FUS IFPS II Revised Appendices- 02-03-12

Follow Up Study IFPS II

List of Appendices

Page

Appendix A: List of contact points with the samples and materials 2

Appendix B: Pre-notification letters 3

Appendix C: Introductory letters for first questionnaire mailing 9

Appendix D: Questionnaire (Separate file)

Appendix E: Demographic questionnaire 16

Appendix F: Post card reminders 19

Appendix G: Introduction letters for second questionnaire mailing 22

Appendix H: Introductions for the telephone interview 28

Appendix I: Debriefing questionnaire for pilot study 32

Appendix A

FOLLOW UP STUDY IFPS II

Contact Points for all Samples

Contact Point	Mail panel member	Internet panel member	Non-panel member
Pilot
Pilot pre-notification letter	P01-M	P01-I
Pilot letter and informed consent 1st mailing	P02-M	P02-I
Pilot post card reminder	P03-M	P03-I
Pilot letter and informed consent 2nd mailing	P04-M	P04-I
Pilot telephone intro qn	P05-M	P05-I
Main Study
Main pre-notification letter (to identify respondents to track)	MS01-M	MS01-I	MS01-NP
Main letter and informed consent 1st mailing	MS02-M	MS02-I	MS02-NP
Main post card reminder	MS03-M	MS03-I	MS03-NP
Main letter and informed consent 2nd mailing	MS04-M	MS04-I	MS04-NP
Main telephone intro qn	MS05-M	MS05-I	MS05-NP

Key for Numbering Scheme:

P = Pilot

M = Mail panel member

I = Internet panel member

MS = Main Study

NP = Non-panel member

Explanation: The main study sample will include current mail and internet panel members and former panel members. Because the incentive structure is different for the mail and internet panel members, a different letter is needed for each of these groups. The panel contact name, Marie Brighton, is the only name under which materials are sent to the panel, but this name is not allowed to be used for people who are not current panel members. Therefore, the letters for former panel members will be signed by the study director at Synovate. For this reason, three versions of each letter in the main study are needed.

The pilot study will not include any non-panel or former panel members. Therefore, only two versions of each contact material are needed.

Appendix B: Pre-notification letters

FOLLOW UP STUDY IFPS II

Pilot Study

Pre-notification letter

Internet panel members

(Note: We will test whether the amount of incentive, the equivalent of $10 or $15, affects the response rate)

Dear Panel Member,

You soon will receive a survey for an important study we’re doing for the Food and Drug Administration. The study is for mothers of young children and asks about the diet and health of one child in your household. Its results will be used to develop programs and policies related to the nutrition of children.

The survey will take up to 30 minutes to complete. You’ll receive xx reward points for your participation in this study. Please know that, as always, we’ll only release results after removing all personally identifiable information.

You should receive this questionnaire within the next two weeks. I hope to hear from you shortly afterward!

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Pilot Study

Pre-notification letter

Mail panel members

Dear Panel Member,

You soon will receive a survey for an important study we’re doing for the Food and Drug Administration. The study is for mothers of young children and asks about the diet and health of one child in your household. Its results will be used to develop programs and policies related to the nutrition of children.

The survey will take up to 30 minutes to complete. You’ll receive $xx in Consumer Cash Coupons for your participation in this study. Please know that, as always, we’ll only release results after removing all personally identifiable information.

You should receive this questionnaire within the next two weeks. I hope to hear from you shortly afterward!

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Pre-notification letter

Internet panel members

Dear Panel Member,

You soon will receive a survey for an important new study we’re doing for the Food and Drug Administration (FDA). Beginning in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that Synovate did for the FDA. The study asked about your pregnancy and, after your baby was born, about infant feeding and care. You gave us critical information for that study. Results have been used to develop nutrition policies for infants and improve maternal and infant health and care.

We’re going to begin a new study to find out more information about you and your child who was born in 2005 or early 2006. The survey will take up to 25 minutes to complete. You’ll receive 10,000 reward points for your participation in this study. Please know that, as always, we’ll only release results after removing all personally identifiable information.

