NCT07437976

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: National Institute of Environmental Health Sciences (NIEHS) · NIH
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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 ...

Detailed description

Study Description: This is a longitudinal study to predict pubertal timing in 5-12-year-old girls and boys with obesity. We hypothesize that: 1) Children with obesity with exposure to estrogenic environmental compounds will demonstrate earlier puberty than those without such an exposure. 2) A polygenic risk score (PRS) of alleles that confer risk for voice break in boys will associate with age at Tanner II pubertal development in boys with obesity. 3) A polygenic risk score (PRS) of alleles that confer risk for menarche in girls will associate with age at stage II pubertal development in girls with obesity. 4) Children with obesity who demonstrate a decrease in BMI percentile of \> 5 percentage points will demonstrate later stage II pubertal development than children with no change or an increase in BMI percentile but will demonstrate earlier pubertal development than peers of normal weight. Objectives: * Primary Objective: To identify predictors of pubertal timing in 5-12-year old children with obesity. * Secondary Objectives: To determine the effect of obesity on reproductive hormones and adrenarche. Endpoints: * Primary Endpoint: pubertal markers by questionnaire, physical exam (testicular volume, breast development), and ultrasound (breast morphological stage). Pubertal development will be defined as breast morphological stage B and a testicular volume of 4 cc. * Secondary Endpoints: Tanner pubic hair staging, reproductive hormones (luteinizing hormone (LH), Follicle-stimulating hormone (FSH), estradiol, total testosterone, dehydroepiandrosterone sulfate (DHEAS), androstenedione)

Conditions

• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-22
• Primary completion: 2036-12-23
• Completion: 2036-12-23
• First posted: 2026-02-27
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States