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CTRI Number  CTRI/2025/07/090356 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   A study for enabling high school students to combat communicable diseases. 
Scientific Title of Study   Developing and testing a One Health educational module for enabling the community engagement to prevent communicable diseases: A quasi – experimental study among high school children of Udupi Taluk  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishikant Kumar 
Designation  Research scholar 
Affiliation  Institute: Department of Basic Medical Sciences 
Address  Department of Basic Medical sciences, MAHE, Manipal, Udupi, Karnataka, India, 576104
Department of Basic Medical sciences, MAHE, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India 
Phone  9740628718  
Fax    
Email  nishikant.dbmsmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sreejith G 
Designation  Associate Professor and deputy Registrar- Evaluation 
Affiliation  Institute: Department of Basic Medical Sciences 
Address  Department of Microbiology, Department of Basic Medical sciences, MAHE, Manipal, Udupi, Karnataka, India, 576104
Department of Basic Medical sciences, MAHE, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India 
Phone  9980959353  
Fax    
Email  g.sreejith@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Peralam Yegneswaran Prakash 
Designation  Associate Professor 
Affiliation  Kasturba Medical College 
Address  Department of Microbiology, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9886616153  
Fax    
Email  prakash.py@manipal.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Nishikant Kumar 
Address  Department of Basic Medical Sciences, Melaka Manipal Medical College, MAHE, Madhav nagar, Manipal, Udupi, Karnataka, India, 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sreejith G  Institute: Department of Basic Medical Sciences  Room number: 2, Second floor, Division of Microbiology, Department of Basic Medical Sciences, MAHE, Manipal, Udupi, Karnataka, India,576104
Udupi
KARNATAKA 		 9980959353

g.sreejith@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants aged from 12 year to 16 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable.  not applicable. 
Intervention  One Health module based interventional study against communicable diseases.  One Health-based educational intervention for enabling the high school children on the prevention of communicable diseases will be conducted as a single day program. Later a follow up session will be conducted after three months. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Students enrolled in classes 8th and 9th in selected government, aided and unaided high schools of Udupi Taluk. 
 
ExclusionCriteria 
Details  Students with any type of identified learning difficulties will be excluded.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Level of change in the knowledge, attitude and skills among the school children about the prevention of communicable diseases after successful implementation and adoption of the One Health educational module in schools  Day of the intervention through post post-test, then three months and six months later  
 
Secondary Outcome  
Outcome  TimePoints 
The change in the level of knowledge, attitude, & skills among the peers on the prevention of communicable diseases after the implementation of peer training by the high school children  After three months & six months of school based training by the high school children to their peers. 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   15/07/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  Data of individual students collected during the study

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Not applicable

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response (Others) -  Not applicable

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Not applicable
Brief Summary  

The study will be conducted in selected high schools in Udupi Taluk, Karnataka, India. A total of 144 students from government, 136 from aided, and 116 from unaided will be included in the study for training purposes. Data collection for assessing knowledge, attitude and practices about communicable diseases and One Health approach will be conducted from 1st till 9th months of this study. Groups of public health experts, various health professionals including veterinary, agriculture and environment science, and interprofessional educationists will be interviewed for developing and testing One Health educational module from the period of 10th till 15th months of this study. For implementation, five students from 10 different schools of Academy of General Education, MAHE, Manipal will be selected. One teacher will also be invited from each school during the training. Consent will be taken from parents or guardians of students for conducting this study. Selected peer educators will undergo a comprehensive training program through the One Health educational module workshop. Workshops for 3-4 hours sessions will be conducted in Manipal. Trained peer educators will conduct educational sessions for their peer learners through a half-day activity followed by continuous peer mentoring and monitoring of their behavior change over a period of 12 weeks. Both the training the trainers and peer training will be conducted during the beginning of an academic year.

 
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