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National Children's Study in The News

Data Driven: Recruitment Begins for National Children's Study (Tulane Global Health News, January 2012)

The National Children’s Study, the largest and longest-running study of children’s total health, kicks off next year, with Tulane University School of Public Health researchers and partners providing both essential early data and a role in recruitment and data management for the next 25 to 30 years.

Nationally, the goal is to recruit and follow 100,000 children from pre-birth through adulthood. Along the way, researchers will gather a broad spectrum of information related to their health, ranging from their mother’s health during pregnancy to environmental exposures in the home and community. Blood and urine samples will be included in the data collection, creating a massive database of information intended to shed some light on the complexity of children’s health.

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The Source (Gambit, November 1, 2011)

by Missy Wilkinson

The National Children's Study (www.nationalchildrensstudy.gov), which will follow 100,000 children from before birth to age 21 to glean a deeper understanding of how to maximize their health, is recruiting participants. Dr. LuAnn White is the principle investigator of The National Children's Study at Tulane University Study Center, one of 105 sites conducting the nationwide study. She shares information about what the study will accomplish and what participants can expect.

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Orleans Parish Selected in largest Study for Children's Health (The Trumpet, March/April 2011)

Orleans Parish has been selected to take part in the largest long-term study of children’s health and development ever undertaken in the United States. The National Children’s Study will examine the effects of environmental influences on the health and development of 100,000 children across the United States, from before birth until age 21.The goal is to improve the overall health and well-being of children.

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Tulane to conduct study of childhood development (Clarion Herald, March 2011)

New Orleans is one of 105 study sites nationwide selected to participate in a federally funded National Children’s Study conducted by the National Institute of Child Health and Human Development, the U.S. Department of Health and Human Services and the Environment Protection Agency. Liz Langlois, the local study’s communications manager, said this long-term study targets pregnant mothers in random Orleans Parish neighborhoods will collect data on their children up until age 21.

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Meg Farris / Medical Reporter (WWL TV, March 2011)

NEW ORLEANS - The New Orleans area is about to play a role in history as the largest study ever on children's health and development will use local people to gather important information. And you can be a part of it. Tulane researchers are looking for pregnant women or any women planning to get pregnant in the next few years. They need you to be a part of a nationwide study that will follow children from before they are born until they are 21 years of age.

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Data Driven: Recruitment Begins for National Children's Study (Tulane Global Health News, January 2012)

The National Children’s Study, the largest and longest-running study of children’s total health, kicks off next year, with Tulane University School of Public Health researchers and partners providing both essential early data and a role in recruitment and data management for the next 25 to 30 years.

Nationally, the goal is to recruit and follow 100,000 children from pre-birth through adulthood. Along the way, researchers will gather a broad spectrum of information related to their health, ranging from their mother’s health during pregnancy to environmental exposures in the home and community. Blood and urine samples will be included in the data collection, creating a massive database of information intended to shed some light on the complexity of children’s health.

This study builds upon the knowledge gained from smaller studies that have examined facets of children’s health, such as lead exposure or early heart disease risk factors.

“While there is a lot that we know from smaller, issue-specific studies, there is just a lot we don’t know,” says Associate Dean for Academic Affairs LuAnn White, professor of global environmental health sciences. White directs the Tulane Center for Applied Environmental Public Health and is principle investigator for the Tulane children’s study site. “This is a comprehensive study that follows the health of children from pre-birth and it will be a monumental amount of data that will be coordinated in many ways, environmental, behavioral, and sociological.”

White compares the study to the Nurses Health Study, which looked at the health of adult women over a long period of time. The National Children’s Study is a study without a hypothesis, she stresses. Instead, it is simply observational, seeking to gather as many datapoints as possible for analysis. For example, within a few years of the start of the study, researchers hope to have a rich source of data that can answer questions about health factors during pregnancy, birth outcomes, and early development.

“While we tend to study diseases and illnesses, very seldom do we look at health and what makes us healthy,” continues White, explaining “most of our normal values for clinical parameters of health for children were set back in the 50s on very few people. This study should help develop a gold standard for what is to be expected of healthy children in terms of those clinical values.”

As ambitious as the study is, researchers know that its success hinges on the participation of over 100,000 families in communities around the country. The first challenges for study sites – challenges that the Tulane team has embraced – seemed at first to be simple: recruit participants and protect the confidentiality of their data.

Challenges of Recruitment

Imagine a researcher coming to your door, asking about your pregnancy or plans for pregnancy, to recruit you or your wife and your unborn child for a 25-year-long study of children’s health, starting with a three-hour interview. Invasive and costly, this recruitment method (used by the first seven study centers in the NCS) raised red flags early in the study’s planning process. As a result, the first part of the study – the phase that is in process now – seeks to test a variety of recruitment methods.

In 2008, Tulane received a contract for $14.9 million to assist with the NCS. Tulane is one of 30 study sites nationwide. In 2011 the team, based in the school’s Center for Applied Environmental Health Sciences, began implementing several recruitment strategies developed between 2008 and 2010. Tulane is one of 10 study centers testing a recruitment strategy that relies on mass advertising (billboards, radio, and direct mail) and on community outreach through partners and community events such as health fairs and the weekly Freret Street Market. Twenty additional study centers are testing provider-based and door-to-door recruitment approaches.

“The buzzwords they’ve been using lately are acceptability, feasibility, and cost,” says program manager Elizabeth Langlois, MPH. Between 2008 and 2010 Langlois and Tulane researchers assisted in developing the initial study to find recruitment methods that were acceptable to the participants, feasible for all involved, and cost-effective. The communities identified using a national sampling approach vary around the country in terms of population density, ethnic makeup, and factors such as rural or urban development. But, for most, says Langlois, finding willing pregnant women is “like finding a needle in a haystack.”

Families who agree to participate at this stage will be in either a high or low level of data collection. The high level is a little more intense, explains Langlois, as women will be agreeing to the collection of biological (blood and urine) and environmental samples (such as soil and dust).

Response from the community has been wary but increasingly warm to the idea, says Langlois, who adds that the Tulane study site already includes some babies born after recruitment began in March 2011. Participants do receive a small amount of compensation for their time and their contribution of information to the study. During pregnancy and the first years of a child’s life, participants may be interviewed approximately every three months.

“We’ve had a pretty good representation of people calling into our study line,” says Langlois. “I think generally most people seem on board that this is a great idea and is something this city needs to have because we have such problems with our children.”

However, she notes, people in New Orleans also feel somewhat fatigued by the seemingly endless studies that have been done in Orleans Parish, especially since Hurricane Katrina. As a result, she says, the question of how to retain participants for the full course of the study and how to build a sense of community support for them stays at the forefront.

These issues will be addressed as the national study participants develop the final protocol, which will roll out in 2012. Those women who have enrolled already will continue to participate in the larger study.

But exactly who is participating remains a secret that Tulane researchers keep in a virtual – and literal — vault.


Floor Plans, Ceilings, and Data Management

Langlois and White both state – often – that this study has more levels of confidentiality than any other study they have worked on.

“Part of it is because of the sensitivity of pregnant women and children and it’s a national study,” says Langlois. “We’ve been building our own information management system which means we are dealing with lots of security standards defined by the federal information management security act, which governs how you keep data safe.”

The data collected at individual sites also has to be compatible with data collected elsewhere around the country, while still protecting individual health information.

“The idea is to make it a restricted public data set. People can apply to it and use the data for a variety of research projects,” explains Langlois. But since the data collection could include genetic information, some participants are concerned about how their samples will be labeled and used.

“These are not screening samples,” she emphasizes. “They are research samples and any individual’s name will be struck off it and it will go into a large database with everyone else who is in the study.”

In order to gain approval for the team’s data storage plan, Langlois and others had to provide floor plans and building details like wiring to demonstrate that not only was the virtual database secure, but its physical location was, too. A high-quality data management program has allowed Tulane to build a clinical training and research center specifically for the study, with an investment in equipment and materials that supports the level of confidentiality required by the study.

Ultimately, these early investments in identifying the most appropriate recruitment strategies and carefully planning a data management system will yield a solid foundation for the largest study of children’s health in US history.

“There’s nothing like this in the U.S.,” says Langlois. “Really the idea is just to look at what is making children healthy and for those who aren’t healthy, what could explain their poor health.”

Tulane is joined in this study, which was mandated at the congressional level with the Children’s Health Act of 2000, by several partners: Battelle Center for Public Health Research and Evaluation, Louisiana State University Health Sciences Center’s Department of Obstetrics/Gynecology, the Louisiana Public Health Institute, Women with a Vision, and the Louisiana Office of Public Health.


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The Source (Gambit, November 1, 2011)

by Missy Wilkinson

dr whiteThe National Children's Study (www.nationalchildrensstudy.gov), which will follow 100,000 children from before birth to age 21 to glean a deeper understanding of how to maximize their health, is recruiting participants. Dr. LuAnn White is the principle investigator of The National Children's Study at Tulane University Study Center, one of 105 sites conducting the nationwide study. She shares information about what the study will accomplish and what participants can expect.

Q: What is The National Children's Study?

A: It's a landmark study that follows children from pre-birth to adulthood, age 21 years. This will be one of the largest studies of children and health, and it will provide a tremendous amount of information not only on diseases and illnesses, but also how we define health and what makes a healthy child.

Q: What would the time commitment be for someone who wants to participate?

