Attach 16

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DEPARTMENT OF HEALTH & HUMAN SERVICES

National.

Institutes of Health

~~,~~~~~

Ronald J. Iannotti, PhD ,

December 22, 2009

Prevention Research Branch
Eunice Kennedy Shriver National

Institute of Child Health and

Superintendent Name

Superintendent
Street Address
City, State, Zipcode

Human Development
6100 Building Room 7B05 MSC 7510
Bethesda, MD 20892-7510
Phone: 301 435-6951

Fax: 301 402-2084
E-mail: iannottr(Çmail.nih.gov

Dear Dr. Last Name

Obesity has become a major problem in the United States and the National Institute of Child Health
and Human Development (NICHD) has recently reported that adolescents in the U.s. are more likely
to suffer from overweight and obesity than adolescents in other developed countries. School
administrators are concerned because adolescent obesity and substance use and the health behaviors
related to these health problems have been shown to affect school performance. Health professionals

are concerned because adolescent obesity has been shown to lead to diabetes, heart disease, and many
other health problems in adolescents and adults. In order to better understand this critical phase of
u.s. adolescent health, the National Institutes of Health (NIH) is embarking on a 4-year nationwide

longitudinal study of U.S. adolescents, called the NEXT Generation Health Study (NEXT). Three
Institutes within NIH have partnered to conduct this study, they are: NICHD; the National Heart,
Lung, and Blood Institute; and the National Institute of Alcohol Abuse and Alcoholism. In addition,
the Maternal and Child Health Bureau of the Health Resources and Services Administration is also
conh'ibuting resources to this important public health initiative.

The NEXT Generation Health Study wil gather data on health behaviors and their social and
environmental contexts from students in a four-year longitudinal, nationally-representative sample
of 10th-grade children in the U.s. The study provides a unique opportunity to assess the
determinants of adolescent health, health risk behaviors, and mental health over an extended period
and during significant family and career/ education transitions. Through a combination of inschool surveys and assessments, as well as online surveys, NEXT wil gather information on
adolescent nuh'ition and dietary practices; physical activity and sedentary behaviors; sleep; driving
behavior; substance use; and the inuence of family, friends, and coirunities on these health

behaviors.

The purpose of this letter is to inorm you that school dish'icts within your State have been
randomly selected to participate in NEXT. Approximately 80 schools in the United States have been
selected to participate in this national health study.
The following school districts in your State were randomly selected to represent adolescents in the
United States:
(List Dish'icts)

Within each school district, approximately (insert number) schools wil be randomly selected to
participate in the study. Approximately two grade 10 classrooms (NOT the entire grade) wil be

randomly selected in each schooL. Students in these classrooms wil be asked to take a health
survey, have their height, weight, and waist measured, and asked to provide a saliva sample during
the first year of the study. During the second and third years of the study, NEXT health researchers
wil revisit these same schools to collect height, weight, and waist measurements for those
participants who are still attending the same schooL. Surveys wil be completed online. During the
first year of the study, data collection wil occur sometime between February 2010 and June 2010
and wil be scheduled at each school's convenience. Data collection in subsequent years of the
study wil occur between January 2011 and June 2011 and between January 2012 and June 2012. In

order to provide you with additional inormation on the NEXT study, the following items are
enclosed for your review:
. NEXT Study Fact Sheet

. NEXT Study Brochure

We recognize that confidentiality is a primary concern; therefore, no school districts, schools,
students, or locations wil be identified in any reports or-publications. We are commtted to
ensuring that the data collection wil be carried out with as little inconvenience to the districts,
research team from The CDM Group,
schools, faculty, and students as possible. A very experienced
Inc. has been awarded the contract to conduct the NEXT data collection. If you have any immediate
questions or concerns about the participation of these Districts please do not hesitate to contact Ms.
Mary An D'Elio (NEXT Project Director) of The CDM Group at this toll-free number: 866-864-9972.

We appreciate your support for this important health study. Students who volunteer to participate
in this study wil benefit from the health screening provided. The participation of the school
districts in your state wil help improve efforts to reduce health problems among our Nation's
youth. At the conclusion of the study, we wil gladly provide you with a copy of the published
report. Recognizing our shared interest in the health of our youth, we look forward to working
with you and others in your State.
Sincerely,

£1
Ronald J. Iannotti, PhD
Director, NEXT Generation HealthStudy

1~li

Professional Endorsements

NEXT Generation

Health Study
The National Education Association Health Information Network. Society for Adolescent Medicine. American Association for Health Education. The New
York Academy of Medicine * Council of Chief State School Officers + American Academy of Pediatrics

.ih;,~

"The American Association for the Advancement of

Health Education (AAHE) is pleased to

support the NEXT Generation Health Study. The membership of AAHE is closely involved
with school health education which is primarily taught at the high school

."..~,-,....-.....-.

~.ll;~0~.;~_~~~i::,

leveL. Current

data on adolescent health and behavior leading to health related decisions is of paramount
importance for the development and implementation of
high quality school health education programs:'
-Becky J. Smith, PhD, Executive Director, American Association for Health Education

"We consider efforts to better understand and improve the health of adolescents in
the United States to be of paramount importance and very consistent with the goals of
our organization. We look forward to the findings from this very important study of
changes in adolescent health behaviors:'
-Leslie Goldman, Senior Advisor to the President, The New York Academy of

Medicine

"The American Academy of Pediatrics, a professional organization of more than 60,000
pediatricians, applauds the efforts of the National Institute of Child Health and (Human)
Development and the Maternal and Child Health Bureau as they embark on a new project, the NEXT Generation Health Study:'
- Errol R. Alden, MD, FAAP, Executive Director/CEO, American Academy of Pediatrics

"Since its inception, the National Education Association Health Information Network
has addressed numerous health and safety issues that affect students... We are impressed

by how the data compiled in the NEXT study wil provide necessary information to
improve adolescent health services and to create prevention programs that actually work
for teenagers:'
- Jerry Newberry, Executive Director, NEA Health Information Network

Full-text endorsement letters available at: http://next.cdmgroup.com

/'7ø

National

t.,~ DEPARTMENT OF HEALTH & HUN SERVICES

Institutes of Health

Ronald J. Iannotti, PhD
Prevention Research Branch
Eunice Kennedy Shriver National

Institute of Child Health and

Date
"SupCFname)) "Supt_Lname))

Human Development
6100 Building Room 7B05 MSC 7510
Bethesda, MD 20892-7510

Superintendent

Phone: 301 435-6951

((DistName))

Fax: 301 402-2084

((D _STREET))

E-mail: iannottr(Çmail.nih.gov

"D _CITY)), ((District_mailng_state)) ((SupCZip))-(SupCZip4))
Dear Superintendent ((Supt_Lname)):

Obesity has become a major problem in the United States and the National Institute of Child Health
and Human Development (NICHD) has recently reported that adolescents in the U.S. are more likely to
suffer from overweight and obesity than adolescents in other developed countries. School
administrators are concerned because adolescent obesity and substance use and the health behaviors
related to these health problems have been shown to affect school performance. Health professionals

are concerned because adolescent obesity has been shown to lead to diabetes, heart disease, and many
other health problems in adolescents and adults. In order to better understand ths critical phase of U.s.

adolescent health, the National Institutes of Health (NIH) is embarking on a 4-year nationwide
longitudinal study of u.s. adolescents, called the NEXT Generation Health Study (NEXT). Three
Institutes within NIH have partnered to conduct ths study, they are: NICHD, the National Heart,
Lung, and Blood Institute, and the National Institute of Alcohol Abuse and Alcoholism. In addition,
the Maternal and Child Health Bureau of the Health Resources and Services Administration is also
conh'ibutin'g resources to this important public health initiative.

The NEXT Generation Health Study wil gather information from a nationally-representative sample
of 10th-grade children in the U.s. about adolescent nutrition and dietary practices; physical activity

and sedentary behaviors; sleep; driving behavior; substance use; and the influence of family, friends,
and communities on these hearth behaviors.
The purpose of ths letter is to inform you that (insert # of schools) school/ schools within your

district has/have been randomly selected to participate in NEXT. Approximately 80 schools in the
United States have been selected to participate in this national health study.
The following school(s) in your district has/have been randomly selecteq:
· (Insert school names)

The following reserve school(s) wil be contacted ONLY if one or more of the above schools is unable to
participate:
· (Insert school names)

Approximately two grade 10 classrooms (NOT the entire grade) wil be randomly selected in
the/ each schooL. During 10th grade, students in these classrooms wil be asked to take a health

survey, have their height, weight, and waist measured, and provide a saliva sample to test for
markers of disease such as heart disease, diabetes, and obesity. Data collection wil occur sometime
between February 2010 and June 2010 and wil be scheduled at the/ each school's convenience. In
2010 only, school administrators wil be asked to complete a brief survey about their schools' health
policies, programs, and practices.

During the second and thrd years of the study, NEXT health researchers wil revisit this/ these same
schools to collect height, weight, and waist measurements for those participants who are still

attending the same schooL. These assessments wil occur in the springs of 2011 and 2012. Surveys,
however, wil be completed online and no additional saliva samples wil be collected.

In order to provide you with additional information on the NEXT study, the following items are
enclosed for your review:

· NEXT Study Fact Sheet
. NEXT Study Brochure

· A copy of the student survey
· Professional Endorsements

We recognize that confidentiality is a primary concern; therefore, no school districts, schools, students,
or locations wil be identified in any reports or publications. Participating districts and schools wil
receive a report on the prevalence of adolescent health problems nationwide and in different regions of
the countr; this report wil also compare the health of u.s. adolescents with students in 40 other

countries. Also, for each participating district and school, the Research Team wil provide a districtlevel report summarizing the findings of the Administrator Surveys compared to national and regional
findings of school health policies, programs, and practices.
We are committed to ensuring that the data collection wil be carried out with as little inconvenience
to the districts, schools, faculty, and students as possible. A very experienced research team from The
CDM Group, Inc. has been awarded the contract to conduct the NEXT data collection. Upon securing
Federal approval from the Offce of Management and Budget to conduct this data collection effort (a

required part of any large Federal research study) we wil notify the schools listed above about the
opportunity to participate in ths important study. If you have any immediate questions, please call

Ms. Deboran Darcis (NEXT Project Coordinator) of The CDM Group at this toll-free number: (888246-9626). For your convenience, we have enclosed a business card with Deborah Darcis' contact
information.

