A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
2 other identifiers
observational
400
1 country
1
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 ...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
June 17, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2036
Study Completion
Last participant's last visit for all outcomes
December 23, 2036
June 12, 2026
February 23, 2026
10.5 years
February 26, 2026
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To identify predictors of pubertal timing in 5-12-year-old children with obesity
1\. pubertal markers by questionnaire, physical exam (testicular volume, Tanner breast staging), and 2. ultrasound (breast morphological stage).
1. Every 6 months2. Every 6 - 12 months, investigator discretion
Secondary Outcomes (1)
To determine the effect of obesity on reproductive hormones and adrenarche.
Every 6 months
Study Arms (2)
Normal weight children
BMI \> 5th percentile and \<85th percentile for age and sex
Obese weight children
BMI \> 95th percentile for age and sex
Interventions
Pediatric Weight Management Clinic, which utilizes multiple, individualized strategies to effect weight loss (such as nutrition, behavioral therapy, exercise programs)
No strategies for weight loss
Eligibility Criteria
Children from the community and the Obesity Weight Management Clinic within the greater Raleigh, Durham, Chapell Hill North Carolina area.
You may qualify if:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records
- Male or female, aged 5 to 7 years at the screening visit
- Normal weight (defined as BMI \> 5th percentile and \<85th percentile for age and sex) or Obese weight (defined as BMI \> 95th percentile for age and sex)
- Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and/or to sign a written assent document.
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Known diagnosis of syndromic/genetic form of obesity
- Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)
- Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator
- Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator
- International adoptee (associated with earlier puberty)
- Individuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Environmental Health Sciences Clinical Research Unit
Research Triangle Park, North Carolina, 27709, United States
Related Publications (3)
Li W, Liu Q, Deng X, Chen Y, Liu S, Story M. Association between Obesity and Puberty Timing: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2017 Oct 24;14(10):1266. doi: 10.3390/ijerph14101266.
PMID: 29064384BACKGROUNDOrtega MT, McGrath JA, Carlson L, Flores Poccia V, Larson G, Douglas C, Sun BZ, Zhao S, Beery B, Vesper HW, Duke L, Botelho JC, Filie AC, Shaw ND. Longitudinal Investigation of Pubertal Milestones and Hormones as a Function of Body Fat in Girls. J Clin Endocrinol Metab. 2021 May 13;106(6):1668-1683. doi: 10.1210/clinem/dgab092.
PMID: 33630047BACKGROUNDCarlson L, Flores Poccia V, Sun BZ, Mosley B, Kirste I, Rice A, Sridhar R, Kangarloo T, Vesper HW, Duke L, Botelho JC, Filie AC, Adams JM, Shaw ND. Early breast development in overweight girls: does estrogen made by adipose tissue play a role? Int J Obes (Lond). 2019 Oct;43(10):1978-1987. doi: 10.1038/s41366-019-0446-5. Epub 2019 Aug 28.
PMID: 31462689BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalie D Shaw, M.D.
National Institute of Environmental Health Sciences (NIEHS)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2026
First Posted
February 27, 2026
Study Start (Estimated)
June 17, 2026
Primary Completion (Estimated)
December 23, 2036
Study Completion (Estimated)
December 23, 2036
Last Updated
June 12, 2026
Record last verified: 2026-02-23
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Starting 6 months after publication, aggregated and summarized data would be made available.
- Access Criteria
- Data could be made available for sharing upon request, with requesters securing appropriate IRB approvals, and following establishment of a data transfer agreement. @@@@@@@@@@@@WES/WGS and RNAseq data are planned to be deposited in dbGaP, a controlled access database, at the time of publication for those subjects who consented to deposit data in dbGaP. @@@@@@
Deidentified/coded Individual participant data: Demographics, Clinical Data (medical history, medications, phenotypic data, questionnaire data, physical exam, lab tests), Genomic Data (DNA and RNA sequencing), Exposomic data, and Metabolomic data.