You will receive this questionnaire within the next few weeks. I hope to hear from you shortly afterward.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Pre-notification letter

Mail panel members

Dear Panel Member,

You soon will receive a survey for an important new study we’re doing for the Food and Drug Administration (FDA). Beginning in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that Synovate did for the FDA. The study asked about your pregnancy and, after your baby was born, about infant feeding and care. You gave us critical information for that study. Results have been used to develop nutrition policies for infants and improve maternal and infant health and care.

We’re going to begin a new study to find out more information about you and your child who was born in 2005 or early 2006. The survey will take up to 25 minutes to complete. You’ll receive $10 in Consumer Cash Coupons for your participation in this study. Please know that, as always, we’ll only release results after removing all personally identifiable information.

You will receive this questionnaire within the next few weeks. I hope to hear from you shortly afterward.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Pre-notification letter

Non-panel members

Dear XXX (We will insert the mother’s name)

I realize that you are no longer a member of our Global Opinion Panel. I am contacting you because beginning in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that was sponsored by the Food and Drug Administration (FDA). The study asked about your pregnancy and then about infant feeding and care after your baby was born. You gave us critically important information for that study, and the results have been used to improve maternal and infant health and care and to develop nutrition policies for infants.

We’re going to begin a new study to find out more information about you and your child who was born in 2005 or early 2006, and we are hoping you will participate. The survey will take up to 25 minutes to complete. Your response is extremely important to this study. Only a few mothers were asked to be a part of Project FIRST, and only these mothers will be contacted for the new study. No one else can take your place. You will receive a gift of $10 for your participation in this study. Please know that, as always, we’ll only release results after removing all personally identifiable information.

You will receive this questionnaire within the next few weeks. I hope to hear from you shortly afterward.

Regards,

Valerie DiPaula, Ph.D.

Director, Project FIRST

Synovate

Appendix C: Introductory letter for first questionnaire mailing

FOLLOW UP STUDY IFPS II

Pilot Study

Letter & Informed Consent – 1^st mailing

Internet panel member

Dear Panel Member,

Today, I’m asking mothers of young children for help with an important study for the Food and Drug Administration (FDA). The FDA will use the results of this study about the diet and health of children to develop programs and policies related to child nutrition.

You’ll receive XX reward points for your participation in this study!

This survey will take up to 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

In order to improve our study, we’d like your feedback about this survey. After you complete the questionnaire, please answer the questions found on the back on this letter. Then, you can mail the questionnaire and letter back to me in the postage-paid envelope provided.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

   Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is XXXX. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRB Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Pilot Study

Letter & Informed Consent – 1^st mailing

Mail panel member

Dear Panel Member,

Today, I’m asking mothers of young children for help with an important study for the Food and Drug Administration (FDA). The FDA will use the results of this study about the diet and health of children to develop programs and policies related to child nutrition.

You’ll receive $XX in Consumer Cash Coupons for your participation in this study!

This survey will take up to 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

In order to improve our study, we’d like your feedback about this survey. After you complete the questionnaire, please answer the questions found on the back on this letter. Then, you can mail the questionnaire and letter back to me in the postage-paid envelope provided.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

   Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is XXXX. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRB Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Letter & Informed Consent – 1^st mailing

Internet panel member

FOR THE MOTHER OF THE 6-YEAR-OLD CHILD IN YOUR HOUSEHOLD

I need your help with an important study for the Food and Drug Administration (FDA). You may have received a letter about this study a few weeks ago, as I hoped to alert you that this study would be starting soon.

Recall that in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that asked about your pregnancy and, after your baby was born, about infant feeding and care. You provided critical information during that study. The results have been used to develop nutrition policies for infants and to improve maternal and infant health and care.

The study we’re conducting now needs to find out more information about you and your child who was born in 2005 or early 2006. The FDA will use results from this study to learn more about how infant feeding is related to the diet and health of children. Findings will help the FDA develop programs and policies related to child nutrition.

Your response is extremely important. Only a few mothers were asked to participate in Project FIRST, and only these mothers will be contacted for this new study. No other panel member can take your place.

You’ll receive 10,000 reward points for your participation in this study.

This survey and the form to update your basic information will take about 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

  Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Letter & Informed Consent – 1^st mailing

Mail panel member

FOR THE MOTHER OF THE 6-YEAR-OLD CHILD IN YOUR HOUSEHOLD

I need your help with an important study for the Food and Drug Administration (FDA). You may have received a letter about this study a few weeks ago, as I hoped to alert you that this study would be starting soon.

Recall that in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that asked about your pregnancy and, after your baby was born, about infant feeding and care. You provided critical information during that study. The results have been used to develop nutrition policies for infants and to improve maternal and infant health and care.

The study we’re conducting now needs to find out more information about you and your child who was born in 2005 or early 2006. The FDA will use results from this study to learn more about how infant feeding is related to the diet and health of children. Findings will help the FDA develop programs and policies related to child nutrition.

Your response is extremely important. Only a few mothers were asked to participate in Project FIRST, and only these mothers will be contacted for this new study. No other panel member can take your place.

You’ll receive $10 in Consumer Cash Coupons for your participation in this study.

This survey and the form to update your basic information will take about 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

 Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Letter & Informed Consent – 1^st mailing

Non- panel member

FOR THE MOTHER OF THE 6-YEAR-OLD CHILD IN YOUR HOUSEHOLD

I realize that you are no longer a part of our Global Opinion Panel. Recall that in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that asked about your pregnancy and, after your baby was born, about infant feeding and care. You provided critical information during that study. The results have been used to develop nutrition policies for infants and to improve maternal and infant health and care.

Today I am asking for your help with another important study for the Food and Drug Administration (FDA). You may have received a letter about this study a few weeks ago, as I hoped to alert you that this study would be starting soon.

The study we’re conducting now needs to find out more information about you and your child who was born in 2005 or early 2006. The FDA will use results from this study to learn more about how infant feeding is related to the diet and health of children. Findings will help the FDA develop programs and policies related to child nutrition.

Your response is extremely important. Only a few mothers were asked to participate in Project FIRST, and only these mothers will be contacted for this new study. No one else can take your place.

You’ll receive $10 for your participation in this study.

This survey and the form to update your basic information will take about 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

 Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Valerie DiPaula, Ph.D.

Director, Project FIRST

Synovate

Appendix D: Questionnaire

Separate file because it is legal size

Appendix E: Demographic questionnaire

1. Date of birth Month____day____year____

2. Gender

• Male

• Female

3. Marital Status

• Now Married

• Widowed

• Divorced

• Separated

• Never Married

• Domestic Partnership

4. Highest Level of Education Completed

• Some Grade School

• Grade School

• Some High School

• High School Graduate

• Some College, No Degree (1-3 years)

• Associate Degree in College (2 years)

• Bachelor’s Degree (for example BA, AB, BS)

• Master’s Degree (for example MA, MS, MBA)

• Doctorate (PhD)

• Professional Degree (for example MD, JD)

5. Race

• White

• Black or African American

• Asian

• American Indian or Alaskan Native

• Native Hawaiian or Other Pacific Islander

• Other

6. Are you of Spanish/Hispanic origin?

• No (not Spanish/Hispanic)

• Yes, Mexican, Mexican American, Chicano

• Yes, Puerto Rican

• Yes, Cuban

• Yes, Other Spanish/Hispanic

• Yes, Mestizo Hispanic

7. What is your household’s combined yearly income before taxes? Please include any income from all sources – employment, pensions, social security, etc.

