Pediatric Obesity, Time Restricted Eating, Time Restricted Feeding
Conditions
Keywords
Obesity, Intermitted-fasting, Time Limited Eating
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.
Interventions
BEHAVIORALEarly Time Restricted Eating
Early Time Restricted Eating 7 AM to 3 PM
BEHAVIORALLate Time Restricted Eating
Late Time Restricted Eating 12 PM to 8 PM
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in weight in excess of the 95th percentile at week 24 compared to baseline | week 24 | Change in weight in excess of the 95th percentile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in systolic and diastolic blood pressure at week 24 compared to baseline | week 24 | Measured systolic and diastolic blood pressure at baseline and week 24 |
| Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline | week 24 | Change in total body fat mass measured on DEXA scan |
| Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline | week 24 | %TIR captured on CGM |
| Mean change in hemoglobin A1c at week 24 compared to baseline | week 24 | HgA1c measured at baseline and week 24 |
| Mean change in ALT at week 24 compared to baseline | week 24 | ALT measured at baseline and week 24 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlaina Vidmar, MD
Children's Hospital Los Angeles
Outcome results
None listed