PMID- 32682994
OWN - NLM
STAT- MEDLINE
DCOM- 20210924
LR  - 20210924
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Print)
IS  - 1551-7144 (Linking)
VI  - 95
DP  - 2020 Aug
TI  - Time limited eating in adolescents with obesity (time LEAd): Study protocol.
PG  - 106082
LID - S1551-7144(20)30160-9 [pii]
LID - 10.1016/j.cct.2020.106082 [doi]
AB  - BACKGROUND: Time limited eating (TLE) has been shown to be effective for weight 
      loss and improvement of glycemic control in adults with obesity and type 2 
      diabetes (T2D), but has not been well studied in adolescents. TLE may be a more 
      feasible, flexible and effective dietary intervention for adolescents because it 
      removes the need for intensive counting of calories or macronutrients, and 
      emphasizes eating during a specified time period. OBJECTIVES: The aim of this 
      study is to assess the feasibility of a TLE approach in adolescents with obesity 
      using a continuous glucose monitor (CGM) to promote adherence to the 
      intervention. METHODS: We propose a prospective, randomized controlled trial, in 
      60 adolescents (ages 14-18) with obesity (BMI% >/= 95th percentile). Youth will be 
      randomized to one of three treatment groups for a 12-week intervention: Group 1) 
      Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar 
      (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor 
      adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE 
      (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ 
      real time feedback via CGM (to evaluate effect of providing CGM data on 
      intervention efficacy). Outcomes will include change in total body fat (TBF) 
      percentage measured on DEXA scan, BMI status and fasting blood glucose at 
      12 weeks compared to baseline. CONCLUSIONS: TLE is a potentially powerful 
      lifestyle intervention that could be readily integrated into pediatric weight 
      management programs to optimize their impact and accelerate healthy changes. 
      CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03954223.
CI  - Copyright (c) 2020 Elsevier Inc. All rights reserved.
FAU - Vidmar, Alaina P
AU  - Vidmar AP
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America. Electronic address: 
      avidmar@chla.usc.edu.
FAU - Goran, Michael I
AU  - Goran MI
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America.
FAU - Naguib, Monica
AU  - Naguib M
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America.
FAU - Fink, Cassandra
AU  - Fink C
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America.
FAU - Wee, Choo Phei
AU  - Wee CP
AD  - CTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States of 
      America.
FAU - Hegedus, Elizabeth
AU  - Hegedus E
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America.
FAU - Lopez, Kelleen
AU  - Lopez K
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America.
FAU - Gonzalez, Janelle
AU  - Gonzalez J
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America.
FAU - Raymond, Jennifer K
AU  - Raymond JK
AD  - Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, 
      Department of Pediatrics, Children's Hospital Los Angeles and Keck School of 
      Medicine of USC, Los Angeles, CA, United States of America.
LA  - eng
SI  - ClinicalTrials.gov/NCT03954223
GR  - UL1 TR000130/TR/NCATS NIH HHS/United States
GR  - UL1 TR001855/TR/NCATS NIH HHS/United States
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20200716
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
RN  - 0 (Blood Glucose)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Blood Glucose
MH  - Blood Glucose Self-Monitoring
MH  - Child
MH  - *Diabetes Mellitus, Type 2
MH  - Humans
MH  - *Pediatric Obesity/therapy
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic
PMC - PMC8359671
MID - NIHMS1726408
OTO - NOTNLM
OT  - Continuous glucose monitoring
OT  - Obesity
OT  - Pediatrics
OT  - Time limited eating
COIS- Declaration of Competing Interest The authors have no financial relationships or 
      conflict of interest relevant to this article to disclose.
EDAT- 2020/07/20 06:00
MHDA- 2021/09/25 06:00
PMCR- 2021/08/12
CRDT- 2020/07/20 06:00
PHST- 2020/03/09 00:00 [received]
PHST- 2020/06/22 00:00 [revised]
PHST- 2020/07/06 00:00 [accepted]
PHST- 2020/07/20 06:00 [pubmed]
PHST- 2021/09/25 06:00 [medline]
PHST- 2020/07/20 06:00 [entrez]
PHST- 2021/08/12 00:00 [pmc-release]
AID - S1551-7144(20)30160-9 [pii]
AID - 10.1016/j.cct.2020.106082 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2020 Aug;95:106082. doi: 10.1016/j.cct.2020.106082. Epub 
      2020 Jul 16.