Clinical trial NCT06541418: The Effect of Behavior Exchange Program on Risky Behaviors
Official title: The Effect of Transtheoretical Model Based Behavior Exchange Program on Risky Behaviors of University Students Receiving Health Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Keywords: risky behavior
transtheoretical model
behavior change
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2024-08-07
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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

1. 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.
2. Students with a high score as a result of the Risk Behaviors Scale-University Form will be determined.
3. The Behavior Change Stages Short Questionnaire will be applied to students with a high risky behavior tendency.
4. Students whose behavior change stages are determined as 'Thinking' and 'Preparation' will be included in the study universe.
5. Assignment will be made to the experimental and control groups by making a random selection from the study universe.
6. The Self-Efficacy-Efficacy Scale will be applied to the experimental and control groups.
7. 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.
8. All measurements of the experimental and control groups will be repeated after the program and 3 months after the end of the program.
9. The data will be statistically analyzed and evaluated.
10. The report will be written.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* students who do not meet the inclusion criteria
* who refused to participate in the study

Primary outcomes:
measure: Risky behaviors scale-university form
timeFrame: 1 year
measure: self-efficacy scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Istanbul Cerrahpaşa University
name: Leyla KÜÇÜK, 2
role: STUDY_CHAIR
References: