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CTRI Number  CTRI/2024/10/075729 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Nutrition education program and evaluation of dietary habits among female school teachers  
Scientific Title of Study   Effect of nutrition education program and assessment of dietary patterns in women school teachers  
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 Monal Velangi 
Designation  Senior Dietician 
Affiliation  K.J. Somaiya Hospital & Research Center 
Address  Somaiya Ayurvihar, Dietetics department, ground floor, Eastern Express Hwy, Sion East, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9136097274  
Fax    
Email  dr.monalvelangi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Monal Velangi 
Designation  Senior Dietitian  
Affiliation  K.J. Somaiya Hospital & Research Center 
Address  Somaiya Ayurvihar, Dietetics department, ground floor, Eastern Express Hwy, Sion East, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9136097274  
Fax    
Email  dr.monalvelangi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monal Velangi 
Designation  Senior Dietitian  
Affiliation  K.J. Somaiya Hospital & Research Center 
Address  Somaiya Ayurvihar, Dietetics department, Ground floor, Eastern Express Hwy, Sion East, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9136097274  
Fax    
Email  dr.monalvelangi@gmail.com  
 
Source of Monetary or Material Support  
Dr. BMN College of Home Science 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra 400019  
 
Primary Sponsor  
Name  Nuwaira Farooq Ahmed Ansari  
Address  Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 
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 Shahina Farooq Ahmed Ansari  Maulana Azad High School  501, Staff room, Ahle Hadees Manzil, Mominpura, Maulana Azad Rd, New Police Line, Municipal Colony, Byculla West, Byculla, Mumbai
Mumbai
MAHARASHTRA 
9082485353

shahinaansari2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Maulana Azad High School  Approved 
Seva Mandal Education Society s Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School teachers below 44 and above 24 years. Teachers working in school Women Residing in Mumbai 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  24.00 Year(s)
Age To  44.00 Year(s)
Gender  Female 
Details  School teachers below 44 and above 24 years.
Teachers working in school
Women
Residing in Mumbai
Not suffering from any critical illness 
 
ExclusionCriteria 
Details  School teachers below 24 and above 44 years. Teachers not working in school
Men
Residing outside Mumbai
Suffering from any critical illness. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1 The effect of Nutrition
Education programs in women school teachers 
4 month 
 
Secondary Outcome  
Outcome  TimePoints 
2 The Assessment of dietary patterns in women school teachers  4 month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   02/11/2024 
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="0"
Months="4"
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  
  • Introduction: The research proposal outlines a specific problem within its field of study, briefly discussing the background and the relevance of the subject matter. It emphasizes the necessity for further investigation, pointing out current knowledge gaps and issues within the scope of the research.

  • Research Objectives: The proposal clearly defines its main objectives, establishing a framework for the study’s goals. It identifies both primary and secondary objectives, aiming to resolve specific research questions or hypotheses through its methodology.

  • Literature Review: Relevant academic work is reviewed, providing insight into past studies, theories, and methods related to the research topic. This analysis serves as a foundation for understanding how the current study will contribute to or differ from the established knowledge base.

  • Research Methodology: The methods for data collection and analysis are described in detail, with explanations on the qualitative or quantitative techniques that will be used. It also elaborates on the selection process for the sample and population, offering justification for the chosen research approach.Significance of the Study: This section underlines the potential impact of the research and its contributions to the field. It explains how the findings will address existing gaps in knowledge and possibly influence future policies or practices within the subject area.

  • Ethical Considerations: Ethical aspects of the research are discussed, ensuring that the proposed study complies with ethical guidelines and standards for conducting responsible research.

  • Conclusion: The conclusion revisits the research aims and expected outcomes, summarizing the significance of the study. It reinforces the importance of the research and its anticipated contributions to advancing the field.

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