CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Low sugar and carbohydrate diet +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03954223
NCT03954223N/ACompleted
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Time Limited Eating in Adolescents (Time LEAd): a Pilot Study

Children's Hospital Los Angeles·interventional·Posted May 17, 2019·Updated Mar 4, 2024

In Brief

A clinical study evaluating Low sugar and carbohydrate diet, Time Limited Eating, and 1 other intervention for Obesity, Childhood. Completed, enrolled 50 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Childhood
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 17, 2019
Enrollment StartMar 1, 2020
Primary CompletionJan 30, 2022
Study CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.1 years ago

Interventions

Low sugar and carbohydrate dietbehavioral

Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)

Time Limited Eatingbehavioral

16-hour fast/8-hour feed for 3 days per week

Continuous Glucose Monitordevice

CGM (used to monitor adherence and glycemic outcomes without real time feedback)