Vitae annual report, Vol. 30 No. 2 

Watch Them Grow

UMass Medical School begins participation in a decades-long study of children's health and development, the largest such initiative in U.S. History.

The shelves in Marianne Felice’s office bookcase sag under the weight of four enormous binders crammed with charts, maps, statistical reports and timelines flagged by numerous and colorful Post-it notes. The binders will serve as an operations manual of sorts for the next two decades and beyond, as the University of Massachusetts Medical School carries out its role in the National Children’s Study (NCS), the largest long-term exploration of children’s health and development ever conducted in the United States.  

Beginning in the summer of 2009, Dr. Felice, chair of pediatrics at UMMS and physician-in-chief of the UMass Memorial Children’s Medical Center, and her team will be aided by a small army of field researchers, environmental experts, obstetricians, pediatricians, nurses and community leaders to recruit 1,000 infants from Worcester County—before they’re born or, in some cases, even conceived—and closely track them until their 21st birthdays. The data the team collects about the childrens’ health and environments will be vast. Children from Worcester County will be part of a cohort of 100,000 enrolled over the course of five years through 105 sites across the country in an unprecedented effort to provide vital new insights into the effects of environmental and genetic factors on human growth, development and disease. Conclusions of the NCS are expected to help the United States set environmental, social and health policy that will affect millions of people for generations to come.

“It’s difficult to overstate the magnitude of this study,” said Felice, principal investigator of the UMMS arm of the NCS, called the Massachusetts Child Health Indicators and Life Determinants (Mass CHILD). Felice and her team were awarded a highly competitive NCS contract in October 2007 that will provide $16.2 million for the first five-year phase of the study, during which UMMS will hire staff, establish laboratory and office space, engage the community and hospitals and recruit participants. UMMS was the only institution in the Commonwealth of Massachusetts to win its own NCS contract. 

The NCS was “born in response to growing concerns, arising in the late 1990s among a number of federal health agencies, about how environmental exposures might be contributing to increases in autism, learning disorders, asthma, obesity, diabetes and other illnesses,” said Peter Scheidt, MD, medical officer for the NCS, a joint endeavor of the National Institute of Child Health and Human Development, the Centers for Disease Control and the Environmental Protection Agency. “We simply did not have sufficient data to pinpoint suspected links.” Congress asked the Department of Health and Human Services to collaborate on a longitudinal study to discover those links through unparalleled data collection.   

The NCS had to be large enough, the populations diverse enough, to derive the statistical power to answer certain hypotheses with conviction. All childhood and adolescent experiences, all ethnic and socioeconomic groups, and all environmental and geographic influences had to be taken into account. Worcester County, like the other NCS sites, was identified through a scientifically rigorous probability sample that represents the nation as a whole. 

In turn, the number and type of samples the NCS will take is mind-boggling: nearly two million biological and environmental specimens, beginning with genetic samples from each parent and including ultrasounds recorded during pregnancy, cord blood samples and other materials taken at the time of birth. As the children grow, samples of the air they breathe, the soil, dust and water they touch (and ingest) from in and around their homes, daycare centers and schools will be gathered. As the study tracks each participant, it will also examine the child’s overall health, eating and exercise habits, TV viewing patterns, friendships, family size and composition, emotional stressors, socioeconomic status and spatial factors, such as the child’s proximity to green space, bodies of water and highways. Through the collection of materials and the completion of detailed questionnaires and home visits during pregnancy (and prior to conception), at birth, throughout growth and into young adulthood, NCS will create a complete picture of childhood in the United States.

“Winning a contract of this magnitude is truly a milestone in UMass Medical School’s history,” said Executive Deputy Chancellor and Provost Terence R. Flotte, MD, dean of the School of Medicine. He noted that the Medical School’s growing reputation in clinical and translational research makes it uniquely positioned to accept this challenge. “Each of the faculty involved in this study exemplify our proud tradition of primary care education, our reputation for methodical research and our close community involvement. We are an institution with both an undeniably strong track record in public health research and an undeniably strong relationship with the community from which mothers will be sought.”

Preliminary calculations estimate that Mass CHILD will need to knock on approximately 13,000 doors to successfully identify 1,000 women who are in their first trimester of pregnancy or who may become pregnant over the four-year enrollment period. Mass CHILD has contracted with the National Opinion Research Center (NORC), based at the University of Chicago and specializing in social science research in the public interest, to assist UMMS  in household screening, enrollment of participants, and computer-assisted interviews both in-person and via telephone. Although NORC will recruit, train and manage most local field staff, UMMS will oversee nurses and medical staff who will obtain the biological samples and clinic and hospital data. Collected data will be downloaded daily to a national processing center, and laptops provided by NCS will be purged nightly to ensure the protection of personal health information. 

The success of the study hinges not only on the recruitment of mothers, but on the retention of their children for more than 20 years of tracking. The task of community engagement will be shared by several Mass CHILD team members, but the bulk of it will sit on the shoulders of Linda Churchill, the community liaison officer. Churchill, who has coordinated public health research with UMMS for 20 years, is well known to women across the region for her role in recruiting participants for the Women’s Health Initiative (WHI).

	As par of the Mass CHILD project, UMass Medical School will work with researchers at Clark University who will assist with environmental sampling and mapping using GEographic Information Systems (GIS). Clark principal investigator Timothy Downs, DEnv, is assistant professor of Environmental Science and Policy in Clark's Department of International Development, Community and Environment (IDCE). Colleague Yelena Ogneva-Himmelberger, PhD, is assistant professor Geographic Information Science, and Robert Goble, PhD, is a senior environmental health research professor, also in IDCE. The GIS creates and overlays maps of geographic, demographic and socio-economic data, as well as maps illustrating potential hazards like highways, waterways and pollution sources, and resources like open space and health care facilities. Maps can show where children are most exposed to hazards and have the most limited access to resources. This information will be paired with data from the Department of Public Health that tracks the county's birth records from the past five years, enabling Mass CHILD to target certain neighborhoods for recruiting. "It will be fascinating to track changing environmental data and health data trends in parallel and seek spatial associations," said Dr. Brown.

“I learned from the WHI to engage study participants person by person, neighborhood by neighborhood,” said Churchill. “Over the course of 21 years we will forge very close relationships and become part of the family as we watch these children grow.” Working through community organizations and physicians’ offices and supported by opinion leaders from throughout the region—community activists and advocates, local elected officials, neighborhood businesspeople and community physicians—Churchill and the Mass CHILD team will build awareness of and enthusiasm for the study. Her efforts will be helped by the Medical School’s considerable history of community partnership and that of UMass Memorial Medical Center—and in particular the UMass Memorial Children’s Medical Center. “We know Worcester County and Worcester County knows us,” Felice said simply. To assist Mass CHILD in community engagement, Felice invited 18 members of the communities within Worcester County to serve on the Community Advisory Board and to be study ambassadors in their respective communities.

UMass Memorial will be intimately involved in the study, in part because 40 percent of the babies born in Worcester County take their first breaths in the maternity wards at the Memorial campus. In addition, all women in the study will have two additional ultrasound examinations during pregnancy, adding 2,000 annual tests to the medical center’s already busy ultrasound service.  Hospital leadership, keenly interested in the study and the advances it may bring to health care, was a key contributor and participant in the UMMS contract bid for the NCS.

In addition to its implications for patient care, the NCS will be influential in public health research for decades beyond its data collection period. “I’m particularly excited about the study for the opportunities it may create for our young faculty who have yet to find their research niche,” said Felice. “Something like this can have a profound impact on a young person’s career.” 

“There is tremendous value in this award not only for the nation but for UMass Medical School in particular. Through it we will be able to leverage other studies and attract additional research funding,” said Professor of Pediatrics and Psychiatry Thomas J. McLaughlin, ScD, Mass CHILD’s co-principal investigator. As a study center, UMMS will have easier access to NCS data than other universities, and there will be opportunities as the study unfolds for clinical science and basic science researchers at UMMS to launch adjunct studies. “We might want to study the role of environmental exposures in modifying DNA expression or in the emergence of a new phenotype such as a disturbance in metabolism or an overt disorder,” suggested Dr. McLaughlin. “If we can identify what environmental triggers might trip a genetic predisposition to a disease, for example, we may have an opportunity to intervene very early in life.”  

Mass CHILD has already begun considering additional research questions that may be answered with the NCS data. Felice, for one, hopes to finally have answers to questions surrounding the high infant mortality rate that has plagued Worcester for years. Chair of the city’s Infant Mortality Reduction Task Force, she said, “With so much data to be gathered from mothers and their babies, this is likely our best shot to answer this question.”  

