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临床试验/CTRI/2026/01/100910
CTRI/2026/01/100910尚未招募不适用

M-HEALTH INTERVENTION TO PROMOTE PHYSICAL ACTIVITY AMONG COLLEGE STUDENTS: A RANDOMIZED CONTROLLED TRIAL

GOVERNMENT INSTITUTE OF MEDICAL SCIENCES GIMS GAUTAM BUDDHA NAGAR1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2026年1月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
220
试验地点
1
主要终点
Effectiveness of an m-Health intervention in increasing the level of physical activity among college students.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • • 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).

排除标准

  • • 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.

结局指标

主要结局

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

时间窗: 6 months

次要结局

  • 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)

研究者

发起方
GOVERNMENT INSTITUTE OF MEDICAL SCIENCES GIMS GAUTAM BUDDHA NAGAR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

PRAVEEN KUMAR SHARMA

GOVERNMENT INSTITUTE OF MEDICAL SCIENCES (GIMS), GAUTAM BUDDHA NAGAR, UTTAR PRADESH, INDIA

研究点 (1)

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