Clinical trial
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Opening soon · Not applicable · 1 countries · Registry ID NCT07437976
What this study is about
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 ...
Basic eligibility
Full registry criteria
Treatments and study arms
Weight loss intervention
Pediatric Weight Management Clinic, which utilizes multiple, individualized strategies to effect weight loss (such as nutrition, behavioral therapy, exercise programs)
No Weight loss intervention
No strategies for weight loss
Primary outcomes
1\. pubertal markers by questionnaire, physical exam (testicular volume, Tanner breast staging), and 2. ultrasound (breast morphological stage).
Study locations
1 locations were listed when this page was built. The first 40 are shown.