| CTRI Number |
CTRI/2020/02/023384 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
High Intensity Short Interval Dance Intervention for prevention of lifestyle diseases in Indian Adolescent Girls |
|
Scientific Title of Study
|
A Novel High Intensity Short Interval Dance Intervention for Non-Communicable Disease (NCD) Prevention in Asian Indian Adolescent Girls – THANDAV - a pilot study |
| Trial Acronym |
THANDAV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RM Anjana |
| Designation |
Managing Director |
| Affiliation |
Dr. Mohans Diabetes Specialities Centre and Madras Diabetes Research Foundation |
| Address |
No.6B
Conran Smith Road
Near Satyam Cinemas Gopalapuram
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
044-43968888 |
| Fax |
044-28350935 |
| Email |
dranjana@drmohans.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjani Harish |
| Designation |
Sr. Scientist and HOD Translational Research |
| Affiliation |
Dr. Mohans Diabetes Specialities Centre and Madras Diabetes Research Foundation |
| Address |
No 6B
Conran Smith Road
Near Satyam Cinemas Gopalapuram
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
044-43968888 |
| Fax |
28350935 |
| Email |
drranjanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjani Harish |
| Designation |
Sr. Scientist and HOD Translational Research |
| Affiliation |
Dr. Mohans Diabetes Specialities Centre and Madras Diabetes Research Foundation |
| Address |
No 6B
Conran Smith Road
Near Satyam Cinemas Gopalapuram
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
044-43968888 |
| Fax |
28350935 |
| Email |
drranjanih@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Research Council
2nd Floor David Phillips Building, Polaris House, North Star
Avenue, Swindon,
United Kingdom SN2 1ET |
|
|
Primary Sponsor
|
| Name |
Medical Research Council MRC RCUK |
| Address |
2nd Floor David Phillips Building, Polaris House, North Star
Avenue, Swindon,
United Kingdom SN2 1ET |
| Type of Sponsor |
Government funding agency |
|
|
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 RM Anjana |
Dr. Mohans Diabetes Specialities Centre |
4, Conran Smith Road
Gopalapuram
Chennai 600080
Chennai
TAMIL NADU |
43968888
28350935
dranjana@drmohans.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Improving fitness in Indian Adolescent girls (10 to 17 years) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HIIT based dance intervention. |
The 10-min THANDAV routine will be developed in association with seasoned choreographers to ensure the ease and safety of the steps being performed. There will be a 2-min high intensity portion followed by a 30-sec low intensity and four such repetitions will constitute a single 10-min routine. This will be taught to the participants by the trained personnel. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
a) Consent and availability of the school and students for the 12 consecutive weeks required for the study
b) Commitment of parents and students to all aspects of the study protocol to ensure completion of data
C) No underlying medical conditions that can affect intervention. |
|
| ExclusionCriteria |
| Details |
Any Underlying medical conditions that can affect the intervention |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in fitness levels of adolescent girls as measured by step count and heart rate. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the metabolic parameters like height, weight, waist circumference and blood pressure |
End of the study |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/02/2020 |
| Date of Study Completion (India) |
31/03/2023 |
| 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)?
|
|
Brief Summary
|
We aim to develop and assess the feasibility, acceptability and improvement in physical activity and fitness levels by a culturally appropriate novel 12- week HIIT dance intervention in Asian Indian girls aged 10 – 17 years enabled by digital technology. The 10-min THANDAV routine will be developed in association with seasoned choreographers to ensure the ease and safety of the steps being performed. There will be a 2-min high intensity (80-100% of max heart rate (HR) achievement) portion followed by a 30-sec low intensity (40-60% max HR) and four such repetitions will constitute a single 10-min routine. This kind of an intervention is the first of its kind and will offer a novel approach to help improve long-term sustainability of physical activity in young women. The THANDAV intervention will be taught by choreographers as part of a 2-day workshop at selected schools. The choreographers and fitness personnel will have the opportunity to teach and engage the students during these classes. A new 10- min routine will be released every month thus by the end of the 3-month period, participants will have been taught three routines. By learning new dance routines instead of repeating a single 10- minute routine, researchers will sustain the interest of the participants throughout the 12-week period. Participants will receive a CD of the intervention, which will also be available on the ‘THANDAV’ digital platform - a website from where they can view, download and save ‘THANDAV’ videos on their computers/laptops/smart phones, allowing them to practice between workshops and later.
|