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Adolescent HealthNCT05246852

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

A study testing healthy lifestyle education in people with Adolescent Health, run by Hakan Avan at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Adolescent Health
What is being tested?
healthy lifestyle education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Apr 2022to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hakan Avan

    Kahramanmaraş, Onikişubat, 46000

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
healthy lifestyle education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • healthy lifestyle educationBehavioural

    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.

Study groups in NCT05246852
Study groupRoleWhat they receive
intervention groupExperimentalNot described
Receives: Behavioral: healthy lifestyle education
control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. develop their self-efficacy related to physical activity

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    Measured: through study completion, an average of 5 week

  2. develop their self-efficacy related to healthy diet

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    Measured: through study completion, an average of 5 week

  3. develop their self-efficacy related to protection from substance abuse

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    Measured: through study completion, an average of 5 week

  4. develop their self-efficacy related to sexuality

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    Measured: through study completion, an average of 5 week

  5. develop their self-efficacy related to check-up

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    Measured: through study completion, an average of 5 week

  6. develop their self-efficacy related to accidents and injuries

    Adolescent Lifestyle Profile and the Self-efficacy Scale

    Measured: through study completion, an average of 5 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start2 Apr 2022
  3. Primary completion25 May 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05246852
Sponsor's protocol ID
"hakanavan-0001
Status last verified
Aug 2022
First submitted
29 Jan 2022
Last updated
17 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing healthy lifestyle education in people with Adolescent Health, run by Hakan Avan at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

develop their self-efficacy related to physical activity (time frame: through study completion, an average of 5 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.

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