The Effect of the Mobile Software Let's Move Program on Changing Sedentary Behaviors of University Students

October 17, 2023 updated by: Marmara University

The Effect of Mobile Software "Let's Move" Program Developed Based on Transtheoretical Model on Sedentary Life Behaviors of University Students

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.

Study Overview

Status

Enrolling by invitation

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.

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • İstanbul, Turkey, 34854
        • Marmara University/ Maltepe
    • İstanbul
      • Maltepe, İstanbul, Turkey, 34500
        • Marmara University/ Maltepe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transtheoretical Model (TTM)-based "Let's Move" mobile software program
Transtheoretical Model (TTM)-based "Let's Move" mobile software program developed for the experimental group will be applied for 12 weeks. Students will be given smart wristbands. Smart wristband data (step numbers) will be integrated into the program. Through this program, students will fill in the pre-test, post-test and follow-up test (at 6 months) and the sedentary lifestyle TTM Sedentary Life Scales (Stages of Change questionnaire, Self-Efficacy and Decision Making scales) and daily step count values.The body mass index, fat and muscle ratios of the students will be evaluated by the researcher. They will be asked to add these values to the program.

Students will complete data collection forms as part of the program. According to International Physical Activity Questionnaire (IPAQ), those who are low in activity and inactive will be assigned to the appropriate intervention program based on their sedentary lifestyle stage.

Students will enter the module system prepared according to the five different stages of change [not thinking (1), thinking (2), preparing (3), acting (4), continuing (5)] of sedentary living.

There are 12 different initiatives for each phase/module of the program. Summary and reinforcing questions are asked at the end of each trial. If participants do not answer the questions, they cannot continue with the next week's initiative.

Participants' daily step counts with the smart wristband are recorded in the program.

Daily alerts/reinforcement messages related to that week's initiative will be sent during all phases.

Other Names:
  • mobile software 'Let's Move' program
Experimental: control group
No intervention will be made in the control group. A smart bracelet will be given as a gift in order to follow the step counts of the students. Students will fill in pre-test, post-test and follow-up test (at 6 months) and sedentary lifestyle TTM Sedentary Life Scales (Stages of Change questionnaire, Self-Efficacy and Decision Making scales) and daily step count values via online forms. The body mass index, fat and muscle ratios of the students will be evaluated by the researcher. These values will be recorded.
No intervention will be applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline

Physical activity categories by total score Metabolic Equivalent (MET) by IPAQ;

  • Inactive level; 599 MET and below
  • Minimal level; between 600 MET -3000 MET
  • Very active level; 3001 MET and above.
Baseline
Transtheoretical Model Sedentary Life Stages of Change Survey
Time Frame: Baseline

Sedentary life change stages constitute the core structure of the Transtheoretical Model. It reflects the individual's attitudes, intentions and behaviors during the change phase. Behavior change; It is a situation assessment consisting of five options and two questions: precontemplation, contemplation, preparation, action and maintenance.

  1. Precontemplation (PC); The individual is either unaware of the problem or has little awareness of it. He has no intention of changing his problematic behavior within 6 months.
  2. Contemplation (C); The individual considers the positive and negative aspects of his/her problematic behavior and is the stage where he/she thinks to change within 6 months.
  3. Preparation (P); The individual intends to change their problematic behavior within 30 days.
  4. Action (A); The individual changed his problematic behaviors within 6 months.
  5. Maintenance (M); The individual has changed his unhealthy behavior 6 months ago at this stage.
Baseline
Transtheoretical Model Sedentary Life Self-efficacy Scale
Time Frame: Baseline
Self-efficacy Scale; It is an individual's belief about himself/herself that he/she can successfully perform a certain behavior, and it reflects self-confidence. The scale consists of 6 items that include self-confidence in quitting sedentary behavior. It is a five-point Likert type. It ranges from 1: Not at all trusting to 5: Very confident. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on the self-efficacy scale indicates that the student's self-efficacy in changing sedentary life behavior has increased.
Baseline
Transtheoretical Model Sedentary Life Decision Balance Scale
Time Frame: Baseline

The decision-making scale consists of two sub-dimensions that measure the benefits and harms of making a behavior change decision.

