Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK
Centre for Chronic Disease Control, Delhi, India.
BMJ Open. 2020 Sep 6;10(9):e036277. doi: 10.1136/bmjopen-2019-036277.
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.
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.
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 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.
CTRI/2019/05/018893.
印度有大量人口面临 2 型糖尿病（T2DM）的高风险。身体活动和健康饮食（健康的生活方式）可改善 T2DM 高危人群的血糖水平。然而，不健康的生活方式在印度人中很常见。瑜伽涵盖了身体活动和健康饮食，可以帮助预防 T2DM。主要随机对照试验（RCT）要解决的研究问题是，与强化标准护理相比，预防 T2DM 的瑜伽方案（YOGA-DP）是否能有效预防印度高危人群的 T2DM。在本当前研究中，我们正在确定进行主要 RCT 的可行性。
YOGA-DP 是一种结构化的生活方式教育和运动计划。运动部分基于瑜伽，包括 Shithilikarana Vyayama（松解运动）、Surya Namaskar（太阳敬礼运动）、Asana（瑜伽姿势）、Pranayama（呼吸练习）和 Dhyana（冥想）和放松练习。
这是一项多中心、两臂、平行组、可行性 RCT，采用盲法结局评估和综合混合方法过程评估。合格的参与者应年龄在 18-74 岁之间，处于 T2DM 的高风险（空腹血糖水平 5.6-6.9mmol/L），并且能够安全地进行身体活动。将有至少 64 名参与者被随机分配到干预组或对照组，最终随访时间为 6 个月。将估计设计主要 RCT 所需的重要参数，例如结局测量（6 个月随访时的空腹血糖水平）的标准差、招募、干预依从性、随访、潜在污染和进行研究所需的时间。将对 20-30 名参与者、拒绝参与的参与者样本、4 名 YOGA-DP 指导员和大约 8 名研究人员进行半结构化定性访谈，以探讨他们对参与研究和干预的看法和经验、不参与的原因、实施干预和开展研究的经验。
以下研究伦理委员会已批准伦理：诺丁汉大学医学与健康科学学院（英国）；慢性病控制中心（CCDC，印度）；Bapu 自然疗法医院和瑜伽静修处（BNCHY，印度）和斯瓦米·维韦卡南达瑜伽阿南萨那萨姆斯坦（S-VYASA，印度）。结果将通过多种途径在主要利益攸关方中广泛传播。
CTRI/2019/05/018893。
