Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Time Restricted Eating | Experimental | early-day TRE (7:00 to 15:00 h) |
|
| Late Time Restricted Eating | Experimental | late TRE (12:00 to 20:00 h) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Time Restricted Eating | Behavioral | Early Time Restricted Eating 7 AM to 3 PM |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaina Vidmar, MD | Contact | 323-361-4606 | avidmar@chla.usc.edu | |
| Harvey Peralta | Contact | hperalta@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alaina Vidmar, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D000093763 | Intermittent Fasting |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Late Time Restricted Eating | Behavioral | Late Time Restricted Eating 12 PM to 8 PM |
|
%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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |