- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05883930
The Effect of the Mobile Software Let's Move Program on Changing Sedentary Behaviors of University Students
The Effect of Mobile Software "Let's Move" Program Developed Based on Transtheoretical Model on Sedentary Life Behaviors of University Students
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İstanbul, Turkey, 34854
- Marmara University/ Maltepe
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İstanbul
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Maltepe, İstanbul, Turkey, 34500
- Marmara University/ Maltepe
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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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:
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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.
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No intervention will be applied to the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline
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Physical activity categories by total score Metabolic Equivalent (MET) by IPAQ;
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Baseline
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Transtheoretical Model Sedentary Life Stages of Change Survey
Time Frame: Baseline
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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.
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Baseline
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Transtheoretical Model Sedentary Life Self-efficacy Scale
Time Frame: Baseline
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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.
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Baseline
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Transtheoretical Model Sedentary Life Decision Balance Scale
Time Frame: Baseline
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The decision-making scale consists of two sub-dimensions that measure the benefits and harms of making a behavior change decision.
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Baseline
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Step counter
Time Frame: Baseline
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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"
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Baseline
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Body Mass Index (BMI)
Time Frame: Baseline
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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.
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Baseline
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Body fat to muscle ratio
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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International Physical Activity Questionnaire (IPAQ)
Time Frame: 12th weekend
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Physical activity categories by total score Metabolic Equivalent (MET) by IPAQ;
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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.
|
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.
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12th weekend
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Step counter
Time Frame: 12th weekend
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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"
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12th weekend
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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
|
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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;
|
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.
|
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.
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: GÖZDE ÖZDEMİR, https://www.marmara.edu.tr/
- Study Director: SAİME EROL, https://www.marmara.edu.tr/
Publications and helpful links
General Publications
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Han H, Gabriel KP, Kohl HW. Evaluations of Validity and Reliability of a Transtheoretical Model for Sedentary Behavior among College Students. Am J Health Behav. 2015 Sep;39(5):601-9. doi: 10.5993/AJHB.39.5.2.
- Kim H, Kohl Iii HW, Pettee Gabriel KK, Han H. Differential Use of Strategic Constructs of the Transtheoretical Model across Accelerometer-determined Sedentary Time. Am J Health Behav. 2020 Jan 1;44(1):18-25. doi: 10.5993/AJHB.44.1.3.
- Lee JS, Kang MA, Lee SK. Effects of the e-Motivate4Change Program on Metabolic Syndrome in Young Adults Using Health Apps and Wearable Devices: Quasi-Experimental Study. J Med Internet Res. 2020 Jul 30;22(7):e17031. doi: 10.2196/17031.
- Kleis RR, Hoch MC, Hogg-Graham R, Hoch JM. The Effectiveness of the Transtheoretical Model to Improve Physical Activity in Healthy Adults: A Systematic Review. J Phys Act Health. 2021 Jan 1;18(1):94-108. doi: 10.1123/jpah.2020-0334. Epub 2020 Dec 1.
- Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.
- Wu YK, Chu NF. Introduction of the transtheoretical model and organisational development theory in weight management: A narrative review. Obes Res Clin Pract. 2015 May-Jun;9(3):203-13. doi: 10.1016/j.orcp.2014.12.003. Epub 2015 Jan 5.
- Han H, Pettee Gabriel K, Kohl HW 3rd. Application of the transtheoretical model to sedentary behaviors and its association with physical activity status. PLoS One. 2017 Apr 27;12(4):e0176330. doi: 10.1371/journal.pone.0176330. eCollection 2017.
- Kim H, Park E, Lee S, Kim M, Park EJ, Hong S. Self-Management of Chronic Diseases Among Older Korean Adults: An mHealth Training, Protocol, and Feasibility Study. JMIR Mhealth Uhealth. 2018 Jun 29;6(6):e147. doi: 10.2196/mhealth.9988.
- Wang JB, Cadmus-Bertram LA, Natarajan L, White MM, Madanat H, Nichols JF, Ayala GX, Pierce JP. Wearable Sensor/Device (Fitbit One) and SMS Text-Messaging Prompts to Increase Physical Activity in Overweight and Obese Adults: A Randomized Controlled Trial. Telemed J E Health. 2015 Oct;21(10):782-92. doi: 10.1089/tmj.2014.0176. Epub 2015 Jun 2.
- Andersen LB, Harro M, Sardinha LB, Froberg K, Ekelund U, Brage S, Anderssen SA. Physical activity and clustered cardiovascular risk in children: a cross-sectional study (The European Youth Heart Study). Lancet. 2006 Jul 22;368(9532):299-304. doi: 10.1016/S0140-6736(06)69075-2.
- Kim BH, Lee H. Associations Between Smartphone Use for Physical Activity by South Korean College Students and Behavioral Change Constructs of the Transtheoretical Model. Percept Mot Skills. 2022 Aug;129(4):1270-1282. doi: 10.1177/00315125221099258. Epub 2022 May 6.
- Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001.
- Tudor-Locke C, Washington TL, Hart TL. Expected values for steps/day in special populations. Prev Med. 2009 Aug;49(1):3-11. doi: 10.1016/j.ypmed.2009.04.012. Epub 2009 May 4.
Helpful Links
- World Health Organization, 2020, Physical Activity
- World Health Organization, 2021, Body Mass Index (BMI)
- World Health Organization, 2020, Adolescent And Young Adult Health
- International Physical Activity Questionnaire (IPAQ) research committee Guidelines for data processing and analysis of International Physical Activity Questionnaire, 2005
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Study Data/Documents
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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
Studies a U.S. FDA-regulated device product
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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