Clinical trial NCT05883930: The Effect of the Mobile Software Let's Move Program on Changing Sedentary Behaviors of University Students
Official title: The Effect of Mobile Software "Let's Move" Program Developed Based on Transtheoretical Model on Sedentary Life Behaviors of University Students
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Public Health Nursing
Keywords: Physical activity
Mobile software
University students
Public health nursing
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Marmara University Scientific Research Projects Unit
name: The Scientific and Technological Research Council of Turkey
First posted: 2023-06-01
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sedentary life means a physically inactive, sedentary life and is the fourth largest risk factor for death worldwide. It is reported that 70% to 85% of young people between the ages of age, representing 15.6% of the population of our country's population, are sedentary. The Transtheoretical Model(TTM) is an easy-to-use and proven model for changing sedentary life. Therefore, in the first stage of this two-stage research, it was aimed to develop the TTM-based 'Let's Move' mobile software program and to test the effect of the mobile software program developed in the second stage on changing the sedentary life behaviors of university students. The universe of this research will consist of 290 students studying at a foundation university in Istanbul. The sample was calculated using the G-power program (3.1.9.4) program. By taking 10% more of the sample, 97 students in the experimental group and 97 students in the control group will be randomly assigned through the Statistical Package for the Social Sciences (SPSS) program. The TTM-based mobile software program "Let's Move" mobile software program developed for the experimental group will be applied for 12 weeks. The effectiveness of the program will be evaluated with the pre-test, post-test and follow-up test, the International Physical Activity Questionnaire, the number of daily steps, the smart bracelet, and the TTM sedentary lifestyle TTM Sedentary Life Scales (Stages of Change, Self-Efficacy and Decision-Making scales). At the end of the research, the effectiveness of the 'Lets's Move' mobile software program "Let's Move" developed in this research in changing the sedentary life will be tested. In addition, it is aimed to increase the number of steps, decrease in sedentary behaviors and make an active lifestyle permanent. All initiatives developed for the TTM sedentary life behavior change stages will be made into a book and the results of the experimental research will be published, contributing and providing evidence to the international literature.

Detailed description: Sedentary lifestyle is an important behavioral problem that threatens health and is reported to be common among young people. University years of study include adolescence and young adulthood. In order to reach the healthy adults of the future, it is very important to spend these periods active, to gain healthy lifestyle behaviors and to make them permanent. Adopting an inactive lifestyle of young people causes many non-communicable diseases (diabetes, hypertension, hyperlipidemia, etc.) later in later ages. For this reason, developing an active lifestyle and changing an inactive lifestyle during the adolescent years are the most important components of reaching healthy societies.

When examining the studies are examined, it is seen that the majority of the studies conducted to reduce sedentary life focus on adults aged \> 30 years and a limited number of experimental studies based on the Transtheoretical Model (TTM) for university students.

The Transtheoretical Model argues that change is a process, and not a result, that the individual changes behavior by going through certain stages, and that in order to be successful in change, appropriate initiatives should be planned for the stage of change that the individual is in. The model recommends appropriate biopsychosocial and behavioral interventions by evaluating the individual's readiness for change with the stages of change questionnaire and the self-efficacy and determination levels with scales. It constantly monitors the stage of change that the individual has reached as a result of the initiatives, and offers initiatives to prevent returns and to make the behavior permanent.

Eligibility criteria: Inclusion criteria for the study;

* First year students studying in Istanbul Beykent University Vocational School health program between September 2022 and September 2024,
* 18-25 years old,
* Being in the inactive (category 1) and minimally active (category 2) categories according to the International Physical Activity Evaluation Questionnaire,
* Not included in any physical activity program,
* Do not have any physical (orthopedic, chronic diseases, etc.) and mental problems diagnosed by a doctor,
* Accepting the measurement of body weight, height, body fat and muscle ratio and calculation of Body Mass Index (BM) before starting the research, at the 12th week and at the 6th month after its completion,
* Agreeing to use pedometer (pedometer),
* Having an iPhone Operating System (iOs) and android based smart phone,
* Have an active internet connection on their phone,
* Students who voluntarily agree to participate in the research will be formed. Exclusion and Exclusion Criteria;
* Willingness to leave the research.

Primary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline
measure: Transtheoretical Model Sedentary Life Stages of Change Survey
timeFrame: Baseline
measure: Transtheoretical Model Sedentary Life Self-efficacy Scale
timeFrame: Baseline
measure: Transtheoretical Model Sedentary Life Decision Balance Scale
timeFrame: Baseline
measure: Step counter
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Body fat to muscle ratio
timeFrame: Baseline
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 12th weekend
measure: Transtheoretical Model Sedentary Life Stages of Change Survey
timeFrame: 12th weekend
measure: Transtheoretical Model Sedentary Life Self-efficacy Scale
timeFrame: 12th weekend
measure: Transtheoretical Model Sedentary Life Decision Balance Scale
timeFrame: 12th weekend
measure: Step counter
timeFrame: 12th weekend
measure: Body Mass Index (BMI)
timeFrame: 12th weekend
measure: Body fat to muscle ratio
timeFrame: 12th weekend
Other outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 24th weekend.
measure: Transtheoretical Model Sedentary Life Stages of Change Survey
timeFrame: 24th weekend.
measure: Transtheoretical Model Sedentary Life Self-efficacy Scale
timeFrame: 24th weekend.
measure: Transtheoretical Model Sedentary Life Decision Balance Scale
timeFrame: 24th weekend.
measure: Step counter
timeFrame: 24th weekend.
measure: Body Mass Index (BMI)
timeFrame: 24th weekend
measure: Body fat to muscle ratio
timeFrame: 24th weekend
Locations:
city: Maltepe
country: Turkey
facility: Marmara University/ Maltepe
state: İstanbul
city: İstanbul
country: Turkey
facility: Marmara University/ Maltepe
Study officials:
affiliation: https://www.marmara.edu.tr/
name: GÖZDE ÖZDEMİR
role: PRINCIPAL_INVESTIGATOR
affiliation: https://www.marmara.edu.tr/
name: SAİME EROL
role: STUDY_DIRECTOR
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