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CTRI Number  CTRI/2018/02/012127 [Registered on: 23/02/2018] Trial Registered Prospectively
Last Modified On: 27/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Cluster Randomized Trial 
Public Title of Study   Innovative Education Technology for Sexual and Reproductive Health for Teens 
Scientific Title of Study   Flipping to empower adolescents for sexual and reproductive health 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratibha Singh 
Designation  Professor & Head 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Basni Phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996941  
Fax    
Email  drpratibha69@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratibha Singh 
Designation  Professor & Head 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Basni Phase 2


RAJASTHAN
342005
India 
Phone  8003996941  
Fax    
Email  drpratibha69@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kuldeep Singh 
Designation  Dean Academics and Professor Pediatrics 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  All India Institute of Medical Sciences, Basni Phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996940  
Fax    
Email  kulpra@hotmail.com  
 
Source of Monetary or Material Support  
Stars in Global Health from Grand Challenges Canada 
 
Primary Sponsor  
Name  Grand Challenges Canada 
Address  MaRS Centre, West Tower 661 University Avenue, Suite 1720 Toronto, ON M5G 1M1 grandchallenges.ca  
Type of Sponsor  Government funding agency 
 
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 Pratibha Singh  All India Institute of Medical Sciences Jodhpur  Room Number 240,OPD Block, Department of Obstetrics and Gynecology
Jodhpur
RAJASTHAN 
8003996941

drpratibha69@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee at AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Educational Impact 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  Students of the school will be provided reproductive health education through conventional method of didactic lectures 
Intervention  Flipped Classroom with mobile based app  The students of selected school will be provided education with innovative method based on pedagogic principle of Flipped Classroom Technology 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  After permission from school authorities, parental consent will be obtained. Only those students whose parents give consent to participate in the study will be included. 
 
ExclusionCriteria 
Details  Those not giving consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gain in knowledge, complex understanding and behavioral skills for sexual and reproductive health among adolescent school children from baseline of 10 % to 40 % after intervention.  1 day, 30 days and at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Satisfaction Index more than 70 %  At 18 months 
 
Target Sample Size   Total Sample Size="4000"
Sample Size from India="4000" 
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)   09/07/2018 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

What is the problem addressed by your innovation? (Maximum response allowed is 500 characters).

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Discussing sexuality is still considered a taboo in Indian Society. Sex education to school children and adolescents is a challenge for teachers and is seldom taught in a way to create medically appropriate, affirmative outlook towards sexuality. The problem is much more compounded by myths associated with sex information resulting in poor sexual behavior, teenage pregnancy, sexually transmitted infections & sexual crimes. The problem is much higher in Rajasthan leading to sex discrimination.

What is your proposed innovation? (Maximum response allowed is 500 characters).

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Active learning by Flipped Classrooms where basic information about sexuality and reproductive health is provided through a mobile application to be viewed at home by the students at his/her own pace and class time in school is utilized for deeper learning, analysis, clarification with help of Clickers in presence of a facilitator who may be a class teacher or a competent and skilled health professionals. Pre class material includes small clips, presentations, short readings, quiz or stories.

 

How will this innovation address this problem more effectively than current approaches? (Maximum response allowed is 500 characters).

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The sexual and reproductive health needs of adolescents in India are currently overlooked or are not understood by the Indian healthcare system. These are also not integrated well into Life skills module. The approaches mostly consist of didactic lectures or talks but seldom encourage active participation. The present innovative idea will enable adolescent girls and boys with sufficient time to ponder over the material, their holistic participation in class will be ensured with help of Clickers.

Describe how your innovation is relevant to poor, marginalized populations in low-or-middle-income countries (LMICs). (Maximum response allowed is 500 characters).

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In the Rajasthan state of India, sex discrimination against the girl child, late schooling, early marriage predispose girls to heavy disadvantages resulting into the poor health of the community. Adolescent children are highly receptive to innovations. The Bold idea revolves around an innovative pedagogy of inverted classroom utilizing mobile app to distribute family acceptable material in local language and active learning during the class time. It is cheap, affordable, and culturally adaptable

 
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