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Your Environment. Your Health.

Body Weight & Puberty Study

Open for Recruitment

Study Background

Body Weight & Puberty Study

Open for Recruitment

Over the past decade, there has been an alarming trend toward earlier breast development in girls. There have been some recent reports that overweight girls are developing breast tissue earlier than normal weight girls. However, questions remain about the validity of reports of early puberty among overweight girls due to the difficulty in distinguishing fatty tissue from breast tissue in this population.

Additional Information

In previous studies, doctors decided whether or not a girl had breast tissue by feeling the chest. This can be a problem in overweight girls because fatty tissue in the chest can often feel like breast tissue. We think that by using breast ultrasound, we can do a better job of telling whether or not an overweight girl has breast tissue. This will help us understand if overweight girls are truly entering puberty before normal weight girls.

The study consists of 2 parts, though the second part is optional and would occur within 6 months of the first. Each part requires 2 study visits, one to the NIEHS Clinical Research Unit (CRU) in Research Triangle Park, North Carolina and one to a nearby Wake Radiology center. Study procedures include a physical exam, blood and urine tests, DXA (for body composition), hand x-ray (for bone age), and breast and transabdominal (pelvic) ultrasounds.

All girls who join the study will be compensated for their time and travel costs. Parents or legal guardians must give permission and come with his/her daughter to all study visits.

For more information on this study, please visit the Clinical Trials Study page.

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Please visit NIEHS Syndication to get started.

Eligibility

Girls may be eligible for this study if they meet the following criteria:

  • 8-14 years old
  • Healthy (feeling well and can perform normal activities)
  • Some breast development
  • Have not started their first period

What will participants do?

  • Participate in 2-4 study visits within a 6 month time frame to the NIEHS Clinical Research Unit (CRU) and a nearby Wake Radiology center.
  • The following procedures will take place at the NIEHS CRU during the first visit, which is expected to last a total of 1-1.5 hours:
    • Physical Exam
    • Breast Ultrasound
    • Urine Test
    • Blood Draw
  • The following procedures will take place at a nearby Wake Radiology Center during the second visit, which is expected to last a total of 1-1.5 hours:
    • Pelvic Ultrasound
    • DXA Scan (to measure body composition)
    • Hand X-ray
  • We will invite participants back after 6 months to repeat all of the study procedures for the optional second part of the study, if they choose to do so.
  • Participants are compensated for their time and travel costs.
  • Parents/Legal Guardians must give permission for their daughter to participate.
  • A parent/legal guardian must always remain at the study site throughout the duration of the study visit.

Why Participate?

  • Children learn from a very young age the concept of altruism – they find that helping others by volunteering and contributing to science is a very rewarding experience.
  • Girls have many questions about their growth. During this experience they will learn about their reproductive hormones, pubertal development, and body composition.
  • Having access to state-of-the-art pediatric medicine. This is an opportunity for a comprehensive physical exam that may benefit some children that face barriers to healthcare.

Study Location

All study visits occur at the NIEHS Clinical Research Unit located in Research Triangle Park, North Carolina and at select nearby Wake Radiology centers.

Protocol Number: 16-E-0006

Enrollment and Contact Information

For more information and to enroll in this study, please contact Demitrice Magee at 919-541-4973 or at Demitrice Magee.

Principal Investigator

Natalie Shaw
Natalie D. Shaw, M.D., MMSc.
Principal Investigator
Tel 919-541-7798
natalie.shaw@nih.gov
P.O. Box 12233
Mail Drop A2-03
Durham, N.C. 27709