• Under $5,000

• $5,000 to $7,499

• $7,500 to $9,999

• $10,000 to $12,499

• $12,500 to $14,999

• $15,000 to $17,499

• $17,500 to $19,999

• $20,000 to $22,499

• $22,500 to $24,999

• $25,000 to $27,499

• $27,500 to $29,999

• $30,000 to $32,499

• $32,500 to $34,999

• $35,000 to $39,999

• $40,000 to $44,999

• $45,000 to $49,999

• $50,000 to $59,999

• $60,000 to $74,999

• $75,000 to $84,999

• $85,000 to $99,999

• $100,000 to $124,999

• $125,000 to $149,999

• $150,000 to $174,999

• $175,000 to $199,999

• $200,000 to $249,999

• $250,000 to $299,999

• $300,000 and over

8. COUNTING YOURSELF, how many people currently live in your household? Include all other members that live in your household for at least 9 months of the year.

• Enter Number ______

9. What is your employment status?

• Work for someone else full time

• Temporarily unemployed

• Self-employed

• Work for someone else part time

• Retired and not employed

• Full-time homemaker

9. What is your occupation?

• Professional

• Executive, administrative, or managerial

• Administrative support, including clerical

• Sales

• Precision production, craft, and repair

• Operator, fabricator, and laborer

• Technician and related support

• Farming, forestry, and fishing

• Service

• Not employed

Appendix F: Post card reminders

FOLLOW UP STUDY IFPS II

Pilot Study

Post card reminder

Internet panel member

Dear Panel Member,

I recently sent you a survey for a study we’re conducting with the Food and Drug Administration (FDA) about children’s diet and health.  If you already completed and mailed the questionnaire, please accept my thanks.  If you haven’t mailed it back, it’s not too late! We appreciate your participation and value your time.

 

If you need a new copy of the FDA questionnaire, please call 1-800-745-4267.

 

Remember that you’ll receive xx reward points for your participation in this study!

 

Regards,

Marie Brighton

Panel Director

FOLLOW UP STUDY IFPS II

Pilot Study

Post card reminder

Mail panel member

Dear Panel Member,

I recently sent you a survey for a study we’re conducting with the Food and Drug Administration (FDA) about children’s diet and health.  If you already completed and mailed the questionnaire, please accept my thanks.  If you haven’t mailed it back, it’s not too late! We appreciate your participation and value your time.

 

If you need a new copy of the FDA questionnaire, please call 1-800-745-4267.

 

Remember that you’ll receive $xx in Consumer Cash Coupons for your participation in this study!

 

Regards,

Marie Brighton

Panel Director

FOLLOW UP STUDY IFPS II

Main Study

Post card reminder

Internet panel member

For the mother of the 6-year-old child in the household

I recently sent you a survey for a study we’re conducting with the Food and Drug Administration (FDA) about children’s diet and health.  If you already completed and mailed the questionnaire, please accept my thanks.  If you haven’t mailed it back, it’s not too late! We appreciate your participation and value your time.

 

If you need a new copy of the FDA questionnaire, please call 1-800-745-4267.

 

Remember that you’ll receive 10,000 reward points for your participation in this study!

 

Regards,

Marie Brighton

Panel Director

FOLLOW UP STUDY IFPS II

Main Study

Post card reminder

Mail panel member

For the mother of the 6-year-old child in the household

I recently sent you a survey for a study we’re conducting with the Food and Drug Administration (FDA) about children’s diet and health.  If you already completed and mailed the questionnaire, please accept my thanks.  If you haven’t mailed it back, it’s not too late! We appreciate your participation and value your time.

 

If you need a new copy of the FDA questionnaire, please call 1-800-745-4267.

 

Remember that you’ll receive $10 in Consumer Cash Coupons for your participation in this study!

 

Regards,

Marie Brighton

Panel Director

FOLLOW UP STUDY IFPS II

Main Study

Post card reminder

Non-panel members

For the mother of the 6-year-old child in the household

 

 I recently sent you a survey for a study we’re conducting with the Food and Drug Administration (FDA) about children’s diet and health.  If you already completed and mailed the questionnaire, please accept my thanks.  If you haven’t mailed it back, it’s not too late! We appreciate your participation and value your time.

