| CTRI Number |
CTRI/2025/08/092965 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A study to find the impact of behaviour modification strategies on sedentary behaviour among adolescents in selected urban Schools in South India |
|
Scientific Title of Study
|
Impact of Behavior Modification Strategies on Sedentary Behaviour Among Adolescents in selected urban Schools in South India |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Glory H |
| Designation |
Phd nursing research scholar Associate Professor |
| Affiliation |
PSG COLLEGE OF NURSING |
| Address |
PSG college of nursing
Peelamedu
Coimbatore
Department of Pediatric Nursing,
PSG College of Nursing,
Avinashi road, Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9626484080 |
| Fax |
|
| Email |
gloryharis81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nalini.M |
| Designation |
HOD, Professor, Department of Psychiatric Nursing, |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Department of Psychiatric Nursing,
Nitte Usha Institute of Nursing Sciences,
Mangalore
Department of Psychiatric Nursing,
Nitte Usha Institute of Nursing Sciences,
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8095679510 |
| Fax |
|
| Email |
nalini@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Glory H |
| Designation |
Phd nursing research scholar Associate Professor |
| Affiliation |
PSG COLLEGE OF NURSING |
| Address |
PSG college of nursing
Peelamedu
Coimbatore
Department of Pediatric Nursing,
PSG College of Nursing,
Avinashi road, Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9626484080 |
| Fax |
|
| Email |
gloryharis81@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Sarvajana HIgher secondary school & ABC school
|
|
|
Primary Sponsor
|
| Name |
Glory H |
| Address |
Department of Pediatric Nursing,
PSG college of nursing
Peelamedu
Coimbatore -641004
9626484080
Email ID gloryharis81@gmail.com |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Glory H |
PSG sarvajana school & ABC school |
Peelamedu
Coimbatore
Coimbatore
TAMIL NADU |
9626484080
gloryharis81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Nitte usha institute of nursing sciences |
Approved |
| School permission letter |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sedentary adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
No control group |
| Intervention |
Play activities in form of games and nutritional counselling |
Games asper their likes once in a week for 30 minutes for duration for a period of 9 months and nutritional counselling for healthy diet |
| Intervention |
Tai chi slow movement exercise |
Tai chi slow mind body movements for 30 mts once in a week for 9 months duration |
| Intervention |
Yoga asanas |
Yoga asanas for 30 mts once in a week for 9 months duration |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents with sedentary and under active
Adolescents who are willing to participate
Adolescents who give assent and parental consent to take part in study |
|
| ExclusionCriteria |
| Details |
Adolescents who are sick
Adolescents with physical disabilities
Adolescents who are attending extra physical activity classes
Obese Adolescents with normal physical activity |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sedentary behaviour, anthropometric measurements, dietary behaviour |
Initial survey at 1st week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction of sedentary behaviour, physical activity & dietary behaviour |
12 weeks, 24 weeks & 36 weeks |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Impact of behaviour modification strategies on sedentary behaviour among adolescents in selected urban Schools in South India is planned to be conducted on June 2025 to establish healthy lifestyle among adolescents. |