Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Time Restricted Eating, Late Time Restricted Eating.
- Who it may be relevant to
- Registry conditions: Pediatric Obesity, Time Restricted Feeding, Time Restricted Eating. Basic parameters: 12 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Mean change in weight in excess of the 95th percentile at week 24 compared to baseline [Time frame: week 24]
Secondary outcome measures (5)
- Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline [Time frame: week 24]
- Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline [Time frame: week 24]
- Mean change in hemoglobin A1c at week 24 compared to baseline [Time frame: week 24]
- Mean change in ALT at week 24 compared to baseline [Time frame: week 24]
- Mean change in systolic and diastolic blood pressure at week 24 compared to baseline [Time frame: week 24]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital Los Angeles — Los Angeles
Identifiers
NCT: NCT05740254 · CHLA-22-00395