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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05246852
Other study ID # "hakanavan-0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2, 2022
Est. completion date June 30, 2022

Study information

Verified date August 2022
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 30, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Hakan Avan Kahramanmaras Onikisubat

Sponsors (1)

Lead Sponsor Collaborator
Hakan Avan

Country where clinical trial is conducted

Turkey, 

Outcome

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