NCT06541418

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2022

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

February 22, 2022

Last Update Submit

August 6, 2024

Conditions

Keywords

risky behaviortranstheoretical modelbehavior change

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 year

Study Arms (2)

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.

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.

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years - 33 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Leyla KÜÇÜK, 2

    Istanbul Cerrahpaşa University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Experimental and control groups were masked in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2022

First Posted

August 7, 2024

Study Start

October 15, 2020

Primary Completion

April 15, 2021

Study Completion

July 15, 2021

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

I can share privately if desired.

Locations