Attach B13. LOI2-QUEX-14 IRB Approval Letters

1 of 3

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3DHVDDRO2EE30/fromSt...

Attach B13. LOI2-QUEX-14 IRB Approval Letters
11000 Kinross Avenue, Suite 102
Los Angeles, CA 90095-1694
http://ohrpp.research.ucla.edu
GC-IRB: (310) 825-7122
M-IRB: (310) 825-5344

APPROVAL NOTICE
New Study
DATE:
TO:
FROM:
RE:

3/15/2011
LENORE ARAB
MEDICINE-GENERAL MEDICINE & HLTH SRVCS.
ALISON MOORE
Chair, SGIRB
IRB#10-001535
Improving Dietary Assessment in Pregnant Women and Children in the National
Children's Study
Version: LOI-2-14

The UCLA Institutional Review Board (UCLA IRB) has approved the above-referenced study. The UCLA IRB's Federalwide Assurance (FWA) with Department of
Health and Human Services is FWA00004642 (IRB00004474).
Submission and Review Information
Type of Review

Full Board Review

Approval Date

3/15/2011

Expiration Date of the Study

1/10/2012

Funding Source(s)

1) NIH/NATIONAL INST OF CHILD HEALTH AND HUMAN
DEVELOPMENT
Grant Title: Improving Dietary Assessment in Pregnant Women and
Children in the National Children's Study
Grant Number: LOI-2-14

5/14/2012 1:37 PM

2 of 3

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3DHVDDRO2EE30/fromSt...

Regulatory Determinations

-- The UCLA IRB waived the requirement for signed informed consent for the screening under 45 CFR
46.117(c)(2).
-- The UCLA IRB waived the requirement for obtaining the assent of the children under 45 CFR 46.116(d) for the
entire study.
-- The UCLA IRB determined that the research meets the requirements of 45 CFR 46.404 for research involving
children as subjects.

Documents Reviewed included, but were not limited to:

Document Name
Craigslist Text.Child Chinese CLEAN.pdf
Craigslist Text.Pregnant Indian CLEAN.pdf
Eligibility Screener Script (preschooler) .pdf
Flyer Pregnant Chinese CLEAN 2.28.11.pdf.pdf
Craigslist Text.Child Indian CLEAN.pdf
Consent form Pregnant women.pdf
Flyer Children Chinese CLEAN 2.28.11.pdf.pdf
Consent form preschoolers.pdf
Flyer Pregnant SouthEastIndian CLEAN 2.28.11.pdf.pdf
Flyer Pregnant Filipino CLEAN 2.28.11.pdf.pdf
Craigslist Text.Child Filipino CLEAN.pdf
Recruitment Flyer (Children Filipino) CLEAN.pdf
Eligibility Screener Script (pregnant).pdf

Document
Version #
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01

5/14/2012 1:37 PM

3 of 3

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3DHVDDRO2EE30/fromSt...

Craigslist Text.Pregnant Filipino CLEAN.pdf
Flyer Children South East Indian CLEAN 2.28.11.pdf.pdf
Craigslist Text.Pregnant Chinese CLEAN.pdf

0.01
0.01
0.01

Important Note: Approval by the Institutional Review Board does not, in and of itself, constitute approval for the implementation of this research. Other UCLA
clearances and approvals or other external agency or collaborating institutional approvals may be required before study activities are initiated. Research
undertaken in conjunction with outside entities, such as drug or device companies, are typically contractual in nature and require an agreement between the
University and the entity.
General Conditions of Approval
As indicated in the PI Assurances as part of the IRB requirements for approval, the PI has ultimate responsibility for the conduct of the study, the ethical
performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the IRB.
The PI and study team will comply with all UCLA policies and procedures, as well as with all applicable Federal, State, and local laws regarding the protection of
human subjects in research, including, but not limited to, the following:
Ensuring that the personnel performing the project are qualified, appropriately trained, and will adhere to the provisions of the approved protocol,
Implementing no changes in the approved protocol or consent process or documents without prior IRB approval (except in an emergency, if necessary to
safeguard the well-being of human subjects and then notifying the IRB as soon as possible afterwards),
Obtaining the legally effective informed consent from human subjects of their legally responsible representative, and using only the currently approved
consent process and stamped consent documents, as appropriate, with human subjects,
Reporting serious or unexpected adverse events as well as protocol violations or other incidents related to the protocol to the IRB according to the OHRPP
reporting requirements.
Assuring that adequate resources to protect research participants (i.e., personnel, funding, time, equipment and space) are in place before implementing
the research project, and that the research will stop if adequate resources become unavailable.
Arranging for a co-investigator to assume direct responsibility of the study if the PI will be unavailable to direct this research personally, for example, when
on sabbatical leave or vacation or other absences. Either this person is named as co-investigator in this application, or advising IRB via webIRB in
advance of such arrangements.

