Actively Recruiting

Age: 8Years - 14Years
FEMALE
Healthy Volunteers
NCT02583646

Investigating the Impact of Obesity on Pubertal Development in Girls

Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-05-07

150

Participants Needed

1

Research Sites

563 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Studies suggest that overweight girls may be developing breast tissue, and therefore starting puberty, earlier than normal weight girls. However, it is hard to distinguish breast tissue from fatty tissue. Researchers think that by using breast ultrasound, among other tests, they can do a better job of telling whether an overweight girl has breast tissue. This will help them understand if overweight girls are truly entering puberty before normal weight girls. Objective: To find out if overweight girls go through puberty earlier than normal weight girls. Eligibility: Healthy girls 8-14 years old who: * Are normal weight or overweight * Have some breast development * Have not started their first period Design: Parents of participants will be screened over the phone. Most participants will have 1 visit. However, they can choose to have multiple visits within 4 weeks. The visit will include: * Physical exam that includes examination of the breasts and genital area * Breast ultrasound: A small hand-held device will be passed back and forth over the chest. It uses sound waves to create a picture of the breast tissue. * Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower belly. It uses sound waves to create a picture of the ovaries. * Urine and blood test * A special x-ray called a DXA to measure the amount of fat in the body: The participant will lie still on a table while the x-ray takes pictures of the body. X-ray of the hand: The picture will tell researchers how mature the participant s bones are. Participants may be asked to come back 6 months later to repeat these tests.

CONDITIONS

Official Title

Investigating the Impact of Obesity on Pubertal Development in Girls

Who Can Participate

Age: 8Years - 14Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Girls without a chronic medical condition
  • Normal weight (BMI 5th-85th percentile) or overweight/obese (BMI above 85th percentile)
  • Aged 8 to 14 years
  • Some breast development present
  • Have not started their first menstrual period (pre-menarchal)
Not Eligible

You will not qualify if you...

  • Taking medications that may affect reproductive hormones (e.g., birth control pills)
  • Currently pregnant
  • Any condition that the principal investigator believes would make participation unsafe or inappropriate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, United States, 27709

Actively Recruiting

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Research Team

N

NIEHS Join A Study Recruitment Group

CONTACT

N

Natalie D Shaw, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Investigating the Impact of Obesity on Pubertal Development in Girls | DecenTrialz