- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07087457
- Original Trial
The Effect of Transtheoretical Model-Based Exercise Interventions on Increasing Physical Activity in Office Workers (FIT-MOS)
The Effect of Human and Digital Stimulus Exercise Interventions Based on the Transtheoretical Model on Increasing Physical Activity Levels in Sedentary Office Workers: A Randomized Crossover Study
This study aims to evaluate the effect of human and digital stimulus exercise interventions based on the transtheoretical model on increasing physical activity levels in sedentary office workers. In the study, which is planned to be conducted with a randomized crossover design, participants will be randomly assigned to different intervention conditions (human and digital stimulus). Interventions will be structured in accordance with the behavior change stages of individuals and will be implemented over a certain period of time. Within the scope of the study, physiological indicators such as heart rate variability will be evaluated along with physical activity level. This study is aimed to contribute to the development of evidence-based intervention models to support the physical activity habits of individuals working in an office environment.
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Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sebahat GÖZÜM, Prof.Dr.
- Phone Number: +902423106916
- Email: sgozum@akdeniz.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Office workers scoring <600 METdk/week according to the FAA survey Employees who agreed to participate in the study. Employees who are in reflection and preparation stages of TTM change.
Exclusion Criteria:
- Part-time workers, Pregnant women, People with health problems that may increase the risk of walking (musculoskeletal system disorders, people with advanced heart failure diagnosis (based on self-report), rheumatologic, etc.) Workers who are in not thinking, moving and sustaining stages of TTM change.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A-The digital stimulus command
The digital stimulus command: This group will receive only digital alerts for 4 weeks. Following the washout period, they will participate in a 5-day, 30-minute walking program, accompanied by a researcher, for 4 weeks. |
The digital stimulus command: Providing information on the harms of inactivity and sedentary lifestyle on online, digital platforms.
The individual will take the HRV measurement in a sitting position for 5 minutes every morning (before consuming tobacco products for smokers) as taught and will send the screenshot of the data to the researcher via WhatsApp.
Ensuring that the digital stimulus commands that will remind the activity in line with TTM are followed by reminders sent to the computer screen or mobile phones.
Taking a break from sitting when the command "It's time for activity" comes (taking a total of 6 breaks in the working hours of 08:30 - 17:30, 1 every 60 minutes recording the activity as "completed" in the digital diary and survey form) *Activities of office workers other than the time they spend sitting; Recording the number of steps and activities in the office, its surroundings and in daily life in a digital diary.
5 day 30-minute walking program.
This group was also defined as the human stimulus group because, in addition to the digital stimulus command, they will be invited by the researcher and will participate in the walking program with the researcher.
This group will first receive the activity program and simultaneously will also receive the digital stimulus command interventions.
|
|
Experimental: Group B- 5-day 30-minute walking program
5 day 30-minute walking program.
This group will participate in a 30-minute walking program for 5 days a week, accompanied by a researcher, for 4 weeks.
Following the washout period, they will receive in the digital stimulus commands for 4 weeks.
|
The digital stimulus command: Providing information on the harms of inactivity and sedentary lifestyle on online, digital platforms.
The individual will take the HRV measurement in a sitting position for 5 minutes every morning (before consuming tobacco products for smokers) as taught and will send the screenshot of the data to the researcher via WhatsApp.
Ensuring that the digital stimulus commands that will remind the activity in line with TTM are followed by reminders sent to the computer screen or mobile phones.
Taking a break from sitting when the command "It's time for activity" comes (taking a total of 6 breaks in the working hours of 08:30 - 17:30, 1 every 60 minutes recording the activity as "completed" in the digital diary and survey form) *Activities of office workers other than the time they spend sitting; Recording the number of steps and activities in the office, its surroundings and in daily life in a digital diary.
5 day 30-minute walking program.
This group was also defined as the human stimulus group because, in addition to the digital stimulus command, they will be invited by the researcher and will participate in the walking program with the researcher.
This group will first receive the activity program and simultaneously will also receive the digital stimulus command interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Physical Activity Assessment
Time Frame: At baseline, in the washout period after intervention A (6th week) and after intervention B (11th week)
|
International Physical Activity Questionnaire Short Form: The questionnaire consists of seven questions covering all types of physical activity.
Physical activity levels are categorized as physically inactive, low physical activity, and adequate physical activity.
|
At baseline, in the washout period after intervention A (6th week) and after intervention B (11th week)
|
|
Transtheoretic Model Scale for physical activity
Time Frame: At baseline, in the washout period after intervention A (6th week) and after intervention B (11th week)
|
This scale has four dimensions.
|
At baseline, in the washout period after intervention A (6th week) and after intervention B (11th week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability
Time Frame: At baseline, during the washout period after intervention A (week 6), and after intervention B (week 11)
|
Heart Rate Variability is an important physiological indicator related to the interactions between the sympathetic and parasympathetic divisions of the autonomic nervous system.
HRV, a control system used to regulate unconscious actions such as heart function, respiration, digestion, blood pressure, urination, and pupil dilation/contraction, is used to analyze the autonomic nervous system.
In our study, we will use the Polar H10 Chest Strap, a widely used research tool, to determine HRV.
In a validation study, linear HRV measurements obtained from the Polar H10 chest strap demonstrated strong agreement compared to ECG recordings.
|
At baseline, during the washout period after intervention A (week 6), and after intervention B (week 11)
|
Collaborators and Investigators
Sponsor
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
Keywords
Other Study ID Numbers
- TBAEK-164
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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