Randomized Controlled Feasibility Trial of Late 8-Hour Time-Restricted Eating for Adolescents With Type 2 Diabetes.
Humans
Feasibility Studies
Female
Adolescent
Diabetes Mellitus, Type 2
/ diet therapy
Male
Young Adult
Blood Glucose
/ analysis
Glycemic Control
/ methods
Time Factors
Fasting
Pediatric Obesity
/ therapy
Body Composition
Glycated Hemoglobin
/ analysis
Meals
Blood Glucose Self-Monitoring
/ methods
Treatment Outcome
Metformin
/ therapeutic use
Time restricted eating
pediatric obesity
type 2 diabetes
Journal
Journal of the Academy of Nutrition and Dietetics
ISSN: 2212-2672
Titre abrégé: J Acad Nutr Diet
Pays: United States
ID NLM: 101573920
Informations de publication
Date de publication:
Aug 2024
Aug 2024
Historique:
pmc-release:
01
08
2025
medline:
28
10
2024
pubmed:
28
10
2024
entrez:
28
10
2024
Statut:
ppublish
Résumé
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). 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. A 12-week, randomized, controlled, feasibility study of lTRE compared to control in adolescents with obesity and new onset T2D was conducted. 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. 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). Study recruitment, retention and adherence to intervention arms were captured to operationalize feasibility. Glucose control (HbA1c), weight loss (%BMI Analyses were based on the intention to treat (ITT) population. Between-group differences in clinical outcomes were assessed using mixed-effects longitudinal regression models. 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 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.
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
A 12-week, randomized, controlled, feasibility study of lTRE compared to control in adolescents with obesity and new onset T2D was conducted.
Participants/setting
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
Study recruitment, retention and adherence to intervention arms were captured to operationalize feasibility. Glucose control (HbA1c), weight loss (%BMI
Statistical Analysis
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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.
Identifiants
pubmed: 39464252
doi: 10.1016/j.jand.2023.10.012
pmc: PMC11507361
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin
0
Metformin
9100L32L2N
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1014-1028Déclaration de conflit d'intérêts
Conflict of Interest: The authors have no financial relationships or conflict of interest relevant to this article to disclose.