[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05740254":3,"trial-entities:NCT05740254":98,"trial-summary:NCT05740254":101},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":47,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":79,"locations":82,"central_contacts":91,"overall_officials":92,"references":96,"see_also_links":97},"NCT05740254","CHLA-22-00395","Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)","COMPLETED","2026-06-01","2026-08","2026-08-31","2023-03-27","Children's Hospital Los Angeles","OTHER",true,"Determine the effectiveness of how limiting the time you eat within an early or late eating window and fasting for remainder of the day will impact weight loss and body mass index (BMI).","In adults, there is growing evidence that early TRE is more effective in improving metabolic outcomes than other forms of TRE, however it is unclear whether adolescents will be able to adhere to such recommendations. Hence, in the present study we propose a 24-week, 2-arm, parallel randomized pilot trial in 100 adolescents (age 13-18 years, all gender expressions, anticipate 65% Latino) with obesity, to test the preliminary efficacy of early vs. late TRE on glycemic profiles, weight loss, and body composition. We hypothesize that, among adolescents who can adhere to the meal timing recommendations, early TRE will result in greater improvement in metabolic endpoints than late TRE. We will test the hypothesis with 3 specific aims: Aim 1: Test the effect of early vs. late TRE on glycemic profiles and β-cell function. Aim 2: Test the effect of early vs. late TRE on obesity and body composition, and cardiometabolic risk factors. Aim 3: Test the effect of early vs. late TRE on exploratory outcomes including sleep, physical activity, and dietary intake to explore how meal timing may influence occurrence, timing, and distribution of sleep and movement as well as dietary intake and caloric distribution. This study is the first study evaluating the effectiveness of early vs. late TRE in adolescents with obesity at risk for diabetes.",[18,19,20],"Pediatric Obesity","Time Restricted Feeding","Time Restricted Eating",[22,23,24],"Obesity","Intermitted-fasting","Time Limited Eating","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},94,"ACTUAL",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Early Time Restricted Eating","Early Time Restricted Eating 7 AM to 3 PM",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Late Time Restricted Eating","Late Time Restricted Eating 12 PM to 8 PM",[39],[43],{"measure":44,"description":45,"timeFrame":46},"Mean change in weight in excess of the 95th percentile at week 24 compared to baseline","Change in weight in excess of the 95th percentile","week 24",[48,51,54,57,60],{"measure":49,"description":50,"timeFrame":46},"Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline","Change in total body fat mass measured on DEXA scan",{"measure":52,"description":53,"timeFrame":46},"Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline","%TIR captured on CGM",{"measure":55,"description":56,"timeFrame":46},"Mean change in hemoglobin A1c at week 24 compared to baseline","HgA1c measured at baseline and week 24",{"measure":58,"description":59,"timeFrame":46},"Mean change in ALT at week 24 compared to baseline","ALT measured at baseline and week 24",{"measure":61,"description":62,"timeFrame":46},"Mean change in systolic and diastolic blood pressure at week 24 compared to baseline","Measured systolic and diastolic blood pressure at baseline and week 24","ALL","12 Years","21 Years",false,{"inclusion":68,"exclusion":72,"raw_text":78},[69,70,71],"12-21 years with obesity (BMI\\>95th percentile)","participant must be willing and able to adhere to the assessments, visit schedules, and eating\u002Ffasting periods","baseline eating window greater than 12 hours.",[73,74,75,76,77],"diagnosis of Prader-Willi Syndrome, brain tumor, or diabetes serious intellectual disability","previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder)","parent\u002Fguardian-reported physical, mental of other inability to participate in the assessments","previous bariatric surgery","current participation in other interventional weight loss studies.","Inclusion Criteria:\n\n* 12-21 years with obesity (BMI\\>95th percentile)\n* participant must be willing and able to adhere to the assessments, visit schedules, and eating\u002Ffasting periods\n* baseline eating window greater than 12 hours.\n\nExclusion Criteria:\n\n* diagnosis of Prader-Willi Syndrome, brain tumor, or diabetes serious intellectual disability\n* previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder)\n* parent\u002Fguardian-reported physical, mental of other inability to participate in the assessments\n* previous bariatric surgery\n* current participation in other interventional weight loss studies.",[80,81],"CHILD","ADULT",[83],{"facility":12,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Los Angeles","California","90027","United States",{"lat":89,"lon":90},34.05223,-118.24368,[],[93],{"name":94,"affiliation":12,"role":95},"Alaina Vidmar, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":100},[22],[],{"nct_id":4,"found":14,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is a 24-week, two-group study where participants are randomly assigned to either the Early or Late Time-Restricted Eating group. It plans to include 120 participants.","completed","Early vs. Late Time-Restricted Eating for Adolescents with Obesity","This study, called EL TREA, is looking at how different eating schedules affect weight and body mass index (BMI) in adolescents (young people aged 12-21) who have obesity. You would be assigned to one of two groups: either eating only between 7 AM and 3 PM (Early Time-Restricted Eating) or eating only between 12 PM and 8 PM (Late Time-Restricted Eating). The main goal is to see which eating schedule leads to a greater change in weight over 24 weeks. To join, you need to be 12-21 years old with obesity (BMI above the 95th percentile for your age and sex) and be willing to follow the eating and fasting times. You cannot have certain medical conditions like Prader-Willi Syndrome or diabetes. The study aims to enroll 120 participants, but its current status is unclear.","Participants are followed for 24 weeks to measure changes in weight.",135,"You would need to follow specific eating and fasting periods for 24 weeks and attend study assessments and visits.","Not stated in the trial record.",[],"v2"]