| CTRI Number |
CTRI/2025/03/082638 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
What is the undergraduate students ability to understand health information and their lifestyle in day to day practice? |
|
Scientific Title of Study
|
A study to assess the health literacy and lifestyle behavior among non-
health science undergraduate students in a selected University of Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aleena Mathew |
| Designation |
Semester Seven B.Sc Nursing student |
| Affiliation |
B.Sc Nursing student. Manipal College of Nursing |
| Address |
Manipal College of Nursing, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895288256 |
| Fax |
|
| Email |
mathewsaleena72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Prima J J D Souza |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Fundamentals of Nursing, Room No. 601, Manipal College of Nursing, Manipal, Manipal Academy of Higher Education, Manipal, Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9986244210 |
| Fax |
|
| Email |
prima.jj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Prima J J D Souza |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Fundamentals of Nursing, Manipal College of Nursing, Manipal, Manipal Academy of Higher Education, Manipal, Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9986244210 |
| Fax |
|
| Email |
prima.jj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Fundamentals of Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, 576104. |
|
|
Primary Sponsor
|
| Name |
Aleena Mathew |
| Address |
Seventh Semester B.Sc Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi district, Karnataka,576104 |
| 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 |
| Mrs Prima J J D Souza |
Manipal College of Nursing |
Department of Fundamentals of Nursing, Room No. 601, Manipal College of Nursing, Manipal Academy of Higher Education, Udupi District, Karnataka, 576104.
Udupi
KARNATAKA |
9986244210
prima.jj@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College/Kasturba Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Undergraduate students |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate non-health science students from first to final year |
|
| ExclusionCriteria |
| Details |
Students who are not willing to participate. Students with Health Economics or
health-related subjects. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health literacy |
1 time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="462"
Sample Size from India="462"
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)
|
30/03/2025 |
| 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="0"
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
|
The objective of the study is to assess the health literacy and lifestyle behavior among non-health science undergraduate students. The study aims to explore health literacy and lifestyle behavior among non- health science undergraduate students. The study will be conducted among 462 students from non-health science institutions of a deemed University using a cross- sectional design. The health literacy will be assessed using European Health Literacy Questionnaire Q16 and lifestyle behavior will be assessed using Lifestyle Behavior Questionnaire. The Lifestyle Behavior Questionnaire is developed by the researcher whereas European health literacy questionnaire is standardised tool. Ethical permission will be obtained from the Institutional Ethics Committee and administrative permission will be taken from the University and Heads of the Institutions. Informed consent will be obtained from the participants. Data will be collected with online survey. Descriptive and inferential statistics will be used to analyse the data. |