5/14/2012 1:37 PM

1 of 3

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3DHVDDRO2EE30/fromSt...

11000 Kinross Avenue, Suite 102
Los Angeles, CA 90095-1694
http://ohrpp.research.ucla.edu
GC-IRB: (310) 825-7122
M-IRB: (310) 825-5344

APPROVAL NOTICE
New Study
DATE:
TO:
FROM:
RE:

3/15/2011
LENORE ARAB
MEDICINE-GENERAL MEDICINE & HLTH SRVCS.
ALISON MOORE
Chair, SGIRB
IRB#10-001535
Improving Dietary Assessment in Pregnant Women and Children in the National
Children's Study
Version: LOI-2-14

The UCLA Institutional Review Board (UCLA IRB) has approved the above-referenced study. The UCLA IRB's Federalwide Assurance (FWA) with Department of
Health and Human Services is FWA00004642 (IRB00004474).
Submission and Review Information
Type of Review

Full Board Review

Approval Date

3/15/2011

Expiration Date of the Study

1/10/2012

Funding Source(s)

1) NIH/NATIONAL INST OF CHILD HEALTH AND HUMAN
DEVELOPMENT
Grant Title: Improving Dietary Assessment in Pregnant Women and
Children in the National Children's Study
Grant Number: LOI-2-14

5/14/2012 1:37 PM

2 of 3

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3DHVDDRO2EE30/fromSt...

Regulatory Determinations

-- The UCLA IRB waived the requirement for signed informed consent for the screening under 45 CFR
46.117(c)(2).
-- The UCLA IRB waived the requirement for obtaining the assent of the children under 45 CFR 46.116(d) for the
entire study.
-- The UCLA IRB determined that the research meets the requirements of 45 CFR 46.404 for research involving
children as subjects.

Documents Reviewed included, but were not limited to:

Document Name
Craigslist Text.Child Chinese CLEAN.pdf
Craigslist Text.Pregnant Indian CLEAN.pdf
Eligibility Screener Script (preschooler) .pdf
Flyer Pregnant Chinese CLEAN 2.28.11.pdf.pdf
Craigslist Text.Child Indian CLEAN.pdf
Consent form Pregnant women.pdf
Flyer Children Chinese CLEAN 2.28.11.pdf.pdf
Consent form preschoolers.pdf
Flyer Pregnant SouthEastIndian CLEAN 2.28.11.pdf.pdf
Flyer Pregnant Filipino CLEAN 2.28.11.pdf.pdf
Craigslist Text.Child Filipino CLEAN.pdf
Recruitment Flyer (Children Filipino) CLEAN.pdf
Eligibility Screener Script (pregnant).pdf

Document
Version #
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01

5/14/2012 1:37 PM

3 of 3

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3DHVDDRO2EE30/fromSt...

Craigslist Text.Pregnant Filipino CLEAN.pdf
Flyer Children South East Indian CLEAN 2.28.11.pdf.pdf
Craigslist Text.Pregnant Chinese CLEAN.pdf

0.01
0.01
0.01

Important Note: Approval by the Institutional Review Board does not, in and of itself, constitute approval for the implementation of this research. Other UCLA
clearances and approvals or other external agency or collaborating institutional approvals may be required before study activities are initiated. Research
undertaken in conjunction with outside entities, such as drug or device companies, are typically contractual in nature and require an agreement between the
University and the entity.
General Conditions of Approval
As indicated in the PI Assurances as part of the IRB requirements for approval, the PI has ultimate responsibility for the conduct of the study, the ethical
performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the IRB.
The PI and study team will comply with all UCLA policies and procedures, as well as with all applicable Federal, State, and local laws regarding the protection of
human subjects in research, including, but not limited to, the following:
Ensuring that the personnel performing the project are qualified, appropriately trained, and will adhere to the provisions of the approved protocol,
Implementing no changes in the approved protocol or consent process or documents without prior IRB approval (except in an emergency, if necessary to
safeguard the well-being of human subjects and then notifying the IRB as soon as possible afterwards),
Obtaining the legally effective informed consent from human subjects of their legally responsible representative, and using only the currently approved
consent process and stamped consent documents, as appropriate, with human subjects,
Reporting serious or unexpected adverse events as well as protocol violations or other incidents related to the protocol to the IRB according to the OHRPP
reporting requirements.
Assuring that adequate resources to protect research participants (i.e., personnel, funding, time, equipment and space) are in place before implementing
the research project, and that the research will stop if adequate resources become unavailable.
Arranging for a co-investigator to assume direct responsibility of the study if the PI will be unavailable to direct this research personally, for example, when
on sabbatical leave or vacation or other absences. Either this person is named as co-investigator in this application, or advising IRB via webIRB in
advance of such arrangements.

5/14/2012 1:37 PM

https://eprost.med.miami.edu/Eprost/Doc/0/7F6NMGRDHCE...

EXPEDITED – APPROVAL
February 2, 2012

Tracie Miller, M.D.
University of Miami
Department of Pediatrics, Pediatric Clinical Research
Medical Campus, Locator Code: D 820
1580 NW 10th Avenue, Room 542
Miami, FL 33136

HSRO STUDY NUMBER:

20100921

STUDY TITLE:

National Children's Study Diet Data Collection

IRB ACTION DATE:

1/28/2012

STUDY APPROVAL
EXPIRES:

1/4/2013

FWA #:

FWA00002247

SPONSOR NAME:

The Eunice Kennedy Shriver National Institute of Child Health and
Human Development

On 1/28/2012 an IRB Designee approved the following items under the expedited review process.
APPROVAL INCLUDES:
Amendment (20100921-02)
Addition of the University of Hawaii and John Hopkins approval letter
Removal of UCLA as a performance site.
A request to continue this study must be submitted to the HSRO at least 45 days before IRB approval expires. If
this study does not receive continuing IRB approval prior to expiration, all research activities must cease, and it
may be officially suspended or terminated.

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7/11/12 9:06 AM

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Sincerely,
[This is a representation of an electronic record
that was signed electronically and this page is
the manifestation of the electronic signature]
Amanda Coltes-Rojas, MPH, CIP
Director
Regulatory Affairs & Educational Initiatives
/ar
cc:

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IRB File
There are no items to display

7/11/12 9:06 AM

file:///C|/Documents%20and%20Settings/cookela.NIH/Desktop/FR%2314_IRBApproval_UniversityOfMinnesota.htm

From:
Sent:
To:
Cc:
Subject:
Continuing Review
Follow Up Flag:
Flag Status:

stang002 [stang002@umn.edu]
Wednesday, June 27, 2012 3:04 PM
Fuller, Jill E
Grace Fung
Fwd: 1012S93872 - PI Stang - IRB - APVD
Follow up
Flagged

Hi Jill,
I am forwarding our IRB continuation letter - they only send an email. If you need a copy of the
original IRB approval letter, I can find that as well. Thanks. jamie
PS Looks like the budget for the expanded recruitment will be about $146k
Jamie Stang, PhD, MPH, RD, LN
Director, Leadership Education & Training Program in MCH Nutrition
Co-Director, Midwest Center for Lifelong-Learning in Public Health
University of Minnesota, School of Public Health

-------- Original Message -------Subject:1012S93872 - PI Stang - IRB - APVD Continuing Review
Date:Thu, 22 Dec 2011 23:19:39 -0600 (CST)
From:irb@umn.edu
To:stang002@umn.edu
TO : helle023@umn.edu, stang002@umn.edu, deb@cccs.umn.edu, ukest001@umn.edu,