We appreciate your support for this important health study. Students who volunteer to participate in
this study wil benefit from the li,alth screening provided. The participation of the schools in your
district wil help improve efforts to reduce health problems among our Nation's youth. Recognizing
our shared interest in the health of our youth, we look forward to working with you and the
principals and staff in your district's selected schools.
Sincerely,

ri

L_:

Ronald J. Iannott, PhD
Director, NEXT Generation Health Study
(((DISTRICT)) J

/'7ø

National

Institutes of Health

t~,-:'t DEPARTMENT OF HEALTH & HUMAN SERVICES
Ronald J. Iannotti, PhD '
Prevention Research Branch
Eunice Kennedy Shriver National

Date

Institute of Child Health and

"p _Fnan1e)) "p _Lname))

Principal
"SchIName))

Human Development
6100 Building Room 7B05 MSC 7510
Bethesda, MD 20892-7510
Phone: 301 435-6951

"SCHL_STREET ))

Fax: 301 402-2084

"SCHL_ CITY)), "SCHL_State)) "SCHL_Zip))

E-mail: iannottr(Çmail.nih.gov

Dear Principal "p _Lname)):

Obesity has become a major problem in the United States and the National Institute of Child Health and
Human Development (NICHD) has recently reported that adolescents in the U.s. are more likely to suffer
from overweight and obesity than adolescents in other developed countries. School administrators are
concerned because adolescent obesity, substance use and health behaviors related to these health
problems have been shown to affect school performance. Health professionals are concerned because
adolescent obesity has been shown to lead to diabetes, heart disease, and many other health problems in
adolescents and adults. In order to better understand this critical phase of U.s. adolescent health, the
National Institutes of Health (NIH) is embarking on a 4-year nationwide longitudinal study of U.s.
adolescents, called the NEXT Generation Health Study (NEXT). Three Institutes within NIH have
partnered to conduct this study, they are: NICHD, the National Heart, Lung, and Blood Institute, and the

National Institute of Alcohol Abuse and Alcoholism. In addition, the Maternal and Child Health Bureau
of the Health Resources and Services Administration is also contributig resources to this important

public health initiative.

The NEXT Generation Health Study wil gather inormation from a nationally-representative sample of
10th-grade children in the U.s. about adolescent nutrition and dietary practices; physical activity and

sedentary behaviors; sleep; driving behavior; substance use; and the inuence of family, friends, and
communities on these health bßhaviors.
The purpose of this letter is to inform you that your school has been randomly selected to participate in
NEXT. Approximately 80 schools in the United States have been selected to participate in this national
health study. Along with "SchlName)), the following schools have also been selected from the (District
name) :

(insert school names)
The "SCHL_State)) Department of Education is aware that you have been selected to participate in
NEXT, and information about the study has been presented to your District Superintendent (Supt. First
Name) (Supt. Last Name).

One or two classrooms from grade 10 in your school wil be randomly selected to participate in the study.
During 10th grade, students in these classrooms wil be asked to take a health survey, have their height,
weight, and waist measured, and provide a saliva sample to test for markers of disease such as heart
disease, diabetes, and obesity. Data collection wil occur sometime between February 2010 and June 2010
and wil be scheduled at your school's convenience. In 2010 only, a school administrator wil be asked to
complete a brief survey about your school's health policies, programs, and practices.

During the second and third years of the study, NEXT health researchers wil revisit your school to
collect height, weight, and waist measurements for those participants who are still attending

"SchIName". These assessments wil occur in the spring of 2011 and 2012. Surveys, however, wil be
completed online or by phone, outside of school time.

We recognize that confidentiality is a primary concern; therefore, no school districts, schools, students, or
locations wil be identified in any reports. Participatig districts and schools wil receive a report on the

prevalence of adolescent health problems nationwide and in different regions of the country; this report
wil also compare the health of U.S. adolescents with students in 40 other countries. Also, for each
participatig district and schooL, the research team wil provide a District-level report summarizing the
findings of the administrator surveys compared to national and regional findings of school health
policies, programs, and practices.
We are committed to ensuring that the data collection wil be carried out with as little inconvenience to
your school, your faculty, and your students as possible.
In order to provide you with additional information on the NEXT study, the following items are
enclosed for your review.
. NEXT Study Fact Sheet

. NEXT Study Brochure
. Professional Endorsements
. A copy of the student survey

A very experienced research team from The CDM Group, Inc. has been awarded the contract to
conduct the NEXT data collection. Upon securing Federal approval from the Office of Management

and Budget to cònduct this data collection effort (a required part of any large Federal research
study), a representative from The CDM Group wil contact you to discuss the study and answer any
questions you may have. We anticipate approval in mid to late December. If you have any immediate
questions, please call Deborah Darcis (NEXT Project Coordinator) of The CDM Group at this toll-free
number: (&88) 246-9626.

We appreciate your support for this important health study. Students who volunteer to participate in
this study wil benefit from the health screening provided. The participation of "SchIName" wil help
improve efforts to reduce health problems among our Nation's youth. Recognizing our shared interest
in the health of our youth, we 19ok forward to working with you and your staff.
Sincerely,

1/
Ronald J. Iannotti, PhD
Director, NEXT

Enclosures
"School"

IIII

NEXT Generation

FACT Sheet

Health Study
Q. What is NEXT?
A. The NEXT Generation Health Study is a nationally-representative longitudinal

study focusing on key health behaviors and the health status of older adolescents as
they transition into young adulthood. NEXT will follow one group of students,

beginning when they are in grade 10 and continuing through the first year after high
school, to monitor predictors of changes in key health behaviors and mental health
during significant family and career/education transitions. One goal of NEXT is to

assess how health status and health behaviors change over time as adolescents move

into adulthood.
Q. Who is funding this study?
A. NEXT is funded by the U.S. Department of Health and Human Services. More
specifically, it is sponsored by the National Institute of Child Health and Human
Development (NICHD), the National Heart, Lung and Blood Institute (NHLBI), and the
National Institute on Alcohol Abuse and Alcoholism (NIAA) of the National Institutes
of Health (NIH), and the Maternal and Child Health Bureau (MCHB) of the Health
Resources and Services Administration (HRSA).

Q. How does NEXT differ
~.. from all of the other surveys on health behavior?
A. The 2010-2013 NEXT Generation Health Study will fill significant gaps in the
current state of knowledge about adolescent health behaviors. At present, there are
no ongoing national

longitudinal surveys of key health behaviors or mental health

concerns, and their determinants, during this critical developmental period. Most
other national health surveys of adolescents (such as the Youth Risk Behavior Survey
or Monitoring the Future) focus on monitoring trends in general health behaviors

across the general population of adolescents (but not the same students) over time.

NEXT is not only nationally-representative, it will follow the same group of adolescent
students over four years and focus directly on a set of key health issues, such as
obesity, risky teen driving, and substance abuse, that are becoming increasingly

important for this age group's short- and long-term well-being. NEXT also is unique
because it examines that important period in adolescents' lives when they leave high
school, become more independent, and engage in health .behaviors or make

independent decisions about health issues that will have long term consequences as
they move into adulthood and beyond. Finally, NEXT not only will track how
adolescent health status and key health behaviors change over time, it also will

investigate how these changes are related to an individual's personal, social, and
environmental influences. By understanding the circumstances that place students at

greater risk for health concerns as adults, it becomes possible to identify actions that
could reduce their level of health risk.

Q. What will students be asked to do?
A. NEXT will span the period from grade 10 through the year after high school during
which each participating student will complete a total of four health surveys. The first
survey will be conducted in school (when the students are in grade 10) and the
following three surveys wil be completed once annually thereafter, either online or
over the telephone. Students will answer similar questions across all four surveys to
identify changes in their behaviors. Height, weight, and waist circumference will be

measured once annually in schools during grades 10, i i, and 12 by trained health
researchers. Also, during the grade 10 assessment, trained health researchers will
collect saliva samples from students to test for markers of disease, such as heart

disease, diabetes andobesity.
Q. How wil the results of this study be used?
A. The findings from the NEXT data will be published (in aggregated form only) in
national reports and in articles prepared for health professionals. The data will be

used by policy makers, government agencies, curriculum developers, education
agencies, and community organizations to modify or develop public health policies and
programs, target public information campaigns, and to explore innovative strategies
for improving adolescent health. What we learn from this study will provide necessar

information to improve adolescent health services and to create prevention programs
that actu'ally work for teenagers.
Q. Who wil conduct the survey?

A. The CDM Group and Abt Associates, two nationally recognized survey research
firms, have been contracted by NICHD to work with school districts, schools, and
students to conduct the survey. This research team has years of experience working

with schools and students and is committed to ensuring that the data collection will

be carried out with as little inconvenience to your school, your faculty, and your
students as possible. Specially trained health researchers, hired by the NEXT

research team, will be sent to each school to administer the survey. This helps assure
students that their answers will not be seen by school personneL. It also reduces the

work for the participating schools. Following completion of thé survey, consented
students wil be individually measured for height, weight, and waist circumference and
provide a saliva sample to these professionally trained health researchers.

Q. How were'schools selected?
A. A sample of 80 schools was selected randomly in a way that ensures appropriate

representation of urban, suburban, and rural schools from all regions of the United
States. The probability of a school's selection was based on the size of the student
enrollment in grade 10.

