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NCT07437976 · ClinicalTrials.gov registry record
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Not yet
- Registry status
- 400
- Enrollment target
NCT07437976: Clinical Trial study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT07437976 is a clinical trial that has not yet begun recruiting, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 400 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07437976 has not yet begun recruiting, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- NOT YET RECRUITING
- Registry status
- 400 participants
- Enrollment target
Study Summary
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 ...
Primary Outcome
1\. pubertal markers by questionnaire, physical exam (testicular volume, Tanner breast staging), and 2. ultrasound (breast morphological stage).
Interventions
- BEHAVIORAL Weight loss intervention
- BEHAVIORAL No Weight loss intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2036-12-23 |
What is known before NCT07437976 opens enrollment
NCT07437976 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Weight loss intervention is the first listed.
NCT07437976 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07437976 about?
NCT07437976 is a clinical study titled "A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity". 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 ...
What is the current status of trial NCT07437976?
This trial is currently not yet recruiting. The enrollment target is 400 participants. The study started on 2026-07-15. Estimated completion is 2036-12-23.
What interventions are being tested in trial NCT07437976?
The interventions under investigation include: Weight loss intervention (BEHAVIORAL), No Weight loss intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT07437976?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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