Survey Protocol and Consents

Attachment A.

Protocol for NHANES National Youth Fitness Survey (ages 3-15)

National Health and Nutrition Examination Survey (NHANES)

National Youth Fitness Survey

OMB no. 0920-0237

Expires: 11/30/2012

Assurance of confidentiality – All information which would permit identification of an

individual, a practice, or an establishment will be held confidential, will be used for

statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).

Public reporting burden of this collection of information is estimated to average 60 minutes per response, including the time for screening for eligibility, 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333. ATTN: PRA (0920-0237).

NHANES National Youth Fitness Survey Protocol:

Eligibility: Children and adolescents ages 3 through 15 years who are not participants in NHANES will be eligible for the survey. Study participants will be selected from within screened households from which no member was eligible for NHANES.

Informed Consent: The informed consent process for the NYFS will follow the procedures established for the NHANES. If a parent/guardian for one or more sample persons identified through screening is available, the interviewer will continue with the household interview. If the parent/guardian for the selected sample person is not available, the interviewer will make an appointment to return to administer the sample person (SP) and family questionnaires. The informed consent documents begin on page 5 of this attachment.

Exclusion Criteria: The exclusion criteria for this survey are found in Attachment B under the heading General Exclusion Questions, within the section entitled NYFS Examination Data Collection Forms. All exclusion questions will be asked of the parent/guardian at the check-in to the examination center to identify children who cannot participate in survey components. Pregnant girls will be excluded from the health examination. All other children will be able to participate in the dietary recall interview.

Survey Design:

The NYFS is a survey of youth fitness to be conducted in conjunction with the 2012 sample of the NHANES.  Children ages 3-15 years will be selected from an independent sample of dwelling units (DUs) within the segments selected in the NHANES 2012 PSU sample. To accomplish this, the minimum measure of size for the 2012 segments will be increased above the rates established for the 2011-2014 NHANES sample to ensure there are enough DUs for both surveys in the selected segments.  No households will have both NHANES and NYFS participants.

The target sample size for the NYFS is 1,500 fifteen hundred examined children 3-15 years old, distributed as shown in Table 1. For the purpose of calculating sampling rates, an 80% response rate to the exam is estimated. Table 1 contains estimates of the total population in each sampling domain.  This table also gives the projected amount of screening required to obtain one examined person in the domain and the projected annual amount of screening required to attain the target number of examined persons in each domain.  Domains for the NYFS will be defined by gender and age only. 

Table1. Calculation of screening amount for the NYFS

Sex	Age	Projected population in year 2011-2014*	Estimated NYFS response rate	Target number of NYFS exams	Target number of NYFS SPs	Projected amount of screening required to obtain 1 examined person** (# households)	Projected amount of screening required to obtain target # exams in a self-weighting area sample (# households)
M	3-5	6,418,335	80%	173	216	23	3,991
	6-11	12,983,222	80%	346	433	11	3,946
	12-15	8,519,830	80%	231	288	17	4,009
F	3-5	6,418,335	80%	173	216	23	3,991
	6-11	12,477,784	80%	346	433	12	4,106
	12-15	8,239,995	80%	231	288	18	4,145
Total		55,057,503		1,500	1,875

*Population projection created for the NHANES 2011-2014 PSU selection.

** Estimated number of occupied households is 118,410,614 as created for the NHANES 2011-2014 PSU selection.

The study will take place at NHANES location. However, a trailer designed for use in Community NHANES will serve as the examination center for the dress rehearsal and study.

The NYFS will include the components tested in the NHANES Children’s Physical Activity Feasibility Study (CPAFS), as well as additional body measurements, expansion of the target ages for the physical activity monitor and treadmill, and addition of the hand grip test and dietary recall interview.  The NYFS will also include screener, sample person, and family questionnaires administered in the household. 

Examination Components Included in the National Youth Fitness Survey (NYFS)	Target Age	Source	Report of Findings
1.  Body measurements -- Anthropometry	3-15 y	NHANES	Yes (Height, weight, BMI)
2.  Physical activity monitor --       Accelerometry	3-15 y	NHANES/CPAFS	No
3.  Treadmill	6-15 y	NHANES/CPAFS	Yes (12-15 y only)
4.  Lower body muscle strength	6-15 y	CPAFS	No
5.  Grip strength	6-15 y	NHANES	Yes
6.  Modified pull-up	5-15 y	CPAFS	Yes
7.  Plank	3-15 y	CPAFS	No
8.  Gross motor skills	3-5 y	CPAFS	No
9.  Dietary recall interview	3-15 y	NHANES	No
10. Computer-assisted self interview (CASI)	12-15 y	NHANES	No

Report of Findings:

Height, weight, BMI and aerobic capacity will be reported to participants.

Advance Letter

A member of your family may have a chance to take part in an activity that will be important to the health and well-being of our children.

The National Center for Health Statistics, a part of the Centers for Disease Control and Prevention, is conducting the National Health and Nutrition Examination Survey (NHANES) - National Youth Fitness Survey.   The NHANES National Youth Fitness Survey will tell us about the physical activity of children across the United States.

In the next few weeks, one of our health representatives may visit your home. She or he will show you official Centers for Disease Control (CDC) identification and ask some short, easy questions about your family. This interview will take only a few minutes of your time. The purpose of these questions is to see if a member of your family will be asked to participate in the NHANES National Youth Fitness Survey. Answering the questions is completely voluntary, and you may choose not to answer any questions. I assure you there will be no penalties or loss of benefits of any kind from refusing to answer.

The survey is authorized by the Public Health Service Act. All of your answers will be kept in strict confidence. We will use this information only for statistical research and reports. Your answers will be added to others, so no one can identify which are yours.

If a household member is chosen for this survey, we hope they will participate.

Thank you in advance for helping.

Sincerely,

Edward J. Sondik, Ph.D.

Director

P.S. If you have questions call Mr. George Zipf of my staff at 1‑800‑452‑6115.

The call is free, and we would be happy to answer your questions.

OMB # 0920-0237

Exp, Date: 11/30/2012

National Youth Fitness Survey

Home Interview Consent

Participants 3 – 15 years old

Print name of child participant _________________ ______________________ _____________________

First Middle Last

Your child has been chosen to take part in the National Youth Fitness Survey (NYFS), conducted by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention (CDC). This research tells us about the physical activity and fitness of children in the United States. It combines an interview with a fitness exam. Our interviewer will ask questions about his or her level of physical activity. The questions today will take about ten minutes.

We are required by law (read box below) to use your information for statistical research only and to keep it confidential. The law prohibits us from giving anyone any information that may identify you or your family without your consent.

You may take part in this interview or not. The choice is yours. You will not lose any benefits if you say no. If you choose to take part, you don’t have to answer every question.

Do you have more questions about the survey? You can make a toll-free call to Dr. Kathryn Porter at the U.S. Public Health Service at 1-800-452-6115, Monday-Friday, 8:30 AM-6:00 PM EST. If you have questions about your rights about being in the survey, call the Research Ethics Review Board at the National Center for Health Statistics, toll free, at 1-800-223-8118. Please leave a brief message with your name and phone number. Say that you are calling about Protocol # tbd. Your call will be returned as soon as possible.

SIGNATURE OF PERSON ANSWERING QUESTIONS:

I have read the information above. I agree to proceed with the interview.

______________________________________________________________ ___________________

Date

(Check here if emancipated minor )

I observed the interviewer read this form to the person named above and he/she agreed to participate by signing or marking this form.

___________________________________ ___________________

Witness (if required) Date

Name of staff member present when this form was signed: ________________________________________________

HOUSEHOLD ID ___ ___ ___ ___ ___ ___ ___ ___ ___ FAMILY # ___ ___

SAMPLE ID ___ ___ ___ ___ ___ ___

Assurance of Confidentiality – All information which would permit identification of an individual, a practice, or an establishment will be held confidential, will be used only by NCHS staff, contractors, and other agents authorized by NCHS to perform statistical activities, only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL‑107‑347). By law, every employee as well as every agent has taken an oath and is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

Public reporting burden of this collection of information may take up to 2.5 hours per response for total participation, 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 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0920-0237).

OMB # 0920-0237

Exp, Date: 11/30/2012

National Youth Fitness Survey

Home Interview Consent for Physical Activity Questions

Participants 12 – 15 years old

Print name of child participant ______________ _______________ ____________________

First Middle Last

You have been chosen to take part in the National Youth Fitness Survey (NYFS), conducted by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention (CDC). This research tells us about the physical activity and fitness of children in the United States. It combines an interview with a fitness exam. Our interviewer will ask questions about your level of physical activity. The questions today will take about ten minutes.

