Recruiting

Observational Study

Sponsor:

National Institute of Environmental Health Sciences (NIEHS)

Code:

NCT02583646

Conditions

Obesity

Puberty

Normal Physiology

Eligibility Criteria

Sex: Female

Age: 8 - 14

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Obesity

Puberty

Normal Physiology

Study ID

NCT02583646

Start date

Dec 15, 2015

Status verified date

Dec 8, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 8 - 14

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • 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 CRITERIA:

  • Treated with medications that may affect reproductive hormones (e.g. birth control pills).
  • Pregnancy

During the study, the PI s discretion may be used to determine final eligibility. The PI s discretion may be used at any point in the study (pre-screening, clinical/lab assessments, etc.) to ensure participants are not subjected to unnecessary procedures or visits.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

normal weight

Girls age 8-14 below 85% in respect to weight for their age group

overweight

Girls age 8-14 at or above 85% in respect to weight for their age group

Primary outcome measure

  • To determine the correlation between Tanner breast staging and breast maturation scores using breast ultrasound in girls [ Time Frame: semiannually ]

Central Contacts and Locations

Central contacts

NIEHS Join A Study Recruitment Group

(855) 696-4347myniehs@nih.gov

Locations

NIEHS, Research Triangle Park

Recruiting

Research Triangle Park, North Carolina, United States, 27709

Contacts

NIEHS Join A Study Recruitment Group

855-696-4347myniehs@nih.gov

More Information

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Last update posted

Sep 1, 2026

Last verified

Dec 8, 2025

Keywords

  • Obesity
  • Puberty
  • Ultrasound
  • Pediatric
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Environmental Health Sciences (NIEHS) on 2026-09-01.