Early vs. Late Time Restricted Eating in Adolescents With Obesity at Risk for Diabetes

Pediatric Obesity Clinical Trial

Official title: Early vs. Late Time Restricted Eating in Adolescents With Obesity at Risk for Diabetes

Status Recruiting

Clinical Trial Summary

Many adolescents find it challenging to adhere to conventional treatment for pediatric obesity because they require daily calorie counting, easy access to fresh food, and the ability to change the home environment. As such, adherence is poor which limits efficacy. One simpler and promising approach is limiting the timing of eating, instead of changing the food quality or quantity. This approach is called, Time-restricted eating (TRE) and involves eating over an 8- to 10-hour eating window and fasting for the remainder of the day.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity
• Time Restricted Eating
• Time Restricted Feeding

• NCT number: NCT05740254
• Study type: Interventional
• Source: Children's Hospital Los Angeles
• Contact: Alaina Vidmar, MD
• Phone: 323-361-4606
• Email: avidmar@chla.usc.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Completion date: January 1, 2027