Impact of Yoga Intervention on Physical and Mental Health of Adults with Type 2 Diabetes: Study Design and Methodology

Objective: The aim of this study was to discuss the components of yoga intervention and experimental design used to assess its effectiveness in diabetes care centers in Chennai. Materials and Methods: An interventional, randomized prospective study design was adopted. The study was conducted over a 6-month period. Based on inclusion and exclusion criteria, participants were selected from Dr Mohan's Diabetes Specialities Centre. Informed consent was obtained, and participants were randomly assigned to either the intervention or the control group in a 1:1 ratio. Participants in the intervention group underwent yoga training every 2 weeks for up to 3 months. Each yoga session lasted 35 min and included a variety of asanas and pranayama techniques. Participants were also given an audio recording (CD) of the yoga instructions, and they were encouraged to practice yoga at home and advised to keep track of their progress in a dairy provided. Diabetes care was provided to the control group on a routine basis. In addition to biochemical parameters, mental health parameters were also assessed. Independent t-test was performed using SPSS 24.0. Results: A total of 152 participants were screened and randomized with 76 in the intervention arm and 76 in the control arm. There were no challenges in participants recruitment and retention. Data were collected during enrollment, 13 and 26 weeks. At baseline, the intervention arm's mean HbA1c (%) was 8.4 +/- 1.1%, whereas in the control arm, it was 8.3 +/- 1.1% (P = 0.290), and fasting blood glucose levels were 142 +/- 27 mg/dL in the intervention arm and 141 +/- 29 mg/dL in the control arm (P = 0.811). There was no significant difference between groups in terms of lipid profile or mental health parameters at baseline. Conclusion: There is a major lacuna for controlled trials with methodological rigor in yoga intervention; this study may contribute to fill this requirement by systematically elucidating the role of yoga in the management of diabetes and to prevent complications. This study will provide a cost-effective care for people with diabetes.