Q. What do schools receive for participating in NEXT?

NEXT Generation Health Study: 2010-2013

2

A. Participating districts and schools wil receive a report on the prevalence of
adolescent health problems nationwide and in different regions of the country; this
report will also compare the health of U.S. adolescents with students in 40 other
countries. For each participating district and school, the research team will also
provide a district-level report summarizing the findings of the administrator surveys
compared to national and regional findings of school health policies, programs, and

practices. In addition, as a symbol of appreciation for contributing their time and
support and for being a significant partner in NEXT, a total of $ 1 ,000 is made

available to each participating school: $500 in the first year, and $250 in each
subsequent year. We encourage schools to use these funds to purchase educational

materials. However, there are no restrictions on how schools can use these funds.
Q. What do students receive for participating in NEXT?
A. All participating students will receive the following gifts for completing each
respective task:

Year of

Participation

Completing
Survey

Completing Weight,

Total by

Height, and Waist
Circumference

Year

Measurements and Saliva

Sample
ioti' grade

$0
$10
$10

$10
$10
$10

After high
school*

$10

No measurement conducted

Overall Total

$30

$30 value

1 1 tll grade*

1 ih grade!k

$10
$20
$20
$10
$60 value

* - After grade 10 all surv.eys will be completed online or by telephone.

Q. What if school districts, schools, or students choose to not participate?
A. Participation in the NEXT Generation Health Study is voluntary. However, to
priority health-risk attitudes and behaviors
among youth, participation rates must be high. Your participation will help ensure
that U.S. teen health research and programs are based on realistic information. Each
student may choose to participate or not. A student may choose to complete the
health survey without participating in height, weight and waist circumference
develop accurate national estimates of

measurements or providing a saliva sample.

Q. Is student participation confidential? How is student privacy protected?
A. Survey administration procedures are designed to protect student privacy and allow

for confidential participation. The survey is administered by health researchers hired
and trained by the research team and not affiliated with the schooL. Students will seal

their completed questionnaires in envelopes. No personal identifiers are used on the
survey, body measurement materials, or saliva collection materials. During the study,
each student's data, including address and phone number, will be kept private and

NEXT Generation Health Study: 2010-2013

3

will not be shared with others outside the NEXT study. All data will be stored safely in

locked fies. An ID number will be assigned to each student at the start of the study
and this number only wil be used for record keeping and data analysis. Reports win
not include names of participating cities, school districts, schools, or students.
Q. How many students wil participate in NEXT?
A. Our goal is that at least 2,700 students from 80 randomly selected schools wil
participate in NEXT.

Q. What grades are included?
A. During the 2009-2010 school year 2,700 grade 10 students from public, parochial,

and private schools will be randomly selected to participate in NEXT. These same
students will be followed through grades 11 and 12 as well as the first post-high
school year.

Q. How many students will be surveyed in each selected school?
A. Typically, only two class sections will be selected. We do not want to survey the
entire 10th grade. All the students in these two class sections will be invited to
participate.
Q. What kinds of questions are asked on the NEXT Survey?

A. The student survey wil focus on the following major topic areas: obesity, substance
abuse, young drivers, and the social networking of peers and/ or parental influences
on risk behaviors. Students will answer questions about their diet, physical activity,
driving habits, sleep habits, and sedentar behaviors, in addition to questions about
alcohol, tobacco, drug use, and more.

Q. How long does it take to fill out the student survey?
A. Approximately one 45-minute class period is needed for the administration of the
paper-and-pencil student survey that consists of multiple-choice items. This includes
distributing the survey materials, reading the directions to the students, and collecting

the completed surveys.
Q. How long wil it take to measure height, weight and waist circumference and
collect a saliva sample on each student?
A. Before or after completion of the survey, consenting students will be individually

measured for height, weight, and waist circumference and provide a saliva sample to
professionally trained staff. Less than 10 minutes will be required to complete all of

these assessments.
Q. What if a student moves to a different school or does not advance to the next

grade level?

NEXT Generation Health Study: 2010-2013

4

A. If a student moves to a different school or drops out of high school, NEXT will
maintain contact with that student and ask them to complete online or telephone

health surveys once each year through the year after high school (a total of four
surveys). The NEXT research team will NOT collect height, weight, and waist
circumference measurements on students who move to a different school or drop out
following the grade 10 in-school survey and assessments. A student does not need to
advance within the same grade level to participate in NEXT. The NEXT research team

will continue to contact students who are either not promoted or skip a grade and ask
them to complete online or telephone health surveys once each year for three years
beyond grade 10 (total of four surveys). As long as a student is stil in the same school
he/she will also be asked to complete in-school height, weight and waist

circumference measurements during the spring of 2011 and 2012 with other
participating students.
Q. Do students answer the questions truthfully?

A. Research indicates that data of this nature may be gathered as reliably from
adolescents as from adults. Internal reliability checks are conducted to help identify

the small percentage of students who falsify their answers. To obtain truthful
answers, students must perceive the survey as important and know that procedures

have been developed to protect their privacy and allow for confidential participation.
Q. How is the NEXT Study coordinated at each school?

A. Each principal will be asked to designate someone at the school to serve as a
School Survey Liaison (SSL). The SSL wil work closely with the NEXT research team
to coordinate the visit, reducing the burden on the Principal or other school staff.
Specifically, the SSL will be asked to help promote the study in the school by
answering questions and being an enthusiastic supporter, distribute and collect

parental consent forms to the students in the selected classes, and prepare the school
for the data collection visit in the spring. In particular, SSL's wil assist the NEXT
research team with identifying a suitably discreet and comfortable location for
conducting height, weight, and waist circumference measurements. We estimate that

this will take approximately 10 to 12 hours in year 1. For assisting the NEXT research
team with our school visit, the SSL wil be paid their hourly wage plus fringe as a
consultant for their assistance with the grade 10 visit. We estimate assistance with
the grade 11 and grade 12 visits will take 5-6 hours each visit; again the SSL will
again be paid their hourly wage plus fringe. Surveys will not be administered inschool during grades 11 and 12; in these years, only height, weight and waist
circumference measurements wil be performed at the schooL.

Q. When wil the data be collected?
A. During the first year of the study, data collection will begin in Februar 2010 and
continue through June 2010. The NEXT research team will work closely with the SSL

and school Principal to set a visit schedule that is convenient for the school and does
not interfere with standardized testing requirements. NEXT wil visit these same
schools again the following spring of 2011 and 2012 to collect height, weight, and
waist circumference measurements on the original student participants. Surveys will
not be collected in the schools during the follow-up years. These students will be

NEXT Generation Health Study: 2010-2013

5

.'""",~,,-

contacted outside of school and asked to complete an online or telephone survey about
health-related attitudes and behaviors.

Q. How can we get a copy of the survey results?
A. Copies of aggregate results will be sent automatically to each of the participating

schools.
Q. What is NEXT Plus?
A. NEXT Plus will be conducted outside of schooL. Among the 2,700 participating

students in NEXT, a small group of 750 students from 54 randomly selected schools
wil be asked to participate in a smaller, more focused study that is related to NEXT,
but conducted in the students' homes. NEXT Plus will include more extensive
assessments of factors affecting cardiovascular health. In particular, NEXT Plus will
more closely examine: adolescent physical activity, sedentar behavior, and sleep
patterns; adolescent diet and nutrient intake; as well as markers for obesity and
cardiovascular disease. Similar to NEXT, NEXT Plus will follow these 750 students
beginning in grade 10 through the first year post-high schooL. The specific goals of
NEXT Plus are to evaluate how adolescent cardiovascular risk factors change over time

and to identify key predictors of cardiovascular disease among adolescents.
Q. Where can additional information be obtained?

A. To obtain additional information about the NEXT Generation Health Study, contact
Ms. Mar Ann D'Elio of

The CDM Group, Inc. at toll-free (888) 246-9626 or email

next(cdmgrou p. com.

NEXT Generation Health Study: 2010-2013

..

6

11111

SCHOOL SURVEY LIAISON

NEXT Generation

Job Description

Health Study
liked
by the students and teachers, is good with details, and has some interest in student health behaviors. The selected
individual will serve as a liaison between the NEXT research team and the school's staff and students. The SSL will work
closely with the NEXT Project Coordinator to make sure the survey and student assessments will occur with as little
disruption as possible for the school, staff, and students. We anticipate this will take 10-12 hours of time in year 1 and 5-6
hours of time in years 2 and 3. SSLs will be compensated at their hourly wage (plus fringe) for their work on the project.
The ideal candidate would be someone on the school staff who has some flexibility with his or her schedule, is well

SSL Position Tasks:
Recruitment Stage Tasks (January 2010): Preparing schools for

the data collection

. Provide a list of grade 10 classes in the schooL.

. Notify the principal (and teachers) once classes have been randomly selected for participation.

. Work with the NEXT Project Coordinator to schedule survey administration and student assessment dates and

times.
. Distribute study materials, including brochures, and information packets to participating teachers in order to

promote the survey within the schooL.

. Explain the NEXT study to staff and students and address any related inquiries in order to gain the students' full

cooperation.
assent procedures for each selected classroom, including collecting
signed parental consent and student assent documents. These documents will need to be kept in a private and
secure location until they are sent to the NEXT team prior to data collection.

. Facilitate parental consent and student

. Maintain ongoing communication with the NEXT Project Coordinator, including faxing bi-weekly reports (over a
two week period) while recruitífig students.
. Provide report on the characteristics of those students who do not agree to participate for comparison analyses

and/or overall characteristics of the entire class.
Site Visit and Data Collection Tasks (Spring 2010): Assisting data collectors during their site visits

. Provide directions
. Help identify suitable classrooms or other space to conduct the survey and student assessments

. Assist health researchers during their site visits (e.g., introduce them to school staff, and escort them to

classrooms).
. Keep the NEXT Project Coordinator informed about any schedule changes at the school

leveL.

. Arrange online make-up surveys for students who are absent on the day of the survey.

Follow-up Tasks (Spring 2011 and 2012): Assisting health researchers with site visits in follow-up years

. Work with the NEXT Project Coordinator to schedule a site visit date for student measurements in follow-up

years
. Help identify suitable classrooms or other space to conduct student measurements

Imli

I

NEXT Generation

Health Study

You are the experts - W eivant and appreciate your help!

