Early vs. Late Time Restricted Eating in Adolescents With Obesity at Risk for Diabetes

Pediatric Obesity Clinical Trial

Official title:

Early vs. Late Time Restricted Eating in Adolescents With Obesity at Risk for Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740254
• Other study ID #: CHLA-22-00395
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: December 2023
• Source: Children's Hospital Los Angeles
• Contact: Alaina Vidmar, MD
• Phone: 323-361-4606
• Email: avidmar[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity
• Time Restricted Eating
• Time Restricted Feeding

Intervention

Behavioral:
• Early Time Restricted Eating
Early Time Restricted Eating 7 AM to 3 PM
• Late Time Restricted Eating
Late Time Restricted Eating 12 PM to 8 PM

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

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