An interventional study of Time Limited Eating and Components Common to All Study Arms. in Pediatric Obesity, Type 2 Diabetes and Time Restricted Eating, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
To find the effectiveness of a diet plan (Time Limited Eating or TLE) on glycemic control, B-cell function, body fat, and body mass index (BMI) in adolescents with type 2 diabetes.
Intervention Design This is a prospective, pilot randomized controlled trial testing the efficacy of time-limited eating (TLE) on glycemic control, β-cell function, and body composition among predominantly Latinx adolescents with T2D compared to a prolonged eating period (12+hours). One-hundred adolescents with T2D will be recruited from CHLA. All participants will receive standard nutritional counseling and will be randomized to one of two meal-timing schedules to be followed for 12 weeks: (1) Control: 12-hour or more eating window without mealtime restrictions and (2) TLE: 8-hour eating period (16 hours of daily fasting).
The implementation steps of the proposed RCT are as follows:
(7) To further inform future trials and scalability we will continuously collect recruitment, consent, and retention rates, and barriers to engagement.
(8) Adverse Event Monitoring will be monitored. If at any time, the study staff notices any unhealthy compensatory behaviors the PI will be notified and a treatment plan will be created to ensure that the participant receive the appropriate screening, work-up, and diagnosis from their primary care provider and are withdrawn from the study if appropriate.
(9) The PI and research team will meet bi-weekly to monitor all study procedures and oversee data management and analysis.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 87 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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All adolescents with T2D and referred to the endocrinology clinic at CHLA will be screened. Inclusion criteria are: (1) age 12-21 years; (2) Tanner stage III and above; (3) diagnosis of T2D based on the ADA diagnostic guidelines; (4) hemoglobin A1c \< 9%; and (5) participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods. To limit confounding factors, individuals will be considered ineligible to participate if they meet any of the following exclusion criteria: (1) previous diagnosis of Prader-Willi Syndrome, brain tumor or hypothalamic obesity; (2) serious developmental or intellectual disability; (3) previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder); (4) parent/guardian-reported physical, mental of other inability to participate in the assessments (e.g., inability to wear CGM, inability to undergo imaging testing without sedation); (5) previous or planned bariatric surgery; (6) current planned use of an anti-obesity or other diabetes medication (e.g., phentermine, topiramate, orlistat, glucagon-like-peptide-1 agonist, naltrexone, or bupropion); or (7) current participation in other interventional weight loss studies.
Control: Habitual daily eating period (no meal time restrictions)
Behavioral: Components Common to All Study Arms. · Behavioral: Control · Device: Continuous Glucose Monitor
Time Limited Eating: 8-hour eating period (16 hours of daily fasting).
Behavioral: Time Limited Eating · Behavioral: Components Common to All Study Arms. · Device: Continuous Glucose Monitor
The TLE intervention arm will involve instructing participants to consume their usual kind and amount of food and beverages (all calories) within a pre-specified 8-hour period, fasting for the remaining 16-hours. They will be free to divide their food and beverage intake into as many meals or snacks as desired during the 8-hour period. Participants will be allowed to consume non-caloric beverages (water, tea, coffee) during the fasting period. No energy restriction will be required.
Also known as: TLE
All participants will receive two hours of standard nutrition counseling recommended for adolescents living with T2D. No specific caloric restriction will be recommended. All participants will maintain their usual lifestyle, including physical activity and sleep patterns. Physical activity and sleep recommendations consistent with the American Academy of Pediatrics guidelines for adolescents will be encouraged but not formally prescribed.
Participants assigned to the control arm will be instructed to consume food over a 12-h or more eating window. No energy restriction will be required.
All participants will be trained to wear a blinded continuous glucose monitor sensor using manufacturer educational materials under the supervision of research staff. Participants will be asked to wear the CGM for the duration of the study. During each study visit, the CGM reader will be connected to the site database to create an individual participant report. Participants will be provided enough sensors to replace the sensor every 14 days. The participants and guardians will be educated on how to use the CGM and receive 1:1 coaching on how to change the sensor, which will be completed either independently or under study team guidance. At each weekly phone meeting, study staff will monitor any challenges related to CGM wear, including participant discomfort, skin adherence, and other issues.
Change in percent time in range
Change in percent time in range, as measured on CGM over the study period
Time frame: Measured at week 0,4, 12
Change in Hemoglobin A1c
Change in hemoglobin A1c at week 12 compared to baseline
Time frame: Week 12 compared to baseline
Change in insulinogenic index
Change in insulinogenic index after mixed meal tolerance test
Time frame: Week 12 compared to baseline
Change in total body fat mass (kg)
Change in total body fat mass as measured by DEXA at week 12 compared to baseline
Time frame: Week 12 compared to baseline
ASA 24 Dietary Recall
Twenty-four-hour dietary recalls will be conducted for all participants pre- and post-intervention. One weekday and one weekend day will be collected for all participants.
Time frame: Measured at week 0,4, 12
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) has been developed to estimate levels of habitual physical activity across different countries and socio-cultural environments and will be collected at 5 time points.
Time frame: Measured at week 0,4, 12
Munich Chronotype Questionnaire for children and adolescents (MTCQ)
The Munich ChronoType Questionnaire (MCTQ) is a self-rated scale to assess sleep structure, patterns, duration, and quality and will be collected at 5 time points.
Time frame: Measured at week 0,4, 12
Pittsburg Sleep Quality Index
PSI self-reported sleep scale of quality and quantity
Time frame: Measured at week 0,4, 12
Change in BMI in excess of the 95th percentile (%BMIp95)
Change in %BMIp95
Time frame: Measured at week 0,4, 12
Binge eating disorder screen
The 7 item Binge-Eating Disorder Screener is a brief screener for BED, can assist physicians in identifying patients who may have BED and making the necessary follow-up decisions related to patient referrals or additional assessment and potential diagnosis of BED.
Time frame: Measured at week 0,4, 12
Adult eating behavior Questionnaire
The AEBQ will be used to assess participants' approach to food and eating along three dimensions: emotional, external, and restrained eating. There is a high degree of stability for each of these three eating behavior scales. The DEBQ has high internal consistency and validity. We will compare changes in DEBQ scores across study arms to monitor possible iatrogenic effects of TLE.
Time frame: Measured at week 0,4, 12
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Children's Hospital Los Angeles