| CTRI Number |
CTRI/2024/11/077038 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of health education on imparting healthy lifestyle among undergraduate MBBS medical students in Madurai Medical College |
|
Scientific Title of Study
|
Effect of health education on imparting healthy lifestyle among undergraduate medical students in Madurai Medical College, Tamilnadu - a Randomized control 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 |
Dr R Keerthana |
| Designation |
Post graduate student |
| Affiliation |
MADURAI MEDICAL COLLEGE |
| Address |
PG Room 1,Institute of community medicine,first floor,New Academic Block, Madurai Medical College, Panagal road, Alwarpuram, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
7305614105 |
| Fax |
|
| Email |
rkeerthana1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Keerthana |
| Designation |
Post graduate student |
| Affiliation |
MADURAI MEDICAL COLLEGE |
| Address |
PG room 1,Institute of community medicine,first floor,New Academic Block, Madurai Medical College, Panagal road, Alwarpuram,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
7305614105 |
| Fax |
|
| Email |
rkeerthana1998@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr A Ra Boornema |
| Designation |
Assistant professor |
| Affiliation |
MADURAI MEDICAL COLLEGE |
| Address |
Assistant professor room- 2,Institute of community medicine,first floor,New Academic block, Madurai Medical College, Panagal road, Alwarpuram, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
7598960987 |
| Fax |
|
| Email |
drpoornichandran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Community Medicine ,first floor,New Academic Block,Panagal road,Alwarpuram, Madurai Medical College, Madurai-625020 |
|
|
Primary Sponsor
|
| Name |
Madurai Medical College |
| Address |
Panagal road, Alwarpuram, Madurai-625020 |
| 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 R Keerthana |
MADURAI MEDICAL COLLEGE |
Institute of Community Medicine,first floor, New Academic Block,Madurai,Panagal road, Alwarpuram, Madurai-625020
Madurai
TAMIL NADU |
7305614105
rkeerthana1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MADURAI MEDICAL COLLEGE AND GOVT. RAJAJI HOSPITAL, MADURAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
First professional MBBS students admitted in 2024 batch of Madurai Medical college |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
health education on healthy lifestyle |
The first session will be a common health education session for both the groups.This will be followed by 3 reinforcement sessions for the intervention group . And each session will be for 40 minutes.The reinforcement session will be given every 3 months and followed up at the end of 1 year |
| Comparator Agent |
no reinforcement |
first session will be a common health education session for both the groups but there will not be reinforcement sessions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
first year MBBS students of 2024 batch admitted in Madurai Medical College |
|
| ExclusionCriteria |
| Details |
chronic absentees and those not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of health education intervention on lifestyle behavior of undergraduate first professional medical students |
One common health education session for both study and control groups followed by three separate sessions at three months interval for the participants in the study group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine the post interventional change in body mass index and stress among study participants |
in first session and last session , the details will be collected |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
01/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
AIM
TO FIND THE EFFECTIVENESS OF HEALTH EDUCATION ON IMPARTING HEALTHY LIFESTYLE AMONG UNDERGRADUATE MEDICAL STUDENTS IN MADURAI MEDICAL COLLEGE, TAMILNADU – A RANDOMIZED CONTROL STUDY
Objective1.To determine the effectiveness of health education intervention on lifestyle behavior of undergraduate first professional medical students. 2.To estimate the post interventional change in Body Mass Index (BMI) among first professional medical students. 3.To estimate the post interventional stress change among first professional medical students
METHODOLOGY
1.Study Design :.Interventional study 2.Study Area : Madurai Medical College 3.Study Population : First professional undergraduate medical students in Madurai Medical College, Madurai 4.Study Period : 1 year
SELECTION CRITERIA
a)Inclusion criteria ·All First professional undergraduate medical students of 2024 batch willing to participate in the studyb) Exclusion criteria
b)Exclusion criteria • Chronic absentees and Students who refuse to give consent for the study
5. SAMPLE SIZE:
All the First professional 250 undergraduate medical students will be included in the study.
6. STUDY TOOL : A.Global Physical Activity Questionnaire(GPAQ) B.Perceived Stress Scale (PSS) C.Weighing machine D.Stature meter E.Inch tape
•Informed and written consent will be obtained from the subjects before the start of the study. •A semi structured questionnaire will be used to collect the data. •Confidentiality of the subject will be maintained throughout the study. Baseline data will be collected from all the participants.
•A common session of health education will be given to both intervention and control group. •Three sessions of health education at an interval of 3 months will be conducted to the students in intervention group. •At the end of one year, data will be collected from all the participants and analysed. •The health education module includes motivational pictures, phrases, posters, and videos to encourage participants to adopt a healthy lifestyle. •The module prepared will be imparted in the classroom setting to the intervention group in all the sessions by distributing handouts and showing posters that include ways of living a healthy lifestyle to prevent obesity, while the control group will be imparted with the same health education module during the first visit only after taking their responses on the questionnaire.Anthropometrics will be recorded in the first and after the fourth session for both groups. • A printed questionnaire will be given and will be filled by face to face interview method in the first and after the fourth session for both the groups.
METHODS OF ANALYSIS The Chi-square test will be used to find the association between qualitative variables . p value less than 0.05 will be considered significant |