NCT05740254

Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Obesity
• Time Restricted Feeding
• Time Restricted Eating

Interventions

Type	Name	Description
BEHAVIORAL	Early Time Restricted Eating	Early Time Restricted Eating 7 AM to 3 PM
BEHAVIORAL	Late Time Restricted Eating	Late Time Restricted Eating 12 PM to 8 PM

Timeline

• Start date: 2023-03-27
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2023-02-22
• Last updated: 2024-10-22

Locations

1 site across 1 country: United States