| CTRI Number |
CTRI/2025/01/079163 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Link Between Dietary Habits, Diversity, and Adolescent Weight Patterns in Mumbai |
|
Scientific Title of Study
|
To study the association between dietary intake dietary, dietary diversity and weight status of adolescents 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 |
Babita Gupta |
| Designation |
Student |
| Affiliation |
Dr BMN college of Home science Matunga |
| Address |
Dr.BMN College of Home Science 338 Rafi Ahmed Kidwai Rd Matunga East Mumbai
Dr BMN college of Home science Matunga
Mumbai (Suburban)
MAHARASHTRA
421201
India |
| Phone |
8652804087 |
| Fax |
|
| Email |
babitag3002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita behel |
| Designation |
Assistant professor |
| Affiliation |
Smt PN Doshi college JAG DHIR BODA VIDYA SANKUL Camalane Ghatkopar West Mumbai Maharashtra 400086 |
| Address |
Smt PN Doshi college JAG DHIR BODA VIDYA SANKUL Camalane Ghatkopar West Mumbai Maharashtra 400086
Smt PN Doshi college JAG DHIR BODA VIDYA SANKUL Camalane Ghatkopar West Mumbai Maharashtra 400086
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
9892974370 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita behel |
| Designation |
Assistant professor |
| Affiliation |
Smt PN Doshi college JAG DHIR BODA VIDYA SANKUL Camalane Ghatkopar West Mumbai Maharashtra 400086 |
| Address |
Smt PN Doshi college JAG DHIR BODA VIDYA SANKUL Camalane Ghatkopar West Mumbai Maharashtra 400086
Smt PN Doshi college JAG DHIR BODA VIDYA SANKUL Camalane Ghatkopar West Mumbai Maharashtra 400086
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
9892974370 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai |
|
|
Primary Sponsor
|
| Name |
Babita Gupta |
| Address |
Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 Amrita behel |
Dr. Amrita behel |
JAG DHIR BODA VIDYA SANKUL, Camalane, Ghatkopar West, Mumbai, Maharashtra 400086
Mumbai (Suburban)
MAHARASHTRA |
9892974370
amritabehel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Educational Society Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
N/A |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Day(s) |
| Age To |
19.00 Day(s) |
| Gender |
Both |
| Details |
Sample size includes 200 participants both males and females were taken. |
|
| ExclusionCriteria |
| Details |
Adolescents with known chronic diseases or medical conditions affecting dietary intake and weight. Those who are on specific dietary regimens for medical reasons.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| A positive association between higher dietary diversity and healthier weight status (e.g., lower prevalence of underweight or overweight). |
A positive association between higher dietary diversity and healthier weight status (e.g., lower prevalence of underweight or overweight). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A positive association between higher dietary diversity and healthier weight status (e.g., lower prevalence of underweight or overweight). |
A positive association between higher dietary diversity and healthier weight status (e.g., lower prevalence of underweight or overweight). |
|
|
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)
|
01/02/2025 |
| 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="10"
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 - NO
|
|
Brief Summary
|
1. To assess the dietary intake of adolescents in Mumbai. 2. To evaluate the dietary diversity of adolescents in Mumbai. 3. To determine the weight status of adolescents in Mumbai. 4. To analyze the association between dietary intake, dietary diversity, and weight status. |