University Times

As the nation embarks on the largest children’s health study ever undertaken in the United States, Pitt is among the institutions playing a role in collecting data.

The National Children’s Study (NCS), authorized by the Children’s Health Act of 2000, aims to examine the effects of genetic and environmental factors on the growth, health and development of U.S. children by following a representative sample of women through pregnancy and birth, then following their babies through age 21.

The study, a collaborative effort between the U.S. Department of Health and Human Services (including the National Institute of Child Health and Human Development, the National Institute of Environmental Health Sciences at the National Institutes of Health and the Centers for Disease Control and Prevention) and the U.S. Environmental Protection Agency, seeks to recruit 100,000 children nationwide. Participants will be recruited from 105 study locations across the United States that collectively make up a “micro-U.S.A.” from a statistical standpoint, based on demographics and expected birth rates.

Pitt is the lead institution for study centers in Westmoreland County, Pa., and in Marion County, W.Va.

The study involves observations — no medications or treatments — although biological and environmental samples will be collected from some participants, said epidemiology professor Jane Cauley, principal investigator for the Pitt study site.

Jane Cauley

Findings from the study will be released as they become available throughout the course of the study. Current study activities include determining which recruitment approaches may be most feasible and cost-effective.

The Westmoreland County site’s recruiting is based on a direct consumer marketing theory. In fact, students in a Pitt-Greensburg marketing course have been assisting with some of the marketing approaches, Cauley noted, adding that because many of those students are of similar age to the women being recruited, they’ve had some very insightful ideas on how to reach those groups, including using social media.

To reach the local study site’s goal of 1,000 babies, 4,000 women ages 18-49 must be recruited, Cauley said. So far, about 30 pregnant women and 30 women who are trying to become pregnant have enrolled. In addition, there are a large number of women who are not trying to become pregnant, but who have agreed to keep in touch. Given that about 50 percent of pregnancies are unplanned, some research subjects eventually may be recruited from that group as well, Cauley noted.

While Cauley is responsible for the West Virginia site as well, colleagues at West Virginia University are subcontractors for the research to be conducted in Marion County, which is south of Morgantown. That study site also is seeking to enroll 1,000 babies.

“NCS wants to comprehensively study how we can help children and families be healthy,” Cauley said, noting that the study stands to shed light on many interesting and important health questions.

“Some studies have suggested that the rate of autism spectrum disorders has increased 370 percent from 1980. Attention deficit disorders have increased by approximately 250 percent since 1990. And childhood obesity has tripled from 5 percent in 1980 to about 17 percent currently. Think of those three statistics,” Cauley said.

In addition, she said, “Out of 100 U.S. children right now, seven will develop asthma, 12 will develop ADHD and 17 will be obese. If you add all that up, that’s one-third of U.S. children.”

Locally, the study is being launched at an important time, as Marcellus shale development is expanding.  “That’s very topical when I go out into the community,” she said. “People are really concerned. … That’s definitely something we’re going to be interested in.”

The study’s definition of children’s environment is wide-ranging, going far beyond air and water. “It’s the food they eat, it’s their neighborhoods, their intrauterine environment, their biological environment. Environment is the genes that we have — it’s very broadly defined. So I think it hopes to be a very comprehensive study.”

Environmental assessments are being phased in, she said. Initially researchers want to obtain umbilical cord blood and maternal blood samples when participants deliver their babies. Water samples as well as dust samples — collected from vacuum cleaner bags in participants’ homes — also are being taken. When the study is in full swing, there are plans to leave air quality monitors in participants’ homes and perhaps to take additional biological samples including placenta and breast milk samples, she said.

Although Cauley’s research interests have not been in the specific areas of reproductive health or children’s health, she’s been involved in the NCS study from very early in the process. Cauley has had a research facility in Monessen, Westmoreland County, since 1986, from which she has conducted studies and clinical trials related to her research on osteoporotic fractures. Initially, epidemiology chair Roberta Ness was Pitt’s NCS site PI, but Cauley took on the role in 2008 when Ness left to become dean of the University of Texas School of Public Health.

Cauley said she hopes to build on her own research background by looking at how childhood exposures impact fractures in later life. “Osteoporosis is sometimes considered a pediatric disease with adult consequences,” she said, noting that a study of vitamin D exposure in utero or measurements of bone density and attainment of peak skeletal mass in children could be valuable in better understanding risks for fractures in later life.

She sees ample opportunity for other University researchers, particularly those involved in pediatric, reproductive health and pregnancy-related research.

“I would really foster collaborative work across the University in terms of investigators who are interested in proposing an ancillary study once we’re allowed to submit them,” Cauley said. Currently such proposals aren’t being accepted while the study focuses on determining its recruitment approaches and settling exactly what analyses will be conducted as part of the study.

The initial study design exceeds what is affordable, so priorities must be set. According to the NCS site, federal funding has been allocated each year since 2000; for fiscal year 2010, up to $193.8 million was designated for the study nationwide.

To date, Pitt has received $4.6 million, Cauley said.

Cauley said researchers hope to know early next year what will be included in the final protocol. “The investigators very much want to be a part of helping to decide,” she said, noting that researchers are part of the steering committee that will make such decisions. “Really, there’s a lot of expertise amongst the steering committee and a lot of people have been doing this type of research for a very long time, so I think hopefully we’ll be able to have some input,” she said.

Information on the local site can be found at www.ncsinwestmoreland.org; information on NCS is available at nationalchildrensstudy.gov.

—Kimberly K. Barlow