| CTRI Number |
CTRI/2025/11/096752 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the magnitude of overweight and obesity among adolescents aged 10-19 years in an urban area of Delhi and study the lifestyle factors for it |
|
Scientific Title of Study
|
Prevalence and Associated Factors of Overweight and Obesity
among Adolescents in an Urban Area of Delhi |
| 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 Surbhi Khanna |
| Designation |
Postgraduate Resident |
| Affiliation |
Department of Community Medicine, Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College,2-Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
9818217461 |
| Fax |
|
| Email |
ksurbhi2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Director Professor |
| Affiliation |
Department of Community Medicine, Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College,2-Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
9811656127 |
| Fax |
|
| Email |
prtickle07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surbhi Khanna |
| Designation |
Postgraduate Resident |
| Affiliation |
Department of Community Medicine, Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College, 2-Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
9818217461 |
| Fax |
|
| Email |
ksurbhi2022@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,2-Bahadur Shah Zafar Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2-Bahadur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Surbhi Khanna |
Maulana Azad Medical College |
Department of Community Medicine, Maulana Azad Medical College, New Delhi-110002
New Delhi
DELHI |
9818217461
ksurbhi2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight and Obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents aged 10-19 years residing in the study area for at least six months before the study |
|
| ExclusionCriteria |
| Details |
1-Adolescents who won’t be available even after two informed visits, after the primary visit for
data collection
2-Adolescents suffering from neurological conditions like stroke, paralysis or having skeletal deformities that can affect their anthropometric measurements
3-Adolescents who are unable to communicate, are bedridden or have severe mental illness that
precludes their ability to interact meaningfully during the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of study participants who are overweight and obese |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of overweight & obesity with the socio-demographic & lifestyle factors of the
adolescents |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="315"
Sample Size from India="315"
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)
|
13/11/2025 |
| 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="0"
Months="9"
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 is a community-based cross-sectional study to assess the magnitude of overweight and obesity and their associated factors among
adolescents in Delhi. It will be conducted among 315 adolescents aged 10-19 years in the field practice area of the Urban Health Training Centre (UHTC),
Gokalpuri of the Department of Community Medicine, Maulana Azad Medical College and Associated
Hospitals. The primary outcome will be proportion of study participants who are overweight and obese.
Secondary Outcome will be to assess the association of overweight and obesity with the socio-demographic and lifestyle factors of the
adolescents. |