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CTRI Number  CTRI/2024/12/078247 [Registered on: 17/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the impact of ultra-processed food on the health of preschool children in urban slums.  
Scientific Title of Study   Assessment of Ultra-Processed Food intake and nutritional status of preschool Children (ages 3-7 years) from an urban slum.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bushra Mohammad Ismail Shaikh  
Designation  Student 
Affiliation  Dr BMN College of Home Science 
Address  Room No 903, D-Wing Department of Post Graduate Clinical Nutrition and Dietetics Dr BMN College of Home Science Kidwai Road Matunga

Mumbai (Suburban)
MAHARASHTRA
400019
India 
Phone  09167845120  
Fax    
Email  skbushi21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakshmi Menon 
Designation  Professor  
Affiliation  Dr BMN College of Home Science 
Address  Room No 903, D-Wing Department of Post Graduate Clinical Nutrition and Dietetics DR BMN College of Home Science Kidwai Road Matunga

Mumbai (Suburban)
MAHARASHTRA
400019
India 
Phone  9003072531  
Fax    
Email  lakshmimenon@bmncollege.com  
 
Details of Contact Person
Public Query  
Name  Dr Lakshmi Menon 
Designation  Professor  
Affiliation  Dr BMN College of Home Science 
Address  Room No 903, D-Wing Department of Post Graduate Clinical Nutrition and Dietetics DR BMN College of Home Science Kidwai Road Matunga

Mumbai (Suburban)
MAHARASHTRA
400019
India 
Phone  9003072531  
Fax    
Email  lakshmimenon@bmncollege.com  
 
Source of Monetary or Material Support  
Evergreen English School & Junior College of Arts, Commerce & Science 
 
Primary Sponsor  
Name  Mohd Ismail 
Address  Road NO 1 Room no 9 Shivaji Nagar Govandi Mumbai. Pin code 400043. Country code 91 
Type of Sponsor  Other [Father] 
 
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 
Mujahid   Evergreen English School and Junior College  Road No.1. Near Jain Mandir, Shivaji Nagar, Govandi, Mumbai-400043
Mumbai (Suburban)
MAHARASHTRA 		 9029314902

evergreenenglishschool2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seva Mandal Education Society  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy childrens consuming ultra processed foods living in urban slum.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Age:- 3-7 years of old children. Both male and female studying in local school of Shivaji Nagar Govandi
 
 
ExclusionCriteria 
Details  Children with surgery and life threatening illnesses like Cancer, AIDS.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To understand the nutritional status of children living in urban slums and to identify the consumption of ultra processed food.   Outcome will be assessed within 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare between the 2 foods group NOVA & NIN 2024 guidelines.   4 weeks 
 
Target Sample Size   Total Sample Size="245"
Sample Size from India="245" 
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)   30/12/2024 
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="6"
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [skbushi21@gmail.com].

  6. For how long will this data be available start date provided 12-05-2025 and end date provided 31-12-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary   Rapid urbanization and lifestyle changes in urban slums have contributed to an increased  consumption of Ultra-processed foods among children. These foods characterized by high level of added sugars, unhealthy fats and low nutritional value. This study aims to assess the dietary intake of ultra-processed and its association with the nutritional status of preschool children living in urban slum.  
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