| 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
|
|
|
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
|
|
|
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. |