| CTRI Number |
CTRI/2025/08/092349 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the nutritional status of participants aged 10 to 12 years studying in public schools in Mumbai |
|
Scientific Title of Study
|
A Study Of Nutritional Status Of Students Aged 10-12 Years Studying In Public Schools In Mumbai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrawani Rajesh More |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Divya Rishi Apartment,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai-400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9326361021 |
| Fax |
|
| Email |
moreshrawani27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha Chopra |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Divya Rishi Apartment,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai-400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9969810104 |
| Fax |
|
| Email |
harshachopra@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Harsha Chopra |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Divya Rishi Apartment,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai-400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9969810104 |
| Fax |
|
| Email |
harshachopra@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College Of Home Science |
|
|
Primary Sponsor
|
| Name |
Shrawani Rajesh More |
| Address |
338, Rafi Ahmed, Kidwai Road, Matunga East 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 Harsha Chopra |
Dr BMN College of Home Science |
Divya Rishi Apartment,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai-400019
Mumbai
MAHARASHTRA |
9969810104
harshachopra@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Status Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individual with no disease conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Observational Study No Intervention Is Involved |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 10-12 years.
Enrolled in selected public schools
Children without any known medical conditions affecting growth & diet
|
|
| ExclusionCriteria |
| Details |
Children less than 10 and more than 12 years
Children with any known medical conditions
Children with any congenital abnormality |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of nutritional status (undernutrition, normal, overnutrition) measured by BMI-for-age Z-scores, MUAC, WHR — assessed at baseline. |
Baseline (Single time point during study period) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of socioeconomic status using SES, dietary patterns using FFQ, IDDS and physical activity using IPAQ in public school children aged 10 to 12 years . |
Baseline (Single time point during study period) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
14/08/2025 |
| 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="0"
Months="0"
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 aims to assess the nutritional status of students aged 10–12 years studying in selected public schools in Mumbai. Using anthropometric measurements (height, weight, BMI-for-age Z-score, MUAC, waist-to-hip ratio), the study will evaluate the prevalence of undernutrition or overnutrition. It will also assess dietary patterns using a Food Frequency Questionnaire (FFQ) and 7-day Individual Dietary Diversity Score (IDDS), physical activity using the IPAQ-Short Form, and socioeconomic background using Kuppuswamy’s scale. The results will help identify gaps and guide future interventions for improving child nutrition in public schools. |