You may take part in this interview or not. The choice is yours. You will not lose any benefits if you say no. If you choose to take part, you don’t have to answer every question.

SIGNATURE OF PERSON ANSWERING QUESTIONS:

I have read the information above. I agree to proceed with the interview.

______________________________________________________________ ___________________

Date

A PARENT/GUARDIAN MUST ALSO SIGN BELOW:

(Unless participant is an emancipated minor )

_______________________________________________________________ ___________________

Signature of parent/guardian Date

I observed the interviewer read this form to the person named above and he/she agreed to participate by signing or marking this form.

___________________________________ ___________________

Witness (if required) Date

Name of staff member present when this form was signed: ________________________________________________

HOUSEHOLD ID ___ ___ ___ ___ ___ ___ ___ ___ ___ FAMILY # ___ ___

SAMPLE ID ___ ___ ___ ___ ___ ___

Assurance of Confidentiality – All information which would permit identification of an individual, a practice, or an establishment will be held confidential, will be used only by NCHS staff, contractors, and other agents authorized by NCHS to perform statistical activities, only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL‑107‑347). By law, every employee as well as every agent has taken an oath and is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

Public reporting burden of this collection of information may take up to 2.5 hours per response for total participation, 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 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0920-0237).

National Youth Fitness Survey

Examination Consent Brochure

Overview

The National Youth Fitness (NYFS) is a survey conducted by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention. We have designed the survey to learn about physical activity and fitness of youth ages 3 through 15.

Our survey combines a home interview with health measurements, which we do in mobile units. These special mobile centers travel across the country with a highly trained medical team.

Why is this health survey important?

The NYFS will provide current information on the physical fitness levels, physical activity, and dietary behaviors of American youth. The last comprehensive assessment of the fitness of American youth occurred more than 20 years ago.

The NYFS will be used to measure progress in obtaining national objectives for youth fitness and healthy eating established by the Department of Health and Human Services and provide information needed to develop policy and program recommendations to improve youth fitness and dietary behaviors.

You may choose to be in the survey and you may allow your child to be in it, too. That is your choice. There is no penalty if you refuse. You or your child may refuse any part of the exam and are free to drop out anytime. Also, during the interviews you may choose not to answer every question.

What will we ask your child to do at the mobile center?

<photo of trailer>

Our examination team will:

Check your child’s height, weight and other measures related to growth and development <photo of child having his height measured>

Ask questions about what your child eats <photo of dietary interview and child>

Have your child perform age-specific physical activities <photo of child performing physical activity>

A list of the specific measurements by age is included on the attached Health Measurements list.

Are the tests safe?

The tests are safe. Your child may have a little muscle soreness a day or two after the exam if he or she is not used to doing the activities we ask them to do during the examination.

Will you ask personal questions?

At the mobile center your child will be asked a few personal questions if he or she is between 12-15 years old. These questions will be answered on a piece of paper that does not include their name. Like all of the other data we collect, the answers you and your child gives us are kept strictly private.

Will I get the results?

Yes, you will get a report of your child’s results the day you visit the exam center. Some tests are not reported because they will be used only for research and are not used for health care. NYFS does not cover the cost of any health care you may decide to get after the exam. If you have questions about getting your results, please call 1-800-452-6115.

Will my child’s information be kept private?

We respect your privacy. Public laws keep all information you give private. These laws do not allow us to give out data that identifies you or your family without your permission. This means that we cannot give out any facts about you or your child, even if a court of law asks for it. However, if we find signs of child abuse during an exam, we will report it to the local department of social services or the police.

We will keep all survey data safe and secure. When we share data with our partners, we do so in a way that protects your privacy as required and guaranteed by law. Our interviewer can provide you a list of our partners if you wish to learn more.

More questions?

Our survey representative can discuss other questions or concerns you might have or give you printed material that can help you. She or he can give you a phone number in your area that you can call for more facts about the survey. Also, you can make a free call to Dr. Kathryn Porter of the U.S. Public Health Service to discuss any aspect of the survey. She can be reached at 1-800-452-6115, Monday-Friday, 8:30 AM-6:00 PM EST. You may also contact her regarding any harm to you resulting from this survey. You can also get answers to your questions by mail (Room 4322, 3311 Toledo Rd., Hyattsville, MD 20782). You may have questions about your rights as a participant in this research study. If so, please call the Research Ethics Review Board at the National Center for Health Statistics, toll-free, at 1-800-223-8118. Please leave a brief message with your name and phone number. Say that you are calling about Protocol # new. Your call will be returned as soon as possible.

