NCT03954223: TimeLEAd

Time Limited Eating in Adolescents (Time LEAd): a Pilot Study

Completed NA Results posted Last updated 4 March 2024

What this trial tests

NA trial testing Low sugar and carbohydrate diet in Obesity, Childhood in 50 participants. Completed in 1 March 2022.

Timeline

1 March 2020

Primary endpoint
30 January 2022

1 March 2022

Quick facts

Lead sponsor	Children's Hospital Los Angeles
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	1 March 2020
Primary completion	30 January 2022
Estimated completion	1 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Low sugar and carbohydrate diet
• Time Limited Eating
• Continuous Glucose Monitor

Conditions studied

• Obesity, Childhood — all drugs for Obesity, Childhood →

Sponsor

Children's Hospital Los Angeles

Who can join

Adults 14 to 18, any sex, with Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in BMI in Excess of the 95th Percentile (%BMIp95) Primary · %BMIp95 at Week 12 minus %BMIp95 at baseline

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 normal distribution and its inverse function. Standard normal distribution tables can be found in stat

Group	Value	95% CI
LSC + Blinded CGM	-3.27	± 3.34
LSC+TLE + Blinded CGM	-3.76	± 5.76
LSC+TLE+ Real Time Feedback Via CGM	-4.85	± 5.08

Average Glucose Secondary · Change in average glucose at week 12 minus average glucose at baseline

Affect of TRE on change in average glucose

Group	Value	95% CI
LSC + Blinded CGM	0.5	-20.2 – 6.0
LSC+TLE + Blinded CGM	-7.1	-18.2 – 6.0
LSC+TLE+ Real Time Feedback Via CGM	-4.2	-14.7 – 6.1

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Time-Limited Eating and Continuous Glucose Monitoring in Adolescents with Obesity: A Pilot Study.
   Vidmar AP, Naguib M, Raymond JK, Salvy SJ, et al · · 2021 · cited 39× · PMID 34835953 · DOI 10.3390/nu13113697
2. Continuous Glucose Monitoring in Adolescents With Obesity: Monitoring of Glucose Profiles, Glycemic Excursions, and Adherence to Time Restricted Eating Programs.
   Naguib MN, Hegedus E, Raymond JK, Goran MI, et al · · 2022 · cited 24× · PMID 35282464 · DOI 10.3389/fendo.2022.841838
3. Time limited eating in adolescents with obesity (time LEAd): Study protocol.
   Vidmar AP, Goran MI, Naguib M, Fink C, et al · · 2020 · cited 11× · PMID 32682994 · DOI 10.1016/j.cct.2020.106082
4. Effects of 8-h time-restricted eating on energy intake, dietary composition and quality in adolescents with obesity.
   Bakhsh JA, Vu MH, Salvy SJ, Goran MI, et al · · 2024 · cited 4× · PMID 39188065 · DOI 10.1111/ijpo.13165