Evidence map›Paper›PMID 32682994›Full record

ArticleContemporary clinical trials2020

Time limited eating in adolescents with obesity (time LEAd): Study protocol.

Alaina P Vidmar, Michael I Goran, Monica Naguib, Cassandra Fink, Choo Phei Wee, Elizabeth Hegedus, Kelleen Lopez, Janelle Gonzalez, Jennifer K Raymond

2 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03954223 nacompletednot on this map

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

TypeinterventionalSponsorChildren's Hospital Los AngelesRan2020 to 2022Enrolled50ConditionsObesity, ChildhoodArmsLow sugar and carbohydrate diet, Time Limited Eating, Continuous Glucose Monitor
NCT05031429 nacompletednot on this mapstarted 2022, after this paper: background citation

Time Limited Eating in New-Onset Type 1 Diabetes: Feasibility, Acceptability, and Effect on β-cell Function

TypeinterventionalSponsorChildren's Hospital Los AngelesRan2022 to 2023Enrolled12ConditionsType 1 DiabetesArmsTime Limited Eating
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Alaina P VidmarDiabetes & 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.
Michael I GoranDiabetes & 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.
Monica NaguibDiabetes & 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.
Cassandra FinkDiabetes & 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.
Choo Phei WeeCTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States of America.
Elizabeth HegedusDiabetes & 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.
Kelleen LopezDiabetes & 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.
Janelle GonzalezDiabetes & 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.
Jennifer K RaymondDiabetes & 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.

Funding

Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
Southern California Clinical and Translational Science InstituteUL1TR000130 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI BUCHANAN, THOMAS A · 2012 to 2015
$36.0M
NCATS NIH HHS UL1 TR000130NCATS NIH HHS UL1 TR001855
6 · The paper itself

Abstract

backgroundTime 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.

objectivesThe 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.

methodsWe 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.

conclusionsTLE 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 registrationClinicalTrials.gov identifier: NCT03954223.

Indexed as

Diabetes Mellitus, Type 2Pediatric ObesityAdolescentAdultBlood GlucoseBlood Glucose Self-MonitoringChildHumansProspective StudiesRandomized Controlled Trials as TopicBlood GlucoseContinuous glucose monitoringObesityPediatricsTime limited eating

Identifiers

PMID32682994
PMCPMC8359671

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.