| CTRI Number |
CTRI/2024/08/071842 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of community-based Yoga Program on diabetes, blood pressure, lipid profile and wellness in Community Setting |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 30 Centre for Community Medicine Old OT Block AIIMS New Delhi
South DELHI 110029 India |
| Phone |
01126593773 |
| Fax |
|
| Email |
drpuneetresearch@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 30 Centre for Community Medicine Old OT Block AIIMS New Delhi
DELHI 110029 India |
| Phone |
01126593773 |
| Fax |
|
| Email |
drpuneetresearch@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 30 Centre for Community Medicine Old OT Block AIIMS New Delhi
DELHI 110029 India |
| Phone |
01126593773 |
| Fax |
|
| Email |
drpuneetresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Puneet Misra |
All India Institute of Medical Sciences, New Delhi |
Centre for Community Medicine, Old OT Block South DELHI |
9810696386
doctormisra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
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
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable. We will offer intervention to the wait-listed control group as per standard practice once the study participant completes follow-up. |
We will compare these findings from the area in the wait-listed control arm of study where we will continue to give routine intervention as per standard practice once the study participant completes follow up.
These individuals will be followed up for a total of twelve months.
They will be evaluated at three, six and twelve months from baseline data.
|
| Intervention |
Structured yoga program |
Structured Yoga Program developed by trained personnel from Centre for Integrated Medicine and Research AIIMS, New Delhi will be used for the study as an intervention program.
Two-week intensive yoga training at community setting (rural and tribal), followed by yoga at a place convenient to them for next 10 weeks with biweekly home visits by research staff and yoga instructor to see compliance with offer to help if any required for training there.
Participants will be encouraged to continue yoga same way, unsupervised after 12 weeks to see long term feasibility, however they will be offered help if they actively seek by contacting us to make them self-reliant.
These individuals will be followed up for a total of twelve months and effect will be evaluated after three, six and twelve months from baseline data. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- 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
|
|
| ExclusionCriteria |
| Details |
- Any major illness which limits their capability to do yoga
- Pregnant women
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive outcome of yoga on diabetes, lipid profile,blood pressure and wellness, in rural and tribal areas |
3 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="384" Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: In view of the rising burden of type 2 diabetes mellitus (DM) cases in India, there is an urgent need for an effective, lowâ€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-Andolanâ€. 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. |