App_CC.Cross-walk of materials

APPENDIX CC

AGE 3 EXTENSION WIC INFANT AND TODDLER FEEDING PRACTICES STUDY – II

CROSSWALK OF MATERIALS

Crosswalk between materials included and approved in the Base Study that have been revised for the Age 3 Extension.

	Base Study		Age 3 Extension
Appendix	#		#
Consent Form	Y	What Would I Do in the Study? Take Part in Telephone Interviews If you agree to participate in this study we will contact you regularly by phone to interview you. If you are pregnant right now, we’d like to interview you once during your pregnancy. We’ll also interview you by phone up to ten times during your baby’s first two years. Interviews will take place every other month during the first year starting about when your baby is one month old (or starting at three months if your baby is already more than one month old). During your child’s second year we’ll interview you when your child is thirteen months, fifteen months, eighteen months, and twenty-four months old. The interviews will ask you about your background, your household, your experiences in WIC, your health and your child’s health, the choices you make about how and what to feed your baby, your beliefs and advice you’ve gotten about feeding babies and toddlers, and your family’s and child’s behavior and habits. Each interview will take about thirty minutes. Allow Us to Seek Birth Hospital Records We will, with your permission, seek information about your baby’s birth from the hospital where you gave birth. This will include your baby’s health at birth, any complications at birth, and how your baby was fed in the hospital. If Necessary, Allow Us to Seek a Health Professional’s Measures of Child Length and Weight As long as you remain in WIC, we will get information about your child’s length and weight from WIC. But if you stop going to WIC we will ask your permission to get length and weight from either your child’s doctor, or if your child hasn’t seen a doctor, from a study nurse who will make arrangements with you to come measure and weigh your child. What Are the Benefits of Being In This Study? There are no direct benefits to you for taking part in this study. The information collected during the study will help the Food and Nutrition Service understand better how WIC mothers choose to feed their babies and toddlers, and how WIC services help mothers with those choices. They will then use this information to continue to improve WIC services for everyone. To thank you for the time you take to be in this study, we will offer you a prepaid MasterCard with $50 sent by mail within two weeks after you join for this first introduction to the study, and $20 for every interview you complete after that. Who Should I Call if I Have Questions? If you have questions about the study itself and what we are doing, a member of our study team can help you. For those questions, please contact #NAME at XXX-XXX-XXXX. If you have a problem that the study team member couldn’t help you resolve, please call Dr. Gail Harrison at 310-825-3738.	C	What Would I Do in the Study? Take Part in Telephone Interviews If you agree to participate in the extension of this study we will contact you when your child is 2½ years old and 3 years old. The interviews will ask you about your background, your household, your experiences in WIC, your health and your child’s health, the choices you make about how and what to feed your baby, your beliefs and advice you’ve gotten about feeding babies and toddlers, and your family’s and child’s behavior and habits. Each interview will take about thirty minutes. Allow Us to Seek Information on Your Toddler’s Length and Weight If your child is no longer receiving WIC at age 3, we may ask you to return to the WIC office to have your child weighed and measured. If you cannot return to the WIC office, we will, with your permission, seek information about your child’s height and weight from your child’s medical provider. What Are the Benefits of Being In This Study? There are no direct benefits to you for taking part in this study. The information collected during the study will help the FNS understand better how WIC mothers choose to feed their children, and how WIC services help mothers with those choices. They will then use this information to continue to improve WIC services for everyone. To thank you for the time you take to be in this study, we will provide you with a cash incentive of $30 (or $40 if you are using your own cell phone to completed the interview) for the 2½ year-old interview and $40 for the 3 year-old interview (or $50 if you are using your own cell phone), added to your study debit card. We will provide you with a $30 incentive for taking your child to the WIC office to be measured if your child is no longer enrolled in WIC at age 3. Who Should I Call if I Have Questions? If you have questions about the study itself and what we are doing, a member of our study team can help you. For those questions, please contact [STUDY LIAISON] at 888-888-8888. If you have a problem that the study team member couldn’t help you resolve, please call Dr. Nancy Weinfield at 1-800-937-8281, x. 2480.
HIPAA Form	H	If you sign this document, you are giving permission to (1) the hospital or medical facility where you gave birth to your child and (2) your child’s doctor…… The health information that we will use for the Feeding My Baby Study includes both your medical records and your child’s medical records from the hospital stay when you gave birth to your child; and your child’s weight, length, and health status information from your child’s doctor up until your child is two years old. Both the hospital or medical facility where you gave birth, and your child’s doctors are required by law to protect your health information….. The hospital, medical facility, or your child’s doctor may not refuse to treat you because of your decision to sign or not sign this authorization….. By signing this document, you are authorizing the hospital or medical facility where you gave birth, and your child’s doctor to release information on your child’s height and weight to Westat for this research. The permission is only for the study period of November 1, 2012, to April 1, 2016.	V	If you sign this document, you are giving permission to your child’s doctor…… The health information that we will use for the Feeding My Baby Study includes your child’s weight and length from your child’s doctor up until your child is 3 ½ years old. Your child’s doctors are required by law to protect your health information…. Your child’s doctor may not refuse to treat you because of your decision to sign or not sign this authorization….. By signing this document, you are authorizing your child’s doctor to release information on your child’s height and weight to Westat for this research. The permission is only for the study period of May 15, 2013, to December 31, 2018.
24-month follow-up survey	S		D	Removed SD41 – Use of emergency food sources Added (CM1-CM7) Participant Contact Information module (This module is asked at Prenatal, 1-, 3-, 5-, 7-, 9-, 13-, 15-, 18-, and 24- month interview in the Base Study)
State Agency HT/WT Administrative Data request form	BB	This document provides specific information about the data Westat needs to obtain from your WIC administrative files for the Feeding My Baby study. We have already discussed with you in some detail the most efficient way to collect this information in your State, and are prepared to work with you to make the process as simple as possible over the next 3 years. Westat will resend these specifications in an email each time we make a data request. Data Request Periodicity Required Data Elements Data Specifications File Delivery Data Security	O	As you know, specific data are being requested a few times for participants in the Feeding My Baby study. The data elements requested for each woman and infant/child participant enrolled in the study and the time period for the data collection were defined in Appendix B of the original correspondence. This appendix (an appendix to the Addendum to the original correspondence) is for the Age 3 Extension. It defines the additional data collection. Data Request Periodicity - DELETED Data Requested For Participants Enrolled In The Study For Age 3 Extension – REMOVED: Food Package Type Data Specifications - ADDED: more detail on specifications including field length and data type. File Delivery - CHANGED WORDING: to reflect more flexibility in developing procedures and protocols for secure data transfer that fit each State’s needs. Data Security – ADDED: Consent Forms and Data Use Agreements
Confidentiality & disclosure Agreement	TT	--	AA	No change

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