[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05747976":3,"trial-entities:NCT05747976":73,"trial-summary:NCT05747976":78},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":38,"minimum_age":22,"maximum_age":22,"healthy_volunteers":14,"eligibility_criteria":39,"std_ages":45,"locations":49,"central_contacts":66,"overall_officials":70,"references":71,"see_also_links":72},"NCT05747976","H-44596","Genetic Disorders of Obesity Program Database","RECRUITING","2030-12-31","2026-05","2026-05-12","2020-08-30","Baylor College of Medicine","OTHER",false,"This study collects data on children with severe, early-onset obesity.","Children and adolescents who have suffered from severe weight gain prior to 5 years of age and who are seen in the Genetic Disorders of Obesity Program at Texas Children are asked to participate in a prospective, observational study. The investigators collect demographic information, body measurements, medical\u002Ffamily history, as well as other questionnaires. Additionally, genetic information, medical lab results, and responses to treatment options are collected. The goal of the study is to determine if the investigators can better understand which children would benefit from testing and further workup as well as to understand how obesity develops in these children and adolescents.",[18,19],"Obesity, Childhood","Genetic Disease",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},500,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Prevalence of genetic causes of severe, early-onset obesity","We will measure the number of genetic variants identified in clinical testing","through study completion, an average of 10 years",[34],{"measure":35,"description":36,"timeFrame":37},"Change in BMI over time","BMI in kg\u002Fm2 will be documented over time. BMI is calculated using weight and height","through participant completion, an average of 2 years","ALL",{"inclusion":40,"exclusion":43,"raw_text":44},[41,42],"For individuals 2 years and older, BMI \\> 97 percentile","For individuals \\\u003C 2 years old, weight-to-length ratio \\> 95th percentile",[],"Inclusion Criteria:\n\n* For individuals 2 years and older, BMI \\> 97 percentile\n* For individuals \\\u003C 2 years old, weight-to-length ratio \\> 95th percentile\n\nExclusion Criteria:\n\n* No other exclusion criteria",[46,47,48],"CHILD","ADULT","OLDER_ADULT",[50],{"facility":12,"status":7,"city":51,"state":52,"zip":53,"country":54,"contacts":55,"geoPoint":63},"Houston","Texas","77030","United States",[56,60],{"name":57,"role":58,"email":59},"Citrine Elatrash","CONTACT","citrine.elatrash@bcm.edu",{"name":61,"role":62},"Stephanie Sisley, MD","PRINCIPAL_INVESTIGATOR",{"lat":64,"lon":65},29.76328,-95.36327,[67],{"name":61,"role":58,"phone":68,"email":69},"713-798-0391","Sisley.lab@bcm.edu",[],[],[],{"nct_id":4,"conditions":74,"biomarkers":77},[75,76],"Genetic Disorder","Obesity",[],{"nct_id":4,"found":79,"summary":80,"prompt_version":89},true,{"design":81,"status":82,"heading":6,"summary":83,"follow_up":84,"word_count":85,"commitments":86,"compensation":87,"drugs_mentioned":88},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include 500 participants.","completed","This study is creating a database about children and adolescents with severe obesity that started early in life. It's for individuals seen in the Genetic Disorders of Obesity Program at Texas Children's. Researchers will collect information like your child's measurements, medical and family history, and genetic details. They will also look at lab results and how your child responds to treatments. The main goal is to understand how obesity develops in these children and to figure out which children might benefit most from further testing. This study is currently unclear if it's recruiting new participants.","Information will be collected throughout the study completion, which is an average of 10 years.",95,"You would provide demographic information, body measurements, medical\u002Ffamily history, and complete questionnaires. Genetic information, medical lab results, and responses to treatment options will also be collected.","Not stated in the trial record.",[],"v2"]