Effectiveness of a Video-Based Lifestyle Education Program Compared to Usual Care in Improving HbA1c and Other Metabolic Parameters in Individuals with Type 2 Diabetes: An Open-Label Parallel Arm Randomized Control Trial (RCT).

ABSTRACT

INTRODUCTION: This study was designed to investigate the effectiveness of a video-based lifestyle education program (VBLEP) in improving glycemic control in people with type 2 diabetes mellitus compared with usual care. METHODS: Patients on stable oral glucose-lowering agents for at least 3 months and HbA1c 7.5-10% were randomized in a 11 ratio. Primary outcome measure was the difference in change in mean HbA1c between groups. RESULTS: The participants (n = 81) had mean (± SD) age of 50.1 (± 9.4) years and HbA1c of 8.5 ± 0.7% (68.87 ± 7.56 mmol/mol). The follow-up data were available in 96% (78/81) of participants. Of 40 participants, 36 (90%) attended ≥ 75% (≥ 3 out of 4) of the sessions in the VBLEP. In the intention-to-treat analysis, a significant reduction [0.6% 95% CI (0.1, 1.1), p = 0.013] in HbA1c was seen in the VBLEP group compared with usual care. A ≥ 1% reduction in HbA1c was observed in 39.5% of participants in the VBLEP compared with 15% in the usual care arm. However, a ≥ 0.5% reduction in HbA1c was observed in 65.8% of participants in the VBLEP compared with 37.5% in the usual care arm (p = 0.012). There was a significant change in weight and body mass index in the VBLEP group compared with usual care. The participants who were employed, had a family history of diabetes, had no diabetes-related complications, and were in the VBLEP group had higher odds of having a favorable HbA1c reduction (≥ 0.5%, combined analysis both groups) from baseline. CONCLUSION: The VBLEP demonstrated a significant and clinically relevant HbA1c reduction compared with usual care. A simple VBLEP, when delivered in an interactive manner, can aid in improving glycemic outcomes in the Indian population. TRIAL REGISTRATION CTRI/2017/05/008564.