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

NCT07437976 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-05-22

No results posted yet for this 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

...

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

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Natalie D Shaw, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2036-12-23
Completion
2036-12-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07437976 on ClinicalTrials.gov