How can you help?
The School Survey Liaison (SSL) wil come to your class and explain the purpose
of the NEXT Generation Health Study. Stil, many students (or their families)

may come to you for further explanation or look to you for reassurance about
participating. You are a valuable resource, and you can be a tremendous help
if you:

· Help the NEXT health researcher keep the classroom quiet during the
study.

lill

NEXT Generation

Health Study
Dear Parent:

Winter/Spring 2010

Obesity is a major problem in the United States. In fact, the National Institute of Child Health and
Human Development (NICHD) recently reported that adolescents in the U.S. are more likely to suffer
from obesity and being overweight than adolescents in other developed countries. School administrators
are concerned because adolescent obesity and substance use and the health behaviors related to these
health problems have been shown to affect school performance. Health professionals are concerned
because adolescent obesity has been shown to lead to diabetes, heart disease, and many other health
problems in adolescents and adults. In order to better understand this critical phase of U.S. adolescent

health, the National Institutes of Health (NIH) is embarkig on a 4-year nationwide longitudinal study
of U.S. adolescents, called the NEXT Generation Health Study (NEXT).
last name) to conduct the study in (school name),
your child's classroom was selected to take part in NEXT. (School name) is one of many schools across
the country participating in this important study and the information in this packet tells you a little more
about what your chid wil be asked to do.

After receiving permission from Principal (principal

NEXT wil follow students from 10rh grade into young adulthood. Students wil be asked to complete
the survey for four consecutive years, beginning in the 10rh grade (in-school) and online or by phone
each year thelieafter. They wil participate in height, weight, and waist measurements at school in grades
10, 11, and 12 and, in the first year only, they wil also be asked to provide a saliva sample to test for
markers of disease such as heart disease, diabetes, and obesity. The suiveys and measurements wil be
conducted by professionally trained and certified health researchers hied by the NEXT research team.
All information collected from yCJr child is confidential, and all of your child's information, including
his or her name, address, and phone number, wil be kept private and not shared with anyone outside
the NEXT study. Your child's participation is voluntary. It wil not affect your child's grades at school
if you decide he or she should not complete the suivey or participate in the physical measurements.
Please read all of the enclosed materials carefully so you understand what your child wil be asked to do.
The information gathered during NEXT wil help inform future U.S. policies and programs to help our
children stay healthy. We hope you wil allow and encourage your child to ~e a part of NEXT by
signing the enclosed consent form. If you agree, please review the student assent form with your teen
and have him. or her mark and sign the form.

I will be happy to answer any questions or concerns you may have about NEXT. If you would like to
contact me at any tie, my toll-free phone number is 866-864-9972. You also can call the School

Suivey Liaison, at
Sincerely,

(pC Name)

NEXT Project Coordinator
The CDM Group, Inc.

IBIII

NEXT Generation

Health Study
Spring 201 a

Dear ((class1_ T chr_Sah) ((class1_ T chl-Lname)) i

Your classroom has been selected to participate in the NEXT Generation Health (NEXT)
Study. ((SCHLNAME)) is one of many schools across the nation to take part in this

important study. This letter tells you a little more about the study andyour students'
participation in it.

NEXT is the only nationally-representative longitudinal study that focuses on a few key
adolescent health behavior areas that are understudied. The' information from the study
wil be used to create policies and programs that wil address the health needs of children
violence. The study wil be conducted by certified health
researchers who have lots of experience working with students. The questions and
procedures used in the study have been thoroughly reviewed, approvedi and used
extensively in past national studies.
and reduce problemsi like school

Everything we learn about students from the study wil remain strictly confidentiaL.
The participation of your students is voluntary. However, the NEXT study is very

important, and we hope you wil encourage your students to be a part of it by expressing
enthusiasm and support for the study.
Principal ((P _Lname)) has given us permission to conduct the study in your school and
((SSL_Fname)) ((SSL_Lname))~is the School Survey Liaison (SSL) helping us coordinate the

study. Attached are a few documents we hope you wil find helpfuL. Should you have

any questions or concerns, you may speak with your SSL or call me directly at our toll-free
number: 1-888-246-9626.
Best regardsi

(PC_Fname) (PC_Lname)

NEXT Project Coordinator
((class1_classid))

NEXT(acdmQ:rouD.com

work for teens.

create health programs that really

to improve health services and

professionals wil use these findings

(toll-free) 888-246-9626

Health Study

NEXT Generation

1~11i

Mary Ann D'Elio, M.S.
The COM Group, Inc.

may lead to heart disease. Health

It you have questions or want more
information about NEXT, please contact:

Administration

Health Resources and Services

and

Alcoholism

National Institute on Alcohol Abuse and

National Heart, Lung, and Blood Institute

and friends, as well as their neighborhoods, may affect teen health.
For example, this information will
help us predict why some teens
become overweight and how that

how relationships with their family

and drug use. We also wil

several years, we wil

teenagers in the U.S. and examine
changes in their health status as
they become young adults. Over
look at teenagers' eating, physical activity,
driving, and their alcohol, tobacco,
learn

about the health activities of older

The Study
NEXT(NEXT)
Generation
Health
will teach
us

Human Development

National Institute of Child Health and

U.S. Department of Health and
Human Services

NEXT is sponsored ~y:

Health Study

NEXT Generation

10111

materials.

!f'''''

l' .' \

h, .'1J\.

J

.... 'f~':

Participation is voluntary, but we hope
everyone who is asked will participate in
NEXT.

Saliva samples are done in 1 Oih grade only.

sample to test for markers of disease, such
as heart disease, diabetes, and obesity.

3. With your permission, provide a saliva

121h grades.

measured at school once in 101h, l1lh, and

2. Have his or her height, weight, and waist

she leaves high schooL.

and 121h grades, and the year after he or

1. Complete a 35 minute survey at school in
1 Ui, grade and online or by phone in Illh

things:

and ask your teen to do the following three

on the surveyor body measurement

and students wil come to your teen's school

learned about your teen to anyone.
Information will always be kept private.

researchers cannot release information

Contìdentiality" which means the

. Finally, NEXT has a "CertiIÌcate of

cities, school districts, schools. or students.

Your teen's information will not be shared
with people outside of NEXT. Reporrs will
never include the names of
participating

tìles and password protected databases.

. i\ll information collected is stored in locked

privately, one-at-a-tirne by the health
researchers.

. Students will be weighed and measured

. No names, only ID humbers, are ever used

NEXT. All of the school districts, schools, and
classrooms that are taking part were selected
by chance. Trained health researchers who
have lots of experience working with schools

$ 30

$ 10

$ 10

$ 10

none

$ 30

conducted

No measurement

$ 10

$ 10

$ 10

$60

$10

$20

$20

$10

to purchase educational materials.

year. We encourage schools to use these funds

/\11 schools will receive a total of $1,000: $500
in the tìrst year, and $250 in each subsequent

helping with the study?

What wil my teen's school receive for

Overall
Total

school

After high

1ih grade

11 th grade

10th grade

Sample in Year 1)

I

,

I

Total by I
Year

Completing Weight, Height,

Year of
Completing and Waist Circumference
Participation
Survey
Measurements (and Saliva

incentives can be found below.

Your teen wil receive incentives for comthese
pletingNEXT tasks. A summary of

Yes. The NEXT research team uses careful
procedures that are designed to protect student
privacy during every part of
the study. Some
of these steps are outlined here:

About 2,700 U.S. students in the ioil' grade
ii'om 80 different schools will participate in

my teen be asked to do?

What wil my teen receive for participating?

Wil my teen's information be kept private?

Who wil take the survey and what wil

Public reporting burden for this collection of information is estimated to average 5 minutes per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of information. An agency may not conduct
or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspeçt
of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance
Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (####-####). Do not
return the completed form to this address.

INFORMED CONSENT FORM FOR PARENTS OR GUARDIANS
Dear Parent or Guardian:

Your child's school is involved in a longitudinal research study called The NEXT Generation
Health Study (NEXT) and it is funded by the National Institute of Child Health and Human
Development (NICHD), the National Heart, Lung and Blood Institute (NHLBI), and the

National Institute on Alcohol Abuse and Alcoholism (NIAAA), three of the National Institutes
of Health, as well as the Health Resources and Services Admiistration (HRSA). Only students
in 10th grade during the 2009-10 school year can be in NEXT. We would like your child (in 10th
grade) to help us by taking part in this important study. This form explains why the research
study is needed, what information we wil collect during the study, how the inormation will be
used, how the information wil be protected, and what your child wil receive for participating.

Please read this form carefully and ask any questions that you have before you decide about
letting your son or daughter be in the study. If you give permission for your child to be in the

study, you wil be given a copy of this form to keep.
WHAT 16 THE TITLE OF THE STUDY?
The NEXT Generation Health Study (NEXT)

WHAT IS THE PURPOSE OF THE STUDY?
Sometimes teenagers develop unhealthy habits that may be related to having heart disease or
other health problems later i1ì life. Changes in their physical activity, eatmg habits, and sleep

may contribute to teens becomig overweight. For example, teenagers, especially girls, tend to
reduce the amount of exercise they get during this period. Because teens have more control
over their diets, they may eat more of the types of food that are not good for them, like fast
foods or unhealthful snacks. They also spend more time away from their families and with
their friends, who could infuence their health behaviors in either good or bad ways.
,

The period from early high school through the first year after high school is also important for
adolescent drug and alcohol use. Problem drinking usually begins during these years (ages 15
to 18) and increases in ages 18 to 20. The year after high school is particularly important,
because students often increase their alcohol use and increase problem drining as they start
working or enter their first year of college.
Motor vehicle crashes are the leading cause of injury and death among adolescents. Crash rates

are higher among adolescents than among older drivers. Crash rates particularly increase
during the first year they start driving, but remain high into the twenties. The major causes of
crashes among young drivers include inexperience and driver error, risk taking, and dish"action.
The NEXT Generation Health Study is designed to learn more about these important health issues

for adolescents. We wil ask your child questions about his or her eating, physical activity, and
1

alcohol, tobacco, and drug use, as well as about relationships with their family and friends, and
their driving behavior. What we learn from this study wil provide necessary information to
improve health services and to create prevention programs that actually work for teenagers.
The main purposes of NEXT are:

1. To learn more about the changes in heart disease-related risk factors and behaviors in
older adolescents as they become independent young adults; what causes obesity and
what contributes to the risk for heart disease.
2. To understand when and why drug or alcohol use in students begins (or stops) during
or after high school; what predicts that a student wil be a problem drinker during the
year after high school; and how famiies or friends influence students' drining or drug
use.
3. To learn more about teen risky driving behavior and whether their views about driving

and their driving behavior change as they get older.
4. To better understand how a network of friends may influence a student's positive or
negative health behaviors.

5. To learn more about teenagers' genetic predisposition to heart disease or substance use.
Everyone's genes are a little different. If we can learn more about these differences we
might learn how to prevent and treat certain diseases better.
We wil

learn about these things by asking students to complete the activities described below.

WHAT is INVOLVED?
Your son or daughter wil be asked to complete the following activities during the spring
semester of his or her 10th grade year, the spring semesters of 11 th and 12th grades, and the
spring of the year after leaving high schooL.

In 10th grade students involved in the study wil:

1. Fil out a 35-45 minute survey at their school about their diet, physical activity,
substance use, and friends,
2. Have their height, weight, and waist circUmference measured at their schooL.
3. Have a saliva sample collected at their schooL.
In 11th grade students involved in the study wil:

4. Fil out a survey on-line or by phone about their diet, physical activity, substance
use, and friends.
5. Have their height, weight, and waist circumference measured at their schooL. If they
are no longer at the same school, they do not have to be measured.
In 12th grade students involved in the study wil:

6. Fil out a survey on-line or by phone about their diet, physical activity, substance
use, and friends.
7. Have their height, weight, and waist circumference measured at their schooL. If they
are no longer at the same school, they do not have to be measured.
In the year after high school students involved in the study wil:

8. Fil out a survey on line or by phone about their diet, physical activity, substance
use, and friends.
9. NO height, weight, or waist circumference measurements wil be collected.

2

HOW MANY OTHER PEOPLE WILL BE IN THE STUDY?
About 2,700 10th grade students in 80 schools from across the United States wil be in the study.

HOW LONG WILL WE BE PART OF THE STUDY?
We wil collect inormation from your child four times: in 10th grade, 11th grade, 12th grade, and
the year after high schooL.

REASONS WHY YOUR CHILD MAY NOT BE ALLOWED TO BE INVOLVED:
Your child wil not take part in the study if he or she has:
. No signed inormed consent from parent(s) (this form),

. No informed assent from the student (the attached form),
. If he or she cannot read and understand the questions on the survey, which wil be
written in English, or
. Developmental

limitations that affect your child's ability to understand or provide

age appropriate responses to the questions.
EXPECTED RISKS AND DISCOMFORTS:
We wil ask questions that deal with sensitive health issues, such as what is the student's weight
and whether he or she smokes or drinks alcohoL. Some students may not feel at ease answering
these types of questions. However, most questions on the survey are not highly sensitive and
those that are somewhat sensitive are commonly included in many US surveys. The staff
involved in this study is trained to help limit the amount of discomfort caused by

these questions.

Also, students may not f~el at ease with someone measuring their weight, height, and waist
circumference. A student can refuse to participate in any of the assessments. These
measurements wil be conducted in private by trained and certiied survey staff.
The only potential risk to students participatig in NEXT is a breech of confidentiality. The

survey and measurements are confidential; student responses and measurements are identified
only by a numeric ID. The only link between student inormation and their names is kept in a
separate, password protectéd (h'acking) database at the home office. This inormation is needed
so we may contact students .during the study. A Certificate of Confidentiality has been obtained
from the United States Department of
Health and Human Services (DHHS). With this
Certificate, we cannot be forced (for example by court order or subpoena) to disclose
infOrmation that may identify you in any federal, state, or local civil, criminal, administrative,
legislative, or other proceedings.
You should understand that a Certificate of Confidentiality does not prevent you or a member of
your family from voluntarily releasing information about yourself or your child or your
involvement in this study. Note however, that if an insurer or employer, learns about your
participation, and obtains your consent to receive research information, then we may not use
the Certificate of Confidentiality to withhold this information. This means that you and your
family must also actively protect your own privacy. Finally, you should understand that we will
in all cases take actions necessary, including reporting to authorities, to prevent serious harm to
yourself, your child or others such as in cases of child abuse or neglect. Parents or legal
guardians have the right to information regarding a minor child unless an Institutional Review
Board has approved the study with a waiver of

parental permission.

In addition, methods we wil use to protect your child's privacy and confidentiality are to
provide very careful and thorough h'aining of the data collectors, and to monitor their
3

performance closely. All Survey staff sign confidentiality pledges, stating they wil not share
information with unauthorized persons. Other than this inormed consent form, none of the

questionnaires, interview records, or other paper records kept for this study wil show your
name or your child's name or other identiying inormation like a social security number or
home address. Your child's study ID code number wil be put on all of these items rather tha~
his or her name. All study data wil be sent by the data collectors by overnight delivery to the
home office data entry staff right after it is collected and then entered or scanned into a
password-protected computerized data fie and stored for analysis. The hard copies will be stored

will have access to the computer fies. If any of these
items are lost, it wil not be possible for anyone who finds them to identiy your child. Copies of
informed consent forms and families' contact inormation wil be sent to our office and stored
separately from the other study data, which wil not contain names or other identiying
information.
in locked areas and only authorized staff

WHAT ARE THE POSSIBLE BENEFITS FOR BEING IN THE STUDY?
The results of NEXT wil advance our knowledge of the risk of obesity, heart disease, and
substance use of older adolescents and young adults. This inormation can be used to improve
health services and create prevention programs to help older adolescents and young adults, as
well as set national priorities for school and youth programs. Youth may benefit from the
diagnostic aspects of

the no-risk in-school height, weight, and waist circumference

measurements.

WHAT HAPPENS IF A PROBLEM OR INJURY RESULTS FROM THE RESEARCH
PROCEDURES?
It is highly unlikely that your child wil be injured by being in this study. In the unlikely event

that an injury occurs during the measurement, we wil follow routie school procedures. If an
injury shóuld occur, you wil not be paid for the injury and neither The CDM Group nor the
sponsors of the survey, NICHD, NHLBI, NIAAA, or HRSA, wil pay for treatment.
WHAT WILL MY SON OR DAUGHTER RECEIVE FOR BEING IN THE STUDY?
Your son or daughter wil re5~ive the following for completing the survey and the physical
measurements:

Year of

Participation

Completing
Survey

Completing Weight,

Total by

Height, and Waist
Circumference

Year

Measurements and Saliva

Sample
10111 grade

1 11h grade*

1 ill grade*

After high
school *

Overall Total

$0
$10
$10

$10
$10
$10

$10

No measurement conducted

$30

$30 value

,

$10
$20
$20
$10
$60 value

IS THIS STUDY VOLUNTARY?
Whether your son or daughter takes part in the study is your choice. Also, your son or daughter

may choose not to take part in any or all of the measures at any time or for any reason. If after
giving your consent, you decide to withdraw your son or daughter from the study, this wil not
hurt your or your child's future relations with your son's or daughter's schooL.

IS THIS STUDY CONFIDENTIAL?
4

During the study, all of your son's or daughter's data, including address and phone number,
wil be kept private and wil not be shared with others outside the NEXT study. All data wil be
stored safely in locked fies. An ID number wil be assigned to each child at the start of the
study and this number wil be used for record keeping and data analysis. Please note that we
are required to inorm you, in writing, if your son's or daughter's height or body weight falls
below the growth standards for boys or girls their age. For these reasons, it is very important
that you provide your mailing address, email address (if applicable) and phone number(s) on
the last page of the consent form. After the study is completed, the data wil be available to
other researchers. However, we wil never share any inormation that could be linked to your
son or daughter. His or her name wil never appear in any reports or published papers.
WHO SHOULD I CONTACT IF I HAVE QUESTIONS ABOUT THE RESEARCH STUDY?
You may ask questions about the study or anything you do not understand. If you do not have
questions now, you may ask later. During the study, you wil be told any new facts that could
affect whether you want your child to stay in the study, .For more information about the
research, you may contact Mary Ann D'Elio, NEXT Project Director, at toll-free 866-864-9972 or

NEXTi0cdmgroup.com; or Dr. Ronald J. Iannotti, Principal Investigator, at 301-435-6951 or
iannottr(0mail.nih. gov.

5

PARENTS - Please complete the following:
, If you sign your name below, that means that you have read this consent form and have had a
chance to ask any questions. Also, your son's or daughter's signature on the attached Child

Assent Form means that he or she has agreed to take part in NEXT. If you agree to allow your
son or daughter to be involved, you may change your mind and withdraw your consent at any
time. As mentioned before, your son or daughter should not take part if he or she cannot read
and understand the questions on the survey, which wil be written in English.

Please complete ONE box below
D YES, I agree to have my teen participate in the NEXT Generation Health Study.
Please check below if you do NOT want you teen to do one or both of the activities
listed:
o Saliva sample

o Measurements

If you selected "Yes", please complete the blue Parent Information Sheet and seal it in the small
blue envelope provided. Then place the yellow signed inormed consent and student assent
forms- inside the large envelope, along with the sealed Parent Information envelope. Ask your
child to return the sealed envelope to his or her classroom. We have given clear instructions to
your child's school that this sealed envelope should not be opened by any of the school staff;
only by the data management staff in the NEXT project office.

D Nq, I do not want my teen to take part in the NEXT Generation Health Study.

If you selected "NO", you do NOT have to complete the attached form. However, please ask
your child to return the sigiied consent form to his or her classroom.

Child Date of Birth: / _/

boy

My child is a

gir 1.