The IRB: Human Subjects Committee renewed its approval of the referenced study listed below:
Study Number: 1012S93872
Principal Investigator: Jamie Stang
Expiration Date: 12/19/2012
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file:///C|/Documents%20and%20Settings/cookela.NIH/Desktop/FR%2314_IRBApproval_UniversityOfMinnesota.htm

Approval Date: 12/21/2011

Title(s):
Improving Dietary Assessment in Pregnant Women and Children in the National Children's Study

This e-mail confirmation is your official University of Minnesota HRPP notification of continuing review
approval. You will not receive a hard copy or letter. This secure electronic notification between password
protected authentications has been deemed by the University of Minnesota to constitute a legal signature.
You may go to the View Completed section of http://eresearch.umn.edu/ to view or print your continuing
review submission.
For grant certification purposes you will need this date and the Assurance of Compliance number, which is
FWA00000312 (Fairview Health Systems Research FWA00000325, Gillette Childrens Specialty Healthcare
FWA00004003). Approval will expire one year from that date. You will receive a report form two months
before the expiration date.
In the event that you submitted a consent document with the continuing review form, it has also been
reviewed and approved. If you provided a summary of subjects' experience to include non-UPIRTSO
events, these are hereby acknowledged.
As Principal Investigator of this project, you are required by federal regulations to inform the IRB of any
proposed changes in your research that will affect human subjects. Changes should not be initiated until
written IRB approval is received. Unanticipated problems and adverse events should be reported to the IRB
as they occur. Results of inspections by any external regulatory agency (i.e. FDA) must be reported
immediately to the IRB. Research projects are subject to continuing review.
If you have any questions, please call the IRB office at (612) 626-5654.

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The IRB wishes you continuing success with your research.

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Page 1 of 1

Office of Human Subjects Research
Institutional Review Boards
1620 McElderry Street, Reed Hall, Suite B-130
Baltimore, Maryland 21205-1911
410-955-3008
410-955-4367 Fax
e-mail: jhmirb@jhmi.edu

Date: January 12, 2012

CONTINUING REVIEW APPROVAL
Review Type:
PI Name:
Study #:
Study Name:

Expedited
Frank Witter
NA_00043877
Improving Dietary Assessment in Pregnant Women and Children in the National Children's
Study

Committee
Chair:

Susan Bassett

Committee:

JHM-IRB X

Date of review: January 9, 2012
Date of approval: January 9, 2012
Date of expiration: January 8, 2013
The JHM IRB approved the above-referenced Continuing Review.
45CFR46.404 and/or 21 CFR 50.51: This study has been approved for the inclusion of children as 'research not
involving greater than minimal risk'. The permission of one parent is required.
Date of Approval and Expiration Date: The approval and expiration date for this research are listed above. If the
approval lapses, the research must stop and you must submit a request to the IRB to determine whether it is in the best
interests of individual participants to continue with treatment interventions.
Changes in Research: All proposed changes to the research must be submitted using an eIRB Change in Research
application. The changes must be approved by the JHM IRB prior to implementation, with the following exception:
changes made to eliminate apparent immediate hazards to participants may be made immediately, and promptly reported
to the JHM IRB.
Continuing Review: Continuing Review Applications should be submitted at least 6 weeks prior to the study expiration
date. Failure to allow sufficient time for review may result in a lapse of approval. If the Continuing Review Application is
not submitted prior to the expiration date, your study will be terminated and a New Application must be submitted to
reinitiate the research.
Unanticipated Problems: You must inform the IRB of any unanticipated problems involving risks to participants or
others.
If this research has a commercial sponsor, the research may not start until the sponsor and JHU have signed a contract.

The Johns Hopkins Institutions operates under multiple Federal-Wide Assurances: The Johns Hopkins University School of Medicine - FWA00005752, The Johns
Hopkins University School of Nursing - FWA00006088, The Johns Hopkins Hospital and Johns Hopkins Health Systems - FWA00006087, Johns Hopkins
Bayview Medical Center - FWA00006089, Howard County General Hospital - FWA00005743, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. FWA00005719, Johns Hopkins Community Physicians - FWA00002251, Suburban Hospital and Health System - FWA00005924

https://e-irb.jhmi.edu/eirb/Doc/0/98F61MMGUOQ4TEM8VSAJ0LQ9E0/fromString.html

2/20/2012

OMB Control Number: 0925-0593
OMB Expiration Date: 07/31/2013
12-Month Mother SAQ

The National Children’s Study
12 Month Follow-up Questionnaire

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. Environmental Protection Agency

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions,
maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person
of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this
for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593*). Do

searching existing data sources, gathering and
is not required to respond to, a collection
collection of information, including suggestions
not return the completed form to this address.

Thank you for agreeing to participate in the National Children’s Study. This self-administered questionnaire will
take about 10 minutes to complete. There are questions about your relationships and questions about your
child’s diet.
Your answers are important to us. There are no right or wrong answers. You can skip over any question. We
will keep everything that you tell us confidential.
If you are married or have a partner, please read the instructions below.
If you are not married or do not have a partner, go to the instructions following Question 6.
The first set of items are about your relationship with your spouse or partner. Please indicate the extent to
which you agree or disagree with each statement.
1. My spouse/partner listens to me when I need someone to talk to.
 Strongly disagree
 Somewhat disagree
 Neither agree nor disagree
 Somewhat agree
 Strongly agree
2. I can state my feelings without him getting defensive.
 Strongly disagree
 Somewhat disagree
 Neither agree nor disagree
 Somewhat agree
 Strongly agree
3. I often feel distant from my spouse/partner.
 Strongly disagree
 Somewhat disagree
 Neither agree nor disagree
 Somewhat agree
 Strongly agree
4. My spouse/partner can really understand my hurts and joys.
 Strongly disagree
 Somewhat disagree
 Neither agree nor disagree
 Somewhat agree
 Strongly agree
5. I feel neglected at times by my spouse/partner.
 Strongly disagree
 Somewhat disagree
 Neither agree nor disagree
 Somewhat agree
 Strongly agree
6. I sometimes feel lonely when we’re together.
 Strongly disagree
 Somewhat disagree
 Neither agree nor disagree
 Somewhat agree
 Strongly agree
QUE
(EHPBHIPBS),
MDES 3.1 Summer
2012,
V3.0 2012,

QUE12-Month
12-MonthSAQ
Mother
SAQ (EHPBHIPBS),
MDES 3.1
Summer
V3.0

1

1

The next questions will ask about the milk, formula, and food your child has eaten in the past 7 days. In
answering include feedings by everyone who feeds the baby. Include snacks and night-time feedings.
Use these guidelines in choosing how to respond:
•
•
•

If the baby was fed this item once a day or more, write the number of feedings per day in the boxes
and then mark the box before “Day.”
If the baby was fed the item less than once a day, write the number of feedings per week in the
boxes and then mark the box before “Week.”
If the baby was not fed the item at all during the past 7 days, write “00” in the boxes.

7. In the past 7 days, how often was your baby fed breast milk (include breast fed and expressed or pumped
breast milk)?

 Number of times per (select one below)
 Day
 Week

8. In the past 7 days, how often was your baby fed formula?

 Number of times per (select one below)
 Day
 Week

9. In the past 7 days, how often was your baby fed cow’s milk?

 Number of times per (select one below)
 Day
 Week

10. In the past 7 days, how often was your baby fed other milk (soy milk, rice milk, goat milk)?

 Number of times per (select one below)
 Day
 Week

11. Please tell me which best describes what your baby has been fed. My baby…
 …is not drinking breast milk now, but was fed breast milk in the past
 …is drinking breast milk now
 …was never fed breast milk
If you answered “My baby is drinking breast milk now” for Question 11, go to Question 14.
If you answered “My baby was never fed breast milk” for Question 11, go to Question 15.
Otherwise go to Question 12.

