| CTRI Number |
CTRI/2025/10/096552 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
To study the effects of overweight and obesity among adolescents and compare percentage body fat and other anthropometeric measures using DXA scan |
|
Scientific Title of Study
|
Study of Metabolic Syndrome and correlation between Percentage Body Fat and Anthropometric Parameters using DXA scan among adolescents with overweight obesity. |
| 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 Vanshika Chauhan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, Madhav Nagar, Manipal 576104, Udupi, Karnataka, India
Udupi KARNATAKA 576104 India |
| Phone |
8894191311 |
| Fax |
|
| Email |
vanshika.dpu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Koushik H |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, Madhav Nagar, Manipal 576104 , Udupi, Karnataka , India
Udupi KARNATAKA 576104 India |
| Phone |
9242308804 |
| Fax |
|
| Email |
koushik.h@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Vanshika Chauhan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, Madhav Nagar, Manipal -576104, Udupi, Karnataka, India
Udupi KARNATAKA 576104 India |
| Phone |
8894191311 |
| Fax |
|
| Email |
vanshika.dpu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and hospital
Madhav nagar , Manipal 576104 Udupi , Karnataka, India |
| NIL |
|
|
Primary Sponsor
|
| Name |
Dr Koushik H |
| Address |
Department of Paediatrics Kasturba Medical College and hospital , Manipal 576104, Udupi ,Karnataka, India |
| 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 Vanshika Chauhan |
Kasturba Medical College and Hospital |
Department of Paediatrics Udupi KARNATAKA |
8894191311
vanshika.dpu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents between 10 - 18 years diagnosed with overweight / obesity as per IAP 2015 growth charts. |
|
| ExclusionCriteria |
| Details |
1. Adolescents with concomitant endocrine or systemic illness.
2. Suspected or proven cases of monogenic or syndromic obesity. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of the study is the correlation between Percentage Body Fat, measured using DXA, and various anthropometric indicators of obesity. The outcome will be expressed as the Pearson correlation coefficient to determine the strength and significance of the association. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="99" Sample Size from India="99"
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)
|
10/11/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Adolescent obesity and its associated complications, particularly metabolic syndrome, are becoming increasingly important public health challenges in India and worldwide. Metabolic syndrome, characterized by central obesity, dyslipidemia, hypertension, and impaired glucose regulation, significantly increases the risk of cardiovascular disease and type 2 diabetes at an early age. Identifying its prevalence and correlating reliable measures of adiposity are essential for early detection and targeted intervention.
This study is an observational prospective study with the aim of assessing the prevalence of metabolic syndrome among adolescents with overweight and obesity. In addition, it seeks to evaluate the correlation between percentage body fat PBF measured by DXA scan and anthropometric parameters such as BMI, waist circumference, and waist to height ratio. The objectives are two fold 1. to determine how common metabolic syndrome is in this high risk group, and 2. to identify which anthropometric measures most accurately reflect body fat as determined by DXA. Findings from this study may help strengthen clinical practice by improving obesity assessment tools and guiding timely preventive interventions for adolescents at risk. |