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

Part of paid clinical trials in Research Triangle Park, North Carolina.

Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Study ID
NCT07437976
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Weight loss intervention — BEHAVIORAL
    Pediatric Weight Management Clinic, which utilizes multiple, individualized strategies to effect weight loss (such as nutrition, behavioral therapy, exercise programs)
  • No Weight loss intervention — BEHAVIORAL
    No strategies for weight loss

Study Details

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 Dates

Start date
Jun 16, 2026
Status verified
Feb 2026
Primary completion
Dec 23, 2036
Completion
Dec 23, 2036

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Normal weight children
    BMI \> 5th percentile and \<85th percentile for age and sex
  • Arm: Obese weight children
    BMI \> 95th percentile for age and sex

Primary Outcome Measure

To identify predictors of pubertal timing in 5-12-year-old children with obesity [ Time Frame: 1. Every 6 months2. Every 6 - 12 months, investigator discretion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute of Environmental Health Sciences Clinical Research UnitResearch Triangle ParkNorth Carolina27709
Natalie Shaw, M.D.
[email protected]
984-287-3716

Find similar trials in Research Triangle Park, NC

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Institute of Environmental Health Sciences Clinical Research Unit· Research Triangle Park, NC

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