QUE
12-Month
SAQ
(EHPBHIPBS),
MDES 3.1 Summer
2012,
V3.0 2012, V3.0
QUE
12-Month
Mother
SAQ (EHPBHIPBS),
MDES 3.1
Summer

22

12. How old was your baby when you completely stopped breastfeeding and pumping or expressing breast
milk? (If your baby was less than one month, enter age in weeks. If your baby was older than one month,
enter age in months.)

 Number of

(select one below)

 Weeks
 Months
13. Have you ever fed your baby pumped or expressed breast milk?
 Yes
 No → Go to Question 15
14. In the past 7 days, about how often was your baby fed pumped or expressed breast milk? Include feedings
by everyone who feeds the baby and include snacks and nighttime feedings.









1 time per week
2 to 4 times per week
Nearly every day
1 time per day
2 to 3 times per day
4 to 6 times per day
More than 6 times per day
Not applicable/ I have not fed my baby breast milk in the past 7 days

15. How old was your baby when he/she was first fed formula on a daily basis?







less than 1 month old
1 to 2 months old
3 to 4 months old
5 to 6 months old
More than 6 months old
Not applicable (never fed formula to baby)

If you answered “00” to Question 8 and “Not applicable (never fed formula to baby)” for Question
15, go to the instructions following Question 21.
If you answered any number “01” or more to Question 8, go to Question 17.
If you were unable to answer Question 8, go to Question 16.
16. Has your baby had formula in the last seven days?
 Yes
 No → Go to Instructions following Question 21
 Not applicable (never fed formula to baby) → Go to Instructions following Question 21

QUE
(EHPBHIPBS),
MDES 3.1 MDES
Summer
2012,
V3.0 2012,

QUE12-Month
12-MonthSAQ
Mother
SAQ (EHPBHIPBS),
3.1
Summer
V3.0

33

17. What kind of infant formula was your baby fed in the past 7 days? Select all of the formulas that you feed
your baby. Include any formula the baby was fed in the past 7 days that is not included on the list under
“Other.”

















































Baby’s Only Organic Dairy
Baby’s Only Organic Soy
Baby’s Only Organic Lactose Free
Bright Beginnings milk-based
Bright Beginnings Gentle milk-based
Bright Beginnings Organic
Bright Beginnings milk-based 2
Bright Beginnings NeoCare
Earth’s Best Organic Infant Formula with DHA & ARA
Earth’s Best Organic Soy Infant Formula with DHA & ARA
EleCare®
Enfamil® Premium with Triple Health Guard
Enfamil® Premium Next Step
Enfamil® ProSobee®
Enfamil® RestFull
Enfamil AR®
Enfamil® Gentlease®
Enfamil® Gentlease® Next Step
Enfamil® Enfacare
Enfamil® Premature
Enfamil® Premium Vanilla or Chocolate
Enfamil® Soy Next Step
Gerber® Good Start® Gentle Plus
Gerber® Good Start® Gentle Plus 2
Gerber® Good Start® Protect Plus
Gerber® Good Start® Protect Plus 2
Gerber® Good Start® Soy Plus
Gerber® Good Start® Soy Plus 2
Nutramigen® with Enflora LGG
Nutramigen® AA
Pregestimil®
Similac® Advance® EarlyShield
Similac Isomil® Advance®
Similac Isomil® DF
Similac® Organic
Similac® Go & Grow
Similac® Go & Grow EarlyShield
Similac® Sensitive
Similac® Sensitive R.S.
Similac® Alimentum®
Similac® Neosure®
Store brand Milk based (like Member’s Mark, Kirkland, Target up & up)
Store brand Gentle or partially broken down whey protein formula
(like Member’s Mark or Target up & up)
Store brand Soy based (like Target up & up)
Store brand Next step (like Target up & up)
Store brand Lacto sensitive (like Target up & up)
Store brand Prebiotic (like Target up & up)
Other ________________________________________________________________________

QUE
(EHPBHIPBS),
MDES 3.1 MDES
Summer
2012,
V3.0 2012,

QUE12-Month
12-MonthSAQ
Mother
SAQ (EHPBHIPBS),
3.1
Summer
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18. Was the formula ready-to-feed, liquid concentrate, powder from a can that makes a single serving, or
powder from single serving packets? Select all of the formulas you feed your baby.





