| CTRI Number |
CTRI/2025/01/079797 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Promoting Healthy Lifestyle Choices Among School Adolescents: An e-Wellness Program in SAS Nagar, Punjab |
|
Scientific Title of Study
|
AdoHealth Initiative: A School-Based cluster randomised controlled trial of an e-wellness initiative for Nurturing Healthy Lifestyle Choices among Adolescents in SAS Nagar, Punjab. |
| 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 Amrit Virk |
| Designation |
Professor and Head, Department of Community Medicine |
| Affiliation |
Dr BR Ambedkar State Institute of Medical Sciences (AIMS), Mohali, Punjab |
| Address |
Room No. 51,
Dr BR Ambedkar State Institute of medical Sciences (AIMS),
SAS Nagar, Mohali, Punjab-160055
Rupnagar
PUNJAB
160055
India |
| Phone |
9815140389 |
| Fax |
|
| Email |
dramritvirk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrit Virk |
| Designation |
Professor and Head, Department of Community Medicine |
| Affiliation |
Dr BR Ambedkar State Institute of Medical Sciences (AIMS), Mohali, Punjab |
| Address |
Room No. 51,
Dr BR Ambedkar State Institute of medical Sciences (AIMS),
SAS Nagar, Mohali, Punjab-160055
Rupnagar
PUNJAB
160055
India |
| Phone |
9815140389 |
| Fax |
|
| Email |
dramritvirk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrit Virk |
| Designation |
Professor and Head, Department of Community Medicine |
| Affiliation |
Dr BR Ambedkar State Institute of Medical Sciences (AIMS), Mohali, Punjab |
| Address |
Room No. 51,
Dr BR Ambedkar State Institute of medical Sciences (AIMS),
SAS Nagar, Mohali, Punjab-160055
Rupnagar
PUNJAB
160055
India |
| Phone |
9815140389 |
| Fax |
|
| Email |
dramritvirk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Amrit Virk |
| Address |
Room No. 51
Dr BR Ambedkar State Institute of Medical Sciences (AIMS), SAS Nagar, Mohali, Punjab |
| 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 |
| Dr Amrit Virk |
Dr BR Ambedkar State Institute of Medical Sciences (AIMS Mohali) |
Department of Community Medicine, Room No 51, Medical College Building
Rupnagar
PUNJAB |
09815140389
dramritvirk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research (IEC-HR), AIMS Mohali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy lifestyle in Adolescent |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
e-wellness programme (AdoHealth Initiative) |
Seven e-modules delivered over seven weeks with focus on addressing the Big 7 Behavioral Risk Determinants (alcohol and tobacco use
initiation, sedentary recreational screen time reduction, mitigation of physical activity decline,
reduction in consumption of unhealthy foods, improvement of sleep quality and reduced
stress). |
| Comparator Agent |
Control Group only health education |
This group will receive health education as advised under NPNCD guidelines. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Adolescent school students aged 14 to 17
years studying in selected schools will be enrolled in the study after obtaining informed written
parental consent and written assent from the study participants |
|
| ExclusionCriteria |
| Details |
Adolescent school students experiencing severe illness or chronic diseases will be excluded from the study since their behavioural and biochemical risk factors may be influenced by their diseased status
Private schools not consenting to be part of the study will be excluded before randomisation |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
• Reduced consumption of sugar-sweetened beverages
• increase in physical activity
• Improved sleep quality
• Reduction in sedentary recreational screen time
• Delayed initiation of tobacco and alcohol
• Reduction in stress |
6 months and 12 months after completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in overall well-being and lifestyle choices among adolescents. |
12 months after completion of intervention |
|
|
Target Sample Size
|
Total Sample Size="18000"
Sample Size from India="18000"
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)
|
01/08/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Virk, A., Lal, D., Sharma, S. et al. AdoHealth e-wellness initiative for adolescent non-communicable disease risk reduction: protocol for a school-based cluster randomised controlled trial in SAS Nagar (Mohali), Punjab, India. Trials (2026). https://doi.org/10.1186/s13063-026-09724-1 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a multisite cluster randomised controlled trial that will be conducted by randomized allocation of 180 Public and Private senior secondary and high schools to either the AdoHealth initiative (e-wellness) intervention or the control group. The AdoHealth Initiative will comprise seven e-modules delivered weekly over seven weeks addressing the ‘Big-7 behavioural risk determinants’. Behavioural and Biochemical evaluation, utilizing the WHO STEPS questionnaire, Perceived Stress Scale-10, Child and Adolescent Sleep Checklist (CASC) – student version and Questionnaire for Screen Time of Adolescents (QueST) will be conducted at baseline, six months, and twelve months after intervention, with primary outcomes centred on the key risk determinants, including; reduced consumption of sugar-sweetened beverages, increase in physical activity, improved sleep quality, reduction in sedentary recreational screen time, delayed initiation of tobacco and alcohol and reduction in stress. Secondary outcome includes improvement in overall well-being and lifestyle choices among adolescents. |