Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India: A Multicenter Feasibility Randomized Controlled Trial.

Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India: A Multicenter Feasibility Randomized Controlled Trial.
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DOI:
10.1007/s13300-023-01395-4
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发表时间:
2023-07
期刊:
影响因子:
3.8
通讯作者:
Prabhakaran, Dorairaj
Prabhakaran, Dorairaj
中科院分区:
医学4区
文献类型:
--
作者:
Chattopadhyay, Kaushik;Mishra, Pallavi;Singh, Kavita;Singh, Kalpana;Harris, Tess;Hamer, Mark;Greenfield, Sheila Margaret;Manjunath, Nandi Krishnamurthy;Nair, Rukamani;Mukherjee, Somnath;Tandon, Nikhil;Lewis, Sarah Anne;Kinra, Sanjay;Prabhakaran, Dorairaj

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2型糖尿病(T2 DM)是一种常见的糖尿病。血糖水平可以通过健康的生活方式(如体育活动和健康的饮食)来改善。瑜伽可以帮助预防T2 DM,是一种文化上适当的改善生活方式的方法。我们开发了T2 DM预防瑜伽计划(YOGA-DP),这是一个为期24周的结构化生活方式教育和锻炼(瑜伽)计划,其中包括27个小组瑜伽课程和在家自我练习瑜伽。在这项研究中,进行一项明确的随机对照试验(RCT)的可行性进行了探讨,将评估干预措施的有效性在印度的高风险个人。在印度进行了一项多中心、两组、平行组、可行性RCT。结局评估员和数据分析员均设盲。空腹血糖水平为100-125 mg/dL(即,2型糖尿病高风险患者)。使用计算机生成的随机化时间表对参与者进行集中随机化。在干预组中,参与者接受了YOGA-DP。在对照组中,参与者接受了加强的标准护理。在本次可行性试验中,参与者的招募耗时4个月(2019年5月至9月)。我们筛选了711人,评估了160人的资格。65名参与者(干预组33名,对照组32名)被随机分组,57名(88%)参与者被随访6个月(干预组32名,对照组25名)。在干预组中,32名(97%)参与者持续参加集体瑜伽课程(参加课程的中位数(四分位数范围,IQR)= 27(3))。在干预组中,30名(91%)参与者在家中自我练习瑜伽(每周的中位数(IQR)天数和每天自我练习的分钟数分别为2(2)和35(15))。在对照组中,一名(3%)参与者在可行性试验期间参加了为期1周的外部瑜伽课程(Pranayama)。未发生严重不良事件。在这项可行性研究中,参与者的招募、随访和对干预措施的坚持是有希望的。在对照组中,潜在污染较低。因此,在未来进行一项明确的随机对照试验来评估YOGA-DP在印度高危人群中的有效性应该是可行的。印度临床试验注册中心(CTRI)CTRI/2019/05/018893;于2019年5月1日注册。
Many Indians are at high risk of type 2 diabetes mellitus (T2DM). The blood glucose level can be improved through a healthy lifestyle (such as physical activity and a healthy diet). Yoga can help in T2DM prevention, being a culturally appropriate approach to improving lifestyle. We developed the Yoga Programme for T2DM Prevention (YOGA-DP), a 24-week structured lifestyle education and exercise (Yoga) program that included 27 group Yoga sessions and self-practice of Yoga at home. In this study, the feasibility of undertaking a definitive randomized controlled trial (RCT) was explored that will evaluate the intervention’s effectiveness among high-risk individuals in India. A multicenter, two-arm, parallel-group, feasibility RCT was conducted in India. The outcome assessors and data analysts were blinded. Adults with a fasting blood glucose level of 100–125 mg/dL (i.e., at high risk of T2DM) were eligible. Participants were randomized centrally using a computer-generated randomization schedule. In the intervention group, participants received YOGA-DP. In the control group, participants received enhanced standard care. In this feasibility trial, the recruitment of participants took 4 months (from May to September 2019). We screened 711 people and assessed 160 for eligibility. Sixty-five participants (33 in the intervention group and 32 in the control group) were randomized, and 57 (88%) participants were followed up for 6 months (32 in the intervention group and 25 in the control group). In the intervention group, the group Yoga sessions were continuously attended by 32 (97%) participants (median (interquartile range, IQR) number of sessions attended = 27 (3)). In the intervention group, Yoga was self-practiced at home by 30 (91%) participants (median (IQR) number of days per week and minutes per day self-practiced = 2 (2) and 35 (15), respectively). In the control group, one (3%) participant attended external Yoga sessions (on Pranayama) for 1 week during the feasibility trial period. There was no serious adverse event. The participant recruitment and follow-up and adherence to the intervention were promising in this feasibility study. In the control group, the potential contamination was low. Therefore, it should be feasible to undertake a definitive RCT in the future that will evaluate YOGA-DP’s effectiveness among high-risk people in India. Clinical Trials Registry—India (CTRI) CTRI/2019/05/018893; registered on May 1, 2019.
DOI: 10.2337/dc14-2814
发表时间: 2015-08-01
期刊: DIABETES CARE
影响因子: 16.2
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期刊: INTERNAL MEDICINE
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