[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053485":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":60,"collaborators":10,"id":62,"slug":10,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal weight children",null,"BMI \\> 5th percentile and \\\u003C85th percentile for age and sex",[13],"Behavioral: No Weight loss intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Obese weight children","BMI \\> 95th percentile for age and sex",[18,13],"Behavioral: Weight loss intervention",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"BEHAVIORAL","Weight loss intervention","Pediatric Weight Management Clinic, which utilizes multiple, individualized strategies to effect weight loss (such as nutrition, behavioral therapy, exercise programs)",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"No Weight loss intervention","No strategies for weight loss",[9,15],[30],{"name":31,"affiliation":32,"role":33},"Natalie D Shaw, M.D.","National Institute of Environmental Health Sciences (NIEHS)","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"NIEHS Join A Study Recruitment Group","CONTACT","(855) 696-4347","myniehs@nih.gov",{"name":31,"role":37,"phone":41,"phoneExt":10,"email":42},"(984) 287-3716","natalie.shaw@nih.gov",[44],{"facility":45,"status":10,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"National Institute of Environmental Health Sciences Clinical Research Unit","Research Triangle Park","North Carolina","27709","United States",{"type":51,"coordinates":52},"Point",[53,54],-78.86029,35.89709,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":59,"phoneExt":10,"email":42},"Natalie Shaw, M.D.","984-287-3716",{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100053485",false,"NCT07437976","A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records\n2. Male or female, aged 5 to 7 years at the screening visit\n3. Normal weight (defined as BMI \\> 5th percentile and \\\u003C85th percentile for age and sex) or Obese weight (defined as BMI \\> 95th percentile for age and sex)\n4. 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\u002For to sign a written assent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known diagnosis of syndromic\u002Fgenetic form of obesity\n2. 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)\n3. Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator\n4. Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator\n5. International adoptee (associated with earlier puberty)\n\nIndividuals 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.","ALL","5 Years","12 Years",{"count":71,"type":72},400,"ESTIMATED","OBSERVATIONAL","Background:\n\nObesity 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.\n\nObjective:\n\nTo learn which factors predict the early start of puberty in children with obesity vs those of normal weight.\n\nEligibility:\n\nChildren aged 5 to 7 years with obesity or of normal weight.\n\nDesign:\n\nParticipants will have clinic visits every 6 months until they reach age 12.\n\nEach clinic visit will include these tests and procedures:\n\nA physical exam.\n\nCollection of blood, urine, and saliva samples. Some samples will be used for genetic tests.\n\nQuestions about medical history and medications and supplements.\n\nA questionnaire about their physical activity over the previous week.\n\nA 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.\n\nBreast 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.\n\nDXA 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.\n\nOptional food diary. Parents may record everything the participant eats for two 24-hour periods\n\n...",[76],"Obesity",[78,76,79,80,81],"ADRENARCHE","Reproductive Hormones","Puberty","Environmental predictors","NOT_YET_RECRUITING","2026-07-10",{"date":85,"type":86},"2026-07-13","ACTUAL",{"date":88,"type":72},"2026-07-16",{"date":90,"type":72},"2036-12-23",{"name":32,"class":6},1]