NCT07437976Not yet recruiting
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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 ...
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 26 Feb 2026
- Start date
- 9 Nov 2026
- Primary completion date
- 23 Dec 2036
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Diseases
- Obesity
- NCT number
- NCT07437976
What you commit to
- Study type: Observational
- Planned participants: 400
- From 9 Nov 2026 to the primary completion date, 23 Dec 2036
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator
- 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.
Lab values
- Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Known diagnosis of syndromic/genetic form of obesity
Criteria the registry did not label
- INCLUSION CRITERIA:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records
- Male or female, aged 5 to 7 years at the screening visit
- 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)
- 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.
Age in the registry: 5 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Environmental Health Sciences Clinical Research Unit Coordinator of this site? Confirm its status | Research Triangle Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.