Sedentary BehaviorNCT04296526
Two-phase Transteoretic Model Research for Participation in Physical Activity
A study testing Exercise Prescription, Exercise Education and Social Support in people with Sedentary Behavior, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the first phase of this study is to determine the physical activity (PA) barriers and motivational factors of university students and their body awareness using the transteoretic model (TTM). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Exercise Prescription, Exercise Education and Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2021to Apr 2022
- 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
- Being between the ages of 18-25
- Being educated at the Faculty of Health Sciences
- Being volunteer
Who cannot join
- Being audial and vision impaired
- Having orthopedic, neurological and metabolic problems that will prevent physical activity
- Being unable to communicate in Turkish
- No pedometer program on the smartphone or using it for less than 1 year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34500
Saliha Gürdal Karakelle, MSc, 02124141500, salihagurdal@hotmail.com
About this study
Official title: Barriers to Participation in Physical Activity Among University Students: Which Intervention? Two-phase Study Using Transteoretic Model
The purpose of the first phase of this study is to determine the physical activity (PA) barriers and motivational factors of university students and their body awareness using the transteoretic model (TTM).
The aim of the second phase of the study is to evaluate the effectiveness of interventions aimed at eliminating barriers determined in students who are in the "precontemplation", "contemplation" and "preparation" stages according to TTM. Also it will be examined the effects of these interventions on PA level.
- Conditions
- Sedentary Behavior
- Being tested
- Exercise Prescription, Exercise Education, Social Support
- Keywords
- physical activity, transtheoretical model, university students
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise PrescriptionBehavioural
Also called Social Support
To prescribe exercise programs that can be easily applied at home/dormitory/living place for students.
Exercise EducationBehavioural
To organize sessions for how to proper exercise.
Social SupportBehavioural
Supports such as peer influence or reminder phone messages
| Study group | Role | What they receive |
|---|---|---|
| Precontemplation | Experimental | Not described Receives: Behavioral: Exercise Prescription; Behavioral: Exercise Education; Behavioral: Social Support |
| Contemplation | Experimental | Not described Receives: Behavioral: Exercise Prescription; Behavioral: Exercise Education; Behavioral: Social Support |
| Preparation | Experimental | Not described Receives: Behavioral: Exercise Prescription; Behavioral: Exercise Education; Behavioral: Social Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise: Stages of Change (Short Form)
It consists of the question "Do you exercise regularly?" and five answers. These answers are "precontamplation", "contemplation", "preparation", "action" and "maintanence".
Measured: Change from baseline at 8 weeks.
Secondary outcomes (5)
Exercise Barrier Scale
It was developed in response to a need for an instrument to determine perceptions of individuals concerning the barriers to participating in exercise.
Measured: At baseline and 8th weeks
International Physical Activity Questionnaire - Short Form
IPAQ-SF provides information on walking, moderate and vigorous activities and time spent sitting, within a week.
Measured: At baseline and 8th weeks
Motivation Scale For Participation In Physical Activity
It is a measurement tool to measure the motivation of students to participate in physical activity.
Measured: At baseline and 8th weeks
Body Awareness Questionnaire
he BAQ is an 18-item scale designed to assess self-reported attentiveness to normal nonemotive body processes, specifically, sensitivity to body cycles and rhythms, ability to detect small changes in normal functioning, and ability to anticipate bodily reactions.
Measured: At baseline and 8th weeks
Number of steps in weekly
Number of steps in weekly will be recorded by smartphone application.
Measured: At baseline and 1-2-3-4-5-6-7-8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study startApr 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saliha Gürdal Karakelle, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296526
- Sponsor's protocol ID
- 99984023-302.20.03
- Status last verified
- Dec 2020
- First submitted
- 3 Mar 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Participation in Physical Activity Among University Students: Which Intervention? Two-phase Study Using Transteoretic Model
- ClinicalTrials.gov ID
- NCT04296526
- Acronym / sponsor ID
- 99984023-302.20.03
- Conditions
- Sedentary Behavior
- Keywords
- physical activity, transtheoretical model, university students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 5 Mar 2020 (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.
The purpose of the first phase of this study is to determine the physical activity (PA) barriers and motivational factors of university students and their body awareness using the transteoretic model (TTM).
The aim of the second phase of the study is to evaluate the effectiveness of interventions aimed at eliminating barriers determined in students who are in the "precontemplation", "contemplation" and "preparation" stages according to TTM. Also it will be examined the effects of these interventions on PA level.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Precontemplation | Experimental | Behavioral: Exercise Prescription, Behavioral: Exercise Education, Behavioral: Social Support |
| Contemplation | Experimental | Behavioral: Exercise Prescription, Behavioral: Exercise Education, Behavioral: Social Support |
| Preparation | Experimental | Behavioral: Exercise Prescription, Behavioral: Exercise Education, Behavioral: Social Support |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-25
- Being educated at the Faculty of Health Sciences
- Being volunteer
Key exclusion criteria (4 listed)
- Being audial and vision impaired
- Having orthopedic, neurological and metabolic problems that will prevent physical activity
- Being unable to communicate in Turkish
- No pedometer program on the smartphone or using it for less than 1 year
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 |
|---|---|---|
| Exercise PrescriptionAlso: Social SupportTo prescribe exercise programs that can be easily applied at home/dormitory/living place for students. | Behavioural | Contemplation, Precontemplation, Preparation |
| Exercise EducationTo organize sessions for how to proper exercise. | Behavioural | Contemplation, Precontemplation, Preparation |
| Social SupportSupports such as peer influence or reminder phone messages | Behavioural | Contemplation, Precontemplation, Preparation |
Primary outcome
Exercise: Stages of Change (Short Form)
Time frame: Change from baseline at 8 weeks.
It consists of the question "Do you exercise regularly?" and five answers. These answers are "precontamplation", "contemplation", "preparation", "action" and "maintanence".
5 secondary outcomes
Exercise Barrier Scale
Time frame: At baseline and 8th weeks
International Physical Activity Questionnaire - Short Form
Time frame: At baseline and 8th weeks
Motivation Scale For Participation In Physical Activity
Time frame: At baseline and 8th weeks
Body Awareness Questionnaire
Time frame: At baseline and 8th weeks
Number of steps in weekly
Time frame: At baseline and 1-2-3-4-5-6-7-8th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Prescription, Exercise Education and Social Support in people with Sedentary Behavior, run by Istanbul University - Cerrahpasa at 1 site 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 3 inclusion and 4 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Saliha Gürdal Karakelle, MSc (02124141500, salihagurdal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise: Stages of Change (Short Form) (time frame: Change from baseline at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2020.