Yoga programme for type-2 diabetes prevention (YOGA-DP) among high-risk people in India: intervention development and feasibility study

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Diabetes (type-2) is a complex metabolic disorder with significant health, social and economic consequences. India has the world's second largest diabetic population. Another huge population in India is at high-risk of developing diabetes, i.e., their blood sugar levels are higher than normal but lower than the established threshold for diabetes itself. They are more likely to develop diabetes and its complications than people with normal blood sugar levels. Physical activity reduces blood sugar levels. However, physical activity levels are lower among Indians, especially among women and older people. Contemporary physical activities have some limitations, which includes their poor acceptability. Yoga, a mind-body discipline that originated in the Indian subcontinent, has some advantages over contemporary physical activities and can meet the aim of the recommended physical activity for diabetes prevention among high-risk people in India (target users).The main aim is to establish whether or not a yoga programme can prevent diabetes among high-risk people in India. This will be tested in a future main study. Before this, we will develop the programme content and will check with our study participants if the future main study can be conducted. This early phase study will be carried out in New Delhi, India - a huge population in New Delhi is at high-risk of developing diabetes.Qualified yoga practitioners will provide group yoga sessions, for 75 minutes, twice a week for six months at local community centres. The development of the programme content will include several steps, such as a systematic review of scientific literature to generate a list of yogic practices that are recommended for managing diabetes. Subsequently, at least 40 experts (yoga and exercise professionals) will validate each of these yogic practices. Based on this, the programme will be drafted and pre-tested among 20-30 target users, recruited using a multipronged approach (i.e., from the community as well as public and private healthcare providers). Yoga practitioners will provide the programme to them, followed by qualitative interviews to improve the programme. Once the programme details are finalised, a study will be conducted among at least 64 target users, to check if the future main study can be conducted. They will be randomly allocated either to the yoga programme group or the control group. The control group participants will receive enhanced standard care, i.e., a leaflet and a group session on routine physical activity advice. The multipronged approach will be used to recruit them. Quantitative data (numerical) will be collected and analysed on study-specific issues, such as a quantity which is needed to estimate study size of the future main study, recruitment and follow-up of participants, and attendance of yoga programme group participants in the yoga programme. Qualitative interviews will take place with 20-30 participants to explore how they have found participating in the study and any particular issues experienced. Those who decline to participate in the study will be interviewed to explore the reasons behind. If the feasibility of undertaking the future main study is promising, the main study will be conducted. If the yoga programme is found to be effective, it will be a low-cost local solution to prevent diabetes among high-risk people in India and to become healthier overall. The future clinical, personal and economic burden of diabetes on patients and their families will be prevented. The benefits of preventing diabetes may extend to the prevention of its complications. They will be provided with more evidence-based choices to meet the recommended physical activity for diabetes prevention. The programme will simultaneously empower participants to manage their health.