NCT05246852

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 29, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

January 29, 2022

Last Update Submit

August 16, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • develop their self-efficacy related to physical activity

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    through study completion, an average of 5 week

  • develop their self-efficacy related to healthy diet

    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

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    through study completion, an average of 5 week

  • develop their self-efficacy related to sexuality

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    through study completion, an average of 5 week

  • develop their self-efficacy related to check-up

    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

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    through study completion, an average of 5 week

Study Arms (2)

intervention group

EXPERIMENTAL
Behavioral: healthy lifestyle education

control group

NO INTERVENTION

Interventions

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.

intervention group

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • speaking Turkish,
  • having parental permission,
  • having no mental or neurological disability,
  • having no chronic illness.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hakan Avan

Kahramanmaraş, Onikişubat, 46000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

January 29, 2022

First Posted

February 18, 2022

Study Start

April 2, 2022

Primary Completion

May 25, 2022

Study Completion

June 30, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations