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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Adolescent Health
- 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 group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: healthy lifestyle education |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
develop their self-efficacy related to sexuality
Adolescent Lifestyle Profile and the Self-efficacy Scale
Measured: through study completion, an average of 5 week
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
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.
- First posted18 Feb 2022
- Study start2 Apr 2022
- Primary completion25 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hakan Avan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakan Avan, Kahramanmaras Sutcu Imam University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Provided According to the Health Promotion Model on Healthy Lifestyles and Self-efficacy in Adolescents
- ClinicalTrials.gov ID
- NCT05246852
- Acronym / sponsor ID
- "hakanavan-0001
- Conditions
- Adolescent Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hakan AvanUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: healthy lifestyle education |
| control group | No intervention | – |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healthy lifestyle educationA 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. | Behavioural | intervention group |
Primary outcome
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.