| CTRI Number |
CTRI/2025/07/091869 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [educational, physical fitness training and Yoga] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Improving Adolescent Health Through a School-Based Program: A Study on Physical, psychosocial, and Sexual Well-Being |
|
Scientific Title of Study
|
Effect of Integrated School-Based Intervention on Physical, Psychosocial, And Sexual Health among
Adolescents. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joelita Dsouza |
| Designation |
Tutor/ Ph.D Scholar |
| Affiliation |
New Bombay college of Nursing , MGM institute of health sciences |
| Address |
Staff room No. 3 first floor Institute of Nursing Education Bambolim Goa, India
MGMIHS sector1, kamothe , Navi Mumbai
South Goa
GOA
403201
India |
| Phone |
9850247665 |
| Fax |
|
| Email |
joelitadsouza@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sindhu Thomas |
| Designation |
Associate Professor |
| Affiliation |
New Bombay college of Nursing , MGM institute of health sciences |
| Address |
MGM New Bombay college of nursing, MGM educational campus, Plot No 1 and 2 Sctor 1 Kamothe Navi Mumbai ,India
MGMIHS sector1, kamothe , Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9920108477 |
| Fax |
|
| Email |
s.thomas@mgmudn-nm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Joelita Dsouza |
| Designation |
Tutor/ Ph.D Scholar |
| Affiliation |
New Bombay college of Nursing , MGM institute of health sciences |
| Address |
Staff room No 3 first floor child health department institute of Nursing education Bambolim Goa India
MGMIHS sector1, kamothe , Navi Mumbai
North Goa
GOA
403201
India |
| Phone |
9850247665 |
| Fax |
|
| Email |
joelitadsouza@gmail.com |
|
|
Source of Monetary or Material Support
|
| institute of Nursing Education Bambolim Goa,India 403201. |
| Self |
|
|
Primary Sponsor
|
| Name |
Joelita Dsouza |
| Address |
Staff room No 3 first floor child health department institute of Nursing education Bambolim Goa India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Joelita Dsouza |
higher secondary schools in Goa |
Goa
South Goa
GOA |
9850247665
joelitadsouza@gmail.com |
| Joelita Dsouza |
high schools in Goa |
Goa
South Goa
GOA |
9850247665
joelitadsouza@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ethics committee of Directorate of Health Services Goa |
Approved |
| The ethics comitte for Research on Human Sunjects of MGM Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
No new intervention will be done pre test and post test will be conducted. routien or standard procedure will be carried out among this group. |
| Intervention |
integrated school baed intervention |
a education session will be conducted on sexual health of the adolescent. followed by physical fitness and yoga session for 20 minutes each. 3 times a week. the data will be collected before the intervention and 1 month , 3 months and 6 months post intervention. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents aged 14 to 19 years of age.
Both males and female participants
Adolescents who are present during the data collection in higher secondary school and high schools.
Samples who willing to sign informed assent and a written parental consent.
|
|
| ExclusionCriteria |
| Details |
Adolescent who are out of schools.
Adolescents with any diagnosed health conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
BMI
Stress level score
emotional stability score
knowledge score on sexual health in adolescents |
Baseline
4th weeks
12th weeks
24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/12/2025 |
| 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="2"
Months="0"
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
|
Youth is the period between childhood and adulthood, marked by important changes in the body,
mind, and social life. It is not defined by a single age range across all countries. For global
statistics, the World Health Organization (WHO) considers adolescents to be 10–19 years old and
youth to be 15–24 years old. In India, the National Youth Policy defines youth as those aged 13–35
years. Together, this population forms a significant part of India’s demographic profile,
highlighting the importance of focusing on their health and development.
Adolescence is a crucial stage for developing healthy habits, coping skills, and a strong foundation
for adult life. It is also a time when physical, emotional, and sexual health issues can emerge.
Despite this, there are still gaps in how adolescent health is monitored and supported—especially
at the state level.
This study focuses on assessing the effect of an integrated school-based intervention aimed at
improving the physical, psychosocial, and sexual health of adolescents. The intervention (education on sexual health, physical fitness training and yogasessions) will be
delivered within the school setting and will address health education, life skills, and supportive
practices that promote healthy development. The goal is to provide early support that can lead to
better outcomes in adolescence, adulthood, and even for future generations.
By evaluating the impact of this intervention, the study hopes to generate valuable insights that can
guide policies, improve adolescent health programs, and strengthen the support system for young
people in Goa. |