Evidence map›Paper›PMID 39464252›Full record

Trial reportJournal of the Academy of Nutrition and Dietetics2024

Randomized Controlled Feasibility Trial of Late 8-Hour Time-Restricted Eating for Adolescents With Type 2 Diabetes.

Elizabeth Hegedus, My H Vu, Sarah Jeanne Salvy, Jomanah Bakhsh, Michael I Goran, Jennifer K Raymond, Juan C Espinoza, Alaina P Vidmar

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the Academy of Nutrition and Dietetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 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

8 authors.

Elizabeth HegedusChildren's Hospital Los Angeles and Keck School of Medicine of USC, Department of Pediatrics, Center for Endocrinology, Diabetes and Metabolism.
My H VuChildren's Hospital Los Angeles and Keck School of Medicine of USC, Department of Pediatrics, the Saban Research Institute Biostatics Core.
Sarah Jeanne SalvyDepartment of Population and Public Health Sciences, University of Southern California.
Jomanah BakhshChildren's Hospital Los Angeles and Keck School of Medicine of USC, Department of Pediatrics, Center for Endocrinology, Diabetes and Metabolism.
Michael I GoranChildren's Hospital Los Angeles and Keck School of Medicine of USC, Department of Pediatrics, Center for Endocrinology, Diabetes and Metabolism.
Jennifer K RaymondChildren's Hospital Los Angeles and Keck School of Medicine of USC, Department of Pediatrics, Center for Endocrinology, Diabetes and Metabolism.
Juan C EspinozaResearch Center for Health Equity, Cedars-Sinai Medical Center, Department of Medicine, Samuel Oschin Comprehensive Cancer Institute, and Lurie Children's Hospital, Department of Pediatrics.
Alaina P VidmarChildren's Hospital Los Angeles and Keck School of Medicine of USC, Department of Pediatrics, Center for Endocrinology, Diabetes and Metabolism.

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
Southern California Center for Chronic Health Disparities in Latino Children and Families.P50MD017344 · NIMHD · CHILDREN'S HOSPITAL OF LOS ANGELES · PI BOUTELLE, KERRI N · 2021 to 2025
$27.8M
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and ModeratorsR01CA258222 · NCI · CEDARS-SINAI MEDICAL CENTER · PI FIGUEIREDO, JANE C., PETERSON, COURTNEY MARIE · 2021 to 2025
$4.1M
Evaluating environmental control (AVOID) and inhibitory control (RESIST) strategies to improve weight management outcomesR01DK130851 · NIDDK · CEDARS-SINAI MEDICAL CENTER · PI Sarah-Jeanne Salvy · 2022 to 2026
$3.5M
Impact of Meal Timing on Glycemic Profiles in Adolescents with Type 2 DiabetesK23DK134801 · NIDDK · CHILDREN'S HOSPITAL OF LOS ANGELES · PI Alaina P Vidmar · 2023 to 2026
$674k
NCATS NIH HHS UL1 TR000130NCATS NIH HHS UL1 TR001855NCI NIH HHS R01 CA258222NIDDK NIH HHS K23 DK134801NIDDK NIH HHS R01 DK130851NIMHD NIH HHS P50 MD017344
6 · The paper itself

Abstract

Background: No trial to date has tested the effects of late time-restricted eating (lTRE) on glycemic control or body composition in adolescents with type 2 diabetes (T2D). Objective: The objective of the current study was to examine the feasibility, acceptability, and preliminary efficacy of lTRE compared to a prolonged eating window in adolescents with T2D. Design: A 12-week, randomized, controlled, feasibility study of lTRE compared to control in adolescents with obesity and new onset T2D was conducted. Participants/setting: Eligible participants were 13-21 years old; with a diagnosis of T2D, on metformin monotherapy, recruited from Children's Hospital Los Angeles, between January 2021 and December of 2022. From 36 eligible participants, 27 were enrolled (75% recruitment rate; age: 16.5 ± 1.7 years, HbA1c: 6.6 ± 0.9%, 22/27 [81%] Hispanic, 17/27 [63%] female, 23/27 [85%] public insurance; all p-values >.05), and 23 of 27 completed the protocol. Intervention: Participants wore a continuous glucose monitor (CGM) daily and were randomized to one of two meal-timing schedules for 12-weeks: (1) lTRE (eating all food between 12:00 PM and 20:00 PM without calorie counting or recommended daily caloric intake) or (2) Control (eating over a period of 12 or more hours per day). Main outcome measures: Study recruitment, retention and adherence to intervention arms were captured to operationalize feasibility. Glucose control (HbA1c), weight loss (%BMI Statistical Analysis: Analyses were based on the intention to treat (ITT) population. Between-group differences in clinical outcomes were assessed using mixed-effects longitudinal regression models. Results: Overall adherence to the 8-hr lTRE was 6.2 ± 1.1 d/wk and Control was 5.9 ± 0.9 d/wk. Participants assigned to lTRE indicated that limiting their eating window did not negatively affect their daily functioning and no adverse events were reported. In this pilot study, lTRE led to a reduction in %BMI Conclusions: Recruitment and retention rates suggest a trial of lTRE in adolescents with T2D was feasible. lTRE was seen as acceptable by participants and adherence was high. A revised intervention, building on the successful elements of this pilot alongside adapting implementations strategies to augment adherence and engagement, should therefore be considered.

Indexed as

Diabetes Mellitus, Type 2Feasibility StudiesAdolescentBlood GlucoseBlood Glucose Self-MonitoringBody CompositionFastingFemaleGlycated HemoglobinGlycemic ControlHumansMaleMealsMetforminPediatric ObesityTime FactorsBlood GlucoseGlycated HemoglobinMetforminpediatric obesityTime restricted eatingtype 2 diabetes

Identifiers

PMID39464252
PMCPMC11507361

What Socratic holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.