CTRI

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CTRI Number

CTRI/2026/01/100910 [Registered on: 12/01/2026] Trial Registered Prospectively

Last Modified On:

11/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Behavioral

Study Design

Randomized, Parallel Group Trial

Public Title of Study

An Interventional Study Using Mobile Health Technology to Promote Physical Activity

Scientific Title of Study

M-HEALTH INTERVENTION TO PROMOTE PHYSICAL ACTIVITY AMONG COLLEGE STUDENTS: 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	PRAVEEN KUMAR SHARMA
Designation	JUNIOR RESIDENT
Affiliation	GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH, INDIA
Address	DEPARTMENT OF COMMUNITY MEDICINE, GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH NIL Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9557383341
Fax	NIL
Email	praveensharma3195@gmail.com

Details of Contact Person
Scientific Query

Name	DEEPSHIKHA VERMA
Designation	ASSISTANT PROFESSOR
Affiliation	GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH, INDIA
Address	DEPARTMENT OF COMMUNITY MEDICINE, GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH NIL Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9317125500
Fax	NIL
Email	dr.deepshikha.vrma@gmail.com

Details of Contact Person
Public Query

Name	DEEPSHIKHA VERMA
Designation	ASSISTANT PROFESSOR
Affiliation	GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH, INDIA
Address	DEPARTMENT OF COMMUNITY MEDICINE, GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH NIL Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9317125500
Fax	NIL
Email	dr.deepshikha.vrma@gmail.com

Source of Monetary or Material Support

NIL (NO EXTERNAL MONETARY OR MATERIAL SUPPORT)

Primary Sponsor

Name	GOVERNMENT INSTITUTE OF MEDICAL SCIENCES GIMS GAUTAM BUDDHA NAGAR
Address	GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH, INDIA
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Praveen Kumar Sharma	Government Institute of Medical Sciences Gautam Buddha Nagar	Room No 4166 Department of Community Medicine GIMS Gautam Buddha Nagar PIN 201310 Gautam Buddha Nagar UTTAR PRADESH	9557383341 praveensharma3195@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee GIMS Greater Noida	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	PHYSICAL ACTIVITY

Intervention / Comparator Agent

Type	Name	Details
Intervention	FIT INDIA MOBILE APPLICATION AND PACER MOBILE APPLICATION	Participants in the intervention group will receive a mobile health (mHealth)–based intervention using the Fit India mobile application and the Pacer mobile application. The Fit India application will be used to deliver structured health education content, including videos related to physical activity and healthy lifestyle practices. The Pacer application will be used to monitor daily physical activity through step count using the smartphone’s built-in sensors. Participants will be encouraged to regularly use both applications throughout the study period.
Comparator Agent	STANDARD HEALTH EDUCATION AND STEP COUNT MONITORING	Participants in the comparator group will receive standard health education in the form of a health talk once every two months. Physical activity will be monitored using the Pacer mobile application for step count measurement without any additional structured mHealth intervention.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	25.00 Year(s)
Gender	Both
Details	• Enrolled in any course at GIMS, Greater Noida. • Owns a smartphone (essential for app-based intervention). • BMI between 18.5 and 29.9 kg/m² (normal to obese range, as per Asia Pacific BMI scale).

ExclusionCriteria

Details

• Pregnant women or those planning pregnancy during the study period.
• Individuals diagnosed with chronic medical conditions affecting physical activity or body weight (e.g., thyroid disorders, eating disorders).
• Individuals currently participating in any other structured weight management, physical activity, or lifestyle modification program.
• Individuals unable to comply with study procedures or follow-up.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Effectiveness of an m-Health intervention in increasing the level of physical activity among college students.	6 months

Secondary Outcome

Outcome	TimePoints
The impact of the intervention on students’ motivation and attitudes toward physical activity.	6 months
Change in BMI and resting heart rate in the study groups.	6 months
The adherence and engagement levels with the m-Health application in the intervention group.	6 months
The feasibility and acceptability of using m-Health tools for physical activity promotion in a college setting.	6 months

Target Sample Size

Total Sample Size="220"
Sample Size from India="220"
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)

30/01/2026

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="1"
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 randomized controlled trial aims to evaluate the effectiveness of a mobile health (m-Health) intervention in promoting physical activity among college students aged 18–25 years at Government Institute of Medical Sciences (GIMS), Greater Noida. The intervention group will receive digital tools such as the Fit India App and Pacer App (for activity tracking), motivational WhatsApp/SMS messages, a health e-booklet, and monthly health education sessions over a 6-month period. The control group will receive standard health talks once every two months.

Physical activity will be assessed using the Global Physical Activity Questionnaire (GPAQ), while motivation and attitude toward exercise will be evaluated using the Attitude Toward Physical Activity Scale (APAS) and Behavioral Regulation in Exercise Questionnaire (BREQ-3). The study will measure changes in MET-minutes/week, BMI, resting heart rate, motivation levels, and adherence to the intervention.

A total of 220 participants (110 per group) will be enrolled after randomization. Data will be analyzed using SPSS version 28 with appropriate statistical tests (p<0.05 considered significant). Ethical approval will be obtained from the Institutional Ethics Committee, and informed consent will be taken from all participants.

The study seeks to assess the feasibility, acceptability, and effectiveness of m-Health tools as scalable solutions to improve physical activity and prevent non-communicable diseases in young adults.