Clinical outcomes of a digitally delivered structured lifestyle program in type 2 diabetes: a randomized controlled trial from India
Background Effective type 2 diabetes (T2D) management extends beyond pharmacotherapy to include structured lifestyle interventions and continuous digital support. Accordingly, this study aimed to evaluate the effectiveness of an integrated, multicomponent 90-day healthcoach-assisted lifestyle intervention program in improving glycemic and related metabolic outcomes among patients with T2D, with assessment of benefits across adherence levels. Methods This prospective, multicenter randomized controlled trial (RCT) included 149 participants with T2D allocated to intervention (n=87) and control (n=62) groups, with subgroup stratification of intervention participants into high-adherence (≥35%; n=62) and low-adherence (<35%; n=25) groups based on median composite adherence scores. The intervention group received a structured lifestyle intervention on diet, exercise, and mental wellness alongside standard of care (SOC), while controls received SOC alone for 90 days. Glycemic, anthropometric, and diabetes distress outcomes were compared between groups and across adherence subgroups. Statistical significance was assessed for all outcomes. Results The intervention group demonstrated statistically significantly greater reductions (p<0.001) compared with the control group in glycated hemoglobin (HbA1c) (1.46 ± 1.82 vs. -0.07 ± 1.22%), fasting blood sugar (FBS) (18.83 ± 60.46 vs. -10.84 ± 55.20 mg/dL), body mass index (BMI) (0.55 ± 4.32 vs. 0.18 ± 0.78 kg/m2), body weight (1.49 ± 2.22 vs. 0.26 ± 2.57 kg), and waist circumference (1.86 ± 2.53 vs. -0.09 ± 3.93 cm). Homeostatic model assessment for insulin resistance (HOMA-IR) decreased (0.36 ± 6.63 vs. -0.27 ± 4.58), while HOMA of β-cell function (HOMA-B) improved (36.28 ± 134.32 vs. 8.72 ± 79.1), as compared with the control group. Further, diabetes-related distress significantly improved in the intervention group, shifting from moderate to low/no distress, whereas the control group approached the threshold for moderate distress (0.57 ± 0.77 vs. 0.27 ± 0.71). Participants with high-adherence showed significant reductions in HbA1c (1.7 ± 1.5 vs. 0.8 ± 1.3%), FBS (25.2 ± 60 vs. 3.1 ± 59.9 mg/dL), and weight (1.6 ± 2.3 vs. 1.4 ± 2.1 kg) compared to low-adherence participants. Conclusion This digitally delivered lifestyle intervention program produced clinically meaningful improvements in glycemic control, anthropometric measures, and diabetes related distress compared with standard care alone, with greater benefit among high adherence participants. These findings support integrating structured, coach guided digital lifestyle programs into routine T2D care, particularly in resource limited, real-world settings such as India. Clinical trial registration https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTA2NDAx&Enc=&userName=, identifier CTRI/2024/05/068043.