Effects of Health Belief Model Interventions on Preventive Beliefs in Secondhand Smoke Exposure

February 12, 2025 updated by: Ercan Asi, Akdeniz University

Effects of Feedback, Education, and Social Media Interventions Based on the Health Belief Model on Preventive Beliefs in Adults Exposed to Secondhand Smoke At Home.

The aim of this study was to compare the effects of feedback, interactive education, and social media interventions based on the health belief model on protective beliefs in adults at risk of exposure to secondhand smoke at home.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Secondhand smoke (SHS) exposure, also known as environmental tobacco smoke, passive smoke or involuntary smoke, is caused by the burning of cigarettes and other tobacco products and the smoke exhaled by a smoker. Although Turkey is one of the best countries in combating SHS exposure, one in four adults is exposed to SHS at home. One of the most important reasons for this exposure is the lack of deterrent policies for the home environment, which is considered a private area. It is entirely possible for non-smoking individuals to be protected from SHS exposure at home through their own efforts. In this context, the knowledge, behaviors and perceptions of non-smoking adults about exposure are important in preventing or reducing SHS exposure at home. Interventions based on the behavior change model can be effective in developing protective behaviors in adults at risk of SHS exposure at home. Individual and group interventions using multiple educational materials and methods based on the Health Belief Model (HBM) (SHS exposure feedback, interactive group education and social media sharing) can develop protective behaviors in individuals at home.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Konyaaltı
      • Antalya, Konyaaltı, Turkey, 07070
        • Akdeniz University Faculty of Nursing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

İnclusion Criteria

  • Non-smokers aged 18-64 who live with at least one smoker,
  • Literate individuals,
  • Individuals who own a smartphone,
  • Individuals who voluntarily agree to participate in the study.

Exclusion Criteria:

  • Individuals who do not speak Turkish,
  • Pregnant individuals,
  • Participants who have been living apart from SHS exposure sources in the week leading up to data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exposure feedback group
Behavioral: Exposure feedback
  • Determining the actual SHS exposure risk level and providing feedback.
  • Determining the urinary cotinine test result and providing feedback.
  • Feedback on the consistency or difference between the perceived SHS exposure risk level and the actual SHS exposure risk level.
Experimental: Interactive education group
Behavioral: Exposure feedback
  • Determining the actual SHS exposure risk level and providing feedback.
  • Determining the urinary cotinine test result and providing feedback.
  • Feedback on the consistency or difference between the perceived SHS exposure risk level and the actual SHS exposure risk level.
Behavioral: Interactive education
Slide presentation, video presentation, Q&A, evaluation of learning and discussion of results
Experimental: Social media group
Behavioral: Exposure feedback
  • Determining the actual SHS exposure risk level and providing feedback.
  • Determining the urinary cotinine test result and providing feedback.
  • Feedback on the consistency or difference between the perceived SHS exposure risk level and the actual SHS exposure risk level.
Behavioral: Social media post
Sharing informational materials such as messages, brochures, and videos related to SHS exposure, including ways to protect yourself from SHS exposure and the adverse health effects of SHS exposure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health belief model scale for prevention behaviors of secondhand smoke exposure (HBM-SHS)
Time Frame: Baseline and at first month later after intervention
The 35-item scale, scored on a five-point Likert scale from "Strongly Disagree (1)" to "Strongly Agree (5)," assesses six subdimensions: "perceived susceptibility," "perceived seriousness," "perceived benefits," "perceived barriers," "self-efficacy," and "behavioral cues." Items on "perceived susceptibility" and "perceived barriers" are reverse coded. Scores range from 35 to 175, with higher scores indicating stronger health beliefs about SHS exposure and greater beliefs in each subdimension.
Baseline and at first month later after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondhand Smoke Exposure Risk Assessment
Time Frame: Baseline and at first month later after intervention
Risk assessment is conducted through four questions addressing whether there is a smoker in the household, household tobacco use rules, tobacco use in enclosed areas, and the time since the last use. Responses are scored categorically: absence of risk is scored as 0, while the presence and intensity of risk are scored as 1 or more. A score of at least one indicates "risk." SHS exposure risk is scored from 0 to 10, with any score of 1 or above indicating the presence of risk. Total risk assessment scores are represented on a real risk scale of 0-10. According to expert evaluations, the content validity index (CVI) of the questions assessing participants' SHS exposure risk level is 0.86.
Baseline and at first month later after intervention
Actual Risk Assessment
Time Frame: Baseline and at first month later after intervention
In adults at risk of SHS exposure, urinary cotinine analysis will be conducted using a cotinine urine test kit. The test detects cotinine in the urine, indicating SHS exposure. The strip is dipped into the urine sample for 10 seconds, and the result is read within 5 minutes. In a negative result, both the control (C) and test (T) lines will appear, while in a positive result, only the control line (C) will appear. If neither the C nor T lines are visible, or if only the T line appears, the test is invalid.
Baseline and at first month later after intervention
Perceived SHS Exposure Risk
Time Frame: Baseline and at first month later after intervention
In adults, SHS exposure risk will be assessed based on the perceived level of risk. Participants' awareness of SHS exposure will be measured by their responses to the question, "How would you describe your risk of being exposed to SHS in your home?" with options such as "No risk at all," "Somewhat at risk," or "At very high risk." Additionally, participants' perceived SHS exposure risk level will be evaluated based on their numerical responses to the question, "What would your risk of SHS exposure in your home be on a scale from 0 to 10?" Each number will represent the participant's perceived (exposure risk probability) risk.
Baseline and at first month later after intervention
ThirdHand Smoke Beliefs Scale (BATHS)
Time Frame: Baseline and at first month later after intervention
This scale was developed by Haardörfer and colleagues in 2017 to identify beliefs about third-hand smoke (THS). The scale includes 5 items related to the health effects of THS and 4 items regarding its persistence in the environment. The items are rated using a 5-point Likert scale, with the following coding: 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree. The total score of the scale is obtained by dividing the sum of the item scores by the number of items. A score closer to 5 for each item indicates the individual believes in the health and environmental effects of THS, while a score closer to 1 indicates disbelief.
Baseline and at first month later after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AU-NF-EA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings