Yoga Programme for Type2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India: A Multicenter Feasibility Randomized Controlled Trial.

Abstract

Many Indians are at high risk of type2 diabetes mellitus (T2DM). The blood glucose level can be improved through a healthy lifestyle (such as physical activity and a healthy diet). Yoga can help in T2DM prevention, being a culturally appropriate approach to improving lifestyle. We developed the Yoga Programme for T2DM Prevention (YOGA-DP), a 24-week structured lifestyle education and exercise (Yoga) program that included 27 group Yoga sessions and self-practice of Yoga at home. In this study, the feasibility of undertaking a definitive randomized controlled trial (RCT) was explored that will evaluate the intervention's effectiveness among high-risk individuals in India. A multicenter, two-arm, parallel-group, feasibility RCT was conducted in India. The outcome assessors and data analysts were blinded. Adults with a fasting blood glucose level of 100-125mg/dL (i.e., at high risk of T2DM) were eligible. Participants were randomized centrally using a computer-generated randomization schedule. In the intervention group, participants received YOGA-DP. In the control group, participants received enhanced standard care. In this feasibility trial, the recruitment of participants took 4months (from May to September 2019). We screened 711 people and assessed 160 for eligibility. Sixty-five participants (33 in the intervention group and 32 in the control group) were randomized, and 57 (88%) participants were followed up for 6months (32 in the intervention group and 25 in the control group). In the intervention group, the group Yoga sessions were continuously attended by 32 (97%) participants (median (interquartile range, IQR) number of sessions attended = 27(3)). In the intervention group, Yoga was self-practiced at home by 30 (91%) participants (median (IQR) number of days per week and minutes per day self-practiced = 2(2) and 35(15), respectively). In the control group, one (3%) participant attended external Yoga sessions (on Pranayama) for 1week during the feasibility trial period. There was no serious adverse event. The participant recruitment and follow-up and adherence to the intervention were promising in this feasibility study. In the control group, the potential contamination was low. Therefore, it should be feasible to undertake a definitive RCT in the future that will evaluate YOGA-DP's effectiveness among high-risk people in India. Clinical Trials Registry-India (CTRI) CTRI/2019/05/018893; registered on May1, 2019.