Ready-to-feed
Liquid concentrate
Powder from a can that makes more than one bottle
Powder from single serving packets

If your baby was ONLY fed ready-to-feed formula, go to Question 21.
Otherwise, go to Question 19.
19. During the past 7 days, what types of water have you and others who care for your baby used for mixing
your baby’s formula? Select all of the types of water you have used for mixing your baby’s formula. If you
have used any other type of water, please list the water type on the line below.





Tap water from the cold faucet
Warm tap water from the hot faucet
Bottled water
Other type of water used _____________________________________________

20. Was the water used to mix the formula boiled?
 Yes
 No
21. In the past 7 days, on the average, how many ounces of formula did your baby drink at each feeding?


 Ounces.

In the past 7 days, about how often did your baby drink from each of the following types of bottles and cups?
22. Plastic baby bottle with disposable bottle liner.
 Never
 Sometimes
 Most of the time
 Always
23. Plastic baby bottle without disposable liner.
 Never
 Sometimes
 Most of the time
 Always
24. Other plastic bottle (for example, a water bottle).
 Never
 Sometimes
 Most of the time
 Always
25. Glass baby bottle.
 Never
 Sometimes
 Most of the time
 Always
QUE
(EHPBHIPBS),
MDES 3.1 MDES
Summer
2012,
V3.0 2012,

QUE12-Month
12-MonthSAQ
Mother
SAQ (EHPBHIPBS),
3.1
Summer
V3.0

55

26. Plastic “no spill” cup.
 Never
 Sometimes
 Most of the time
 Always
27. Has your baby used a pacifier in the past 7 days?
 Yes
 No
28. Has your baby ever been fed cow’s milk that was not sold especially for babies? (This includes whole, lowfat, nonfat, or chocolate milk.)
 Yes
 No → Go to Question 30
29. How old was your baby when he/she was first fed cow’s milk that was not sold especially for babies?

.
 Age in months.
30. How old was your baby when he/she was first fed cereal, including baby cereal, on a daily basis?
 less than 1 month old
 1 to 2 months old
 3 to 4 months old
 5 to 6 months old
 More than 6 months old
 Not applicable (never fed cereal)
31. How old was your baby when he/she was first fed pureed baby food on a daily basis? Please include
commercial (store bought) and homemade baby food.
 less than 1 month old
 1 to 2 months old
 3 to 4 months old
 5 to 6 months old
 More than 6 months old
 Not applicable (never fed pureed baby food)
32. How old was your baby when he/she was first fed table food such as eggs, cheese, or potatoes on a daily
basis?
 less than 1 month old
 1 to 2 months old
 3 to 4 months old
 5 to 6 months old
 More than 6 months old
 Not applicable (never fed table food)
33. Which of the following supplements was your child given at least 3 days a week during the past 2 weeks?
Select all of the supplements your child has taken during the past 2 weeks for at least 3 days a week. If
your child has taken any other vitamins or supplements, please list them on the line beside “Other vitamins
or supplements.”






Fluoride
Iron
Vitamin D
Other vitamins or supplements _____________________________________________
Not applicable (child not given supplements)

QUE
(EHPBHIPBS),
MDES 3.1 MDES
Summer
2012,
V3.0 2012,

QUE12-Month
12-MonthSAQ
Mother
SAQ (EHPBHIPBS),
3.1
Summer
V3.0

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34. Was your baby given any herbal or botanical preparations or any kind of tea or home remedy in the past 7
days? Do not count preparations put on the baby’s skin or anything the baby may have gotten from breast
milk after you took an herbal or botanical preparation.
 Yes
 No

Thank you for participating in the National Children’s Study and for taking the time to complete
this survey.

QUE
(EHPBHIPBS),
MDES 3.1 Summer
2012,
V3.0 2012,

QUE12-Month
12-MonthSAQ
Mother
SAQ (EHPBHIPBS),
MDES 3.1
Summer
V3.0

77

For Office Use Only:

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QUE
(EHPBHIPBS),
MDES 3.1 MDES
Summer
2012,
V3.0 2012,

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12-MonthSAQ
Mother
SAQ (EHPBHIPBS),
3.1
Summer
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