| CTRI Number |
CTRI/2025/12/098450 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Improving Adolescent Health and Quality of Life through Video-Based Interactive Programmes |
|
Scientific Title of Study
|
Effect of Video-Led interactive programme on selected health related behaviours and Quality of Life among adolescents, at selected Schools, Bangalore. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Subbulakshmi |
| Designation |
principal |
| Affiliation |
Chettinad College of Nursing, Chettinad Academy of Research and Education |
| Address |
3rd floor academic block Chettinad College of Nursing, Chettinad Academy of Research and Education, Rajiv Gandhi salai, kelambakkam, Chengalpattu Dist, Tamilnadu
3rd floor academic block Chettinad College of Nursing, Chettinad Academy of Research and Education, Rajiv Gandhi salai, kelambakkam, Chengalpattu Dist, Tamilnadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9944592175 |
| Fax |
|
| Email |
kbsubbulakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subbulakshmi S |
| Designation |
Principal |
| Affiliation |
Chettinad College of Nursing, Chettinad Academy of Research and Education |
| Address |
3rd floor, academic block, Chettinad College of Nursing, Chettinad Academy of Research and Education, Rajiv Gandhi salai, kelambakkam, Chengalpattu Dist, Tamilnadu
3rd floor, academic block, Chettinad College of Nursing, Chettinad Academy of Research and Education, Rajiv Gandhi salai, kelambakkam, Chengalpattu Dist, Tamilnadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9944592175 |
| Fax |
|
| Email |
kbsubbulakshmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Umamaheswari.N |
| Designation |
Professor |
| Affiliation |
PES Institute of Nursing |
| Address |
G floor, Pixel A, 101, PES University
PESU Institute of Nursing
Konappana Agrahara
Electronic city
Bangalore
G floor, Pixel A, 101, PES University
PESU Institute of Nursing
Konappana Agrahara
Electronic city
Bangalore
pin 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
9916151593 |
| Fax |
|
| Email |
umaharithasree@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| Prof UmamaheswariN |
AMAATRA SCHOOL/ACADEMY |
PES University
PESU Institute of Nursing
Konappana Agrahara
Electronic city
Bangalore
pin 560100
PES University
PES Institute of Nursing
Konappana Agrahara
Electronic city
Bangalore
Bangalore
KARNATAKA |
09916151593
umaharithasree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHETTINAD ACADEMY, INSTITUTIONAL HUMAN ETHICS COMMITTEE FOR STUDENT RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
EARLY ADOLESCENT GIRLS POPULATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine teaching |
Regular, standard method of teaching that is already followed in the school |
| Intervention |
VIDEO LED INTERACTIVE SESSION |
An interactive video-led programme uses pre-recorded video content combined with interactive elements like live responses, video is used to present the instructional material and monitor the learning that takes place. It uses a combination of text, graphics, sound and video in enhancing the learning process. Duration of the session will be 45 minutes once in Two weeks for three months. Total 6 sessions which includes two reinforcement sessions. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
The students fulfilling the following criteria will be included
Between the age of 11 and 15 years, studying in the 6th to 10th standard
From urban and rural background
Whose parents give their consent in writing |
|
| ExclusionCriteria |
| Details |
Students whose parents do not give written consent
Students who themselves do not give assent to participate
Students with known serious physical illness
Students who are absent at the time of data collection / intervention |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The adolescent population who are participated in the study will be benefited with health literacy on healthy nutritional behaviour, regular physical activity and improved sleep hygiene thereby, it improves their quality of life |
3 TO 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The virtual facilitated health literacy can indirectly influence the country towards better health and healthy adult in future. These adolescents can indirectly help other peer group in structuring their lifestyle factors and prevent Diabetes mellitus |
3 years |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
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)
|
09/02/2026 |
| 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="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
|
Adolescence is a critical period of physical, psychological, and social development. During this stage, lifestyle practices such as dietary habits, physical activity, and sleep patterns play a vital role in shaping present and future health outcomes. Unfortunately, rapid urbanization, academic pressure, screen time, lack of physical exercise, and changing food habits have led to unhealthy lifestyle patterns among adolescent girls. These behaviors are associated with increased risk of obesity, nutritional deficiencies, sleep disturbances, mental stress, and poor quality of life. Adolescent girls require special attention because they are the future mothers and caregivers and their health strongly influences the health of the next generation. Schools are a key setting for improving adolescent health, as students spend a major part of their day there and are easily reachable for structured interventions. In this digital era, video-led interactive sessions can be an effective and engaging method to provide accurate health education and motivate behavior change. |