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临床试验/CTRI/2024/08/071842
CTRI/2024/08/071842尚未招募2 期

A randomized controlled trial to see effect of community-basedYoga Program on diabetes, blood pressure, lipid profile and wellness in Rural and Tribal Community Setting, and its feasibility to integrate with Health and Wellness centres (HWC) in the country

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
384
试验地点
1
主要终点
Positive outcome of yoga on diabetes, lipid profile,blood pressure and wellness, in rural and tribal areas

研究概览

简要总结

Background: In view of the rising burden of type 2 diabetes mellitus (DM) cases in India, there is an urgent need for an effective, low‐cost, sustainable intervention to control diabetes thus preventing complications. We plan to study the role of yoga in rural and tribal community settings among diabetics to see the impact of yoga in real-life community-based settings rather than facility-based experimental settings with integration to Health and Wellness Centres (HWC).

Yoga has been seen to be beneficial not only in preventing these diseases but also in treatment of many of these.  However, most of studies have been done in a facility based setting, and once person go out of it, many of them discontinue it.

Novelty: This study looks at the effect of yoga done in a community setting at doorstep along with looking feasibility of yoga in field setting.  We have successfully demonstrated in urban community.  To replicate it for masses, we need to demonstrate benefits in rural and tribal communities too, along with exploring challenges and its solutions for field-based yoga implementation in these communities. More importantly we are looking to integrate it with Health and wellness centres (HWCs) under Ayushman Bharat for long term sustainability for huge rural and tribal population of the country even in remotest areas so as to make it successful for this underprivileged group while controlling NCDs such as Diabetes Mellitus. In essence, by integrating various discrete stages of usual research design, we provide a superior methodology in making yoga a “Jan-Andolan”. Furthermore, to our knowledge, no community-based study has been conducted in rural and tribal area on effect of structured yoga program on diabetes, hypertension and wellness.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • General population at least 18 years of age or above 18 years to 65 years of age.
  • Willing to participate, give consent and continue yoga practice.
  • Living in community for at least 6 months.

排除标准

  • Any major illness which limits their capability to do yoga.
  • Pregnant women.

结局指标

主要结局

Positive outcome of yoga on diabetes, lipid profile,blood pressure and wellness, in rural and tribal areas

时间窗: 3 6 and 12 months

次要结局

  • To comprehend the feasibility of impregnating structured yoga program in low- and middle-income socio-economic community setting which would provide evidence for policy making to integrate it with Health and Wellness Centers (HWCs) and help in making sustainable and effective community setting-based yoga intervention program for larger populations for control and prevention of diabetes and other health related issues all over the country in different settings(3 6 and 12 months)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Puneet Misra

AIIMS, New Delhi

研究点 (1)

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