The more we know, the stronger babies will grow!
frequently asked questions
FAQs
Who is conducting the study?
Why are you conducting this study?
Who is eligible to participate in this study?
Can siblings or other children participate in this study?
How is this study related to the original IFED study?
What were the results of the IFED study?
What happens if I/my child doesn’t want to be part of this study?
How long will my child’s participation last?
What will we have to do if my child and I join the study?
Does my child have to provide a urine sample?
Will these questions about puberty make me or my child feel uncomfortable?
What will my child and I receive for taking part in this study?
How do you protect our confidentiality?
What happens if my child and I join the study and then change our minds and no longer want to participate?
Who is conducting the study?
The IFED Puberty Study (IFED-2) is being conducted by scientists at the National Institute of Environmental Health Sciences (NIEHS) at the National Institutes of Health (NIH) in collaboration with scientists at the Children's Hospital of Philadelphia (CHOP), just like the original IFED study. During the infancy study, scientists at the CHOP, working with the NIEHS scientists, collected data at the clinic visits that you and your child attended, with the help of Social & Scientific Systems, Inc., a DLH Holdings Company, a research contractor. For this puberty follow-up study, researchers at DLH, working directly with the NIEHS and CHOP scientists, will collect data from you online, through the mail, and/or by phone. You will not need to attend any in-person clinic visits for this study.
Why are you conducting this study?
We are doing this study to learn how different aspects of infancy, such as what babies eat and how they grow, affect growth, puberty, and hormonal changes during late childhood and adolescence. We hope that this research will help us understand why some children go through puberty earlier than others. The age when puberty starts may be linked to a person’s future health.
Who is eligible to participate in this study?
Children that completed the original IFED study as infants are eligible to participate in this puberty study. The child’s mother or other parent or guardian will be asked to be part of the study by providing additional information about their child’s background, growth, and development.
Can siblings or other children participate in this study?
Only children that were part of the original IFED study as babies can participate in this study. Since we do not have information about siblings or other children when they were infants, we cannot include them in this follow-up study.
How is this study related to the original IFED study?
The goal of the IFED study was to look at how different infant feeding methods may affect infant growth and development. Thanks to the IFED families, researchers collected a lot of information about infant feeding, growth in height and weight, and the development of reproductive organs in infancy through ultrasound measurements (breasts, ovaries and uterus in girls and breasts, testes and penis in boys). IFED researchers also collected blood and urine samples and have measured hormone levels and exposure to chemicals in the environment that may affect growth and development in infants. Very few research studies have collected this much information about babies! If you choose to be part of this puberty study, NIEHS scientists will combine the information that we collected when your child was a baby with the new information that we will collect about puberty to learn more about how exposures during infancy affect growth and development during childhood and adolescence.
What were the results of the IFED study?
After birth, the uterus and vagina of newborn girls still showed the effects of their mother’s hormones that they were exposed to in the womb. In IFED, the girls fed soy formula lost these effects a little more slowly than the other girls. We think this is because there are plant estrogens (female hormones) in soy. No one else has studied these differences in any detail, and we need other studies to tell if they are real. We do know that, in general, there are few if any differences between the way soy-fed girls develop and any other girls develop. We did not see any differences in the way soy-fed boys develop compared with boys fed formula from cow’s milk. Ongoing and future work will examine other exposures that may affect reproductive development after birth using the IFED data.
Data from the IFED study has also been used to learn more about the size of reproductive organs (breasts, ovaries and uterus in girls and breasts, testes and penis in boys) at birth and their growth during infancy. This information can help doctors and researchers understand how babies typically develop and grow.
Learn more on our IFED Publications Page
Please contact the IFED study team if you want to learn more about the findings from the IFED study. We are happy to share copies of published papers using the IFED data with you.
What happens if I/my child doesn’t want to be part of this study?
You do not have to participate in this study. There are no consequences if you choose not to participate. Your participation in the follow-up study does not affect any ongoing or future work being conducted in the original IFED study. You and your child must both agree to participate in this follow-up study.
How long will my child’s participation last?
You and your child will be part of the study for about one year. We may ask you to participate in additional study activities after one year. If so, you may choose not to complete these extra study activities.
What will we have to do if my child and I join the study?
