ObesityNCT02583646
Investigating the Impact of Obesity on Pubertal Development in Girls
An observational study of Obesity and Puberty, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 years, women only
- Conditions the study is for
- Obesity, Puberty, Normal Physiology
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2015to 9 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- Women only
- No healthy volunteers
- Child
Study population: community sample
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
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.
Read more
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.
Read the detailed description
Over the past decade, there has been an alarming trend toward earlier breast development in girls. The contemporaneous obesity epidemic has led to speculation that obesity may be driving early puberty. However, questions remain about the validity of reports of early puberty among obese girls due to the difficulty in distinguishing fatty tissue from breast tissue in this population. The physiological basis for early puberty among obese girls is also unknown. The current proposal aims to investigate pubertal development in pre-menarchal obese compared with normal weight girls using more robust methods such as breast morphological staging via ultrasonography and intensive reproductive axis phenotyping. Study procedures include blood draws, DXA (for body composition), hand x-ray (for bone age), breast and transabdominal (pelvic) ultrasounds, and anthropometrics.
- Conditions
- Obesity, Puberty, Normal Physiology
- Keywords
- Obesity, Puberty, Ultrasound, Pediatric, Natural History
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the correlation between Tanner breast staging and breast maturation scores using breast ultrasound in girls
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.
Measured: semiannually
Secondary outcomes (1)
To determine the contribution of peripheral aromatization to breast development in obese girls.
Repeated measures from the same subject (visits 1,2, and follow up visits) will provide preliminary data for future studies investigating whether there is a difference in the pace of pubertal development in obese compared with normal weight girls. Squamous cells in the urine sample will be categorized as either superficial (mature; eg indicating estrogen exposure) or other . The primary measure of estrogenization will be the percent of superficial cells (%S), as previously described (Adgent 13, Robine 88). The %S will be compared between normal weight and obese subjects after controlling for breast stage determined by ultrasound. We anticipate that up to 25% of urine specimens may need to be excluded because of insufficient cells or inflammation and this may require an increase in enrollment.
Measured: semiannually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start15 Dec 2015
- Primary completion9 Sep 2027 (estimated)
- Study completion9 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Natalie D Shaw, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583646
- Sponsor's protocol ID
- 160006
- Other IDs
- 16-E-0006
- Status last verified
- 11 Sep 2026
- First submitted
- 21 Oct 2015
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herman-Giddens ME, Kaplowitz PB, Wasserman R. Navigating the recent articles on girls' puberty in Pediatrics: what do we know and where do we go from here? Pediatrics. 2004 Apr;113(4):911-7. doi: 10.1542/peds.113.4.911. No abstract available.
PubMed 15060243Kaplowitz PB. Link between body fat and the timing of puberty. Pediatrics. 2008 Feb;121 Suppl 3:S208-17. doi: 10.1542/peds.2007-1813F.
PubMed 18245513Ahmed ML, Ong KK, Dunger DB. Childhood obesity and the timing of puberty. Trends Endocrinol Metab. 2009 Jul;20(5):237-42. doi: 10.1016/j.tem.2009.02.004. Epub 2009 Jun 21.
PubMed 19541497Malave-Ortiz S, McNeley SAM, Denslow S, Bangma J, Ferguson KK, Fenton SE, Shaw ND. The association between PFAS exposure, menstrual cycle parameters, and reproductive hormones in adolescent girls. J Clin Endocrinol Metab. 2026 Aug 13;111(9):2502-2512. doi: 10.1210/clinem/dgag148.
PubMed 41921573Ortega MT, McGrath JA, Carlson L, Flores Poccia V, Larson G, Douglas C, Sun BZ, Zhao S, Beery B, Vesper HW, Duke L, Botelho JC, Filie AC, Shaw ND. Longitudinal Investigation of Pubertal Milestones and Hormones as a Function of Body Fat in Girls. J Clin Endocrinol Metab. 2021 May 13;106(6):1668-1683. doi: 10.1210/clinem/dgab092.
PubMed 33630047