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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03954223
The ClinicalTrials.gov registry entry for NCT03954223 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (85% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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