Investigating the Impact of Obesity on Pubertal Development in Girls

This observational study is looking into whether girls who are overweight or obese start puberty earlier than girls who are a healthy weight. Researchers want to understand if the obesity epidemic is causing earlier breast development in girls. They will use breast ultrasound to better tell the difference between breast tissue and fatty tissue, which can be difficult in overweight girls. This will help them determine if overweight girls are truly entering puberty sooner. The study is enrolling healthy girls between 8 and 14 years old who have some breast development but have not yet had their first period. The main goal is to see how breast development, measured by ultrasound, relates to standard puberty stages over time.

Study design
This is an observational study aiming to enroll 150 participants. It compares pubertal development in obese girls to normal weight girls.
What's involved
Study procedures include blood draws, DXA scans (to measure body composition), hand x-rays (to check bone age), breast and pelvic ultrasounds, and body measurements. These will be measured semiannually.
Compensation
Not stated in the trial record.
Follow-up
Breast development will be measured semiannually, indicating ongoing follow-up during the study.

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NCT02583646

Investigating the Impact of Obesity on Pubertal Development in Girls

Recruiting
Not specifiedAges 8–14Observational
National Institute of Environmental Health Sciences (NIEHS)
~150 participants
Updated 2026-09-01 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the correlation between Tanner breast staging and breast maturation scores using breast ultrasound in girls
Measured over semiannually
Obesity
Puberty
Normal Physiology
1 sites across 1 states
North Carolina1
  • Natalie D Shaw, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Environmental Health Sciences (NIEHS)
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Eligibility criteria

Inclusion

Girls without a chronic medical condition
Normal weight (BMI 5th-85th%) or overweight/obese (BMI \> 85th%)
8-14 years old
Some breast development
Pre-menarchal

Exclusion

Treated with medications that may affect reproductive hormones (e.g. birth control pills).
Pregnancy
  • To determine the correlation between Tanner breast staging and breast maturation scores using breast ultrasound in girlssemiannually

    To test the hypothesis that breast maturation in obese and normal weight girls primarily reflects hypothalamic-pituitary-ovarian activation as opposed to local (breast adipose tissue) estrogen production, we will use linear regression to determine if the relationship between breast maturation and ovarian size, uterine size and bone age (all markers of end organ response to estrogen) differs between the two weight groups (group by ovarian/uterine size/bone age interaction term). The finding of similar regression lines in the two groups would support this hypothesis while an upward shift in the regression line (greater y-intercept, similar slope) in the obese girls would indicate that a given breast maturation stage is achieved at a smaller ovarian/uterine volume and younger bone age in obese girls, suggesting the presence of an additional source of estrogen (adipose tissue) in obese girls.