search
Back to results

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

Primary Purpose

Pediatric Obesity, Time Restricted Feeding, Time Restricted Eating

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Time Restricted Eating
Late Time Restricted Eating
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Time Restricted Eating

Late Time Restricted Eating

Arm Description

early-day TRE (7:00 to 15:00 h)

late TRE (12:00 to 20:00 h)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline
%TIR captured on CGM
Mean change in hemoglobin A1c at week 24 compared to baseline
HgA1c measured at baseline and week 24
Mean change in ALT at week 24 compared to baseline
ALT measured at baseline and 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

Full Information

First Posted
February 8, 2023
Last Updated
April 18, 2023
Sponsor
Children's Hospital Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT05740254
Brief Title
Early vs. Late Time Restricted Eating in Adolescents With Obesity at Risk for Diabetes
Official Title
Early vs. Late Time Restricted Eating in Adolescents With Obesity at Risk for Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Time Restricted Feeding, Time Restricted Eating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Time Restricted Eating
Arm Type
Experimental
Arm Description
early-day TRE (7:00 to 15:00 h)
Arm Title
Late Time Restricted Eating
Arm Type
Experimental
Arm Description
late TRE (12:00 to 20:00 h)
Intervention Type
Behavioral
Intervention Name(s)
Early Time Restricted Eating
Intervention Description
Early Time Restricted Eating 7 AM to 3 PM
Intervention Type
Behavioral
Intervention Name(s)
Late Time Restricted Eating
Intervention Description
Late Time Restricted Eating 12 PM to 8 PM
Primary Outcome Measure Information:
Title
Mean change in weight in excess of the 95th percentile at week 24 compared to baseline
Description
Change in weight in excess of the 95th percentile
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline
Description
Change in total body fat mass measured on DEXA scan
Time Frame
week 24
Title
Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline
Description
%TIR captured on CGM
Time Frame
week 24
Title
Mean change in hemoglobin A1c at week 24 compared to baseline
Description
HgA1c measured at baseline and week 24
Time Frame
week 24
Title
Mean change in ALT at week 24 compared to baseline
Description
ALT measured at baseline and week 24
Time Frame
week 24
Title
Mean change in systolic and diastolic blood pressure at week 24 compared to baseline
Description
Measured systolic and diastolic blood pressure at baseline and week 24
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaina Vidmar, MD
Phone
323-361-4606
Email
avidmar@chla.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yareli Pineda
Email
ypineda@chla.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaina Vidmar, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaina Vidmar
Phone
530-383-1732
Email
avidmar@chla.usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs