| CTRI Number |
CTRI/2023/10/059165 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Adolescent Health Education and Its Impact |
|
Scientific Title of Study
|
Impact of Health Education Intervention on Overall Health and Wellbeing of Adolescent |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha M Shetty |
| Designation |
Assistant Professor |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
JSS Academy of Higher Education and Research, SS Nagara, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
8497087057 |
| Fax |
|
| Email |
deekshamshetty@jssuni.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Deeksha M Shetty |
| Designation |
Assistant Professor |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
JSS Academy of Higher Education and Research, SS Nagara, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
8497087057 |
| Fax |
|
| Email |
deekshamshetty@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha M Shetty |
| Designation |
Assistant Professor |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
JSS Academy of Higher Education and Research, SS Nagara, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
8497087057 |
| Fax |
|
| Email |
deekshamshetty@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deeksha M Shetty |
| Address |
JSS Academy Of Higher Education and Research, S.S Nagara Bannimantap, Mysuru, 570004 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 HBasavana Gowdappa |
JSS Academy of Higher Education and Research |
JSS Academy of Higher Education and Research, S.S. Nagara, Bannimantap, Mysuru 570004
Mysore
KARNATAKA |
8497087057
deekshamshetty@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC JSS Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents from the age group of 10 to 19 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Impact of Health Education Intervention on Overall Health and Wellbeing of Adolescent |
Health education intervention. Followup is done for case group participants for 12 months of the study period
|
| Comparator Agent |
Impact of Health Education Intervention on Overall Health and Wellbeing of Adolescent |
No Health education will be given to control group participants. Followup will be done for 12 month of study period |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Parents who provide consent for their adolescent children in the respective age group will be included in the study. |
|
| ExclusionCriteria |
| Details |
Parents who do not provide consent for their adolescent children in the respective age group will be excluded in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study includes identifying the improvement in health outcomes such as reduced BMI, and improved quality of life of study participants after the intervention (12 months), when compared to the baseline data before the intervention.
These outcomes will be measured at respective time points before and after the health education intervention
|
Baseline 3 months 6 months 9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study includes identifying the improvement in health outcomes such as reduced BMI, & improved quality of life of study participants after the intervention (12 months), when compared to the baseline data before the intervention.
The Secondary outcomes of the study include improved academic performance, improved physical activity, life style changes with respect to dietary habits, reduced screen time leading to emotional stability
These outcomes will be measured at respective time points before & after the health education intervention |
Baseline 3 months 6 months 9 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/11/2023 |
| 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 Yet Recruiting |
| 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
Modification(s)
|
Adolescent health behaviors significantly impact their current and future health. School, an essential setting for socialization, plays a crucial role in influencing lifestyle. School-based health promotion is essential, and schools can help teenagers navigate false information by distributing reliable online sources and encouraging critical thinking. The study will recruit 10-19-year-olds with informed consent from parents, guardians, and school authorities to collect data on their academic performance, anthropometric information, knowledge assessment, adolescent wellbeing scale, WHO Qol Scale, and screen time questionnaire. Data will be collected at baseline every 3rd, 6th, and 9th month. Parents and teachers will be orientated about the study and consent obtained for enrollment. Adolescent and parent education materials will be shared through posters, brochures, and planners. Weekly follow-ups will be conducted via Google Forms and WhatsApp broadcasts. Expert advice will also be provided. The collected data will be analyzed to identify the impact of health education on adolescent health and wellbeing. |