Pediatric Obesity Clinical Trial
Official title:
Early vs. Late Time Restricted Eating in Adolescents With Obesity at Risk for Diabetes
Many adolescents find it challenging to adhere to conventional treatment for pediatric obesity because they require daily calorie counting, easy access to fresh food, and the ability to change the home environment. As such, adherence is poor which limits efficacy. One simpler and promising approach is limiting the timing of eating, instead of changing the food quality or quantity. This approach is called, Time-restricted eating (TRE) and involves eating over an 8- to 10-hour eating window and fasting for the remainder of the day.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Mean change in hemoglobin A1c at week 24 compared to baseline | HgA1c measured at baseline and week 24 | week 24 | |
Secondary | Mean change in ALT at week 24 compared to baseline | ALT measured at baseline and week 24 | week 24 | |
Secondary | 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 |
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