A: The time commitment is minimal. There are some initial questionnaires for the pregnant mother that ask about general factors. There are up to two or three pre-birth questionnaires, depending on when she comes in; if it's early in the pregnancy, it may be more. There's a birth visit to get information about the birth, and then periodic follow-up questionnaires that are more frequent when the child is young. There are questionnaires every three to six months, and then as the child gets older, once a year. At some point, we will collect environmental samples and biological specimens, but these will be minimal time commitments. We'd like women and children to participate in every questionnaire and activity, but if they can't, they can ... still be in the study.

Q: What if a participant moves out of New Orleans?

A: Since this is a nationwide study, there are study centers in many places across the country, so (the mother) could transfer. If she moves where there isn't a center, there is a way to stay in the study and proceed.

What are the benefits of participating?

A: As a research study, the benefit is really for the greater good, for understanding the factors that contribute to health in children. Right now we know a lot about many diseases; in addition to that, we'll look at what actually makes children healthy, what makes them thrive. That's the primary benefit. For each questionnaire a woman completes, she receives a gift card. For the people who participate, this is a voluntary activity.

Q: When does the study begin?

A: It has started in the sense that we are recruiting participants. We're in the pilot phase of testing out methods we will use. The main study will begin in 2013, but we are actively recruiting participants now. Those who enter in the pilot study will be full participants; they'll receive everything the main study participants will receive. And we hope this will go on for the next 20 to 25 years.

Q: What do you hope we'll learn from the study?

A: If you look at the clinical parameters we have, most were developed in the '50s and '60s. We have what is abnormal, and then we say a certain range is normal. But what makes a child minimally healthy, what makes one who is healthy, and what makes one who is thriving?

We realize children are not tiny adults. Things that affect them early in childhood may have longer ramifications than we once thought. We don't know (how that works) unless we have a large study that measures environmental and sociological effects in children and follows the children over long periods of time.

There's not just one aspect to a child's health — it's not just environment, nutrition, exercise, what goes on in a home — it is interrelated, and this study is looking at all factors across the board. We'll gather information on home life, stress, nutrition, exercise, and we'll be looking at the gene interactions, so this will set the public health and clinical standards for many years to come.

Q: How can people learn more about participating?

A: Anyone who is interested can call us at 988-1NCS (988-1627) and get more information on the study. This is geared toward Orleans Parish residents, but anyone who is interested can call. Women who are planning to become pregnant may also join the study.


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Meg Farris / Medical Reporter (WWL TV, March 2011)

NEW ORLEANS - The New Orleans area is about to play a role in history as the largest study ever on children's health and development will use local people to gather important information.

And you can be a part of it.

Tulane researchers are looking for pregnant women or any women planning to get pregnant in the next few years. They need you to be a part of a nationwide study that will follow children from before they are born until they are 21 years of age.

"We don't have very much information, so this is just a wonderful opportunity to begin to gather data for scientists to begin to understand better what goes on inside the womb," said Dr. LuAnn White the Principal Investigator of the local arm of the study who is the Director of the Center for Applied Environmental Public Health at Tulane.

A team of experts hopes to sign up 1,000 children in Orleans Parish over the next few years. That information gathered for the next two decades, will be added to data collected from 42 other centers across the U.S. It is hoped that 100,000 children will be followed from the womb to their 21st birthdays.

"We'll collect data at birth, and then in the first year of life, every three to six months, we'll collect data. And then after two years old, it will probably go to once a year," Dr. White explained.

There will be no medications or medical procedures done. There will mostly be questionnaires.

"We can gather more information by asking questions like, 'What do you eat? What is your diet? How much do you exercise? What kind of environment do you live in?' That gives us a tremendous amount of information and then we can supplement that with blood tests or with urine tests," Dr. White said.

There is no way of knowing just how much important information is going to come out of this huge study. In fact, the children who aren't even born yet may affect the health care of children for generations to come.

"Having that information gives us tremendous power to be able to inform physicians, to be able to form public health services and various other agencies, on what are the best practices," Dr. White continued.

They will uncover patterns in diseases, the effects of the environment and social issues, and how this city compares to others.

"We'll be looking at growth and development if parents happen to go through a divorce or if there's tragedy in the family or if there's good things," Dr. White explained.

And scientists of the future will have a gold mine of data for new health questions that haven't even been thought of yet.

Research and community outreach jobs will be created and participants will be compensated with monetary gift cards.

For more on 'The National Children's Study,' call 988-1627.

They will also be at the Freret Street Market Saturday afternoon signing up people.

e-mail: ncsnola@tulane.edu website www.nationalchildrensstudy.gov

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CAEPH, 1440 Canal Street, New Orleans, LA 70112, 504-988-1774 website@tulane.edu