 

If you need a new copy of the FDA questionnaire, please call 1-800-745-4267.

 

Remember that you’ll receive $10 for your participation in this study!

 

Regards,

Valerie DiPaula, Ph.D.

Director, Project FIRST

Synovate

Appendix G: Introduction letter for second questionnaire mailing

FOLLOW UP STUDY IFPS II

Pilot Study

Letter & Informed Consent – 2^nd mailing

Internet panel member

Dear Panel Member,

A few weeks ago, I asked mothers of young children for help with an important study for the Food and Drug Administration (FDA). I sent you a questionnaire regarding this study and asked for your participation. If you have already completed and mailed it, I want to thank you for your time. If you didn’t complete the questionnaire and need another one, I have enclosed a copy.

Your response is extremely important to this study. The FDA will use the results of this study about the diet and health of children to develop programs and policies related to the nutrition of children.

You’ll receive XX reward points for your participation in this study.

This survey will take up to 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

In order to improve our study, we’d like your feedback about this survey. After you complete the questionnaire, please answer the questions found on the back on this letter. Then, you can mail the questionnaire and letter back to me in the postage-paid envelope provided.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

   Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is XXXX. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRB Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Pilot Study

Letter & Informed Consent – 2^nd mailing

Mail panel member

Dear Panel Member,

A few weeks ago, I asked mothers of young children for help with an important study for the Food and Drug Administration (FDA). I sent you a questionnaire regarding this study and asked for your participation. If you have already completed and mailed it, I want to thank you for your time. If you didn’t complete the questionnaire and need another one, I have enclosed a copy.

Your response is extremely important to this study. The FDA will use the results of this study about the diet and health of children to develop programs and policies related to the nutrition of children.

You’ll receive $XX in Consumer Cash Coupons for your participation in this study.

This survey will take up to 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

In order to improve our study, we’d like your feedback about this survey. After you complete the questionnaire, please answer the questions found on the back on this letter. Then, you can mail the questionnaire and letter back to me in the postage-paid envelope provided.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

   Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is XXXX. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRB Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Letter & Informed Consent – 2^nd mailing

Internet panel member

For the mother of the 6-year-old child in the household

About a month ago, I sent you a questionnaire for a new study we’re doing with the Food and Drug Administration (FDA). If you already completed and mailed it, I want to thank you for your time. If you didn’t and need another copy, I have enclosed one here.

Recall that beginning in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that asked about your pregnancy and, after your baby was born, about infant feeding and care. You provided critical information during that study. The results have been used to develop nutrition policies for infants and to improve maternal and infant health and care.

This current study is aimed at finding out more information about you and about your child who was born in 2005 or early 2006. FDA will use results from this study to learn more about how infant feeding is related to the diet and health of children. Findings will help the FDA develop programs and policies related to child nutrition.

Your response is extremely important. Only a few mothers were asked to participate in Project FIRST, and only these mothers will be contacted for this new study. No other panel member can take your place.

You’ll receive 10,000 reward points for your participation in this study.

This survey and the form to update your basic information will take about 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

 Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Letter & Informed Consent – 2^nd mailing

Mail panel member

For the mother of the 6-year-old child in the household

About a month ago, I sent you a questionnaire for a new study we’re doing with the Food and Drug Administration (FDA). If you already completed and mailed it, I want to thank you for your time. If you didn’t and need another copy, I have enclosed one here.

Recall that beginning in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that asked about your pregnancy and, after your baby was born, about infant feeding and care. You provided critical information during that study. The results have been used to develop nutrition policies for infants and to improve maternal and infant health and care.

This current study is aimed at finding out more information about you and about your child who was born in 2005 or early 2006. FDA will use results from this study to learn more about how infant feeding is related to the diet and health of children. Findings will help the FDA develop programs and policies related to child nutrition.

