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

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.

India has the world's second largest type-2 diabetes (T2DM) epidemic. Another huge population in India is at high-risk of T2DM (their blood sugar concentrations are higher than normal). They are more likely to develop T2DM and its complications than people with normal concentrations. Physical activity is effective in reducing blood sugar concentrations. However, physical activity levels are lower among Indians, especially among women and older people. Contemporary physical activities have some limitations. Yoga, an ancient Indian mind-body exercise, has some advantages over contemporary physical activities and can meet the aim of the recommended physical activity for T2DM prevention among high-risk people in India.

The overarching aim is to explore whether a yoga programme can prevent T2DM among these high-risk people as compared to enhanced standard care. Group yoga sessions will be provided by yoga practitioners, for 75 minutes, twice a week for six months. The enhanced standard care will include a leaflet and a group session on routine physical activity advice, delivered by a different team member. Intending to following up this work with a future randomised controlled trial (RCT), the subsidiary objectives of this early phase study are:

1) To develop the intervention: A systematic iterative process will be followed to develop the intervention content. A systematic review will be conducted to generate a list of yogic practices that are recommended for managing diabetes. Then, yoga and exercise professionals will validate these yogic practices. The prototype intervention will be drafted and pre-tested among our study participants.

2) To determine the feasibility of undertaking the future RCT: Participants will be recruited and randomised to intervention and control groups. Quantitative data will be collected to estimate important parameters that are needed to design the RCT. Semi-structured interviews will be conducted to explore study-specific issues.

The whole project has the potential to directly benefit people (who are at high-risk of type-2 diabetes (T2DM)), health policy makers and managers, and yoga practitioners in India.

Health interventions should be informed by and compatible with social and cultural expectations of people and their health beliefs. Yoga, an ancient Indian therapy, is such an intervention in India. If the feasibility of undertaking the future randomised controlled trial is promising, it will be conducted to determine the effectiveness of the intervention. If found to be effective, it will be a low-cost local solution to prevent T2DM among high-risk Indians and to become healthier overall. The future clinical, personal and economic burden of T2DM on patients and their families will be prevented. The benefits of preventing T2DM may extend to the prevention of its complications. They will be provided with more evidence-based choices to meet the recommended physical activity for T2DM prevention. The intervention booklet for participants, a commonly used format for yoga practice in India, will be available in local languages. The booklet will inform participants and the public about what the yoga practitioners should be teaching, further influencing their adoption. The intervention will simultaneously empower participants to manage their health. It will reduce health inequalities in T2DM prevention and be beneficial to all of the society.

The Indian government is committed to and has prioritised the prevention and management of chronic diseases like T2DM through traditional Indian therapies like yoga. The idea of United Nation's International Day of Yoga (21 June) was first proposed by the Indian government. The Ministry of AYUSH is dedicated exclusively towards traditional Indian therapies. The intervention could be used alongside the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke. Policy makers and managers (of public and private healthcare providers) will benefit from the availability of a low-cost and acceptable solution to prevent T2DM since more expensive T2DM prevention models currently in use in developed countries are unaffordable to them. The future economic burden of T2DM on the health system and the economy will be prevented. The intervention may improve the efficiency of healthcare (through the standardised prevention package), providing better value for money. The intervention manual for yoga practitioners (detailing structure and content) can be used to do their prospective and retrospective audits (in preventing T2DM) - it will provide ready process measures (review criteria) for rating compliance with best practices, which will support quality improvement activities.

In India, public as well as private healthcare providers employ yoga practitioners, both in urban and rural areas (such as under the National Rural Health Mission). Other healthcare professionals, especially those who provide advice on T2DM prevention, can recommend the intervention to high-risk people. Yoga practitioners will potentially get a boost due to greater interest in their services, and this may also enhance their job opportunities. They will have access to a well-developed and well-tested intervention for T2DM prevention. The intervention will close the gap between what they do for preventing T2DM and what scientific evidence supports. It will reinforce their position in T2DM prevention and offer them medico-legal protection.

Yoga is also popular in many other countries. Given that T2DM prevention is a global concern and costs are a concern everywhere, a low-cost T2DM prevention option will be of interest in other countries, particularly in other South Asian countries and in countries with South Asian ethnic minorities. The intervention can be adapted, evaluated and implemented to prevent T2DM in other settings or populations. Thus, the study has the potential to impact around the world.