FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close