NCT06492772

Brief Summary

Purpose:This research aims to examine the effect of a mobile application developed against smoking behavior on teachers' self-efficacy, decision-making and carbon monoxide levels in breath.The research was planned as a randomized controlled experimental type.Working in public schools in Izmir/Narlıdere District teachers constitute the universe of the research. According to the calculations made, it was decided to include 35 people in the experimental group and 35 people in the control group. After obtaining institutional permissions, teachers who meet the inclusion criteria will be determined.To ensure homogeneity, control and intervention groups will be stratified according to age, gender, and addiction levels.Assignment to intervention and control groups will be made by simple randomization method.The average scores of teachers' self-efficacy, breath carbon monoxide and decision-making levels are the dependent variables of the study.The status of using the mobile application is the independent variable. "Personal Information Form", "Fagerstrom Nicotine Dependency Test (FNBT)", "Self-Efficacy Scale", "Classification of Stages of Change Scale", "Decision Making Scale" and "Carbon Monoxide Measurement Values Tracking Form" will be used in this research. SPSS 26.0 Package program will be used to analyze the data in the study. It will be evaluated statistically at a 95% confidence interval and a significance level of p\<0.05. Number and percentage distributions for sociodemographic characteristics will be used in the analysis of the data.In comparisons between groups, parametric or nonparametric tests will be used after evaluating the normal distribution feature of the scale scores. Hypotheses 1 H1:There is a difference between the breath CO level scores of intervention and control group teachers according to time (pre-test - 1st month, 3rd month and 6th month). Hypotheses 2 H1:There is a difference between the self-efficacy scale scores of intervention and control group teachers according to time (pre-test, 1st month, 3rd month, 6th month). Hypotheses 3 H1: There is a difference between the decision-making level scores of teachers in the intervention and control groups according to time (pretest-1st month, 3rd month and 6th month).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 1, 2024

Last Update Submit

July 1, 2024

Conditions

Keywords

mobile applicationsmokingbreathing carbon monoxideself-efficacy

Outcome Measures

Primary Outcomes (1)

  • Fagerstrom Nicotine Dependency Test (FNBT):

    It measures the addiction levels of individuals. It was developed by Fagerström in 1989 and consists of 6 questions. The scores that can be obtained from the scale are between 0 and 10.High scores from the scale indicate a high level of nicotine addiction, and low scores indicate a low level of nicotine addiction.

    1,3,6. months

Secondary Outcomes (1)

  • Self-Efficacy Scale:

    1,3,6. months

Other Outcomes (3)

  • Classification of Stages of Change Scale:

    1,3,6. months

  • Decision Making Scale

    1,3,6. months

  • Carbon Monoxide Measurement Values Monitoring Form:

    1,3,6. months

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will be provided with smoking cessation training based on the transtheoretical model.Individuals will be required to use the mobile application for 6 months. Measurements will be made at 1, 3, and 6 months.

Other: experimental group

Control Group

OTHER

The control group will be given ordinary smoking cessation information. Measurements will be made at 1, 3, and 6 months.

Other: experimental group

Interventions

The experimental group will be asked to use a mobile smoking cessation application based on the transtheoretical model. Individuals will be required to use the mobile application for 6 months. Measurements will be made at 1, 3, and 6 months.

Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a smartphone and daily internet access
  • Volunteering to participate in the study
  • Getting a score of 5 medium level or above according to the Fagerström Nicotine Dependency Test rules test
  • Not always having any smoking cessation support or a smoking cessation intervention

You may not qualify if:

  • Those who did not agree to participate in the research
  • Those who do not smoke or have quit smoking
  • Those who use any tobacco product other than cigarettes (e-cigarette, hookah, cigar, etc.)
  • Those who have severe chronic health problems (vision-hearing problems, dementia and Alzheimer's, chronic lung diseases)
  • Those who do not use smartphones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gülengül MERMER, Assoc.Prof.

    https://unisis.ege.edu.tr/researcher=gulengul.s.mermer

    STUDY DIRECTOR

Central Study Contacts

Seda KUTLU, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

September 1, 2024

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations