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

Background No trial 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 with a prolonged eating window in adolescents with T2D. Design A 12-week, randomized, controlled, feasibility study of lTRE compared with control in adolescents with obesity and new-onset T2D was conducted. Participants/Setting Eligible participants were 13 to 21 years of age 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; hemoglobin A1c [HbA1c], 6.6% +/- 0.9%; 22/27 [81%] Hispanic, 17/27 [63%] female, 23/27 [85%] public insurance; all Pvalues > 0.05), and 23 of 27 completed the protocol. Intervention Participants wore a continuous glucose monitor (CGM) daily and were randomized to 1 of 2 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), p95 ), total body fat mass on dual-energy X-ray absorptiometry, sleep, and dietary intake were explored as secondary outcomes. Statistical Analysis Analyses were based on the intention-to-treat population. Between-group differences in clinical outcomes were assessed using mixed-effects longitudinal regression models. Results Overall adherence to the 8-hour 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%confidence interval [CI], -6.1, -0.7, P = 0.02), HbA1c (-0.4%; 95%CI, -0.9, -0.01; P = 0.06), and alanine transaminase (ALT; e31.1 U/L; 95%CI, -60, -2; P = 0.05) within the group. There was no significant difference observed between lTRE and control across these measures (all P > 0.05). The lTRE group had a -271.4 (95% CI, -565.2, 5.2) kcal/day energy reduction compared with a +293.2 (95% CI, 30.4, 552.7) kcal/day increase in Control (P = 0.01). 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.