OMB # 0920-0237

Exp, Date: 11/30/2012

National Youth Fitness Survey

Consent/Assent and Parental Permission for Examination at the Mobile Examination Center

Print name of participant ____________________ _________________ _____________

First Middle Last

PARENT OR GUARDIAN OF SURVEY PARTICIPANT WHO IS UNDER 18 YEARS OLD:

F or the Parent or Guardian of the Survey Participant who is a minor (unless the participant is an emancipated minor ):

I have read the Examination Brochure and the Health Measurements List which explain the nature and purpose of the survey. I freely choose to let my child take part in the survey.

________________________________ ______

Signature of parent/guardian Date

SURVEY PARTICIPANT WHO IS 12 YEARS OLD OR OLDER:

I have read the Examination Brochure and the Health Measurements List which explain the nature and purpose of the survey. I freely choose to take part in the survey.

________________________________ _____

Signature of participant Date

I observed the interviewer read this form to the person named above and he/she agreed to participate by signing or marking this form.

____________________________________________________________ _________________

Witness (if required) Date

Name of staff member present when this form was signed:

______________________________________________________________________________

Assurance of Confidentiality – All information which would permit identification of an individual, a practice, or an establishment will be held confidential, will be used only by NCHS staff, contractors, and other agents authorized by NCHS to perform statistical activities, only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347). By law, every employee as well as every agent has taken an oath and is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

___ ___ ___ ___ ___ ___

SP ID

National Youth Fitness Survey

ASSENT FORM

Your parent says that you can take part in this special survey. This survey measures strength and skills that are part of exercising. It is important that kids are able to take part in physical activities so that they have good health when they are young and when they grow up. We will weigh and measure you, ask you to walk and run on a treadmill, do exercises, and wear a special monitor for a week to record your body movement. You may feel tired or sore after the survey, like you do after you exercise or play.

Only you, your parents, and the people who work on the survey will know your results.

The survey will take about 1 and half hours.

You do not have to do this survey if you do not want to. You can stop at any time and during any part of the survey. If you have questions about this survey, or if you have any questions during the survey, please ask any adult who is working on this survey.

If you want to take part in the survey, write your name below.

__________________________________________

Print first, middle, last name of participant

__________________________________________________________

Signature of participant 7-11 years old Date

I observed the examiner read this form to the person named above and he/she agreed to participate by signing or marking this form.

___________________________________________________________

Witness Date

Name of staff member present when this form was signed:

___ ___ ___ ___ ___ ___

SP ID

National Youth Fitness Survey

Health Measurements List

You will receive the results of health measures shown with a black diamond (♦).

The adult accompanying the child will provide this information (P). The adult accompanying the child will be asked questions about the child to make sure all measurements are safe.

Children ages 3-5 years will receive:

Height, weight and other measures of growth and development ♦

A physical activity monitor to wear for 7 days to be mailed back in a prepaid envelope.

A measurement of abdominal or core muscle strength

A measurement of upper body muscle strength (5 year olds only) ♦

An assessment of your child’s coordination and balance (3-5)

An interview related to eating (P)

Children ages 6-11 years will receive:

Height, weight and other measures of growth and development ♦

A physical activity monitor to wear for 7 days to be mailed back in a prepaid envelope.

A measurement of measure abdominal or core muscle strength

A measurement of lower body muscle strength

Grip strength test will be measured ♦

A treadmill fitness measure consisting of walking and running

An interview related to eating (P)

Children ages 12-15 years will receive:

Height, weight and other measures of growth and development ♦

A physical activity monitor to wear for 7 days to be mailed back in a prepaid envelope.

A measurement of abdominal or core muscle strength

A measurement of lower body muscle strength

Grip strength test will be measured ♦

A treadmill fitness measure consisting of walking and running ♦

An interview related to eating

Questions about smoking, alcohol and drug use will be asked

[You will answer these questions on paper that does not include your name]

If you have questions about getting your results, please call 1-800-452-6115

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