families involved in the Study, as well as by engaging local community groups and activists. Some tools and activities to promote connection and cohesion among participants may include newsletters, interactive Web sites for the children, periodic get-togethers, and public presentations. As with most studies of this kind, participants will receive compensation for their participation.
The National Children’s Study Research Plan received approval from the White House Office of Management and Budget in 2008, which was the signal the Study needed to start recruitment at the seven Vanguard Centers in the winter and spring of 2009. The Study received approval from the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Institutional Review Board (IRB). This approval helps pave the way for future approval by numerous local IRBs nationwide.