xml: <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/NCT06022120</url>
    </required_header>
    <id_info>
      <org_study_id>REG-068-2023</org_study_id>
      <nct_id>NCT06022120</nct_id>
    </id_info>
    <brief_title>Health Literacy Among Youth</brief_title>
    <official_title>Health Literacy Among Youth (Danish: Sundhedskompetencer Blandt Unge)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Holbaek Sygehus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Holbaek Sygehus</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The linkage between lower educational levels and poorer health has been highlighted as a&#xD;
        mechanism contributing to social inequality in health. However, more research on this&#xD;
        mechanism among youth is needed, e.g. to ensure timing of primary prevention of diseases.&#xD;
        Additionally, health literacy (HL) has been increasingly recognized as a means of reducing&#xD;
        health inequalities. However, knowledge on best practice for HL interventions among youth is&#xD;
        scarce. The aim of this project is to develop, test, and evaluate an integrated,&#xD;
        participatory intervention to improve HL among young adults in Danish school settings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        OBJECTIVE This project aims to develop, test, and evaluate an integrated, participatory&#xD;
        intervention to improve health literacy (HL) through health promoting activities among young&#xD;
        Danes in school settings.&#xD;
  &#xD;
        Research questions:&#xD;
  &#xD;
          -  What are the HL needs of young adults in Danish FGU or similar school settings?&#xD;
  &#xD;
          -  Is an integrated, participatory intervention approach feasible in FGU schools or similar&#xD;
             settings and effective to improve the HL of the students?&#xD;
  &#xD;
        BACKGROUND Social inequality in health refers to health differences between social groups,&#xD;
        and the pattern in which those from economically and socially poorer backgrounds run higher&#xD;
        risks of premature death and illness. Furthermore, the strong linkage between lower&#xD;
        educational levels and poorer health has been highlighted as one of the mechanisms&#xD;
        contributing to social inequality in health. In 2018, approximately 50,000 Danes aged 15-24&#xD;
        years were Not in Employment, Education or Training (NEET) and almost 20% of all Danish&#xD;
        25-year olds had not completed a secondary education. Thus, a relatively large proportion of&#xD;
        Danish youth were at risk of exclusion from the labour market, lower income, and thereby also&#xD;
        reduced health.&#xD;
  &#xD;
        To support young adults who are NEET, preparatory basic educational institutions (Danish:&#xD;
        Forberedende grunduddannelse (FGU)) were initiated in 2019. One report finds that FGU&#xD;
        students are disadvantaged in terms of socio-demographic and educational factors compared to&#xD;
        their peers, and 50% of FGU students have special educational needs, including psychiatric&#xD;
        diagnoses. Hence, students at FGU educations represent a group of young adults who are at&#xD;
        particular risk of adverse health outcomes.&#xD;
  &#xD;
        Health Literacy (HL) is now well-established as a modifiable factor that contributes to the&#xD;
        maintenance of good health across the life course, and globally, there has been an increasing&#xD;
        acknowledgement of HL as a means of reducing health inequalities. However, HL follows a&#xD;
        social gradient, e.g. inadequate HL is more prevalent among vulnerable populations, such as&#xD;
        persons with low education. The World Health Organization (WHO) has stated a need for&#xD;
        development of national strategies to strengthen HL in all populations and in educational&#xD;
        contexts, and more countries have now included HL in national health strategies. However, the&#xD;
        Danish health authorities have not shown similar interest in HL, and their focus have&#xD;
        primarily been on organizational HL responsiveness and not on the individual's HL. With the&#xD;
        increasing calls for more actions on addressing HL and health inequality, school-based HL&#xD;
        interventions have emerged. However, such HL interventions have so far faced implementation&#xD;
        challenges, and there is a shortage of clarity about which intervention strategies are the&#xD;
        most effective in improving HL among children and young adults.&#xD;
  &#xD;
        METHODS In this project, an integrated, participatory intervention to improve HL among young&#xD;
        Danes at FGU schools or similar contexts is developed, tested and evaluated by use of&#xD;
        mixed-methods and the UK Medical Research Counsil's framework for developing and evaluating&#xD;
        complex interventions. The integration means that all intervention activities have a&#xD;
        preventive and health-promoting element. The intervention concept is developed by The&#xD;
        American Total Worker Health (TWH) and the Australian WorkHealth Improvement Network (WIN)&#xD;
        program. Recently, the Department of Occupational and Social Medicine (ASMA) at Holbæk&#xD;
        Hospital tested the WIN concept in a Danish context among adult employees with little or no&#xD;
        education, and preliminary analyses showed promising results. As the intervention concept is&#xD;
        very flexible and is based on local adaption, we assume that it is possible to implement in&#xD;
        two Danish FGU schools or similar settings.&#xD;
  &#xD;
        To this date, one FGU and one technical school has expressed willingness to participate in&#xD;
        the intervention.&#xD;
  &#xD;
        The intervention involves three phases:&#xD;
  &#xD;
        Phase 1: The needs assessment includes: 1) A systematic review about HL interventions among&#xD;
        youth in school settings; 2) Individual, semi structured interviews or focus groups with&#xD;
        local experts (e.g. teachers at FGU schools), who are strategically selected based on their&#xD;
        knowledge about the organizational structure and experience with the target group, to clarify&#xD;
