| CTRI Number |
CTRI/2025/07/091888 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Changes in body composition ,energy intake and energy expenditure over period of residency in the department of anaesthesia ,kgmu |
|
Scientific Title of Study
|
Changes in body composition ,energy intake and energy expenditure over period of residency in the department of anaesthesia ,kgmu a follow up study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil Garg |
| Designation |
Junior Resident |
| Affiliation |
KGMU ,LUCKNOW |
| Address |
Anaesthesia department ,kgmu,lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7888527775 |
| Fax |
|
| Email |
sahilgarg1208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipin kumar Singh |
| Designation |
Additional professor |
| Affiliation |
KGMU,LUCKNOW |
| Address |
Anaesthesia department ,KGMU,LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6387908355 |
| Fax |
|
| Email |
vipintheazad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipin kumar Singh |
| Designation |
Additional professor |
| Affiliation |
KGMU,LUCKNOW |
| Address |
Anaesthesia department ,KGMU,LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6387908355 |
| Fax |
|
| Email |
vipintheazad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sahil garg (MD Anaesthesia) 2nd year resident ,KIng george medical university, lucknow, 226003, India |
|
|
Primary Sponsor
|
| Name |
Dr Sahil garg self sponsered |
| Address |
Department of anaesthesia,kgmu,KGMU lucknow pincode 226003 India |
| Type of Sponsor |
Other [Self sponsered] |
|
|
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 Sahil garg |
Department of Anaesthesia ,kgmu |
Department of Anaesthesia ,kgmu,lucknow,up
Lucknow
UTTAR PRADESH |
7888527775
sahilgarg1208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KGMU INSTITUTIONAL ETHICS COMMITTEE ,LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All the first year residents getting admission in the department of anaesthesiology
Students giving written informed consent will be taken |
|
| ExclusionCriteria |
| Details |
Doctors who could not give consent due to their lack of interest to participate in the study
Pregnant doctors
Those with disabilities |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.prevalence of obesity via BMI
2. To determine body composition changes via dexa scan |
24 weeks and 72 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Additional sedentry behaviour will be assessed based on
Total screen time
Television and screen entertainment
Transport sitting time
Total sitting time
Leisure sitting time
|
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/08/2025 |
| 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="1"
Months="6"
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
|
Changes in body compostion will be studied by DEXA scan Food habits will be studied by food frequency questionnaire Physical activity will be studied by WHO GPAQ Questionnaire |