IFED-2 will collect information from children and a participating parent or guardian three times over the course of about a year - when you join the study (enrollment), 6 months after enrollment, and 12 months after enrollment. There are no in-person visits for this study. You will complete your study activities at home, online, by phone, and/or by sending material through the mail, when it is convenient for you and your child. While we hope that you will complete all study activities, you can still participate if you prefer to complete only a short questionnaire at each time point.
Study activities that the participating parent/guardian (usually the mother) will complete:
-
We will ask the participating parent or guardian to fill out a questionnaire online when they join the study about when they went through puberty, their pregnancies and other medical histories, and conditions during the pregnancy with the IFED child.
-
Every 6 months, we will ask the participating parent or guardian to fill out a questionnaire online about their child’s growth and body changes during puberty.
-
When they join the study, we will ask the participating parent or guardian for their permission to contact the child’s pediatrician to collect medical records about their child’s growth and medical history.
Study activities that the participating child will complete:
-
Every 6 months, we will ask your child to fill out a questionnaire online about their body and how it may be changing during puberty.
-
Every 6 months, we will ask your child to measure, with a parent’s help as needed, their height, weight, waist circumference, and hip circumference. We will send you the materials to take these measurements. Alternatively, we may ask the participating parent or guardian to report your child's height and weight only at some study time points.
-
When they join the study and about one year later, we will ask your child to collect four urine samples (one every day for 4 days in a row) and mail them back to us. We will send you a special kit to collect the samples. The completed kits can be mailed back to us directly from your home.
Does my child have to provide a urine sample?
It will be very helpful to us if your child provides a urine sample because we can measure hormones that change during puberty in urine. However, it is up to your child how many urine samples they provide. Your child can choose not to send in a urine sample and participate in the study only by answering questionnaires, if they prefer.
Will these questions about puberty make me or my child feel uncomfortable?
Everyone’s bodies grow and change as they get older, and a lot of changes happen during puberty. We understand that some people feel more comfortable talking about these changes than others. While we do not mean for the questions to be embarrassing, it is possible that you or your child may feel a little embarrassed or uncomfortable answering some of the questions. To protect your child’s privacy, we ask that you and your child complete your questionnaires separately and do not discuss your answers with each other. We also ask that you complete your questionnaires about your child’s development from memory and do not examine your child. You and your child can skip any of the questions that you don't want to answer. You can also contact the study team at any time to ask us any questions.
What will my child and I receive for taking part in this study?
You will receive an electronic scale and a measuring tape that is yours to keep so that your child can measure their height and weight during the study.
You will also receive an electronic gift card (e-gift card) after completing study activities to thank you and your child for your time and effort. You will receive an e-gift card after each study time point (enrollment, 6 months, and 12 months) when you complete the following activities:
| Study Time Point | Study Activities | E-Gift Card Amount |
|---|---|---|
Time Point #1: (When you join the study) |
Questionnaires (parent & child) Body measurements (child) Urine sample collection (child) |
Up to $75 total for the family
|
| Time Point #2: ~6 months after you join the study |
Questionnaires (parent & child) Body measurements (child)
|
$20 for the family if at least one questionnaire is completed |
Time Point #3: ~12 months after you join the study |
Questionnaires (parent & child) Body measurements (child) Urine sample collection (child) |
Up to $60 total for the family
|
| $15 will be added to the third round of study activities (12 months) if at least one activity (any questionnaire or urine card) is completed at each of the 3 study time points | ||
| At each study timepoint, families that complete at least one study activity will be entered into a drawing for an additional $100 giftcard. | ||
If we ask your family to participate in additional study activities after three timepoints, you will receive additional compensation for continuing to participate in the study.
How do you protect our confidentiality?
We will do everything we can to protect the privacy of you and your child. We will remove your name and your child’s name from all study forms and biological samples and use a study identification number instead. This helps us to keep the information that we collect confidential. This information will eventually be used in publications, but your name and/or your child's name will never be used in any publication. All study materials are stored in a secure manner, such as in a locked building and on secure computers.
What happens if my child and I join the study and then change our minds and no longer want to participate?
We hope that everyone who joins the study will choose to participate for a full year. However, you and your child may choose to withdraw from the study at any time. If you choose to stop participating in the study, we will continue to use any data that you have already provided unless you sign a withdrawal form stating that you no longer allow us to use the data that you previously provided.
