NCT05883930

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

March 29, 2023

Last Update Submit

October 17, 2023

Conditions

Keywords

Physical activityMobile softwareUniversity studentsPublic health nursing

Outcome Measures

Primary 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.

    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. 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

    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

    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

    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)

    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

    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 Outcomes (7)

  • International Physical Activity Questionnaire (IPAQ)

    12th weekend

  • Transtheoretical Model Sedentary Life Stages of Change Survey

    12th weekend

  • Transtheoretical Model Sedentary Life Self-efficacy Scale

    12th weekend

  • Transtheoretical Model Sedentary Life Decision Balance Scale

    12th weekend

  • Step counter

    12th weekend

  • +2 more secondary outcomes

Other Outcomes (7)

  • International Physical Activity Questionnaire (IPAQ)

    24th weekend.

  • Transtheoretical Model Sedentary Life Stages of Change Survey

    24th weekend.

  • Transtheoretical Model Sedentary Life Self-efficacy Scale

    24th weekend.

  • +4 more other outcomes

Study Arms (2)

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.

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.

Other: no intervention

Interventions

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.

Also known as: mobile software 'Let's Move' program
Transtheoretical Model (TTM)-based "Let's Move" mobile software program

No intervention will be applied to the control group.

control group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • First year students studying in Istanbul Beykent University Vocational School health program between September 2022 and September 2024,
  • 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,

You may not qualify if:

  • Willingness to leave the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marmara University/ Maltepe

Maltepe, Istanbul, 34500, Turkey (Türkiye)

Location

Marmara University/ Maltepe

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • GÖZDE ÖZDEMİR

    https://www.marmara.edu.tr/

    PRINCIPAL INVESTIGATOR
  • SAİME EROL

    https://www.marmara.edu.tr/

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

June 1, 2023

Study Start

October 30, 2023

Primary Completion

January 30, 2024

Study Completion

April 30, 2024

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
13.06.2023-13.09.2023
Access Criteria
It can be seen on the page where randomized controlled trial (RCT) data are shared.
More information

Available IPD Datasets

Scales Validity and Reliability Access

Locations