PMID- 37002475 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230606 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 14 IP - 7 DP - 2023 Jul TI - Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India: A Multicenter Feasibility Randomized Controlled Trial. PG - 1137-1154 LID - 10.1007/s13300-023-01395-4 [doi] AB - INTRODUCTION: Many Indians are at high risk of type 2 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. METHODS: 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 100-125 mg/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. RESULTS: In this feasibility trial, the recruitment of participants took 4 months (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 6 months (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 1 week during the feasibility trial period. There was no serious adverse event. CONCLUSIONS: 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. FEASIBILITY TRIAL REGISTRATION: Clinical Trials Registry-India (CTRI) CTRI/2019/05/018893; registered on May 1, 2019. CI - (c) 2023. The Author(s). FAU - Chattopadhyay, Kaushik AU - Chattopadhyay K AUID- ORCID: 0000-0002-3235-8168 AD - Lifespan and Population Health Academic Unit, University of Nottingham, Nottingham, UK. kaushik.chattopadhyay@nottingham.ac.uk. FAU - Mishra, Pallavi AU - Mishra P AD - Centre for Chronic Disease Control, New Delhi, India. FAU - Singh, Kavita AU - Singh K AD - Centre for Chronic Disease Control, New Delhi, India. FAU - Singh, Kalpana AU - Singh K AD - Centre for Chronic Disease Control, New Delhi, India. FAU - Harris, Tess AU - Harris T AD - Population Health Research Institute, St. George's University of London, London, UK. FAU - Hamer, Mark AU - Hamer M AD - Division of Surgery and Interventional Science, Institute of Sport, Exercise and Health, University College London, London, UK. FAU - Greenfield, Sheila Margaret AU - Greenfield SM AD - Institute of Applied Health Research, University of Birmingham, Birmingham, UK. FAU - Manjunath, Nandi Krishnamurthy AU - Manjunath NK AD - Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India. FAU - Nair, Rukamani AU - Nair R AD - Bapu Nature Cure Hospital and Yogashram, New Delhi, India. FAU - Mukherjee, Somnath AU - Mukherjee S AD - Bapu Nature Cure Hospital and Yogashram, New Delhi, India. FAU - Tandon, Nikhil AU - Tandon N AD - Department of Endocrinology, Metabolism and Diabetes, All India Institute of Medical Sciences, New Delhi, India. FAU - Lewis, Sarah Anne AU - Lewis SA AD - Lifespan and Population Health Academic Unit, University of Nottingham, Nottingham, UK. FAU - Kinra, Sanjay AU - Kinra S AD - Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK. FAU - Prabhakaran, Dorairaj AU - Prabhakaran D AD - Centre for Chronic Disease Control, New Delhi, India. CN - YOGA-DP Study Team LA - eng GR - MR/R018278/1/MRC_/Medical Research Council/United Kingdom PT - Journal Article DEP - 20230331 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 EIN - Diabetes Ther. 2023 May 24;:. PMID: 37223849 PMC - PMC10066010 OTO - NOTNLM OT - Blood glucose OT - Diet OT - Feasibility study OT - Lifestyle OT - Physical activity OT - Prediabetes OT - Prevention OT - Randomized controlled trial OT - Yoga COIS- KC, PM, KavS, KalS, TH, MH, SMG, NKM, RN, SM, NT, SAL, SK, and DP have nothing to disclose. EDAT- 2023/04/01 06:00 MHDA- 2023/04/01 06:01 PMCR- 2023/03/31 CRDT- 2023/03/31 23:31 PHST- 2023/02/19 00:00 [received] PHST- 2023/03/08 00:00 [accepted] PHST- 2023/04/01 06:01 [medline] PHST- 2023/04/01 06:00 [pubmed] PHST- 2023/03/31 23:31 [entrez] PHST- 2023/03/31 00:00 [pmc-release] AID - 10.1007/s13300-023-01395-4 [pii] AID - 1395 [pii] AID - 10.1007/s13300-023-01395-4 [doi] PST - ppublish SO - Diabetes Ther. 2023 Jul;14(7):1137-1154. doi: 10.1007/s13300-023-01395-4. Epub 2023 Mar 31.