Clinical trial NCT05740254: Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
Official title: Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Time Restricted Feeding
Time Restricted Eating
Keywords: Obesity
Intermitted-fasting
Time Limited Eating
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean change in weight in excess of the 95th percentile at week 24 compared to baseline
timeFrame: week 24
Secondary outcomes:
measure: Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline
timeFrame: week 24
measure: Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline
timeFrame: week 24
measure: Mean change in hemoglobin A1c at week 24 compared to baseline
timeFrame: week 24
measure: Mean change in ALT at week 24 compared to baseline
timeFrame: week 24
measure: Mean change in systolic and diastolic blood pressure at week 24 compared to baseline
timeFrame: week 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Alaina Vidmar, MD
role: PRINCIPAL_INVESTIGATOR
References: