Pediatric ObesityNCT05740254
Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
A study testing Early Time Restricted Eating and Late Time Restricted Eating in people with Pediatric Obesity and Time Restricted Feeding, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Pediatric Obesity, Time Restricted Feeding, Time Restricted Eating
- What is being tested?
- Early Time Restricted Eating and Late Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
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).
Read the 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.
- Being tested
- Early Time Restricted Eating, Late Time Restricted Eating
- Keywords
- Obesity, Intermitted-fasting, Time Limited Eating
- Medical subject headings
- Pediatric Obesity, Intermittent Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time Restricted EatingBehavioural
Early Time Restricted Eating 7 AM to 3 PM
Late Time Restricted EatingBehavioural
Late Time Restricted Eating 12 PM to 8 PM
| Study group | Role | What they receive |
|---|---|---|
| Early Time Restricted Eating | Experimental | early-day TRE (7:00 to 15:00 h) Receives: Behavioral: Early Time Restricted Eating |
| Late Time Restricted Eating | Experimental | late TRE (12:00 to 20:00 h) Receives: Behavioral: Late Time Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 24
Secondary outcomes (5)
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
Measured: week 24
Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline
%TIR captured on CGM
Measured: week 24
Mean change in hemoglobin A1c at week 24 compared to baseline
HgA1c measured at baseline and week 24
Measured: week 24
Mean change in ALT at week 24 compared to baseline
ALT measured at baseline and week 24
Measured: 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
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start27 Mar 2023
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaina P. Vidmar, MD, Children's Hospital Los Angeles
- Investigators
- Alaina Vidmar, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740254
- Sponsor's protocol ID
- CHLA-22-00395
- Status last verified
- Aug 2026
- First submitted
- 8 Feb 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)
- ClinicalTrials.gov ID
- NCT05740254
- Acronym / sponsor ID
- CHLA-22-00395
- Keywords
- Obesity, Intermitted-fasting, Time Limited Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Time Restricted Eating | Experimental | Behavioral: Early Time Restricted Eatingearly-day TRE (7:00 to 15:00 h) |
| Late Time Restricted Eating | Experimental | Behavioral: Late Time Restricted Eatinglate TRE (12:00 to 20:00 h) |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Time Restricted EatingEarly Time Restricted Eating 7 AM to 3 PM | Behavioural | Early Time Restricted Eating |
| Late Time Restricted EatingLate Time Restricted Eating 12 PM to 8 PM | Behavioural | Late Time Restricted Eating |
Primary outcome
Mean change in weight in excess of the 95th percentile at week 24 compared to baseline
Time frame: week 24
Change in weight in excess of the 95th percentile
5 secondary outcomes
Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline
Time frame: week 24
Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline
Time frame: week 24
Mean change in hemoglobin A1c at week 24 compared to baseline
Time frame: week 24
Mean change in ALT at week 24 compared to baseline
Time frame: week 24
Mean change in systolic and diastolic blood pressure at week 24 compared to baseline
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaina Vidmar, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time Restricted Eating and Late Time Restricted Eating in people with Pediatric Obesity and Time Restricted Feeding, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in weight in excess of the 95th percentile at week 24 compared to baseline (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.