<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03009617</url>
  </required_header>
  <id_info>
    <org_study_id>SBUniversitesi</org_study_id>
    <nct_id>NCT03009617</nct_id>
  </id_info>
  <brief_title>Effectiveness of Web-Based Health Education and Consultation on Health Promotion Behaviors of Adolescents</brief_title>
  <official_title>Effectiveness of Web-Based Health Education and Consultation on Health Promotion Behaviors of Adolescents: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Through the training and consultation program conducted via the web for &quot;health promotion,&quot;&#xD;
      which is an important part of a school's healthcare, interactive communication methods&#xD;
      between school nurses and students were provided. The results of the study showed that&#xD;
      web-based education and counseling positively influenced health promotion behaviors of the&#xD;
      students, and e-health literacy and their knowledge was increased.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Adolescent is a critical period for many health-risk behaviours, such as alcohol&#xD;
      consumption, smoking, having unsafe sex, insufficient exercise, and diet, psychological&#xD;
      problems, which can be reduced by targeted web-based health education and consultation&#xD;
      interventions. Web-based interventions have advantages in terms of acceptability and&#xD;
      accessibility and have shown some study to promote health behaviours and e-Health literacy&#xD;
      among adolescents.&#xD;
&#xD;
      Objective: The aims of this study was to examine the effectiveness of web-based health&#xD;
      education and consultation on health promotion behaviors (ie, smoking, health responsibility,&#xD;
      nutrition, interpersonal relationships, spiritual health, alcohol and substance abuse,&#xD;
      positive life outlook, unsafe sex, malnutrition) of adolescents and their e-health literacy.&#xD;
&#xD;
      Methods: This randomized controlled study consisted of 252 adolescents, of whom 120 were in&#xD;
      the control group and 132 comprised the intervention group. Sociodemographic characteristics&#xD;
      of adolescents, internet usage, Adolescent Lifestyle Questionnaire (ALQ), e-health literacy,&#xD;
      and information levels of the adolescents were determined before the intervention. No&#xD;
      procedures were applied to the control group. A web-based health education and consultation&#xD;
      program designed to promote a healthy lifestyle was applied to the intervention group. The&#xD;
      results were re-evaluated three months after the intervention.&#xD;
&#xD;
      The investigators first hypothesis is that adolescents in the intervention (the web-based&#xD;
      education and consultation) group would report significantly higher level of well-being ( ie,&#xD;
      positive life outlook, stress management, spiritual health and health-related quality of&#xD;
      life) and health behaviors (ie, health responsibility, nutrition, exercise ) at 3-month&#xD;
      follow-up compared to the control group. Second, it is expected that participants in the&#xD;
      intervention group would report a significantly higher level of eHealth literacy and&#xD;
      knowledge at 3-month follow-up compared to the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adolescents' health behaviors</measure>
    <time_frame>6 months</time_frame>
    <description>Adolescent Lifestyle Questionnaire, Information Assessment Form for the Content of Health Education Program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>e-Health Literacy</measure>
    <time_frame>6 months</time_frame>
    <description>The Health Literacy Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">252</enrollment>
  <condition>Adolescent Health</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The educational program and counseling Pre-test before intervention Monitoring, education, and consultation through the Web At least two reminders via e-mail or phone message a week The last test after three months The website was closed three months later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pre-test No intervention The last test after three months Opening the website to the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>the educational program and counseling</intervention_name>
    <description>to examine the effectiveness of web-based health education and consultation on health promotion behaviors of adolescents, their e-health literacy, and their information levels.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  volunteered to participate in the study,&#xD;
&#xD;
          -  students who had not yet started high school education (9th-grade students),&#xD;
&#xD;
          -  students who had not participated in the pilot scheme (10th-grade students), students&#xD;
             who were not non-final year students at the preparation stage for university&#xD;
             (12th-grade students), and 11th-grade students who can use the internet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  students who 9th-grade students,&#xD;
&#xD;
          -  students who participated in the pilot scheme (10th-grade students), students who were&#xD;
             final year students at the preparation stage for university (12th-grade students), and&#xD;
             students who can not use the internet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</investigator_affiliation>
    <investigator_full_name>Gulten Guvenc</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <keyword>adolescents</keyword>
  <keyword>web-based health education</keyword>
  <keyword>eHealth literacy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009617
org study id: SBUniversitesi
nct id: NCT03009617
lead sponsor: 
has dmc: No
Through the training and consultation program conducted via the web for "health promotion,"
      which is an important part of a school's healthcare, interactive communication methods
      between school nurses and students were provided. The results of the study showed that
      web-based education and counseling positively influenced health promotion behaviors of the
      students, and e-health literacy and their knowledge was increased.
Background: Adolescent is a critical period for many health-risk behaviours, such as alcohol
      consumption, smoking, having unsafe sex, insufficient exercise, and diet, psychological
      problems, which can be reduced by targeted web-based health education and consultation
      interventions. Web-based interventions have advantages in terms of acceptability and
      accessibility and have shown some study to promote health behaviours and e-Health literacy
      among adolescents.

      Objective: The aims of this study was to examine the effectiveness of web-based health
      education and consultation on health promotion behaviors (ie, smoking, health responsibility,
      nutrition, interpersonal relationships, spiritual health, alcohol and substance abuse,
      positive life outlook, unsafe sex, malnutrition) of adolescents and their e-health literacy.

      Methods: This randomized controlled study consisted of 252 adolescents, of whom 120 were in
      the control group and 132 comprised the intervention group. Sociodemographic characteristics
      of adolescents, internet usage, Adolescent Lifestyle Questionnaire (ALQ), e-health literacy,
      and information levels of the adolescents were determined before the intervention. No
      procedures were applied to the control group. A web-based health education and consultation
      program designed to promote a healthy lifestyle was applied to the intervention group. The
      results were re-evaluated three months after the intervention.

      The investigators first hypothesis is that adolescents in the intervention (the web-based
      education and consultation) group would report significantly higher level of well-being ( ie,
      positive life outlook, stress management, spiritual health and health-related quality of
      life) and health behaviors (ie, health responsibility, nutrition, exercise ) at 3-month
      follow-up compared to the control group. Second, it is expected that participants in the
      intervention group would report a significantly higher level of eHealth literacy and
      knowledge at 3-month follow-up compared to the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: adolescents' health behaviors
time frame: 6 months
description: Adolescent Lifestyle Questionnaire, Information Assessment Form for the Content of Health Education Program
measure: e-Health Literacy
time frame: 6 months
description: The Health Literacy Scale
arm group label: Intervention Group
arm group type: Experimental
description: The educational program and counseling Pre-test before intervention Monitoring, education, and consultation through the Web At least two reminders via e-mail or phone message a week The last test after three months The website was closed three months later.
arm group label: Control Group
arm group type: No Intervention
description: Pre-test No intervention The last test after three months Opening the website to the control group
intervention type: Behavioral
intervention name: the educational program and counseling
description: to examine the effectiveness of web-based health education and consultation on health promotion behaviors of adolescents, their e-health literacy, and their information levels.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 17 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
investigator full name: Gulten Guvenc
investigator title: Assoc. Prof.
sharing ipd: No