- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246852
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: intervention group
|
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
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
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)
April 2, 2022
Primary Completion (Actual)
May 25, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
January 29, 2022
First Submitted That Met QC Criteria
February 9, 2022
First Posted (Actual)
February 18, 2022
Study Record Updates
Last Update Posted (Actual)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID 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.
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