        the HL needs from a professional perspective; 3) Two focus groups at each school (in total,&#xD;
        n=24-28) with the target group, i.e. students, are conducted pre the intervention to clarify&#xD;
        the HL needs of the students. Qualitative data are analyzed in NVivo software by use of&#xD;
        thematic network analysis and interpreted by use of social practice theory, which has&#xD;
        previously been used to analyze complex relationships between intervention elements&#xD;
        (competencies, materials and meanings) and social context in complex interventions.&#xD;
  &#xD;
        Phase 2: Program implementation: The intervention is implemented after adjustment according&#xD;
        to the needs assessment. The integrated intervention design allows for local adaption, i.e.&#xD;
        the specific focus point for the intervention activities will be based on issues in the local&#xD;
        context brought up by the participants themselves. Additionally, the intervention concept&#xD;
        follows a systematic, participatory approach where participants are supported to develop&#xD;
        their own HL initiatives. The intervention activities includes:&#xD;
  &#xD;
          1. Establishment of a HL committee: A group of students (6-7) and a teacher join a HL&#xD;
             committee at each school. The HL committee participate in two 3-hours workshops where&#xD;
             they will be educated and trained in collaborative methodology and WIN concepts&#xD;
             (particularly in the first workshop).&#xD;
  &#xD;
          2. Development of own initiatives: During the workshops, the HL committee will develop own&#xD;
             initiatives to improve HL among all students at each school.&#xD;
  &#xD;
          3. Implementation of initiatives: Between the workshops, the HL committee will test and&#xD;
             implement their initiatives, e.g. using the Model of Improvement and the&#xD;
             plan-do-study-act (PDSA) cycle (as described below). In every implementation period, the&#xD;
             HL Committee at each school meets and discuss the implementation. The students in the HL&#xD;
             committee will document changes and barriers and facilitators to the implementation by&#xD;
             taking photos and do an on-going evaluation.&#xD;
  &#xD;
        The Model of Improvement consists of a brainstorming part including three key questions&#xD;
        aiming to guide the assessment of which initiatives to focus on: 1) What are we trying to&#xD;
        accomplish?, 2) How will we know that a change will lead to an improvement?, and 3) What&#xD;
        changes can we make that will result in an improvement?). The second part is the &quot;test part&quot;,&#xD;
        which consist of the PDSA cycles: 1) Plan: Thorough planning of the initiative, clarification&#xD;
        of expectations of outcomes, and agreements on data collection, 2) Do: Implementation of the&#xD;
        planned actions as well as data collection, 3) Study: Reflection on effect and learning, data&#xD;
        analysis, and identification of unintended negative and positive consequences, and 4) Act:&#xD;
        Assessment of either continuation of implementation, adjustments, or testing a new&#xD;
        initiative. The experiences from each cycle will systematically be transferred to the next.&#xD;
        Thus, continuous improvements and/or adjustments will be conducted.&#xD;
  &#xD;
        Phase 3: Process- and effect evaluation: Pre-, during (x2), and post the intervention,&#xD;
        questionnaire data are collected among all students at the schools. Until baseline,&#xD;
        participants function as their own controls as in a RCT design. Questionnaire data are&#xD;
        analyzed in linear mixed models that take into account repeated measurements as well as&#xD;
        inter- and intra-effect differences among the participants. Focus groups with 6 students at&#xD;
        each school are conducted to evaluate the implementation of the intervention and its&#xD;
        feasibility by use of a realist evaluation approach.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Using a stepped-wedge design, participants at the enrolled schools function as their own control. Thus, the effect of the intervention is evaluated as in an RCT design. All participants are asked to indicate whether they want to participate in the scientific evaluation of the intervention. Those who wish to participate are invited to the data collection containing: Signing of consent and answering questionnaires. No preparation is required of the participants before data collection begins. Smaller groups of students and teachers participate in focus groups as part of the process evaluation. All intervention activities take place at the participants' school. Calculation, analysis and interpretation of data will take place at the Department of Occupational and Social Medicine, Holbæk Hospital.&#xD;
  The intervention activities are developed by a student commitee, accoording to a participatory approach and following the Work Health Improvements Network concept.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Health Literacy</measure>
      <time_frame>Data on health literacy are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>Change of health literacy level measured by HLS19-Q12 (Danish version), ranging from 1-4, with higher scores indicating a higher level of health literacy, from baseline to 3 and 6 months after randomization.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-perceived health</measure>
      <time_frame>Data on self-perceived health are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire participants are asked: &quot;All in all, how do you think your health is?&quot;. Change of self-perceived health (SF-36, Danish version, by Bjørner et al. 1997), ranging from 0-5 with a higher scores indicating a worse health outcome, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Life satisfaction</measure>
      <time_frame>Data on life satisfaction are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire participants are asked: &quot;How satisfied are you with your life?&quot;. Change of life satisfaction, ranging from 0-10, with higher numbers indicating a higher life satisfaction, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental health</measure>
