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

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Time Restricted Eating; Time Restricted Feeding; Pediatric Obesity

Treatments: Behavioral: Late Time Restricted Eating; Behavioral: Early Time Restricted Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT05740254

CHLA-22-00395

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Early Time Restricted Eating

Experimental group

Description:

early-day TRE (7:00 to 15:00 h)

Treatment:

Behavioral: Early Time Restricted Eating

Late Time Restricted Eating

Experimental group

Description:

late TRE (12:00 to 20:00 h)

Treatment:

Behavioral: Late Time Restricted Eating