Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol
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 health...
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BMJ Publishing Group
2020-09-01
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| author | Mark Hamer Dorairaj Prabhakaran Kavita Singh Nikhil Tandon Sanjay Kinra Kaushik Chattopadhyay Tess Harris Pallavi Mishra Sheila Margaret Greenfield Sarah Anne Lewis Nandi Krishnamurthy Manjunath Rukamani Nair Somnath Mukherjee David Ross Harper |
| author_facet | Mark Hamer Dorairaj Prabhakaran Kavita Singh Nikhil Tandon Sanjay Kinra Kaushik Chattopadhyay Tess Harris Pallavi Mishra Sheila Margaret Greenfield Sarah Anne Lewis Nandi Krishnamurthy Manjunath Rukamani Nair Somnath Mukherjee David Ross Harper |
| author_sort | Mark Hamer |
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| description | 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 with 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 multicentre, 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 5.6–6.9 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 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD 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. Semistructured 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); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.Trial registration number CTRI/2019/05/018893. |
| format | Article |
| id | doaj-art-358baba6e6ca4a85bca2dad5dffcdd16 |
| institution | Kabale University |
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| spelling | doaj-art-358baba6e6ca4a85bca2dad5dffcdd162025-01-07T13:00:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-036277Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocolMark Hamer0Dorairaj Prabhakaran1Kavita Singh2Nikhil Tandon3Sanjay Kinra4Kaushik Chattopadhyay5Tess Harris6Pallavi Mishra7Sheila Margaret Greenfield8Sarah Anne Lewis9Nandi Krishnamurthy Manjunath10Rukamani Nair11Somnath Mukherjee12David Ross Harper13Institute Sport Exercise and Health, Division of Surgery and Interventional Science, University College London, London, UKCentre for Chronic Disease Control, New Delhi, Delhi, India1 Pan-Birmingham Gynaecological Cancer Centre, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, West Midlands, UKAll India Institute of Medical Sciences, New Delhi, IndiaLondon School of Hygiene And Tropical Medicine, London, UKDivision of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, UKPopulation Health Research Institute, St George’s University of London, London, UKCentre for Chronic Disease Control, Delhi, IndiaInstitute of Applied Health Research, University of Birmingham, Birmingham, UKDivision of Epidemiology and Public Health, University of Nottingham, Nottingham, UKSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, IndiaBapu Nature Cure Hospital and Yogashram, Delhi, IndiaDepartment of Oncology, University of Oxford, Oxford, UKsenior consulting fellowIntroduction 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 with 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 multicentre, 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 5.6–6.9 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 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD 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. Semistructured 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); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.Trial registration number CTRI/2019/05/018893.https://bmjopen.bmj.com/content/10/9/e036277.full |
| spellingShingle | Mark Hamer Dorairaj Prabhakaran Kavita Singh Nikhil Tandon Sanjay Kinra Kaushik Chattopadhyay Tess Harris Pallavi Mishra Sheila Margaret Greenfield Sarah Anne Lewis Nandi Krishnamurthy Manjunath Rukamani Nair Somnath Mukherjee David Ross Harper Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol BMJ Open |
| title | Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol |
| title_full | Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol |
| title_fullStr | Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol |
| title_full_unstemmed | Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol |
| title_short | Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol |
| title_sort | yoga programme for type 2 diabetes prevention yoga dp among high risk people in india a multicentre feasibility randomised controlled trial protocol |
| url | https://bmjopen.bmj.com/content/10/9/e036277.full |
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