      <time_frame>Data on mental health are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire participants are asked to indicate their mental health by answereing to what degree they agree with four statements: 1) I was happy last week, 2) I felt my friends were not freindly and did not want to spend time with me, 3) I felt sad, 4) It was not easy to get started this week. Change of mental health, ranging from 1-4, with higher numbers indicating worse mental health, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self efficacy</measure>
      <time_frame>Data on self efficacy are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire participants are asked to indicate to what degree they agree with three statements: 1) Your are good at solve unexpected problems, 2) You can solve most problems, if you really want to, 3) despite what happens in your life, you feel like you will be able to solve it. Change of self efficacy, ranging from 1-5, with higher numbers indicating worse outcome, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ressources for health promotion</measure>
      <time_frame>Data on ressources for health promotion are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire, participants are asked about access to healthy food and physical activity facilities. Change in ressources for health promotion, ranging from 1-4, with higher numbers indicating better outcome, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Leisure time physical activity</measure>
      <time_frame>Data on leisure time physical activity are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire, participants are asked about their level of physical activity in leisure time. Change in leisure time physical activity, ranging from 1-6, with higher numbers indicating a better outcome, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alcohol consumption</measure>
      <time_frame>Data on alcohol consumption are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire, participants are asked about their alcohol consumption. Change in alcohol consumption ranging from 1-7, with higher numbers indicating a worse outcome, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nicotine and weed consumption</measure>
      <time_frame>Data on nicotine/weed consumption are collected at baseline and follow up data are collected 3 and 6 months after randomization.</time_frame>
      <description>In a questionnaire, participants are asked about their nicotine and weed consumption. Change in nicotine/weed consumption ranging from 1-4, with higher numbers indicating a worse outcome, from baseline to 3 and 6 months after randomization.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Health Knowledge, Attitudes, Practice</condition>
    <condition>Health Behavior</condition>
    <condition>Health Literacy</condition>
    <condition>Health-Related Behavior</condition>
    <arm_group>
      <arm_group_label>An integrated health literacy intervention</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Intervention: A group of students at each school will develop and implement their own project activities at meetings two times during the intervention. Activities are implemented in schools for all students.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Reference</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention activities</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>An integrated health literacy intervention</intervention_name>
      <description>The intervention investigates the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish contexts among students at risk of poorer health outcomes compared to their peers with stronger literacy skills.</description>
      <arm_group_label>An integrated health literacy intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Providing an informed signed consent prior to participation.&#xD;
  &#xD;
            -  Student at one of the enrolled schools&#xD;
  &#xD;
            -  15-25 years of age or turns 15 during the project period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under the age of 15 and does not turn 15 during the project period.&#xD;
  &#xD;
            -  above the age of 25 before the project period starts.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vivian Rueskov Poulsen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Holbæk Sygehus</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vivian Rueskov Poulsen</last_name>
      <phone>004559489851</phone>
      <email>vivp@regionsjaelland.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ole Steen Mortensen</last_name>
      <phone>004559489851</phone>
      <email>osm@regionsjaelland.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Occupational and Social Medicine, Holbaek Hospital</name>
        <address>
          <city>Holbaek</city>
          <state>Region Sjælland</state>
          <zip>4300</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vivian Rueskov Poulsen</last_name>
        <email>vivp@regionsjaelland.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Health Literacy</keyword>
    <keyword>Health behavior</keyword>
    <keyword>Intervention</keyword>
    <keyword>School context</keyword>
    <keyword>Youth</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We do not plan to share any individual participant data with other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022120
  org study id: REG-068-2023
  nct id: NCT06022120
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The linkage between lower educational levels and poorer health has been highlighted as a
        mechanism contributing to social inequality in health. However, more research on this
        mechanism among youth is needed, e.g. to ensure timing of primary prevention of diseases.
        Additionally, health literacy (HL) has been increasingly recognized as a means of reducing
        health inequalities. However, knowledge on best practice for HL interventions among youth is
        scarce. The aim of this project is to develop, test, and evaluate an integrated,
        participatory intervention to improve HL among young adults in Danish school settings.
  OBJECTIVE This project aims to develop, test, and evaluate an integrated, participatory
        intervention to improve health literacy (HL) through health promoting activities among young
        Danes in school settings.
  
