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NOT YET RECRUITING
NCT07437976

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

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

View on ClinicalTrials.gov

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 ...

Key Details

Gender

All

Age Range

5 Years - 12 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-04-14

Completion Date

2036-12-23

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Weight loss intervention

Pediatric Weight Management Clinic, which utilizes multiple, individualized strategies to effect weight loss (such as nutrition, behavioral therapy, exercise programs)

BEHAVIORAL

No Weight loss intervention

No strategies for weight loss

Locations (1)

National Institute of Environmental Health Sciences Clinical Research Unit

Research Triangle Park, North Carolina, United States