The Effect of Training Provided According to the Health Promotion Model on Healthy Lifestyles and Self-efficacy in Adolescents

August 16, 2022 updated by: Hakan Avan
The study was designed as a randomized controlled experimental study in a pretest-posttest design to determine the effect of training provided according to the health promotion model concerning the factors which affect healthy lifestyle in adolescents, on health promotion behavior. It is aimed for adolescents to take health responsibility by increasing their self-efficacy levels and make it a part of their lives. The sample will consist of 72 adolescents (36 in intervention group, 36 in control group) at significance level of 5%, power of 80% and effect size of 0.5-0.75 in a population including 45.737 adolescents aged 14 to 17 years in schools affiliated with Kahramanmaraş Provincial Directorate for National Education. In the first stage of determining the sample, two schools will be determined by drawing lots among the schools affiliated to the Provincial Directorate of National Education and the researcher will assign adolescents, who meet the inclusion criteria, to intervention (n=36) and control (n=36) groups from the first and second schools, respectively using the stratified sampling method and the random numbers table. The inclusion criteria will be being aged 14 to 17 years, speaking Turkish, having parental permission, having no mental or neurological disability and having no chronic illness. In the study, the randomization will be conducted according to age, gender, body mass index, department, and family type. The Adolescent and Parent Information Form (Socio-demographic Characteristics), the Adolescent Lifestyle Profile (ALP) and the Self-efficacy Scale (SES) will be used to gather the data. The data will be collected online from 72 adolescents receiving education in the two high schools affiliated with the Provincial Directorate for National Education between 14 February 2022 and 15 May 2022. The first measurements and trainings will be conducted online. In the first measurement, there will primarily be a meeting activity and then the data collection forms (Socio-demographic Characteristics, the ALS, the SES) will be collected online from the intervention and the control group via e-mail or social media applications. Following the first measurement, the first session will be conducted in the intervention group. As of the first session, a total of six sessions, one in every week will be conducted. In the final session where the applications finish, the posttest-1 including the data collection forms (Socio-demographic Characteristics, the ALS, the SES) will be used in the intervention and control groups. The posttest-2 including the same forms will be applied to the groups one month later. A preliminary application will be performed online in 10 adolescents who remain outside the sample and meet the inclusion criteria. According to the results obtained from the preliminary application, necessary arrangements will be made on the forms and the session and the application will be finalized. A total of 6 sessions on physical activity, nutrition, substance abuse, sexual life, check-up, accidents and injuries will be organized for the adolescents in the intervention group. The sessions will be organized every other week. Each session will be conducted in three stages. First Stage: The researcher will provide training on the subject of the session for nearly 15 minutes. Second Stage: The researcher will show animation film (nearly 3 to 5 minutes) developed by him/her related to the session. Third Stage: Groups of six will be created for the Philips 66 technique application and a spokesman will be chosen. Each group will have an online meeting and discuss the session subject in six minutes under the administration of the researcher. The spokesman of each group will present the discussion outcome in the big group meeting at the end of the discussion. The researcher will summarize the subject after the presentation of each spokesman and terminate the session. The nursing intervention according to the SGM will not be performed in the control groups. However, the adolescents will continue their routine training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
72

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 Locations

  • Turkey
    • Onikişubat
      • Kahramanmaraş, Onikişubat, Turkey, 46000
        • Hakan Avan

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

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The inclusion criteria will be being aged 14 to 17 years,
  • speaking Turkish,
  • having parental permission,
  • having no mental or neurological disability,
  • having no chronic illness.

Exclusion Criteria:

  • Those who fill in the forms incompletely or incorrectly
  • Those who do not want to participate in the research during the implementation phase of the research.

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.
No Intervention: control group
Experimental: intervention group
Behavioral: healthy lifestyle education
A total of 6 sessions on physical activity, nutrition, substance abuse, sexual life, check-up, accidents and injuries will be organized for the adolescents in the intervention group. The sessions will be organized every other week. Each session will be conducted in three stages. First Stage: The researcher will provide training on the subject of the session for nearly 15 minutes. Second Stage: The researcher will show animation film (nearly 3 to 5 minutes) developed by him/her related to the session. Third Stage: Groups of six will be created for the Philips 66 technique application and a spokesman will be chosen. Each group will have an online meeting and discuss the session subject in six minutes under the administration of the researcher. The spokesman of each group will present the discussion outcome in the big group meeting at the end of the discussion. The researcher will summarize the subject after the presentation of each spokesman and terminate the session.

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
develop their self-efficacy related to physical activity
Time Frame: through study completion, an average of 5 week
Adolescent Lifestyle Profile and the Self-efficacy Scale
through study completion, an average of 5 week
develop their self-efficacy related to healthy diet
Time Frame: through study completion, an average of 5 week
Adolescent Lifestyle Profile and the Self-efficacy Scale
through study completion, an average of 5 week
develop their self-efficacy related to protection from substance abuse
Time Frame: through study completion, an average of 5 week
Adolescent Lifestyle Profile and the Self-efficacy Scale
through study completion, an average of 5 week
develop their self-efficacy related to sexuality
Time Frame: through study completion, an average of 5 week
Adolescent Lifestyle Profile and the Self-efficacy Scale
through study completion, an average of 5 week
develop their self-efficacy related to check-up
Time Frame: through study completion, an average of 5 week
Adolescent Lifestyle Profile and the Self-efficacy Scale
through study completion, an average of 5 week
develop their self-efficacy related to accidents and injuries
Time Frame: through study completion, an average of 5 week
Adolescent Lifestyle Profile and the Self-efficacy Scale
through study completion, an average of 5 week

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.
Hakan Avan

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 (Actual)

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.
April 2, 2022

Primary Completion (Actual)

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.
May 25, 2022

Study Completion (Actual)

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.
June 30, 2022

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).
January 29, 2022

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.
February 9, 2022

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.
February 18, 2022

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.
August 17, 2022

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.
August 16, 2022

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.
August 1, 2022

More Information

Terms related to this study

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.
  • "hakanavan-0001

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

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