Randomized Controlled Feasibility Trial of Late 8-Hour Time-Restricted Eating for Adolescents With Type 2 Diabetes
Hegedus E, Vu MH, Salvy SJ, Bakhsh J, Goran MI, Raymond JK, Espinoza JC, Vidmar AP
Journal of the Academy of Nutrition and Dietetics · 20 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Albert and Bettie Sacchi Foundation
- Organización sin fines de lucro
- American Diabetes Association
- Universidad u hospital
- Children's Hospital Los Angeles
- Gobierno
- National Institutes of Health
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- National Institute on Minority Health and Health Disparities
- Gobierno
- NCATS NIH HHS
- Gobierno
- NIDDK NIH HHS
- Gobierno
- NIMHD NIH HHS
- Gobierno
- NCI NIH HHS
- Subvenciones
- National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK130851); National Cancer Institute (R01 CA258222); National Center for Advancing Translational Sciences (UL1‐TR‐001855); National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK130851); American Diabetes Association (11-22-ICTSN-32); National Cancer Institute (UL1TR000130); Children's Hospital Los Angeles (UL1TR000130); National Center for Advancing Translational Sciences (UL1‐TR‐000130); National Institute of Diabetes and Digestive and Kidney Diseases (K23 DK134801); National Cancer Institute (UL1TR001855); National Institute on Minority Health and Health Disparities (1P50 MD017344); American Diabetes Association (UL1TR000130); National Institute on Minority Health and Health Disparities (P50MD017344); National Institutes of Health (UL1TR001855); National Institutes of Health (UL1 TR000130)
Según 12 financiadores declarados.
Publicación
- Publicado
- 2023-10-30 · J Acad Nutr Diet · vol. 124 · número 8 · págs. 1014–1028
- Editorial
- Elsevier BV
- Citado
- 23 citas · más que el 93% de estudios similares · 3.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 74 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Dietary Effects on Health · Diabetes Management and Research · Bariatric Surgery and Outcomes
- Palabras clave
- adolescents, type 2 diabetes, obesity, glycemic control, HbA1c, body composition, fat mass, sleep, dietary intake, eating window, metformin, continuous glucose monitoring, intervention adherence, feasibility, weight loss, Latino youth, meal timing, dietary diversity
- MeSH
- humans, diabetes mellitus, type 2, metformin, blood glucose, blood glucose self-monitoring, treatment outcome, fasting, feasibility studies, body composition, time factors, adolescent, female, male, young adult, meals, pediatric obesity, glycemic control, glycated hemoglobin
8 autores
- Elizabeth Hegedus🇺🇸University of Southern California; Children's Hospital of Los Angeles
- My H. Vu🇺🇸University of Southern California; Children's Hospital of Los Angeles; Saban Research Institute
- Sarah‐Jeanne Salvy🇺🇸University of Southern California
- Jomanah A. Bakhsh🇺🇸University of Southern California; Children's Hospital of Los Angeles
- Michael I. Goran🇺🇸University of Southern California; Children's Hospital of Los Angeles
- Jennifer K. Raymond🇺🇸University of Southern California; Children's Hospital of Los Angeles
- Juan Espinoza🇺🇸Cedars-Sinai Medical Center; Lurie Children's Hospital
- Alaina P. Vidmar🇺🇸 · autor de correspondenciaUniversity of Southern California; Children's Hospital of Los Angeles
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 (%BMIp95), total body fat mass on DEXA, sleep, and dietary intake were explored as secondary outcomes.
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 %BMIp95 (-3.4%-95%CI: -6.1, -0.7, p = 0.02), HbA1c (-0.4%, 95%CI: -0.9, -0.01, p = .06), and ALT (-31.1 U/L, 95%CI: -60, -2, p = .05) within the group. There was no significant difference observed between lTRE and control across these measures (all p > .05). The lTRE group had a -271.4 (95% CI, -565.2, 5.2) kcal/day energy reduction compared to a +293.2 (95% CI: 30.4, 552.7) kcal/day increase in Control (p = .01). There were no significant changes observed in sleep or eating behaviors over the study period between groups.
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.
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