Month Day Year

Parent/Guardian Signature

Date

6

P ARENT INFORMATION SHEETS
1. Wil your child be able to read and understand questions written in English?

DYes D No

2. Are you employed?

DYes D No (if no, skip to question 3).
a. Where do you work, for example, at a hospitaL, bank, or restaurant?

b. Please write down exactly what job you do there (for example, are you a teacher,

bus driver, or doctor, etc).

3. What is the highest grade of regular school you have completed?

1. Less than high school diploma
2. High school diploina

3. GED
4. Some college or technical school

5, Associate's degree
6. Bachelor's degree

7. Graduate degree
4. Does another parent"Or guardian for your child live in your household?

DYes

D No (if no, skip to question 7).

*

5. Is he or she employed?

DYes D No (if no, skip to question 6).
a. Where does he or she work, for example, at a hospital, bank, restaurant)?

b. Please write down exactly what job he/ she does there (for example: teacher, bus
driver, doctor).

7

6. What is the highest grade of regular school he or she has completed?
1. Less than high school diploma

2. High school diploma

3. GED
4. Some college or technical school

5. Associate's degree
6. Bachelor's degree

7. Graduate degree
7. Is there a parent or guardian for your child who does NOT live in your household but

contributes to your child's well-being?
DYes

D No (if no, skip to question 10).

8. Is he or she employed?

DYes D No (if no, skip to question 9).
a. Where does he or she work, for example, at a hospital, bank, restaurant)?

b. Please write down exactly what job he or she does there (for example: teacher,
bu,s driver, doctor).

9. What is the highest grade of regular school he or she has completed?
1. Less than high school diploma

2. High school diploma

3. GED
4. Some college or technical school

5. Associate's degree
6, Bachelor's degree

7. Graduate degree

10. What is the current address of your child? NOTE: We wil NOT share your child's
address, phone number, or emaIl with anyone outside of the NEXT study.

Street Address
City
Home telephone:
Cell phone:

Apt

State

#
Zipcode

Email:

8

11. What is your current address? NOTE: We wil NOT share your address, phone

number, or email with anyone outside of the NEXT study,
Sh'eet Address

City
Home telephone:
Cell phone:
Email:

Apt

State

#
Zipcode

12. Who might know where you are should you move from your current address? Please

provide contact inormation for two people who are not living with you now who are most
likely to know how we can get in touch with you should you move from your current address?
NOTE: We wil NOT share the contact person's address, phone number, or email with
anyone outside of the NEXT study.

13, Alternate contact person 1:

Name: (please print)
Street Address

City ~~

Apt

#
Zip

code

Home telephone:
Cell phone:
Email:

Relationship to you (example: sister, father, friend)
14, Alternate contact person 2:

Name: (please print)
Sh'eet Address

City State

Apt

#
Zipcode

Home telephone:
Cell phone:
Email:

Relationship to you (example: sister, father, friend)

Thank you for providing this information. Please place this form in the envelope provided and
seal the envelope. Ask your child to return the envelope to his or her classroom. We have given
clear insh'uctions to your child's school that this envelope should not be opened by any of the
school staff; only by the data management staff in the NEXT project office.

9

Public reporting burden for this collection of information is estimated to average 5 minutes per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of information. An agency may not conduct
or sponsor, and a person is not required to respond to, a collection of information unless it displays a .
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect
of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance
Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (####-####). Do not
return the completed form to this address.

NEXT PLUS INFORMED CONSENT FORM FOR PARENTS OR GUARDIANS
Dear Parent or Guardian:
Your child is participating in a research study called the NEXT Generation Health Study (NEXT)
and it is funded by the National Institute of Child Health and Human Development (NICHD)
and the National Heart, Lung and Blood Institute (NHLBI), two of the National Institutes of

Health. We would like your child to be one of 750 students randomly selected from the 2,700
students participatig in NEXT to also participate in a smaller" substudy" called NEXT Plus.
NEXT Plus is designed to learn even more about the factors associated with heart disease. This

form explains why NEXT Plus is needed, what inormation we wil collect during the study,
how the inormation wil be used, how the inormation wil be protected, and what your child
wil receive for participating. Please read this form and ask any questions that you have before
you decide about lettg your son or daughter be in the study. If you give permission for your
child to be

in the study, you wil be given a copy of this form to keep.

WHAT IS THE TITLE OF THE STUDY?
NEXT Generation Health Study Plus (NEXT Plus)

WHAT IS THE PURPOSE OF THE STUDY?
As we explained for NEXT, sometimes teenagers develop unhealthy habits that may be related

to having heart disease and~óther health problems later in life. Changes in their physical
activity, eating habits, and sleep may conh'ibute to teens becomig overweight. For example,
teenagers, especially girls, tend to reduce the amount of exercise they get during this period.
Because teens have more control over their diets, they may eat more of the types of food that are
not good for them, like fast foods or unhealthful snacks. They also spend more time away from
their families and with their friends, who could inluence their health behaviors in either good
or bad ways.

NEXT wil help us learn lots of important things about risk factors for heart disease. Yet there
are limits to what can be learned in a survey conducted one time each year. NEXT Plus is

designed to learn much more about these important health issues. We wil ask your child to
report what he or she eats on three days each year so we know exactly what and how much he
or she is eatig each day and how much of that food is made up of fat or sugar or protein. We

wil ask your child to wear small monitors which wil show your child's physical activity and
sleep for a week, and check his or her blood pressure. Also, using a simple blood test (collected
by a finger stick), we wil check for things that may show a risk for heart disease, like
cholesterol and blood sugar levels. What we learn from NEXT Plus (along with what we learn

from NEXT) wil provide important information to improve health services and to create
prevention programs that actually work for teenagers.

The main goals of NEXT Plus are:
1. To learn more about whether teenagers' diets meet the guidelines for a heart-healthy
diet and how diet influences their risk for heart disease.
2. To understand what things influence whether a teenager is overweight or not.

3. To learn more about how physical activity and sleep increase or decrease as teenagers
become young adults and how their physical activity and sleep infuence their risk for
heart disease.

4. To understand how biological markers, such as cholesterol and blood sugar levels,
change with physical activity and diet and how they inuence teenagers' risk for heart
disease.
WHAT is INVOLVED?
A trained health researcher wil come to your home, at your convenience, to complete two sets
of activities with your child. First, the health researcher wil show your child how to do the
following:

1. Complete an on-line dietary questionnaire listig all that he or she eats or drinks for
three days.
2. Wear a small activity monitor all day for seven days in a row. The activity monitor wil
measure your child's physical activity levels.
3. Wear a watch on his or her wrist that measures physical activity and sleep patterns for

seven days in a row.
4. Fil out a survey for seven days to report what activities he or she did during the time

thé activity monitor and sleep watch were worn.

Second, the health researcher wil work with your child to do the following:
1. Measure his or her height, weight, and waist circumference.
2. Take his or her bloodpressure.

3. Have your child arrive at school on a specified day without eating breakfast so the
health researcher can collect a small amount of blood from his or her finger after it is
pricked to test for the biological markers listed below. These markers are important
measures of risk for obesity, diabetes, and heart disease. Your child wil then be given
breakfast.
a. Fasting blood glucose.

b. HbAlc.
c. Total cholesterol

d. Triglycerides

e. LDL-C, HDL
f. C-reactive protein

g. Uric acid

h. Cotinine

4. Complete a brief survey asking about the prescription or over-the-counter medicines he

or she takes on a regular basis and details about the neighborhood where you live.

The following is a schedule of when the above activities wil occur:
During 10th grade and the year after high school, students involved in NEXT Plus wil:

1. Complete an on-line dietary survey for three days listig what they have eaten each
day.
2. Have height, weight, waist circumference measured and blood pressure taken,
provide a small amount of blood from a finger stick before eating breakfast, and
complete a brief survey asking about the prescription or over-the-counter medicines
he or she takes on a regular basis and details about the neighborhood where you live.
3. Wear a small activity monitor and sleep watch for seven days to measure physical
activity and sleep.
4. Complete a brief diary each day to report on physical activity.
During 11 th and 12th grade students involved in the study wil:

1. Complete an on-line dietary survey for three days listig what has been eaten each
day.
2. Wear a small activity monitor and sleep watch for seven days to measure physical
activity and sleep.
3. Complete a brief diary each day to report on physical activity.

WILL PARENTS BE ASKED TO DO ANYTHING?
Parents or guardians wil be asked to agree to a home visit and to answer a short survey about
your child's health. If any of your child's test results are outside of normal values we wil

alert you promptly and recommend that you discuss the results with your health care
provider: For these reasons, it is very important that you provide your mailing address, email
address (if applicable) and phone number(s) on the last page of the consent form.
HOW MANY OTHER PEOPLE WILL BE IN THE STUDY?

study. ~..

About 750 10th grade students from 54 schools from across the United States wil be in the

HOW LONG WILL WE BE PART OF THE STUDY?
Just as in NEXT, we wil collect information from your child four times: in 10th grade, 11th
grade, 12th grade, and the year after high schooL

REASONS WHY YOUR CHILD MAY NOT BE ALLOWED TO BE INVOLVED:
Your child cannot take part in the study if he or she has:
. No signed inormed consent from parent(s) (this form),

. No informed assent from the student (the attached form),
. If he or she cannot read and understand the questions on the survey, which wil be
written in English,
. Developmental

limitations that affect your child's abilty to understand or provide

age appropriate responses to the questions, or
. A blood condition that wil not let them stop bleeding after the fingerstick.

