| CTRI Number |
CTRI/2025/06/088271 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
School Health Program About Preventing Common Long-Term Diseases |
|
Scientific Title of Study
|
Effectiveness of School Based Health Promotion Intervention for prevention & control of behavioral risk factors for Non-Communicable Disease: Multicentre cross sectional Pilot study |
| 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 Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
09223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
09223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
09223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital 3rd floor, Service block building, Dr. Ernest Borges road, Parel, Mumbai 400012, Maharshtra |
|
|
Primary Sponsor
|
| Name |
Dr Sharmila Pimple |
| Address |
Tata Memorial Hospital 3rd floor, Service block building, Dr. Ernest Borges road, Parel, Mumbai 400012, Maharshtra |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dolorosa Fernandes |
Homi Bhabha Cancer Hospital & Research Centre |
Department pf Preventive Oncology, Ground floor, Room no 83, Homi Bhabha Cancer Hospital & Research Centre, Vishakhapatnam 530053 Visakhapatnam ANDHRA PRADESH |
9820285625
drdolorosa@gmail.com |
| Dr Vandita Pahwa |
Homi Bhabha Cancer Hospital & Research Centre |
Department of Preventive Oncology, 2nd floor, Block B, Room no 208, Homi Bhabha Cancer Hospital and Research Centre, New Chandigarh 140901 Chandigarh CHANDIGARH |
8197127699
drvanditapahwa@gmail.com |
| Dr Sharmila Pimple |
Tata Memorial Hospital |
Department of Preventive Oncology
3rd Floor Service Block Building
Tata Memorial Hospital
Dr E Borges Marg
Mumbai 400012 Mumbai MAHARASHTRA |
09223207939
pimplesharmila@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-Communicable Disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NIL
|
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Schools with at least 70 students in Class 8.
2.Students aged 13-15 years attending Class 8 in the selected schools.
3.Students willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Schools with fewer than 70 students in Class 8.
2.Students outside Class 8 or outside the age group of 13-15 years.
3.Students unwilling to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhance knowledge about the importance of healthy lifestyle and its effect on health. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Transact & Conduct health promotion activities in schools. |
24 MONTH |
|
|
Target Sample Size
|
Total Sample Size="1200" Sample Size from India="1200"
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)
|
16/06/2025 |
| 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 Applicable |
| 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
Modification(s)
|
Non-communicable diseases (NCDs) like heart disease, diabetes, and cancer are increasing worldwide, affecting people at younger ages. Many of these diseases are caused by unhealthy behaviour’s such as poor diet, lack of exercise, and the use of tobacco and alcohol. Since these habits often begin in childhood, it is important to teach young people how to live healthier lives early on. The School Health Project aims to educate school children aged 13-15 years (8th grade) about the importance of a healthy diet, regular physical activity, and the dangers of tobacco and alcohol use. The project will take place in public and private schools in Mumbai, Punjab, and Visakhapatnam, involving 1,200 students. The project will use interactive classroom sessions, educational videos, and printed materials to improve students’ knowledge and encourage healthier behaviours. A team of trained professionals, including doctors and health educators, will conduct these sessions. Students’ knowledge and habits will be measured before and after the program to assess its impact. The goal is to reduce unhealthy behaviour’s and promote lifelong healthy habits. If successful, this project could be expanded to more schools across India. |