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

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).

Study Overview

• Status: Recruiting
• Conditions: Pediatric Obesity; Time Restricted Feeding; Time Restricted Eating
• Intervention / Treatment: Behavioral: Early Time Restricted Eating; Behavioral: Late Time Restricted Eating

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaina Vidmar, MD; Phone Number: 323-361-4606; Email: avidmar@chla.usc.edu
• Study Contact Backup: Name: Harvey Peralta; Email: hperalta@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Alaina Vidmar; Phone Number: 530-383-1732; Email: avidmar@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Time Restricted Eating; early-day TRE (7:00 to 15:00 h)	Behavioral: Early Time Restricted Eating; Early Time Restricted Eating 7 AM to 3 PM
Experimental: Late Time Restricted Eating; late TRE (12:00 to 20:00 h)	Behavioral: Late Time Restricted Eating; Late Time Restricted Eating 12 PM to 8 PM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in weight in excess of the 95th percentile at week 24 compared to baseline	Change in weight in excess of the 95th percentile	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline	Change in total body fat mass measured on DEXA scan	week 24
Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline	%TIR captured on CGM	week 24
Mean change in hemoglobin A1c at week 24 compared to baseline	HgA1c measured at baseline and week 24	week 24
Mean change in ALT at week 24 compared to baseline	ALT measured at baseline and week 24	week 24
Mean change in systolic and diastolic blood pressure at week 24 compared to baseline	Measured systolic and diastolic blood pressure at baseline and week 24	week 24

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Alaina Vidmar, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 19, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Time Limited Eating; Intermitted-fasting
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: CHLA-22-00395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical characteristics data will be available in CSV format, and will not require the use of specialized tools to be accessed. To facilitate interpretation of the data, study protocol and clinical data dictionary will be shared and associated with the relevant datasets. Information about our research process, including the details of biochemical assays be maintained contemporaneously. This information will be accessible to all members of the research team and will be shared alongside our data. Data to be shared will be made available at the time of associated publication or by the close of the reward. Data will be made available, at minimum, for length of the grant + 5 years. Restrictions on subsequent access, distribution, or reuse of scientific data from this project include confidentiality protections. All data shard will be de-identified and not include any sensitive information or potentially identifying variables.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No