EXPECTED RISKS AND DISCOMFORTS:
Some students may not feel at ease with someone measuring their weight, height, and waist
circumference or taking their blood pressure. The activity monitor wil be attached to an elastic
belt and worn around the waist over your child's clothing. The small size of the activity -

monitor makes if highly unlikely that your child wil feel any discomfort when wearing it. The
sleep watches wil be worn around the wrist like a regular watch and should not cause any
discomfort. Blood samples wil be taken by finger-stick. This wil require enough blood for the
tests listed above. It may sometimes be necessary to do a second finger-stick to get enough
blood. It is usually possible to get enough blood with one stick. Some teenagers find giving a
blood sample to be unpleasant, as it carries the risk of brief pain, stinging, and bruising, and a
very slight risk of inection. We carefully clean the finger and wear sterile gloves to prevent the
risk of inection. A student can refuse to participate in any of the assessments. These
assessments wil be conducted by trained health researchers.
Another potential risk to students participatig in NEXT Plus is a breech of confidentiality. This
risk is miimized because all inormation is kept confidentiaL.

YOU SAY THIS STUDY IS CONFIDENTIAL. HOW DO YOU PROTECT MY CHILD'S
PRIV ACY?

Responses, measurements, and blood test results are identified only by a numeric ID. The only
link between student inormation and their names is kept in a separate, password protected
(tracking) database at the home office. This inormation is needed so we may contact students
during the study. A Certificate of Confidentiality has been obtained to assure that individual
student inormation can never be accessed by parents or school personneL. This Certiicate is
issued to the study by the National Institutes of Health to protect the privacy of research
subjects. The researchers never have to release any" identifying information in any civiL,
criminal, adminish'ative, legislative, or other proceeding, whether at the FederaL, State, or local
level" (OER NIH Website, 2009).

All of the procedures we uséto protect confidentiality have been used with great success in
previous studies of children and adults. For example, one method we use to protect your
child's privacy and confidentiality is to provide very careful and thorough training of the health
researchers, and to monitor their performance closely. All our staff sign confidentiality pledges,
stating they wil not share inormation with unauthorized persons. Other than this NEXT Plus
Informed Consent Form, none of the questionnaires, interview records, or other paper records
kept for this study wil show your name or your child's name or other identifying inormation
like a home address. Only your child's study ID code number wil be put on all of these items
rather than his or her name. All study data (without your child's name) wil be sent by the
health researchers by overnight delivery to the home office data entry staff right after it is
collected and then entered into a password-protected computerized data file and stored for

will have
access to the computer files, You or your teen will send the activity monitor and sleep watch via
overnight delivery in a self-addressed, prepaid Federal Express envelope to the home office
where all data from the activity and sleep monitor will be downloaded into a secured data base.
All
lab results will be entered into a secured data base. All dietary recall data will be uploaded to
a secured data base. If any of these items are lost, it wil not be possible for anyone who finds
them to identify your child. None of these databases wil contain names or other identiying
analysis. The hard copies will be stored in locked areas and only authorized staff

information. A copy of this informed consent form and your family's contact inormation wil
be sent to our office separately and stored separately from the other study data.

After the study is completed, the data without identifying inormation wil be available to other
researchers. We wil never share any inormation that could be liked to your son or daughter.
His or her name wil never appear in any reports or published papers.
WHAT ARE THE POSSIBLE BENEFITS FOR BEING IN THE STUDY?
The results of NEXT Plus wil advance our knowledge of the risk of obesity and heart disease

among older adolescents and young adults. This information can be used to improve health
services and create prevention programs to help older adolescents and young adults, as well as
set national priorities for school and youth programs. In addition, parents and students will
receive a copy of the height, weight, waist circumference, blood pressure, and laboratory

results.
WHAT HAPPENS IF A PROBLEM OR INJURY RESULTS FROM THE RESEARCH
PROCEDURES?
It is highly unlikely that your child wil be injured by being in this study. However, if an injury
should occur, you wil not be paid for the injury and neither The CDM Group nor the sponsors
of the survey, NICHD or NHLBI, wil pay for treatment.

WHAT WILL MY SON OR DAUGHTER RECEIVE FOR BEING IN THE STUDY?
Your son or daughter wil receive the following for participatig in NEXT Plus. This is in
addition to what he or she wil receive for participating in NEXT.
Home
visit:
height,
weight,
waist

Blood
test

10th grade

$10

$10

11 th grade

No visit

12th grade

No visit

After high
school

$10

$10

Overall Total

$20

$20

Year of

Participation

-

Dietary
questionnaire
for three days

$10/ day;

$30 for all
$10/ day;

$30 for all
$10/ day;

$30 for all
$10/ day;

$30 total
$120 possible

Activity
monitor
and
sleep
watch for
seven
days

Activity
diary for

seven
days

Total by Year

$25

$25

$100 value

$25

$25

$80 value

$25

$25 '

$80 value

$25

$25

$100 value

$100

$100

$360 value

IS THIS STUDY VOLUNTARY?
Whether your son or daughter takes part in NEXT Plus is your choice. Also, your child may

choose not to take part in any or all of the measures at any time or for any reason. If after giving
your consent, you decide to withdraw your child from the study, this wil not hurt your or your
child's future relations with your son's or daughter's schooL
WHO SHOULD I CONTACT IF I HAVE QUESTIONS ABOUT THE RESEARCH STUDY?

You may ask questions about the study or anything you do not understand. If you do not have
questions now, you may ask later. During the study, you wil be told any new facts that could
affect whether you want your child to stay in the study. For more information about the
research, you may contact Mary Ann D'Elio, NEXT Plus Project Director, at toll-free 866-8649972 or NEXTigcdmgroup.com; or Dr. Ronald J. Iannotti, NEXT Plus Principal Investigator, at

301-435-6951 or iannottrigmail.nih. gov.

Please complete the following:
If you sign your name below, that means that you have read this consent form and have had?l
chance to ask any questions. Also, your son's or daughter's signature on the attached Child

Assent Form means that he or she has agreed to take part in NEXT Plus. If you agree to allow
your son or daughter to be involved, you may change your mid and withdraw your consent at
any time. As mentioned before, your son or daughter should not take part if he or she cannot
read and understand the questions on the survey, which wil be written in English or has a
blood condition that increases the risk for bleeding.

Please mark one of the choices below:
o Yes, I do consent to have my son/ daughter to take part in NEXT Plus.

o No, I do not consent to have my son/ daughter take part in NEXT Plus.

Parent/Guardian Signature

Date

IBlllt~~
NEXT Generation

FACT Sheet

Health Study
Q. What is NEXT Plus?
A. NEXT Plus is a special adolescent health study that is part of the larger NEXT Generation Health

Study (NEXT). There are 2,700 teenagers participating in NEXT, including your 10th grade child. Of
these students, a group of 750 teens were randomly selected to participate in NEXT Plus. Just like
NEXT, NEXT Plus wil collect information about how adolescent health changes over time. However,
NEXT Plus wil
particular, NEXT Plus wil

look more closely at the risk for heart disease among teenagers and young adults. In
look at teens' activity levels, their sleep habits and their eating habits. NEXT

Plus wil also see how many teens have biological signs of heart disease (like high cholesterol). Just like
NEXT, NEXT Plus wil follow these 750 teenagers from grade 10 through the first year after high schooL.
The goal of NEXT Plus is to see how their risk for heart disease changes over time and to identify ways to

predict heart disease among teenagers.
Q. Who is funding this study?
A. NEXT Plus is funded by the U.S. Department of Health and Human Services. More specifically, it is
sponsored by the National Institute' of Child Health and Human Development (NICHD) and the National
Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Q. How is NEXT Plus different from the NEXT Generation Health Study?
A. The NEXT Generation Health Study is a large multiyear study looking at teenagers' health behaviors
and health status from late adolescence into young adulthood. Teens who participate in NEXT wil

complete health survey questionnaires and have their height, weight, and waist circumference measured
in school periodically beginning in grade 10 and continuing through the first year after high schooL.
NEXT Plus is a part Of NEXT that -collects extra information abo.ut adolescent health on a smaller
number of teenagers. Teens are asked to participate in NEXT Plus after completing the NEXT survey and
height, weight, and waist circumference measurements at their schooL. Teens agreeing to be in NEXT

Plus then wil be asked to complete several additional activities in their homes while they are in grades
10, 11, 12 and during the first year after high schooL. These additional activities are described below.
Q. What wil teens be asked to do in NEXT Plus?
There are four parts to NEXT Plus:

1. Trained NEXT Plus health researchers wil come to your home to talk with you and your teen
about NEXT Plus. During this visit the health researcher wil explain clearly what we wil be

asking your teen to do and provide the instructions you and your teen wil need to successfully
participate in NEXT Plus. The health researcher also wil perform height, weight, and waist
circumference measurements on your teen, check your teen's blood pressure, and ask you and
your teen to complete a brief survey about health conditions affecting your teen, medications your teen

takes on a regular basis, and details about the neighborhood where you live..

2. We wil ask your teen to wear a small activity monitor (called an accelerometer) on his or her
waist band and a sleep watch (called an Actiwatch) on his or her wrist for seven days after our

home visit. The health researcher wil bring the activity monitor and sleep watch to your home
and show you and your teen the proper way to use both items. During the seven-day period

when your teen is wearing the activity monitor and sleep watch he or she also wil need to keep a
daily diary of his or her activities. Your teen wil need to complete his or her activity diary at the
end of each day and then return the completed diar to us at the end of the seven-day period.

The health researcher wil explain the best way to do this during the home visit.
3. We wil ask your teen to complete an online survey once a day for three days that wil ask him or
her about all of the food and drink he or she has consumed that day (this is called a dietar
questionnaire). The health researcher wil explain how to do this during the home visit.

4. We wil schedule a day to stick your teen's finger to perform a simple blood test before he or she
eat breakfast. The health researcher wil perform this finger stick blood collection at your teen's

schooL. This blood test wil check for signs of heart disease (e.g., cholesterol, triglycerides, blood
sugar levels, etc). Test results wil be sent to you and your teen once they are available. If any of
the results are outside of normal

values we wil alert you promptly and recommend that you

discuss the results with your health care provider.