  • Sedentary life behavior change decision-making benefit perception sub-dimension; It consists of 1, 3, 5, 7, 9, and 11 items of the scale. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on this sub-dimension indicates that they are aware of the benefits of behavior change and that they are more likely to change their behavior.
  • Sedentary life behavior change decision making harm sub-dimension; It consists of the 2nd, 4th, 6th, 8th, 10th, and 12th items of the scale. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on this sub-dimension indicates that the harms of behavior change attract more attention and the probability of changing behavior is less.
Baseline
Step counter
Time Frame: Baseline
Categories of steps per day Number of steps per day-Category less than 2500 steps-"basal activity" 2500-4999 steps- "limited activity" Those taking 5000-7499 steps- "little activity" 7500-9999 steps-"somewhat active" 10000-12499 steps taken- "active" Those who take more than 12500 steps- "highly active"
Baseline
Body Mass Index (BMI)
Time Frame: Baseline
According to the World Health Organization's body mass index data, individuals below 18.5 kg/m2 are considered "thin," values between 18.5and 24.99 are considered "normal," 25.0to 29.9 kg/m2 are considered "mildly obese," and 30.0 kg/m2 or more are considered "obese." After completion of the study, participants will be evaluated according to their body mass index.
Baseline
Body fat to muscle ratio
Time Frame: Baseline
For men and women to be physically and psychosocially healthy, the ratio of standard oils (essential oils) should be 15% for men and 23% for women.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire (IPAQ)
Time Frame: 12th weekend

Physical activity categories by total score Metabolic Equivalent (MET) by IPAQ;

  • Inactive level; 599 MET and below
  • Minimal level; between 600 MET -3000 MET
  • Very active level; 3001 MET and above.
12th weekend
Transtheoretical Model Sedentary Life Stages of Change Survey
Time Frame: 12th weekend

Sedentary life change stages constitute the core structure of the Transtheoretical Model. It reflects the individual's attitudes, intentions and behaviors during the change phase. Behavior change; It is a situation assessment consisting of five options and two questions: precontemplation, contemplation, preparation, action and maintenance.

  1. Precontemplation (PC); The individual is either unaware of the problem or has little awareness of it. He has no intention of changing his problematic behavior within 6 months.
  2. Contemplation (C); The individual considers the positive and negative aspects of his/her problematic behavior and is the stage where he/she thinks to change within 6 months.
  3. Preparation (P); The individual intends to change their problematic behavior within 30 days.
  4. Action (A); The individual changed his problematic behaviors within 6 months.
  5. Maintenance (M); The individual has changed his unhealthy behavior 6 months ago at this stage.
12th weekend
Transtheoretical Model Sedentary Life Self-efficacy Scale
Time Frame: 12th weekend
It is an individual's belief about himself/herself that he/she can successfully perform a certain behavior, and it reflects self-confidence. The scale consists of 6 items that include self-confidence in quitting sedentary behavior. It is a five-point Likert type. It ranges from 1: Not at all trusting to 5: Very confident. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on the self-efficacy scale indicates that the student's self-efficacy in changing sedentary life behavior has increased.
12th weekend
Transtheoretical Model Sedentary Life Decision Balance Scale
Time Frame: 12th weekend

The decision-making scale consists of two sub-dimensions that measure the benefits and harms of making a behavior change decision.

  • Sedentary life behavior change decision-making benefit perception sub-dimension; It consists of 1, 3, 5, 7, 9, and 11 items of the scale. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on this sub-dimension indicates that they are aware of the benefits of behavior change and that they are more likely to change their behavior.
  • Sedentary life behavior change decision making harm sub-dimension; It consists of the 2nd, 4th, 6th, 8th, 10th, and 12th items of the scale. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on this sub-dimension indicates that the harms of behavior change attract more attention and the probability of changing behavior is less.
12th weekend
Step counter
Time Frame: 12th weekend
Categories of steps per day Number of steps per day-Category less than 2500 steps-"basal activity" 2500-4999 steps- "limited activity" Those taking 5000-7499 steps- "little activity" 7500-9999 steps-"somewhat active" 10000-12499 steps taken- "active" Those who take more than 12500 steps- "highly active"
12th weekend
Body Mass Index (BMI)
Time Frame: 12th weekend
According to the World Health Organization's body mass index data, individuals below 18.5 kg/m2 are considered "thin," values between 18.5and 24.99 are considered "normal," 25.0to 29.9 kg/m2 are considered "mildly obese," and 30.0 kg/m2 or more are considered "obese." After completion of the study, participants will be evaluated according to their body mass index.
12th weekend
Body fat to muscle ratio
Time Frame: 12th weekend
For men and women to be physically and psychosocially healthy, the ratio of standard oils (essential oils) should be 15% for men and 23% for women.
12th weekend

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire (IPAQ)
Time Frame: 24th weekend.

