| CTRI Number |
CTRI/2025/09/095252 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educative Supportive Program For Adolescents Regarding Life Style Diseases] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Healthy Lifestyle Programme to promote better knowledge, attitudes, and healthy habits in adolescents. |
|
Scientific Title of Study
|
Assess The Effectiveness Of HeLP (Healthy Lifestyle Programme) In Terms Of Knowledge, Attitude, And Practice Related To Selected Lifestyle Diseases Among Adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitika Kaushal |
| Designation |
PhD Scholar |
| Affiliation |
Teerthankar Mahaveer University |
| Address |
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7217212211 |
| Fax |
|
| Email |
nitika.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Toshniwal |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer University |
| Address |
Room No 303, Second Floor Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8057000933 |
| Fax |
|
| Email |
varun.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Toshniwal |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer University |
| Address |
Room No 303, Second Floor Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8057000933 |
| Fax |
|
| Email |
varun.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nitika Kaushal |
| Address |
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad, UTTAR PRADESH 244001 India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nitika Kaushal |
Govt Inter College Jassowala |
Govt Inter College Jassowala Dehradun, Uttarakhand 248142
Dehradun
UTTARANCHAL |
7217212211
nitika.scholar@tmu.ac.in |
| Nitika Kaushal |
Shri Guru Ram Rai Inter College Sahaspur |
Shri Guru Ram Rai Inter College Sahaspur Dehardun Uttarakhand pin code 248197
Dehradun
UTTARANCHAL |
7217212211
nitika.scholar@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, TEERTHANKER MAHAVEER DENTAL COLLEGE & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lifestyle-related diseases (obesity, diabetes, hypertension) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HeLP (Healthy Lifestyle Programme) |
It Is A Interventional Programme Which Include Yoga Aasanas, Aerobics, Meditation, Diet Chart Development, Informational Booklet Distribution, Interective Discussion, Stress Management Sessions And Feedback To Enhance Awareness And Promote Prevention Of Hypertension, Diabities And Obesity Among Adolescents. The Total Duration Of The Programme Will Be 6 Months. |
| Comparator Agent |
Routine Support |
Adolescents In The Control Arm Will Continue With Routine Health Activities And Support As Normally Provided. No Additional Intervention Will Be Introduced. The Total Duration Of The Programme Will Be 6 Months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Adolescents Who Are Available During The Data Collection
2 Adolescents Who Are Willing To Participate In The Research
3 Both Boys And Girls Will Be Included
|
|
| ExclusionCriteria |
| Details |
1 Adolescents Who Are Physically And Mentally Unfit To Respond To The Tool
2 Adolescents Who Are Irregular Or Absent Frequently
3 School-Going Children Less Than 12 Years Old And More Than 16 Years Old Will Be Excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess The Effectiveness And Improvement Of Knowledge Through Multiple Choice Questions And Attitude Through Likert Scale And Practice Through Checklist |
Baseline And 4 months After Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
15/11/2025 |
| 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="6"
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
|
This study aims to assess the effectiveness of the Healthy Lifestyle Programme (HeLP) in improving knowledge, attitude, and practice (KAP) related to lifestyle diseases among healthy school-going adolescents. The programme focuses on prevention of lifestyle-related conditions such as obesity, diabetes, and hypertension by promoting healthy behaviours in the adolescent population. It is hypothesised that participation in HeLP will lead to a significant improvement in knowledge, attitude, and practice regarding prevention of lifestyle diseases compared to baseline. |