Your response is extremely important. Only a few mothers were asked to participate in Project FIRST, and only these mothers will be contacted for this new study. No other panel member can take your place.

You’ll receive $10 in Consumer Cash Coupons for your participation in this study.

This survey and the form to update your basic information will take about 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

 Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Marie Brighton

FOLLOW UP STUDY IFPS II

Main Study

Letter & Informed Consent – 2^nd mailing

Non-panel member

For the mother of the 6-year-old child in the household

About a month ago, I sent you a questionnaire for a new study we’re doing with the Food and Drug Administration (FDA). If you already completed and mailed it, I want to thank you for your time. If you didn’t and need another copy, I have enclosed one here.

Recall that beginning in 2005 or early 2006, you participated in a study called Project FIRST (Feeding Infants Research STudy) that asked about your pregnancy and, after your baby was born, about infant feeding and care. You provided critical information during that study. The results have been used to develop nutrition policies for infants and to improve maternal and infant health and care.

This current study is aimed at finding out more information about you and about your child who was born in 2005 or early 2006. FDA will use results from this study to learn more about how infant feeding is related to the diet and health of children. Findings will help the FDA develop programs and policies related to child nutrition.

Your response is extremely important. Only a few mothers were asked to participate in Project FIRST, and only these mothers will be contacted for this new study. No one else can take your place.

You’ll receive $10 for your participation in this study.

This survey and the form to update your basic information will take about 30 minutes to complete. Your participation is voluntary, and we will only release results after removing all personally identifiable information. This study is authorized by the U.S. government and has been reviewed by the FDA’s research committee.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

 Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Regards,

Valerie DiPaula, Ph.D.

Director, Project FIRST

Synovate

Appendix H: Introduction for the telephone interview

FOLLOW UP STUDY IFPS II

Pilot Study

Introductions for telephone questionnaires

Internet panel members

1. When Panel Member is qualified respondent:

Hi, my name is______ and I’m calling on behalf of Marie Brighton of the Synovate Global Opinion Panels. May I please speak to (PMs name)?

I’m calling about a study we’re doing for the Food and Drug Administration on the diet and health of young children.

We sent a survey a few weeks ago, but since we haven’t heard from you, we’d like to get your responses over the phone. You’ll receive XXX reward points, just as you would for the written survey. This will only take about 20 minutes. Your participation is voluntary and, as always, we’ll keep the information you provide confidential.

FOLLOW UP STUDY IFPS II

Pilot Study

Introductions for telephone questionnaires

Mail panel members

1. When Panel Member is qualified respondent:

Hi, my name is______ and I’m calling on behalf of Marie Brighton of the Synovate Global Opinion Panels. May I please speak to (PMs name)?

I’m calling about a study we’re doing for the Food and Drug Administration on the diet and health of young children.

We sent a survey a few weeks ago, but since we haven’t heard from you, we’d like to get your responses over the phone. You’ll receive $XX in Consumer Cash Coupons, just as you would for the written survey. This will only take about 20 minutes. Your participation is voluntary and, as always, we’ll keep the information you provide confidential.

Because this survey is being conducted for a Federal agency, we are required to provide the following information:

PUBLIC Disclosure Burden Statement

   Public reporting burden for this collection of information is estimated to average 20 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. The OMB control number for this survey is XXXX. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRB Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Main Study

Introductions for telephone questionnaires

Internet panel members

1. When Panel Member is qualified respondent:

Hi, my name is______ and I’m calling on behalf of Marie Brighton of the Synovate Global Opinion Panels. May I please speak to (PMs name)?

I’m calling about a study we’re doing for the Food and Drug Administration on the diet and health of young children.

We sent a survey a few weeks ago, but since we haven’t heard from you, we’d like to get your responses over the phone. You’ll receive 10,000 reward points, just as you would for the written survey. Your participation is voluntary and, as always, we’ll keep the information you provide confidential.

(IF NECESSARY: The survey will take about 40 minutes.)