Physical activity categories by total score Metabolic Equivalent (MET) by IPAQ;

  • Inactive level; 599 MET and below
  • Minimal level; between 600 MET -3000 MET
  • Very active level; 3001 MET and above.
24th weekend.
Transtheoretical Model Sedentary Life Stages of Change Survey
Time Frame: 24th weekend.

Sedentary life change stages constitute the core structure of the Transtheoretical Model. It reflects the individual's attitudes, intentions and behaviors during the change phase. Behavior change; It is a situation assessment consisting of five options and two questions: precontemplation, contemplation, preparation, action and maintenance.

  1. Precontemplation (PC); The individual is either unaware of the problem or has little awareness of it. He has no intention of changing his problematic behavior within 6 months.
  2. Contemplation (C); The individual considers the positive and negative aspects of his/her problematic behavior and is the stage where he/she thinks to change within 6 months.
  3. Preparation (P); The individual intends to change their problematic behavior within 30 days.
  4. Action (A); The individual changed his problematic behaviors within 6 months.
  5. Maintenance (M); The individual has changed his unhealthy behavior 6 months ago at this stage.
24th weekend.
Transtheoretical Model Sedentary Life Self-efficacy Scale
Time Frame: 24th weekend.
It is an individual's belief about himself/herself that he/she can successfully perform a certain behavior, and it reflects self-confidence. The scale consists of 6 items that include self-confidence in quitting sedentary behavior. It is a five-point Likert type. It ranges from 1: Not at all trusting to 5: Very confident. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on the self-efficacy scale indicates that the student's self-efficacy in changing sedentary life behavior has increased.
24th weekend.
Transtheoretical Model Sedentary Life Decision Balance Scale
Time Frame: 24th weekend.

The decision-making scale consists of two sub-dimensions that measure the benefits and harms of making a behavior change decision.

  • Sedentary life behavior change decision-making benefit perception sub-dimension; It consists of 1, 3, 5, 7, 9, and 11 items of the scale. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on this sub-dimension indicates that they are aware of the benefits of behavior change and that they are more likely to change their behavior.
  • Sedentary life behavior change decision making harm sub-dimension; It consists of the 2nd, 4th, 6th, 8th, 10th, and 12th items of the scale. The minimum score to be taken from these scales will be '6' and the maximum score will be '30'. A high score on this sub-dimension indicates that the harms of behavior change attract more attention and the probability of changing behavior is less.
24th weekend.
Step counter
Time Frame: 24th weekend.
Categories of steps per day Number of steps per day-Category less than 2500 steps-"basal activity" 2500-4999 steps- "limited activity" Those taking 5000-7499 steps- "little activity" 7500-9999 steps-"somewhat active" 10000-12499 steps taken- "active" Those who take more than 12500 steps- "highly active"
24th weekend.
Body Mass Index (BMI)
Time Frame: 24th weekend
According to the World Health Organization's body mass index data, individuals below 18.5 kg/m2 are considered "thin," values between 18.5and 24.99 are considered "normal," 25.0to 29.9 kg/m2 are considered "mildly obese," and 30.0 kg/m2 or more are considered "obese." After completion of the study, participants will be evaluated according to their body mass index.
24th weekend
Body fat to muscle ratio
Time Frame: 24th weekend
For men and women to be physically and psychosocially healthy, the ratio of standard oils (essential oils) should be 15% for men and 23% for women.
24th weekend

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: GÖZDE ÖZDEMİR, https://www.marmara.edu.tr/
  • Study Director: SAİME EROL, https://www.marmara.edu.tr/

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2023

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Marmara üniversitesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the end of the 12th week and the 24th week, the results of the research will be shared.

IPD Sharing Time Frame

13.06.2023-13.09.2023

IPD Sharing Access Criteria

It can be seen on the page where randomized controlled trial (RCT) data are shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Scales Validity and Reliability
    Information comments: Ozturk, M. (2005). The validity and reliability of the international physical activity questionnaire and the determination of physical activity level in university students. Unpublished master thesis. Hacettepe University, Institute of Health Sciences, Ankara.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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