| CTRI Number |
CTRI/2025/03/082584 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Body Image, Nutrition, and Health in Teenage Girls of Byculla |
|
Scientific Title of Study
|
Assessment of body image, dietary intake and body composition of female adolescents in Byculla municipal area. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zainab Hotelwala |
| Designation |
PG Student |
| Affiliation |
|
| Address |
Smt. Manjulaben Gunvantrai Shah Department of Postgraduate Studies
M.Sc. in Clinical Nutrition and Dietetics
Dr. BMN College of Home Science, 338, Rafi Ahmed Kidwai Road, Matunga
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9920204968 |
| Fax |
|
| Email |
zainabhotelwala23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Professor |
| Affiliation |
Dr. BMN College Of Home Science |
| Address |
Dr. BMN College of Home Science, 338, Rafi Ahmed Kidwai Road,Matunga, Mumbai -400019
India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9003072531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Profess |
| Affiliation |
Dr. BMN College Of Home Science |
| Address |
Dr. BMN College of Home Science, 338, Rafi Ahmed Kidwai Road,Matunga, Mumbai -400019
India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9003072531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr.BMN College of Home Science, 400019, Matunga |
|
|
Primary Sponsor
|
| Name |
Zainab Hotelwala |
| Address |
Zainab Tower, 13/1306, MA road, Nagpada Jn. Mumbai 400008
|
| 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 Lakshmi Menon |
Dr. BMN College of Home Science |
Smt. Manjulaben Gunvantrai Shah Department of Postgraduate Studies
M.Sc. in Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
9003072531
lakshmimenon@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
middle adolescents |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Data will be collected from 383 middle adolescents female school students. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Data will be collected from 383 middle adolescents female school students. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
17/06/2025 |
| 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="25"
Months="6"
Days="15" |
|
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 body image, dietary intake, and body composition among female adolescents (14–17 years) in the Byculla municipal area. Adolescence is a critical phase where body image concerns, influenced by societal and media pressures, often lead to unhealthy dietary behaviors. Research shows that many adolescent girls experience body dissatisfaction, which can result in restrictive eating, binge eating, and nutritional deficiencies, ultimately impacting body composition. The study will evaluate anthropometric status, dietary intake through a 3-day food recall, and body composition. It will also examine the association between body image and both dietary intake and body composition, addressing gaps in current research on adolescent nutrition and health in India. |