FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088994 [Registered on: 17/06/2025] Trial Registered Prospectively
Last Modified On: 16/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [nursing]  
Study Design  Cluster Randomized Trial 
Public Title of Study   the effectiveness of intervention package on knowledge and perception of adolescent girls. 
Scientific Title of Study   The effectiveness of health promotion intervention package on the knowledge and perception of bio behavioural health in adolescent girls and their parents of selected schools of belagavi city. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUDHA JANGANURE 
Designation  Senior Tutor 
Affiliation  KLE Academy Of Higher Education And Research Center, Belagavi 
Address  KAHER Institute Of Nursing Sciences, Nehru Nagar, Belagavi, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  7022966400  
Fax    
Email  sudhajanganure@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SUDHA JANGANURE 
Designation  Senior tutor 
Affiliation  KLE Academy Of Higher Education And Research Center, Belagavi 
Address  KAHER Institute Of Nursing Sciences, Nehru Nagar, Belagavi, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  7022966400  
Fax    
Email  sudhajanganure@gmail.com  
 
Details of Contact Person
Public Query  
Name  SUDHA JANGANURE 
Designation  Senior tutor 
Affiliation  KLE Academy Of Higher Education And Research Center, Belagavi 
Address  KAHER Institute Of Nursing Sciences, Nehru Nagar, Belagavi, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  7022966400  
Fax    
Email  sudhajanganure@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Sudha Janganure 
Address  KAHER Institute of Nursing Sciences, Nehru Nagar, Belagavi, Karnataka. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sangeeta Kharde  Maratha Mandal English Medium School.  Nehru Nagar Belagavi Karnataka 590010
Belgaum
KARNATAKA 		 07022966400

sudhajanganure@gmail.com 
Dr Sangeeta Kharde  Shri Siddarameshwara Education Trust Nehru Nagar Belagavi Karnataka  Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA 		 07022966400

sudhajanganure@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER ETHICS COMMITTEE ON HUMAN SUBJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ADOLESCENT GIRLS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health promotion intervention package  1.the health promotion intervention package on the knowledge and perception of bio behavioural health in adolescent girls and their parents of selected schools aims All aspects like sexual and reproductive health, mental health, nutritional health, physical, psychological and behavioral changes(Bio behavioral health) are taken into consideration along with parents and teachers as a stakeholders as a multicomponent approach at a one time for adolescent girls 2.This study includes intervention package which includes physical health status assessment, nutritional assessment and educational sessions to improve the bio behavioral health of adolescent girls. 
Comparator Agent  No Treatment  Distribution of Phamphlets to Adolescent girls and parents Comparator group after post test. 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  adolescent girls who are willing to participate in the study. 
 
ExclusionCriteria 
Details  adolescent girls who are not willing 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 
The primary outcome of the study is to assess the knowledge and perception of adolescent girls
To assess the knowledge through pre test structured questionnaire
Delivery of educational health promotion intervention package to assess the knowledge and perception on Biobehavioural health among adolescent girls.
The effectiveness of health promotion intervention package on the knowledge and perception and bio-behavioral health in adolescent girls of selected schools of Belagavi city.
 		 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
Delivery of educational health promotion intervention package to assess the knowledge and perception on Biobehavioural health among adolescent girls.
 		 6 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   02/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This study is an experimental research to evaluate the effectiveness of health promotion intervention package to improve bio-behavioural health among 300 adolescent girls 150 in each group in selected schools of Belagavi Karnataka and other objectives are to assess the knowledge and perception regarding sexual and reproductive health in adolescent girls and to determine the association between selected demographic variables of participants and their parents and its effect on the knowledge of adolescent girls  regarding biobehavioural health.

 
Close