(IF NECESSARY:)

Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

FOLLOW UP STUDY IFPS II

Main Study

Introductions for telephone questionnaires

Mail panel members

1. When Panel Member is qualified respondent:

Hi, my name is______ and I’m calling on behalf of Marie Brighton of the Synovate Global Opinion Panels. May I please speak to (PMs name)?

I’m calling about a study we’re doing for the Food and Drug Administration on the diet and health of young children.

We sent a survey a few weeks ago, but since we haven’t heard from you, we’d like to get your responses over the phone. You’ll receive $10 in Consumer Cash Coupons, just as you would for the written survey. Your participation is voluntary and, as always, we’ll keep the information you provide confidential.

(IF NECESSARY: The survey will take about 40 minutes.)

(IF NECESSARY:)

Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

FOLLOW UP STUDY IFPS II

Main Study

Introductions for telephone questionnaires

Non-panel members

Hello, my name is______ and I’m calling on behalf of the Synovate Global Opinion Panels. May I please speak to (mother’s name)?

I’m calling about a study we’re doing for the Food and Drug Administration on the diet and health of young children.

We sent a survey a few weeks ago, but since we haven’t heard from you, we’d like to get your responses over the phone. You’ll receive $10, just as you would for the written survey. Your participation is voluntary and, as always, we’ll keep the information you provide confidential.

(IF NECESSARY: The survey will take about 40 minutes.)

(IF NECESSARY:)

Public reporting burden for this collection of information is estimated to average 30 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. The OMB control number for this survey is 0910-0696. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services, Food and Drug Administration, CFSAN/PRA Comments/HFS-24, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Appendix I: Debriefing questionnaire for pilot study

Please give us your opinions about this survey by completing the questions below. Your suggestions will be used to improve the survey and make it easier for other mothers to complete.

1. About how long did it take for you to complete the survey? Minutes: ___________

2. Do you have a scale for measuring a person’s weight in your home?

Yes  No 

If you do not have a scale, what did you do to give an answer to the question that asked how much your 6-year-old weighs? ___________________________________________________________________________________

___________________________________________________________________________________________

3. Did you find the instructions for measuring your child’s height easy or hard to follow?

Easy  Neither easy nor hard  Hard 

4. Some of the questions ask you about the past 12 months (for example, the number of doctor visits). Was it easy or hard to remember over that period of time?

Easy  Neither easy nor hard  Hard 

5. Is there anything about your situation that makes it hard to answer some of the questions?

Yes  No 

If yes, which questions, or which topics? Why were they hard for you to answer?

___________________________________________________________________________________________________

___________________________________________________________________________________________________

__________________________________________________________________________________________

6. Did you check any written records to answer the questions about child’s height and weight at a doctor’s visit or to answer the questions about number of doctor’s visits or number of infections in the past 12 months?

Yes 

No, but I am certain that I remembered all of them 

No, but I think my answers are close on all of them 

No, and I guessed on some of them or left them blank 

7. Did you have trouble remembering any of the information for only your 6-year old if you have other children?

Yes  No  I have no other children 

8. For the diet and food questions, the physical activity questions, and the questions about watching TV, videos, and playing video games, did you know for the times you are not with your 6-year-old?

Yes for all these questions 

No, but I made an estimate if I didn’t know so I could include the time I am not with my child 

No, and I only gave answers for the times I am with my child if I didn’t know 

9. Did you find any questions to be particularly hard, or did you have any other problems with the questions?

Yes  No 

If yes, could you tell us which questions and what the problem was? For example, you may have had to think of too many things to answer the question; you may not have known the answer without checking records that would be hard to find; the answer you wanted to give may not have been listed; you may have wanted to give more than one answer when we asked for only one; you may have had trouble deciding what we meant; or anything else.

Qu #	Problem

10. Is there anything else you would like to tell us about this survey?

___________________________________________________________________________________________________

___________________________________________________________________________________________________

__________________________________________________________________________________________

31

ICR Follow Up Study January 2012