Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
- Conditions
- Pediatric ObesityTime Restricted FeedingTime Restricted Eating
- Interventions
- Behavioral: Early Time Restricted EatingBehavioral: Late Time Restricted Eating
- Registration Number
- NCT05740254
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 12-21 years with obesity (BMI>95th percentile)
- participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods
- baseline eating window greater than 12 hours.
- 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/guardian-reported physical, mental of other inability to participate in the assessments
- previous bariatric surgery
- current participation in other interventional weight loss studies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Time Restricted Eating Early Time Restricted Eating early-day TRE (7:00 to 15:00 h) Late Time Restricted Eating Late Time Restricted Eating late TRE (12:00 to 20:00 h)
- Primary Outcome Measures
Name Time Method Mean change in weight in excess of the 95th percentile at week 24 compared to baseline week 24 Change in weight in excess of the 95th percentile
- Secondary Outcome Measures
Name Time Method Mean change in hemoglobin A1c at week 24 compared to baseline week 24 HgA1c measured at baseline and week 24
Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline week 24 Change in total body fat mass measured on DEXA scan
Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline week 24 %TIR captured on CGM
Mean change in systolic and diastolic blood pressure at week 24 compared to baseline week 24 Measured systolic and diastolic blood pressure at baseline and week 24
Mean change in ALT at week 24 compared to baseline week 24 ALT measured at baseline and week 24
Trial Locations
- Locations (1)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States