| CTRI Number |
CTRI/2025/02/080430 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Looking into the weight status and weight loss habits of students studying medical and non-medical courses |
|
Scientific Title of Study
|
Exploring the body weight status and weight management choices among students pursuing healthcare and technical education: A Cross-sectional study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bonu Rachel |
| Designation |
Student |
| Affiliation |
GITAM (Deemed to be University) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8978710898 |
| Fax |
|
| Email |
bonurachel3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bonu Rachel |
| Designation |
Student |
| Affiliation |
GITAM (Deemed to be University) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8978710898 |
| Fax |
|
| Email |
bonurachel3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineel |
| Designation |
Assistant Professor |
| Affiliation |
GITAM (Deemed to be University) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9620094276 |
| Fax |
|
| Email |
vpedapen@gitam.edu |
|
|
Source of Monetary or Material Support
|
| GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh. |
|
|
Primary Sponsor
|
| Name |
Bonu Rachel |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh. |
| 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 Vineel |
GIMSR Hospital |
4th floor GITAM School of Physiotherapy
Visakhapatnam
ANDHRA PRADESH |
9620094276
vpedapen@gitam.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Institute of Medical Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Body weight status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Students pursuing healthcare and technical courses in GITAM University, Visakhapatnam. |
|
| ExclusionCriteria |
| Details |
Students pursuing Physiotherapy course in GITAM University, Visakhapatnam.
Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BMI |
Single point of time as it is a cross-sectional study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
28/02/2025 |
| 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="4"
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
|
Based on the literature that is reviewed it is found that no studies have yet compared students pursuing healthcare and technical education to determine who are more susceptible to comorbidities based on their body weight status and weight management choices. So, there is a need to do a study that compares students pursuing healthcare and technical education, to determine who is relatively more susceptible to co-morbidities based on their body weight status and their weight management choices. Our aim is to review and analyze the results of Weight and Wellness survey and to determine and compare the body weight status and preferred type of weight management among students pursuing healthcare and technical education.
Permission would be taken from the respective Institutional heads of Healthcare and Technical branches in order to circulate the online survey form among students. Fliers including the QR code of the survey form would be displayed on the respective notice boards of the branch for the students to access the survey form. Participants would be able to submit the form only through GITAM mail ID. Data would be analyzed based on the responses received and report would be submitted. |