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NCT03954223 · ClinicalTrials.gov registry record · NA
Time Limited Eating in Adolescents (Time LEAd): a Pilot Study
A NA study of Obesity, Childhood, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03954223: Completed NA study of Obesity, Childhood, sponsored by Children's Hospital Los Angeles.
NCT03954223 is a NA study of Obesity, Childhood that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 50 participants, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03954223, a NA study of Obesity, Childhood, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose a randomized controlled trial in 90 children (age 13-21y) with obesity recruited from clinical programs at the Children's Hospital Los Angeles (CHLA). Patients will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback). Group 2) LSC+TLE (16-hour fast/8-hour feed for 3 days per week) + blinded CGM, Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).
Primary Outcome
Percent Change in BMI in excess of the 95th percentile (%BMIp95) as calculated by the CDC extended SAS equations at week 12 minus %BMIp95 at baseline. For example If the BMI is greater than the 95th percentile: BMI percentile equals 90 plus 10 times the cumulative distribution function (CDF) of the standard normal distribution. Sigma is the value from the data table corresponding to the sex of the child and the age in months. and are the cumulative distribution function (CDF) of the standard no
Conditions Studied
Interventions
- DEVICE Continuous Glucose Monitor
- BEHAVIORAL Time Limited Eating
- BEHAVIORAL Low sugar and carbohydrate diet
Study Locations (1)
California
- Children's Hospital of Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2022-03-01 |
| Phase | NA |
What the finished NCT03954223 record still lists
NCT03954223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Obesity, Childhood appearing as the primary indexed condition, and to 3 interventions - of which Continuous Glucose Monitor is the first listed.
NCT03954223 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03954223 about?
NCT03954223 is a clinical study titled "Time Limited Eating in Adolescents (Time LEAd): a Pilot Study". The investigators propose a randomized controlled trial in 90 children (age 13-21y) with obesity recruited from clinical programs at the Children's Hospital Los Angeles (CHLA). Patients will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrat...
What is the current status of trial NCT03954223?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2020-03-01. Estimated completion is 2022-03-01.
What conditions does trial NCT03954223 study?
This clinical trial studies the following conditions: Obesity, Childhood.
What interventions are being tested in trial NCT03954223?
The interventions under investigation include: Continuous Glucose Monitor (DEVICE), Time Limited Eating (BEHAVIORAL), Low sugar and carbohydrate diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT03954223?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03954223 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03954223's enrollment target sits among peer trials
50 45th of 53 higher than 8 of 53 other Obesity, Childhood trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity, Childhood trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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