Obesity / No Weight loss intervention / Weight loss intervention · Observational Study

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

ClinicalTrials.gov · August 5, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned prospective observational natural history study that will follow children with obesity and normal-weight controls from ages 5–7 to 12 years to identify genetic, hormonal, dietary, and environmental predictors of pubertal timing. No results have been reported in this registry record; the study is not yet recruiting.

What was studied

Observational. Obesity; age from 5 Years; to 12 Years. Intervention: Normal weight children; Obese weight children. Compared with: Normal-weight children serve as comparison group for children with obesity.. n = 400. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned observational natural history study with no results yet reported; it describes the design and methods only.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: To identify predictors of pubertal timing in 5-12-year-old children with obesity (assessed at 1. Every 6 months2. Every 6 - 12 months, investigator discretion)

DesignObservational

PopulationObesity; age from 5 Years; to 12 Years

Sample size400

InterventionNormal weight children; Obese weight children

ComparatorNormal-weight children serve as comparison group for children with obesity.

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size400

Age at enrollment5 to 7 years

Follow-up durationUntil age 12

Primary outcome measurePredictors of pubertal timing in children with obesity

Visit frequencyEvery 6 months

Caveats

This is a registry record only; no results, effect sizes, or outcome data are reported.
Study recruitment has not yet begun (NOT_YET_RECRUITING status).
Specific enrollment sites and geographic locations not specified in registry record.
No published peer-reviewed results are available to assess study quality or findings.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational natural history study with prospective follow-up; no randomization or intervention control.

Directness

moderate

Directly addresses pubertal timing predictors in children with obesity; comparator group of normal weight included.

Consistency

insufficient

Single study; no prior results reported in registry record to assess consistency.

Risk of bias

insufficient

Registry record does not describe allocation concealment, blinding, or methods to reduce bias.

Sample adequacy

moderate

Planned enrollment 400 participants; adequate for observational study but study is not yet recruiting.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07437976). This is a study registration, not published results. Lead sponsor: National Institute of Environmental Health Sciences (NIEHS). Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Obesity. Interventions: BEHAVIORAL: Weight loss intervention; BEHAVIORAL: No Weight loss intervention. Primary outcome measures: To identify predictors of pubertal timing in 5-12-year-old children with obesity , 1. Every 6 months2. Every 6 - 12 months, investigator discretion. Brief 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 ...

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityNational Institute of Environmental Health Sciences (NIEHS)No Weight loss interventionNCT07437976Weight loss intervention