A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

5 years - 12 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

400 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Background:

Obesity affects 1 in 5 children in the United States. Childhood obesity often persists into adolescence and adulthood. It can also raise the risk of sleep apnea, fatty liver disease, and fluid buildup in the brain and lead to early-onset puberty. This natural history study will explore how factors such as genes, hormones, diet, and chemical exposures affect puberty in children with obesity.

Objective:

To learn which factors predict the early start of puberty in children with obesity vs those of normal weight.

Eligibility:

Children aged 5 to 7 years with obesity or of normal weight.

Design:

Participants will have clinic visits every 6 months until they reach age 12.

Each clinic visit will include these tests and procedures:

A physical exam.

Collection of blood, urine, and saliva samples. Some samples will be used for genetic tests.

Questions about medical history and medications and supplements.

A questionnaire about their physical activity over the previous week.

A silicone wrist band. Participants will wear a soft wristband for a week prior to each visit. It will tell researchers what chemicals the children were exposed to during that time.

Breast ultrasound, for girls. A gel will be applied, and a wand will be pressed against the skin. The wand uses sound waves to see the tissue inside the breast.

DXA whole body scan. Once a year, participants will have a DXA (dual energy X-ray absorptiometry) scan. This scan measures the amount of bone, muscle, and fat in the body.

Optional food diary. Parents may record everything the participant eats for two 24-hour periods

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Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records
2. Male or female, aged 5 to 7 years at the screening visit
3. Normal weight (defined as BMI \> 5th percentile and \<85th percentile for age and sex) or Obese weight (defined as BMI \> 95th percentile for age and sex)
4. Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and/or to sign a written assent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Known diagnosis of syndromic/genetic form of obesity
2. Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)
3. Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator
4. Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator
5. International adoptee (associated with earlier puberty)

Individuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.

Study population

Children from the community and the Obesity Weight Management Clinic within the greater Raleigh, Durham, Chapell Hill North Carolina area.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS)

Study start

Nov 15, 2026 Estimated

Primary completion

Dec 23, 2036 Estimated

Study completion

Dec 23, 2036 Estimated

First posted

Feb 27, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts