Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multi-centre feasibility randomised controlled trial protocol

Research output: Contribution to journalArticle

Authors

  • Kaushik Chattopadhyay
  • Pallavi Mishra
  • Kavita Singh
  • Tess Harris
  • Mark Hamer
  • Sarah Anne Lewis
  • Nandi Krishnamurthy Manjunath
  • Rukamani Nair
  • David Harper
  • Nikhil Tandon
  • Sanjay Kinra
  • Prabhakaran Dorairaj

Abstract

Introduction: A huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared to enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.
Intervention YOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.

Methods and analysis: This is a multi-centre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18-74 years, at high risk of T2DM (fasting plasma glucose level 5.6 to 6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at six months. Important parameters, needed to design the main RCT, will be estimated, such as standard deviation of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semi-structured qualitative interviews will be conducted with up to 20-30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.

Ethics and dissemination: Ethics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); CCDC (India); BNCHY (India) and S-VYASA (India). The results will be widely disseminated among key stakeholders through various avenues.

Trial registration: Clinical Trials Registry- India (CTRI) CTRI/2019/05/018893

Details

Original languageEnglish
JournalBMJ open
Publication statusAccepted/In press - 23 Jun 2020

Keywords

  • Yoga, physical activity, diet, lifestyle, prevention, prediabetes, blood glucose, feasibility study, randomised controlled trial