Actively Recruiting
Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
Led by Children's Hospital Los Angeles · Updated on 2024-10-22
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how limiting eating times to an early or late daily window affects weight loss and body mass index (BMI) in adolescents with obesity. This 24-week randomized pilot trial includes 100 adolescents aged 13 to 18 years, aiming to compare early time-restricted eating (7 AM to 3 PM) versus late time-restricted eating (12 PM to 8 PM) and their impact on metabolic health, body composition, and cardiometabolic risk factors. The study also explores how meal timing influences sleep patterns, physical activity, and dietary intake. Participants are randomly assigned to one of two groups: early time-restricted eating or late time-restricted eating. Both groups will follow their assigned eating windows daily for 24 weeks, fasting outside those periods. The study assesses changes in glycemic profiles, beta-cell function, body fat measured by DEXA scans, glucose monitoring, hemoglobin A1c, liver enzymes, and blood pressure. During the study, adolescents will attend scheduled visits and complete assessments on body weight, fat mass, glucose levels, and blood pressure at baseline and week 24. Researchers will monitor adherence to eating and fasting periods, collect data on sleep, physical activity, and dietary intake, and evaluate safety and metabolic outcomes. The total participation duration is 24 weeks, with measurements focused on changes from baseline to study end.
CONDITIONS
Brief Title
Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 12 to 21 years with obesity (BMI greater than 95th percentile)
- Willing and able to follow study assessments, visit schedules, and eating/fasting periods
- Baseline eating window longer than 12 hours
You will not qualify if you...
- Diagnosed with Prader-Willi Syndrome, brain tumor, diabetes, or serious intellectual disability
- Previous diagnosis or symptoms of eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
- Physical, mental, or other inability reported by parent/guardian to participate in assessments
- Previous bariatric surgery
- Currently participating in other interventional weight loss studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants follow either an early or late time-restricted eating schedule to evaluate effects on weight and metabolic health.
Regular visits for assessments during the 24-week period
Trial Site Locations
Total: 1 location
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
Research Team
A
Alaina Vidmar, MD
H
Harvey Peralta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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