Health TrialsbyHealthPanel

Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)

ConditionsPediatric ObesityTime Restricted FeedingTime Restricted Eating
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorChildren's Hospital Los Angeles

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Time Restricted Eating

    Behavioral

    Early Time Restricted Eating 7 AM to 3 PM

  • Late Time Restricted Eating

    Behavioral

    Late Time Restricted Eating 12 PM to 8 PM

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Early Time Restricted EatingExperimental treatment 1 intervention
Group B: Late Time Restricted EatingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
week 24

Secondary outcomes

1

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

Time frame
week 24
2

Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline

%TIR captured on CGM

Time frame
week 24
3

Mean change in hemoglobin A1c at week 24 compared to baseline

HgA1c measured at baseline and week 24

Time frame
week 24
4

Mean change in ALT at week 24 compared to baseline

ALT measured at baseline and week 24

Time frame
week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Los Angeles

Lead sponsor

Source ClinicalTrials.gov
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