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

NCT ID: NCT05740254

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2027-01-01

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.

Conditions

Pediatric Obesity; Time Restricted Feeding; Time Restricted Eating

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Time Restricted Eating

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

Group Type: EXPERIMENTAL

Early Time Restricted Eating

Intervention Type: BEHAVIORAL

Early Time Restricted Eating 7 AM to 3 PM

Late Time Restricted Eating

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

Group Type: EXPERIMENTAL

Late Time Restricted Eating

Intervention Type: BEHAVIORAL

Late Time Restricted Eating 12 PM to 8 PM

Interventions

Early Time Restricted Eating

Early Time Restricted Eating 7 AM to 3 PM

Intervention Type: BEHAVIORAL

Late Time Restricted Eating

Late Time Restricted Eating 12 PM to 8 PM

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Alaina P. Vidmar, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaina Vidmar, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alaina Vidmar, MD

Role: CONTACT

avidmar@chla.usc.edu

323-361-4606

Harvey Peralta

Role: CONTACT

hperalta@chla.usc.edu

Facility Contacts

Alaina Vidmar

Role: primary

avidmar@chla.usc.edu

530-383-1732

Other Identifiers

CHLA-22-00395

Identifier Type: -

Identifier Source: org_study_id