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

糖尿病（2型）是一种复杂的代谢紊乱，具有严重的健康、社会和经济后果。印度拥有世界第二大糖尿病人口。印度的另一大人口是糖尿病高危人群，即他们的血糖水平高于正常水平，但低于糖尿病本身的既定阈值。与血糖水平正常的人相比，他们更容易患上糖尿病及其并发症。体育活动可以降低血糖水平。然而，印度人的体育活动水平较低，尤其是女性和老年人。当代体育活动存在一定的局限性，包括可接受性差。瑜伽，一种起源于印度次大陆的身心训练，比当代的体育活动有一些优势，可以满足印度高危人群（目标用户）预防糖尿病的推荐体育活动的目的。主要目的是确定瑜伽项目是否可以预防印度高危人群的糖尿病。这将在未来的主要研究中进行测试。在此之前，我们将制定节目内容，并将与我们的研究参与者确认是否可以进行未来的主要研究。这项早期阶段的研究将在印度新德里进行——新德里的人口众多，患糖尿病的风险很高。合格的瑜伽练习者将在当地社区中心提供为期六个月的团体瑜伽课程，每周两次，每次75分钟。该计划内容的发展将包括几个步骤，例如对科学文献进行系统的审查，以生成一份用于管理糖尿病的推荐瑜伽练习清单。随后，至少40位专家（瑜伽和运动专业人士）将验证这些瑜伽练习。在此基础上，将起草方案并在20-30个目标用户中进行预先测试，这些用户采用多管齐下的方法（即从社区以及公共和私营医疗保健提供者中招募）。瑜伽练习者将向他们提供课程，然后进行定性访谈以改进课程。一旦方案细节定稿，我们将在至少64个目标用户中进行一项研究，以检查是否可以进行未来的主要研究。他们将被随机分配到瑜伽项目组或对照组。对照组参与者将接受强化的标准护理，即发放传单和进行常规体育活动建议的小组会议。将采用多管齐下的方法来招募他们。定量数据（数字）将收集和分析研究具体问题，如估计未来主要研究的研究规模所需的数量，参与者的招募和随访，瑜伽课程组参与者的出席率。将对20-30名参与者进行定性访谈，以探讨他们如何发现参与研究以及遇到的任何特定问题。那些拒绝参加研究的人将接受采访，以探讨背后的原因。如果进行未来主要研究的可行性有希望，将进行主要研究。如果瑜伽项目被发现是有效的，它将成为一种低成本的地方性解决方案，以预防印度高危人群的糖尿病，并使其整体变得更健康。未来糖尿病对患者及其家庭的临床、个人和经济负担将得到预防。预防糖尿病的好处可能延伸到预防其并发症。他们将获得更多基于证据的选择，以满足预防糖尿病的推荐体育活动。该方案将同时赋予参与者管理自身健康的能力。

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.