| CTRI Number |
CTRI/2017/08/009203 [Registered on: 01/08/2017] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga in Indian Adolescents. |
|
Scientific Title of Study
|
The Impact of Yoga on Stress, Metabolic Parameters and Cognition (Attention & Concentration) of Indian Adolescents
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R M Anjana |
| Designation |
VICE-PRESIDENT |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
NO 4, CONRAN SMITH ROAD,
GOPALAPURAM,
CHENNAI
Chennai
TAMIL NADU
600 086
India |
| Phone |
91-44-43968888 |
| Fax |
91-44-283509345 |
| Email |
dranjana@drmohans.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RANJANI HARISH |
| Designation |
SR. SCIENTIST & HEAD - TRANSLATIONAL RESEARCH |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
NO 4, CONRAN SMITH ROAD,
GOPALAPURAM,
CHENNAI
Chennai
TAMIL NADU
600 086
India |
| Phone |
91-44-43968888 |
| Fax |
91-44-283509345 |
| Email |
ranjani@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
DR RANJANI HARISH |
| Designation |
SR. SCIENTIST & HEAD - TRANSLATIONAL RESEARCH |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
NO 4, CONRAN SMITH ROAD,
GOPALAPURAM,
CHENNAI
Chennai
TAMIL NADU
600 086
India |
| Phone |
91-44-43968888 |
| Fax |
91-44-283509345 |
| Email |
ranjani@mdrf.in |
|
|
Source of Monetary or Material Support
|
| INDIAN COUNCIL OF MEDICAL RESEARCH
V. Ramalingaswami Bhawan
P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029
India |
|
|
Primary Sponsor
|
| Name |
INDIAN COUNCIL OF MEDICAL RESEARCH |
| Address |
V. Ramalingaswami Bhawan
P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR YASHDEEP GUPTA |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Department of Endocrinology and metabolism
Room no 308, Biotechnology building
ANSARI NAGAR, NEW DELHI, INDIA
South
DELHI |
01126593645
01126588663
yash_deep_gupta@yahoo.co.in |
| DR RM ANJANA |
MADRAS DIABETES RESEARCH FOUNDATION |
Department of Diabetology and Physical Activity
NO 4, CONRAN SMITH ROAD, GOPALAPURAM, CHENNAI 600 086,
Chennai
TAMIL NADU |
044-43968888
044-28350935
dranjana@drmohans.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences (AIIMS) |
Approved |
| MADRAS DIABETES RESEARCH FOUNDATION INSTITUTIONAL ETHICS COMMITTEE, CHENNAI, ECR/194/Inst./TN/2013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress levels, metabolic parameters such as body weight, waist circumference, pulse rate, body fat and blood pressure and Attention span and concentration of the subjects will be studied. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
The programe will start with a 45 minute session on healthy living (which will include 15 minutes on healthy eating, 10 minutes on increasing physical activity among adolescents and 10 minutes of simple stretching / exercises and 10 minutes of question and answer). In the control schools, this will be delivered once a month for 5 months where students can also participate and actively discuss to clear any doubts they might have. |
| Intervention |
Yoga |
The program will start with a 45 minute session on healthy living (which will include 15 minutes on healthy eating, 10 minutes on increasing physical activity among adolescents and 10 minutes of simple stretching / exercises and 10 minutes of question and answer). In the intervention schools, this will be delivered only once at the start of the program. For Participants randomized to this group, Yoga sessions will be held twice weekly (16 sessions) for the first two months followed by weekly (8 sessions) for the next two months with a final refresher session in the 5th month (total 25 sessions). These will be held in the school premises for around 45 minutes (one period/class)and will be taught by a trained yoga master. The adolescents will additionally be taught a shorter 10-minute version, which they will need to practise at home on a daily basis.
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Participants in the age groups of 13-15 years (grades VIII-X) from randomly selected
government and private schools across two cities (New Delhi (NCR) and Chennai) will be enrolled into this study |
|
| ExclusionCriteria |
| Details |
Any serious illness |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of an intensive 25-session yoga intervention in adolescents on:
Stress levels, Metabolic parameters, Adoption of healthy lifestyle behaviours and Attention span and concentration |
Baseline, 4 months, 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of yoga intervention on Adoption of healthy lifestyle behaviours and Attention span and concentration |
Baseline, 4 months, 6 months. |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "1807"
Final Enrollment numbers achieved (India)="1807" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2018 |
| Date of Study Completion (India) |
01/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Although yoga is undoubtedly of great value in improving health and well-being, scientific data on metabolic benefits have not been clearly elucidated from India. There have been scattered
reports on the usefulness of yoga in adults, but its value on the health and well-being
of children
has
not been much studied. This study will examine the effectiveness of a school based yoga intervention on stress levels, metabolic parameters and cognition of adolescents studying in grades VIII – X (~ aged 13-15 years). Various standardized tools will be used for measurement
of stress, cognition and behavioral habits (dietary profile, physical activity) as well as
anthropometric and clinical parameters. Appropriate statistical tests will be used to study associations and analyze the outcomes.
We hypothesize that yoga as an intervention in a school setting can be a potentially efficacious strategy for improving child and adolescent health. This project can
help
to study the effects of yoga on the mental
and metabolic health of Indian youth. |