Risk BehaviorNCT06541418
The Effect of Behavior Exchange Program on Risky Behaviors
A study testing Transtheoretic Model Based Behavior Change Program in people with Risk Behavior, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Risky behaviors, which derive their source from features specific to adolescence, may also pose problems in other periods of a person's life and have features that prevent them from becoming responsible adults. Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior
- What is being tested?
- Transtheoretic Model Based Behavior Change Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 15 Jul 2021
- 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 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Getting a high score on the Risk Behavior Modification-University Form scale
- Stages of change being Thinking or Preparation,
- Being over the age of 18,
- Not having major-active psychiatric disease,
- Having Turkish literacy skills
Who cannot join
- students who do not meet the inclusion criteria
- who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: The Effect of Transtheoretical Model Based Behavior Exchange Program on Risky Behaviors of University Students Receiving Health Education
Risky behaviors, which derive their source from features specific to adolescence, may also pose problems in other periods of a person's life and have features that prevent them from becoming responsible adults. These behaviors are defined by Jessor as behaviors that cause personal, social or developmental undesirable consequences and are life-threatening or harmful to health and even actions that can lead to death. Risky behaviors in young people are frequently listed as smoking, alcohol/substance use, nutrition, suicide, school dropout, and destructive behaviors (violence against self/others, etc.). It has been conducted with studies that generally do not take into account the stage of change or accept that all individuals' readiness for behavior change is the same. However, the Transtheoretic Model states that the most appropriate initiatives should be used to facilitate the change in which the individual is at the stage of change. He also states that the initiatives applied without considering the individual's readiness for behavior change develop resistance against behavior change. In this study, it was aimed to determine the effect of the behavior change program prepared based on the transtheoretic model on the risky behaviors of university students receiving health education.
Read the detailed description
Type of Research This study was planned as a randomized controlled experimental study to determine the effect of the Transtheoretical Model-Based Behavior Change Program applied to university students on the tendency to show risky behavior.
The Universe and Place of the Research The general population of the research will consist of students enrolled in the formal education program at Istanbul Medipol University Faculty of Health Sciences between September 2020 and February 2021. Volunteer students who have Turkish literacy skills, are over 18 years old, do not have major-active psychiatric disease, have a high Risk Behavior Scale-University Form score, and are in the Thinking and Preparation phase of change.
2.3. Sample of the Research Sample size was calculated by power analysis. In the calculation made; Predicting a power value of 0.80 and a level of error of 0.05, it was found that the Risk Behaviors Scale-University Form should be administered to at least 348 people from the general population in order to reach the study population. In the calculation made, it was found appropriate to include 40 students in the experimental group and 40 students in the control group. Assignment will be made to the experimental and control groups by making a probabilistic selection from the study universe. One of participants in the experimental group left the study. The study was completed with 79 participants in total.
Variables of the Study
Independent variables
- Transtheoretic model-based behavior change program
- Group consultancy
- Motivational interview
Dependent Variables
- Risky Behaviors Scale-University Form score average
- Behavior Change Stages Short Questionnaire result
- Self-Efficacy-Efficacy Scale mean score
Research Steps
- In order to identify the risky students in the study population, the University Form of the Risk Behaviors Scale will be applied to the students of the Faculty of Health Sciences.
- Students with a high score as a result of the Risk Behaviors Scale-University Form will be determined.
- The Behavior Change Stages Short Questionnaire will be applied to students with a high risky behavior tendency.
- Students whose behavior change stages are determined as 'Thinking' and 'Preparation' will be included in the study universe.
- Assignment will be made to the experimental and control groups by making a random selection from the study universe.
- The Self-Efficacy-Efficacy Scale will be applied to the experimental and control groups.
- Transtheoretic Model Based Behavior Change Program (Annex-1) will be applied to the experimental group. The behavior change program includes group counseling and motivational interviews. Short training will be given to the control group to reduce risky behaviors after the study.
- All measurements of the experimental and control groups will be repeated after the program and 3 months after the end of the program.
- The data will be statistically analyzed and evaluated.
- The report will be written.
- Conditions
- Risk Behavior
- Being tested
- Transtheoretic Model Based Behavior Change Program
- Keywords
- risky behavior, transtheoretical model, behavior change
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtheoretic Model Based Behavior Change ProgramBehavioural
The Behavior Change Program was implemented in 7 sessions of 50 minutes, once a week. Each session in the Behavior Change Program; The warm-up exercise consisted of giving general information about the purpose and the main theme of the session, discussion and feedback on the subject, and the planning of the next week, and a closing process. The Transtheoretic Model Based Behavior Change Program was prepared by the researcher with reference to the behavior change programs in the literature and the elements of the Transtheoretic model.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | As a pre-test, 40 students, who were determined in accordance with the research criteria and assigned to the experimental group, were asked to fill in the Sociodemographic data collection form and SCEÖ.
Before the planned program, students were sent an e-mail and the program days and times were specified. 4 groups of 10 people were formed. Transtheoretic Model Based Behavior Change Program consisting of 7 sessions was given. At the end of the program, the Risky Behavior Evaluation Scale, which was included in the RSS-ÜF, Behavior Change Stages Short Questionnaire, SEYÖ and Soyodemographic data collection form, was applied again. Follow-up was done with the same measurement tools 3 months after the end of the program. Receives: Behavioral: Transtheoretic Model Based Behavior Change Program |
| Control Group | No intervention | As a pre-test, 40 students who were determined in accordance with the research criteria and assigned to the control group were asked to fill in the Sociodemographic data collection form and SCEÖ. For the posttest and 3-month follow-up, the Risky Behavior Evaluation Scale, which was included in the RSS-ÜF, Behavior Change Stages Short Question Form, SEEÖ and Soyodemographic data collection form, was applied again. After the Transtheoretical Model-Based Behavior Change Program given to the experimental group ended, a 1-day training program on changing risky behaviors was applied to the control group in September 2021. All students in the experimental group participated in the program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risky behaviors scale-university form
The scale consists of 60 items and sevendimensions such as; antisocial behaviors, smoking, alcohol use, substance use, suicide tendency, eating habitsand school dropout.
RDÖUF (RBS-UF) is a Likert-type scale consisting of 60 items and seven dimensions. The five-point scale is answered as "always= 5", "usually= 4", "sometimes= 3", "rarely=2" and "never=1". There is no reverse scored item in the scale. Getting a high score on each dimension indicates a higher level of risk in that dimension.
Measured: 1 year
self-efficacy scale
For each item on the 23-item scale; 1-" drink what I don't know", 2-"describes me a little", 3-"I'm undecided", 4-" me best defines me", S-"describes me very well" is requested. The score given for each item is taken as a basis. But 2,4,5,6,7, 10, 11, 12,14,16,17,18,20,22. items are scored in the opposite direction. So from the scale a minimum of 23 and a maximum of 115 points can be obtained.The increase in the total score obtained from the scale, the individual's self-efficacy-efficacy It means that the perception is at a good level.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start15 Oct 2020
- Primary completion15 Apr 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Gülşah KÖRPE, Istanbul Medipol University Hospital
- Investigators
- Leyla KÜÇÜK, 2, Study chair, Istanbul Cerrahpaşa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541418
- Sponsor's protocol ID
- GUL121312
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can share privately if desired.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transtheoretical Model Based Behavior Exchange Program on Risky Behaviors of University Students Receiving Health Education
- ClinicalTrials.gov ID
- NCT06541418
- Acronym / sponsor ID
- GUL121312
- Conditions
- Risk Behavior
- Keywords
- risky behavior, transtheoretical model, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 7 Aug 2024 (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.
Risky behaviors, which derive their source from features specific to adolescence, may also pose problems in other periods of a person's life and have features that prevent them from becoming responsible adults. These behaviors are defined by Jessor as behaviors that cause personal, social or developmental undesirable consequences and are life-threatening or harmful to health and even actions that can lead to death. Risky behaviors in young people are frequently listed as smoking, alcohol/substance use, nutrition, suicide, school dropout, and destructive behaviors (violence against self/others, etc.). It has been conducted with studies that generally do not take into account the stage of change or accept that all individuals' readiness for behavior change is the same. However, the Transtheoretic Model states that the most appropriate initiatives should be used to facilitate the change in which the individual is at the stage of change. He also states that the initiatives applied without considering the individual's readiness for behavior change develop resistance against behavior change. In this study, it was aimed to determine the effect of the behavior change program prepared based on the transtheoretic model on the risky behaviors of university students receiving health education.
Detailed description
Type of Research This study was planned as a randomized controlled experimental study to determine the effect of the Transtheoretical Model-Based Behavior Change Program applied to university students on the tendency to show risky behavior.
The Universe and Place of the Research The general population of the research will consist of students enrolled in the formal education program at Istanbul Medipol University Faculty of Health Sciences between September 2020 and February 2021. Volunteer students who have Turkish literacy skills, are over 18 years old, do not have major-active psychiatric disease, have a high Risk Behavior Scale-University Form score, and are in the Thinking and Preparation phase of change.
2.3. Sample of the Research Sample size was calculated by power analysis. In the calculation made; Predicting a power value of 0.80 and a level of error of 0.05, it was found that the Risk Behaviors Scale-University Form should be administered to at least 348 people from the general population in order to reach the study population. In the calculation made, it was found appropriate to include 40 students in the experimental group and 40 students in the control group. Assignment will be made to the experimental and control groups by making a probabilistic selection from the study universe. One of participants in the experimental group left the study. The study was completed with 79 participants in total.
Variables of the Study
Independent variables
- Transtheoretic model-based behavior change program
- Group consultancy
- Motivational interview
Dependent Variables
- Risky Behaviors Scale-University Form score average
- Behavior Change Stages Short Questionnaire result
- Self-Efficacy-Efficacy Scale mean score
Research Steps
- In order to identify the risky students in the study population, the University Form of the Risk Behaviors Scale will be applied to the students of the Faculty of Health Sciences.
- Students with a high score as a result of the Risk Behaviors Scale-University Form will be determined.
- The Behavior Change Stages Short Questionnaire will be applied to students with a high risky behavior tendency.
- Students whose behavior change stages are determined as 'Thinking' and 'Preparation' will be included in the study universe.
- Assignment will be made to the experimental and control groups by making a random selection from the study universe.
- The Self-Efficacy-Efficacy Scale will be applied to the experimental and control groups.
- Transtheoretic Model Based Behavior Change Program (Annex-1) will be applied to the experimental group. The behavior change program includes group counseling and motivational interviews. Short training will be given to the control group to reduce risky behaviors after the study.
- All measurements of the experimental and control groups will be repeated after the program and 3 months after the end of the program.
- The data will be statistically analyzed and evaluated.
- The report will be written.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Transtheoretic Model Based Behavior Change ProgramAs a pre-test, 40 students, who were determined in accordance with the research criteria and assigned to the experimental group, were asked to fill in the Sociodemographic data collection form and SCEÖ. Before the planned program, students were sent an e-mail and the program days and times were specified. 4 groups of 10 people were formed. Transtheoretic Model Based Behavior Change Program consisting of 7 sessions was given. At the end of the program, the Risky Behavior Evaluation Scale, which was included in the RSS-ÜF, Behavior Change Stages Short Questionnaire, SEYÖ and Soyodemographic data collection form, was applied again. Follow-up was done with the same measurement tools 3 months after the end of the program. |
| Control Group | No intervention | –As a pre-test, 40 students who were determined in accordance with the research criteria and assigned to the control group were asked to fill in the Sociodemographic data collection form and SCEÖ. For the posttest and 3-month follow-up, the Risky Behavior Evaluation Scale, which was included in the RSS-ÜF, Behavior Change Stages Short Question Form, SEEÖ and Soyodemographic data collection form, was applied again. After the Transtheoretical Model-Based Behavior Change Program given to the experimental group ended, a 1-day training program on changing risky behaviors was applied to the control group in September 2021. All students in the experimental group participated in the program. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Getting a high score on the Risk Behavior Modification-University Form scale
- Stages of change being Thinking or Preparation,
- Being over the age of 18,
- Not having major-active psychiatric disease,
- Having Turkish literacy skills
Key exclusion criteria (2 listed)
- students who do not meet the inclusion criteria
- who refused to participate in the study
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 |
|---|---|---|
| Transtheoretic Model Based Behavior Change ProgramThe Behavior Change Program was implemented in 7 sessions of 50 minutes, once a week. Each session in the Behavior Change Program; The warm-up exercise consisted of giving general information about the purpose and the main theme of the session, discussion and feedback on the subject, and the planning of the next week, and a closing process. The Transtheoretic Model Based Behavior Change Program was prepared by the researcher with reference to the behavior change programs in the literature and the elements of the Transtheoretic model. | Behavioural | Experimental Group |
Primary outcome
Risky behaviors scale-university form
Time frame: 1 year
The scale consists of 60 items and sevendimensions such as; antisocial behaviors, smoking, alcohol use, substance use, suicide tendency, eating habitsand school dropout. RDÖUF (RBS-UF) is a Likert-type scale consisting of 60 items and seven dimensions. The five-point scale is answered as "always= 5", "usually= 4", "sometimes= 3", "rarely=2" and "never=1". There is no reverse scored item in the scale. Getting a high score on each dimension indicates a higher level of risk in that dimension.
self-efficacy scale
Time frame: 1 year
For each item on the 23-item scale; 1-" drink what I don't know", 2-"describes me a little", 3-"I'm undecided", 4-" me best defines me", S-"describes me very well" is requested. The score given for each item is taken as a basis. But 2,4,5,6,7, 10, 11, 12,14,16,17,18,20,22. items are scored in the opposite direction. So from the scale a minimum of 23 and a maximum of 115 points can be obtained.The increase in the total score obtained from the scale, the individual's self-efficacy-efficacy It means that the perception is at a good level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No. I can share privately if desired.
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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.
Leyla KÜÇÜK, 2 study chair
Istanbul Cerrahpaşa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transtheoretic Model Based Behavior Change Program in people with Risk Behavior, run by Istanbul Medipol University Hospital 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 7 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Risky behaviors scale-university form (time frame: 1 year). The study lists 2 primary outcomes in all. 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 7 Aug 2024; AzTrials last refreshed its copy on 2 Nov 2026.