Felice, concluded, “I hope that when this study is complete and we’ve been able to put to rest some of the region’s and nation’s concerns about child health and the environment, our participants will look back on what they’ve contributed and will be proud to say,
‘I was a Mass CHILD baby.’”

		A study this large and complex requires expert leadership, a proven track record in conducting public health research and the technical and logistical know-how to mobilize resources to collect and manage precious data. While Chair of Pediatrics Marianne Felice, MD, will be the “face” of the project in the community and will have overall responsibility for it, the Mass CHILD leadership team includes the following UMMS faculty who together possess the public health research acumen to do the job:
		Thomas J. McLaughlin, ScD, is the co-principal investigator of Mass CHILD and responsible for direct oversight of all research activities related to the project. He has been involved in the conceptualization and design of the NCS since 2000. A professor of pediatrics and psychiatry, McLaughlin is also director of the Division of Clinical Research in the Department of Pediatrics and has vast experience as a health services researcher and biostatistician. He is also an expert in longitudinal research design and analysis of longitudinal data, especially in the area of mental health and behavioral disorders, making him well suited to guiding an enormous research project with so many moving parts.
		Assistant Professor of Pediatrics Onesky Aupont, MD, MPH, MA, PhD, is the study director and operations manager for the project. Prior to joining UMMS, Aupont trained in health service research and maternal and child health and was a community prevention specialist and immunization coordinator for the state’s Department of Public Health. He will oversee the day-to-day management of Mass CHILD and direct the activities of all the staff members. Mass CHILD expects to hire the equivalent of 85 full-time employees and will occupy space on the Hoagland-Pincus campus of the Medical School.
		Janet Hardy, MPH, MSc, PhD, a perinatal epidemiologist, has been dedicated to the NCS since 2002 when she participated as an invited member of the first NCS Study Assembly.  Her primary research focus lies in medication safety and other environmental hazards in pregnancy in relation to maternal well-being, teratogenic and adverse neurodevelopmental outcomes in children. With Tiffany Moore Simas, MD, MPH, she will co-lead the efforts to engage all 11 hospitals at which women in Worcester County deliver their infants. Dr. Hardy will supervise the five hospital negotiators to be hired for the project and ensure that relevant hospitals are involved and participating in the project.
		Tiffany A. Moore Simas, MD, MPH, an assistant professor of obstetrics & gynecology and pediatrics, has conducted an  array of research studies related to pregnancy, including biomarkers connected to risk of preeclampsia and screening for domestic violence. With Janet Hardy, MPH, MSc, PhD, she will co-lead the initial efforts at hospital engagement. She will also oversee all obstetrics activities, working with the ultrasonography unit and the nurses and nurse midwives who will conduct prenatal visits at home and in clinic, and will coordinate neonatal exams in collaboration with Felice.
		Judith K. Ockene, PhD, MEd, MA, is the senior advisor on all survey activities. A professor of medicine and chief of the Division of Preventive and Behavioral Medicine and the Barbara Helen Smith Chair in Preventive and Behavioral Medicine, Ockene is principal investigator of the UMMS site for the national Women’s Health Initiative, a longitudinal health study whose findings surprised the medical world and reversed the thinking surrounding hormone replacement therapy in postmenopausal women.
		Professor of Pediatrics and Molecular Medicine Katherine Ruiz de Luzuriaga, MD, is the laboratory director of Mass CHILD and responsible for overseeing all laboratory functions and quality assurance.  Dr. Luzuriaga is widely respected for her patient-oriented research focused on mother-to-child transmission of HIV and has extensive experience in the design, conduct and provision of laboratory support in clinical trials involving mothers and children. She will supervise the senior research associates responsible for overseeing collection, processing and shipment of specimens to ensure that NCS receives clean, accurate materials; she says, “your data are only as good as your samples.”
The Mass CHILD team also includes consultant Robert J. Goldberg, PhD, UMMS professor of medicine, who is well known in the area for his role as principal investigator of the Worcester Heart Attack Study and the Worcester Heart Failure Study. Dr. Goldberg’s role in this project is to advise Mass CHILD leadership about the recruitment and retention of fathers in the study for crucial data collection.		Ronald C. Kessler, PhD, professor of health care policy at the Harvard Medical School and co-director of the World Health Organization’s World Mental Health Surveys being conducted in 28 countries, will advise the Mass CHILD leadership team about the challenges to long-term retention of study subjects.

 Back to contents