Q. When wil all of these NEXT Plus assessments occur?
A. Not all of the activities described above wil occur during every year of NEXT Plus. A timeline of NEXT

Plus assessments is provided here. , These tasks wil occur in addition to NEXT activities (health survey
questionnaire, height, weight and waist circumference measurement at your teen's school, etc.).
Grade 10
i. Within four weeks after you and your teen agree to participate in NEXT Plus, a health researcher

wil visit your home to perform the following tasks:
a. Perform height, weight, and waist circumference measurements on your teen.
b. Take your teen's blood pressure.

c. Ask you and your teen to each complete brief surveys about any health conditions affecting

your teen, medications your teen takes on a regular basis, and details about the neighborhood
where you live.

d. Provide instructions on how to use the activity monitor and sleep watch and how to

complete the seven-day activity diary. The health researcher wil schedule a time for your
teen to wear the activ.ity monitor and sleep watch and complete the activity diary.
e. Provide instructions on how to complete the online dietar questionnaire once a day for

three days. The health researcher wil schedule a time for your teen to complete the

dietary questionnaire.
2. Within four weeks after the home visit, your teen wil be asked to arrive at school without having
eaten breakfast. The health researcher wil greet your teen at school and stick his or her finger to

perform a simple blood test. After the finger stick blood collection is done, your teen wil be given
breakfast. After eating breakfast, your teen wil rejoin his or her iellow students.
Grade 11

1. Your teen wil be asked to wear an activity monitor and sleep watch for seven days and complete a
seven-day activity diary.
2. Your teen wil be asked to complete an online survey once a day for three days that wil ask him or
her about all of the food and drink he or she has consumed that day (this is called a dietar
questionnaire). The health researcher wil schedule a time for your teen to complete the online

dietary questionnaires.
Grade 12

N EXT Plus: 201 0-201 3

2

3, Your teen wil be asked to wear an activity monitor and sleep watch for seven days and complete a

seven-day activity diary.
4. Your teen wil be asked to complete an online survey once a day for three days that wil ask him or

her about all of the food and drink he or she has consumed that day (this is called a dietar
questionnaire). The health researcher wil schedule a time for your teen to complete the online

dietary questionnaires.
One year after Hi~h School

1. Your teen wil receive a visit from a health researcher similar to the one conducted in grade 10. The
health researcher wil visit your teen first thing in the morning and perform the following tasks:
a. Stick your teen's finger to perform a simple blood test. This blood test wil check for signs

of heart disease (e.g., cholesterol, triglycerides, etc).

b. Perform height, weight, and waist circumference measurements on your teen.
c. Take your teen's blood pressure.

d. Ask your teen to complete a brief survey about any health conditions affecting him or her,
medications he or she takes on a regular basis, and details about the neighborhood where he or
she lives.
e. Ask you teen to wear an activity monitor and sleep watch for seven days and complete a

seven-day activity diary during that time. The health researcher wil schedule a time for
your teen to wear the activity monitor and sleep watch and complete the activity diary.

2. Your teen wil be asked to complete an online survey once a day for three days that wil ask him or
(this is called a dietar
questionnaire). The health researcher wil schedule a time for your teen to complete the online

her about all of the food and drink he or she has consumed that day

dietary questionnaire.
Q. What do teens receive for participating in NEXT Plus?
A. Teens wil receive financial incentives for completing NEXT Plus tasks. A summar of these incentives
can be found below. These incentives are in addition to what your teen wil receive for being in the
larger NEXT study.

Year of

Partici pation

Home
visit:
height,
weight,
waist

10tli grade

$10

11 th grade

No visit

12th grade

No visit

After high
school

$10

Blood
test

$10

$10

Dietary
questionnaire
for three days
$10/ day;
$30 for all
$10/ day;
$30 for all
$10/ day;
$30 for all
$10/ day;

$30 total

Wearing
activity
monitor
and sleep
watch for
all seven
days

Completing
activity diary
for all seven
days

$25

$25

$100 value

$25

$25

$80 value

$25

$25

$80 value

$25

$25

$100 value

Total by Year

,

Overall Total
$20
$20
$120 possible
$100
$100
$360 value
t - Grade 10 finger stick blood collection wil occur at the teenager's school or during a separately scheduled 10 minute home visit"

In addition to the financial incentives described above, teens will also receive a free health screening as
part of the NEXT Plus assessments. The results of the health assessments performed by the health

NEXT Plus: 2010-2013

3

-------archers will be sent to you when your teen is less than is years old and to your teen when he or she
resies
or older. These results wil include the finger prick blood test results, which wil check your teen's
ISh 1 sterol, triglycerides, and blood sugar levels, among other things. If any of these results are outside
c f 0 ermal values we wil alert you promptly and recommend that you discuss the results with your

ea '1'

ho n~h care provider. NEXT Plus provides these health screening results as a complimentar se:iice to

its participating famiies.

Q. Is participation confidential? How is privacy protected?
A During the study, all of your teen's information wil be kept private and confidential; nothing will be
~h~r~ked
lD number
be study,
assigned
to each your
teen teen's
at the start
of the
thisstored
number
wil
d with files.
othersAn
outside
of thewil
NEXT
including
schooL.
Allstudy
data and
wil be
safely
: ~sed for record keeping purposes and data analysis. Reports wil NOT include names of participating

teenagers or parents.
Q. How wil the results of this study be used?
A NEXT Plus findings wil be used by health professionals, policy makers, government agencies,
. riculum developers, education agencies, and community organizations to modify or develop public
~~:lth policies and programs, target public information campaigns, and to explore innovative strategies
for improving adolescent health. What we learn from this study wil provide necessary inormation to

improve health services and to create prevention programs that actually work for teenagers.
Q. Who wil conduct the survey?

A. The CDM Group and Abt Associates, two nationally recognized survey research firms, have been
contracted by NICHD to work with schools, teenagers and families to conduct the study. This research

team has years of experience working with teens and is committed to ensuring that the data collection
wil be carried out with as little inconvenience to you and your family as possible. Specially trained
health researchers, hired by the NEXT Plus research team, wil be sent to each home and school to
perform the NEXT Plus assessments. These health researchers wil conduct home visits at a time that is
convenient for your family and wil complete the necessar assessments in a thorough yet timely
manner. As always, the research team wil work with you and your teen to minimize the impact of your

participation in this study on your schedule and other obligations.
Q. How many teens wil participate in NEXT Plus?
A. Approximately 750 teenagers from across the country wil participate in NEXT Plus.

Q. When wil teens be asked to participate in NEXT Plus?
A. Approximately 2-3 weeks after completing the grade io in-school survey and assessments for the
NEXT Generation Health Study, a member of the research team wil contact 750 randomly selected teens
and their families to discuss NEXT Plus. They wil describe NEXT Plus ánd ask the teen and his or her

parents if they are wiling to participate in the study.

Q. What if a teen chooses not to participate?
A. Participation in NEXT Plus is voluntar; no one is required to participate and there is no penalty for
not participating. However, we hope that everyone who is asked to join the study wilL. NEXT Plus wil
help us learn lots ofimportant things about risks for heart disease. By participating in NEXT Plus, you can

help ensure that U.S. teen health research and programs are based on realistic information that applies
to all teens.
Q. How long does it take to complete the home visit?

NEXT Plus: 2010-2013

4

A. The grade 10 home visit wil take approximately 1 V2 hours to complete. This visit wil be scheduled at

a time that is convenient for you and your teen within four weeks after you agree to participate in the
study.

Q. How long does it take to complete the physical activity diary? What about the online ,dietary
questionnaire?
A. The seven-day physical activity diar wil be completed by your teen at the end of each day that he or

she wears the activity monitor and sleep watch. It wil take approximately 10-15 minutes for your teen
to complete a log of every activity he or she engaged in throughout the day. The health researcher wil
provide your teen with a physical activity diary at the home visit that he or she wil use to record this

information. The dietary questionnaire wil be done online at a website given to your teen during the
home visit by the health researcher. Your teen wil be asked to visit the website and enter all of the food
or drink he or she has consumed during the previous day. This process wil take approximately 45
minutes on the first day and 20 minutes each following day. For your convenience, your teen wil be
asked to complete the three-day dietar questionnaire AFTER the week-long period when he or she
wears the activity monitor and sleep watch and completes the activity diary.

Q. How are the home visits scheduled?
A. The NEXT Plus research team will contact you and your teen to schedule the home visit. The health

researcher can accommodate you and your family's schedule. Visits can be scheduled during the day,
evening and on weekends. However, we do ask that you work with the researchers to find a time within
two weeks of their call to complete the home visit if possible.
Q. When wil the data be collected?
A. NEXT Plus assessments wil occur every spring (between March and July) beginning when your teen
is in grade 10 and continuing through the first year after high schooL. During the first year of the study,
data collection wil begin in March 2010 and continue through July 2010. Data collection wil continue
the following spring or summer of 201 1,2012, and finally 2013.

Q. How wil parents be involved in NEXT Plus?

A. Parents or guardians wil be asked to agree to a home visit and to answer a short survey about health
conditions affecting their teen. Parents are asked to attend the home visit in grade 10 to help provide

information about medications that their teen takes on a regular basis for any health conditions.
Parents also wil receive instruction along side their teenager about how to operate the activity monitor
and sleep watch and how to complete the physical activity diar and online dietar questionnaire. It is

very important that parents have a clear understanding of what is being asked of their teens.

Q. What if my teenager is no longer living at home after high school? How wil NEXT Plus do a

home visit if my teen is at college or lives somewhere else?

A. The NEXT Plus research team wil keep in touch with you and your teen during the course of the

study. We wil periodically ask for updated contact information from both of you, including where you or
your teen is presently living, We wil conduct the final home visit (during the first year after high school)
wherever is most convenient for your teen. This visit could take place at your family home, in your
teen's home, at your teen's college, or a different location of your teen's choosing. Again, the NEXT Plus

research team wil work with your teen to minimize the impact of his or,her participation in this study
on his or her schedule and other obligations.
Q. Where can additional information be obtained?
A. To obtain additional information about NEXT Plus contact Ms. Mar Ann D'Elio of

The CDM Group,

Inc. at toll-free (866) 864-9972 or email next(cdmgrouP.com.

NEXT Plus: 2010-2013

5