| CTRI Number |
CTRI/2025/12/098776 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a randomised controlled trial to study the effect of mobile health intervention on smartphone screentime among young adults in an urban community setting of Delhi |
|
Scientific Title of Study
|
Effect of m-health Intervention on smartphone screen time among young adults: A Randomized controlled trial |
| 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 Priyanka C S |
| Designation |
First Year Post graduate resident |
| Affiliation |
Maulana azad medical college |
| Address |
3rd floor pathology block Department of community medicine
Maulana azad medical college
2 Bahadurshah Zafar Marg
New Delhi
110002
New Delhi
DELHI
110002
India |
| Phone |
9567889203 |
| Fax |
|
| Email |
csp06772@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Bhatnagar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Room no 328
3 rd floor
pathology block
Department of community medicine
Maulana Azad medical college
2 Bahadur Shah Zafar Marg
New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
8750647995 |
| Fax |
|
| Email |
bhatnagarnidhi.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Priyanka C.S |
| Designation |
Post graduate resident |
| Affiliation |
|
| Address |
3 rd floor pathology block Department of community medicine
Maulana Azad Medical College
2 Bahadur shah Zafar Marg
New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9567889203 |
| Fax |
|
| Email |
csp06772@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanka C S |
| Address |
3 rd floor, Pathology block
Department of Community Medicine
Maulana Azad medical college
2 Bahadur shah Zafar Marg
New Delhi
110002 |
| 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 Priyanka C S |
Delhi Gate Health Centre -catchment area |
Delhi Gate Health Centre
3373 3374
Tiraha Behram Khan Road
Chatt lal Miya
Chandni mahal
Old Delhi
New Delhi 110002
New Delhi
DELHI |
9567889203
csp06772@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18-24 YEARS YOUNG ADULTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
m health messages |
Intervention in group 1
1st-8th week
total duration of intervention period
8 weeks ( 2 months )
a.One message per week (Sunday morning), about excessive screen time use and related health risks and strategies to reduce screen time on smartphone
b.Screenshots for screentime use to be submitted every week on Saturday evening
|
| Comparator Agent |
m health messages |
Total duration of intervention in comparator group is 8 weeks
m health messages per week (Sunday morning), about general wellness tips and will not include any content on screen time or related behaviour-change strategies
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1.1. Permanent resident of Delhi gate area and expected stay in the study area for at-least 6 months from the date of interview.
2. Owns a smartphone with in-built screen time tracking features (e.g., Digital wellbeing, Screen Time) in iPhone with iOS version 12 (or later) and in android running in android 9 (pie) or later.
3. Smartphone Usage: Minimum weekly average of 4 hours / day.
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed psychiatric and medical disorders: Diagnosed depression, anxiety, schizophrenia, bipolar disorder, or any psychiatric illness requiring hospitalization.
2.Substance Use /disuse Disorders: Individuals frequent.ly consuming alcohol, tobacco, or other psychoactive substance (At-least once per week for more than four weeks preceding the date of interview)
3.History of Digital Detox in the Last 3 Months: Participants who have undergone structured screen-time reduction programs or digital detox retreats in the last 3 months to ensure unbiased intervention effects.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in smartphone screen time (measured in hours per day) from baseline to the end of the 8-week intervention. |
1.baseline
2.after 8 weeks completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean change in anxiety levels (measured using GAD-7 25 scale) from baseline to 8 weeks.
2.Change in proportion of Problematic smartphone use of study subjects (assessed using the Smart phone Addiction Scale short version– SAS-SV) 26 |
1.Baseline
2.after completion of 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
25/12/2025 |
| 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="1"
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
|
This randomized controlled trial evaluates the effect of an m-health intervention on reducing smartphone screen time among young adults (18–24 years) in an urban Delhi community. A total of 180 participants will be randomly allocated into two groups: an intervention group receiving weekly behaviour-change messages and a control group receiving general wellness messages for eight weeks. Baseline and post-intervention assessments will measure screen time, anxiety (GAD-7), and problematic smartphone use (SAS-SV). The study aims to determine changes in mean screen time, anxiety levels, and smartphone addiction while ensuring ethical conduct, confidentiality, and informed consent throughout |