Actively Recruiting

Age: 8Years - 14Years
FEMALE
Healthy Volunteers
ID02583646

Investigating the Impact of Obesity on Pubertal Development in Girls

Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-06-08

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether overweight girls enter puberty earlier than normal weight girls. This study focuses on girls aged 8 to 14 years who have some breast development but have not yet started their first menstrual period. The study aims to better distinguish true breast tissue from fatty tissue using breast ultrasound and other tests, helping to understand if overweight girls truly experience earlier puberty compared to normal weight peers. Participants will undergo various assessments including a physical exam focusing on breast and genital development, breast ultrasound to image breast tissue, pelvic ultrasound to view the ovaries, and urine and blood tests. They will also receive a special x-ray called DXA to measure body fat and a hand x-ray to assess bone maturity. Most girls will have one visit, but they may choose to have multiple visits within four weeks, and some may be asked to return six months later for repeat tests. During the study visits, researchers will collect detailed measurements of pubertal development and body composition. They will use these data to correlate clinical breast staging with ultrasound findings and evaluate hormonal factors related to obesity and puberty. The study includes monitoring bone age, body fat, and reproductive organ development. Participation may last several months if follow-up visits are needed, providing thorough assessment of pubertal timing and progression.

CONDITIONS

Brief 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 greater than 85th percentile)
  • Between 8 and 14 years old
  • Have some breast development
  • Have not started their first menstrual period
Not Eligible

You will not qualify if you...

  • Taking medications that may affect reproductive hormones, such as birth control pills
  • Currently pregnant
  • Final eligibility may be determined by the principal investigator to avoid unnecessary procedures or visits

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 6 years with semiannual assessments

Participants undergo assessments to evaluate pubertal development using blood draws, ultrasounds, x-rays, and body composition measurements.

Visits every 6 months

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

N

Natalie D Shaw, M.D.

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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Published Research Related To This Trial

Navigating the recent articles on girls' puberty in Pediatrics: what do we know and where do we go from here?

Marcia E Herman-Giddens, Paul B Kaplowitz, Richard Wasserman

https://pubmed.ncbi.nlm.nih.gov/15060243