Public Health NursingNCT05883930
The Effect of the Mobile Software Let's Move Program on Changing Sedentary Behaviors of University Students
A study testing 'Let's Move' program in people with Public Health Nursing, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Public Health Nursing
- What is being tested?
- 'Let's Move' program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Marmara University/ Maltepe
Istanbul, 34854
Marmara University/ Maltepe
Maltepe, Istanbul, 34500
About this study
Official title: 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.
Read the 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.
- Conditions
- Public Health Nursing
- Being tested
- 'Let's Move' program, no intervention
- Keywords
- Physical activity, Mobile software, University students, Public health nursing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Let's Move' programOther
Also called mobile software 'Let's Move' 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.
no interventionOther
No intervention will be applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Transtheoretical Model (TTM)-based "Let's Move" mobile software program | Experimental | 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. Receives: Other: 'Let's Move' program |
| control group | Experimental | 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (IPAQ)
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.
Measured: Baseline
Transtheoretical Model Sedentary Life Stages of Change Survey
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.
- 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.
- 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.
- Preparation (P); The individual intends to change their problematic behavior within 30 days.
- Action (A); The individual changed his problematic behaviors within 6 months.
- Maintenance (M); The individual has changed his unhealthy behavior 6 months ago at this stage.
Measured: Baseline
Transtheoretical Model Sedentary Life Self-efficacy Scale
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.
Measured: Baseline
Transtheoretical Model Sedentary Life Decision Balance Scale
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.
Measured: Baseline
Step counter
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"
Measured: Baseline
Body Mass Index (BMI)
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.
Measured: Baseline
Body fat to muscle ratio
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.
Measured: Baseline
Secondary outcomes (7)
International Physical Activity Questionnaire (IPAQ)
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.
Measured: 12th weekend
Transtheoretical Model Sedentary Life Stages of Change Survey
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.
- 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.
- 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.
- Preparation (P); The individual intends to change their problematic behavior within 30 days.
- Action (A); The individual changed his problematic behaviors within 6 months.
- Maintenance (M); The individual has changed his unhealthy behavior 6 months ago at this stage.
Measured: 12th weekend
Transtheoretical Model Sedentary Life 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.
Measured: 12th weekend
Transtheoretical Model Sedentary Life Decision Balance Scale
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.
Measured: 12th weekend
Step counter
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"
Measured: 12th weekend
Body Mass Index (BMI)
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.
Measured: 12th weekend
Body fat to muscle ratio
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.
Measured: 12th weekend
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start30 Oct 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Public Health NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- GÖZDE ÖZDEMİR, Principal investigator, https://www.marmara.edu.tr/SAİME EROL, Study director, https://www.marmara.edu.tr/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883930
- Sponsor's protocol ID
- MARMARA ÜNİVERSİTESİ
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the 12th week and the 24th week, the results of the research will be shared.
Publications
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.
PubMed 26248170Kim 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.
PubMed 31783929Lee 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.
PubMed 32729838Kleis 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.
PubMed 33260143Chen 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.
PubMed 32099716Wu 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.
PubMed 25571777Han 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.
PubMed 28448531Kim 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.
PubMed 29959109Wang 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.
PubMed 26431257Andersen 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.
PubMed 16860699Kim 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.
PubMed 35522152Craig 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.
PubMed 12900694Tudor-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.
PubMed 14715035Tudor-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.
PubMed 19409409
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Software "Let's Move" Program Developed Based on Transtheoretical Model on Sedentary Life Behaviors of University Students
- ClinicalTrials.gov ID
- NCT05883930
- Acronym / sponsor ID
- MARMARA ÜNİVERSİTESİ
- Conditions
- Public Health Nursing
- Keywords
- Physical activity, Mobile software, University students, Public health nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transtheoretical Model (TTM)-based "Let's Move" mobile software program | Experimental | Other: 'Let's Move' programTranstheoretical 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. |
| control group | Experimental | Other: no interventionNo 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Let's Move' programAlso: mobile software 'Let's Move' programStudents 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 | Transtheoretical Model (TTM)-based "Let's Move" mobile software program |
| no interventionNo intervention will be applied to the control group. | Other | control group |
Primary outcome
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.
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.
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.
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.
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"
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.
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.
7 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: 12th weekend
Transtheoretical Model Sedentary Life Stages of Change Survey
Time frame: 12th weekend
Transtheoretical Model Sedentary Life Self-efficacy Scale
Time frame: 12th weekend
Transtheoretical Model Sedentary Life Decision Balance Scale
Time frame: 12th weekend
Step counter
Time frame: 12th weekend
Body Mass Index (BMI)
Time frame: 12th weekend
Body fat to muscle ratio
Time frame: 12th weekend
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Results publication: PubMed 26248170Han 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.
- Results publication: PubMed 31783929Kim 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.
- Results publication: PubMed 32729838Lee 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.
- Results publication: PubMed 33260143Kleis 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.
- Results publication: PubMed 32099716Chen 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.
- Results publication: PubMed 25571777Wu 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.
- Results publication: PubMed 28448531Han 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.
- Results publication: PubMed 29959109Kim 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.
- Results publication: PubMed 26431257Wang 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.
- Results publication: PubMed 16860699Andersen 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.
- Results publication: PubMed 35522152Kim 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.
- Results publication: PubMed 12900694Craig 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.
- World Health Organization, 2020, Physical ActivityLink provided by the sponsor.
- World Health Organization, 2021, Body Mass Index (BMI)Link provided by the sponsor.
- World Health Organization, 2020, Adolescent And Young Adult HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. At the end of the 12th week and the 24th week, the results of the research will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GÖZDE ÖZDEMİR principal investigator
https://www.marmara.edu.tr/
SAİME EROL study director
https://www.marmara.edu.tr/
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Let's Move' program in people with Public Health Nursing, run by Marmara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (IPAQ) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883930, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.