        Research questions:
  
          -  What are the HL needs of young adults in Danish FGU or similar school settings?
  
          -  Is an integrated, participatory intervention approach feasible in FGU schools or similar
             settings and effective to improve the HL of the students?
  
        BACKGROUND Social inequality in health refers to health differences between social groups,
        and the pattern in which those from economically and socially poorer backgrounds run higher
        risks of premature death and illness. Furthermore, the strong linkage between lower
        educational levels and poorer health has been highlighted as one of the mechanisms
        contributing to social inequality in health. In 2018, approximately 50,000 Danes aged 15-24
        years were Not in Employment, Education or Training (NEET) and almost 20% of all Danish
        25-year olds had not completed a secondary education. Thus, a relatively large proportion of
        Danish youth were at risk of exclusion from the labour market, lower income, and thereby also
        reduced health.
  
        To support young adults who are NEET, preparatory basic educational institutions (Danish:
        Forberedende grunduddannelse (FGU)) were initiated in 2019. One report finds that FGU
        students are disadvantaged in terms of socio-demographic and educational factors compared to
        their peers, and 50% of FGU students have special educational needs, including psychiatric
        diagnoses. Hence, students at FGU educations represent a group of young adults who are at
        particular risk of adverse health outcomes.
  
        Health Literacy (HL) is now well-established as a modifiable factor that contributes to the
        maintenance of good health across the life course, and globally, there has been an increasing
        acknowledgement of HL as a means of reducing health inequalities. However, HL follows a
        social gradient, e.g. inadequate HL is more prevalent among vulnerable populations, such as
        persons with low education. The World Health Organization (WHO) has stated a need for
        development of national strategies to strengthen HL in all populations and in educational
        contexts, and more countries have now included HL in national health strategies. However, the
        Danish health authorities have not shown similar interest in HL, and their focus have
        primarily been on organizational HL responsiveness and not on the individual's HL. With the
        increasing calls for more actions on addressing HL and health inequality, school-based HL
        interventions have emerged. However, such HL interventions have so far faced implementation
        challenges, and there is a shortage of clarity about which intervention strategies are the
        most effective in improving HL among children and young adults.
  
        METHODS In this project, an integrated, participatory intervention to improve HL among young
        Danes at FGU schools or similar contexts is developed, tested and evaluated by use of
        mixed-methods and the UK Medical Research Counsil's framework for developing and evaluating
        complex interventions. The integration means that all intervention activities have a
        preventive and health-promoting element. The intervention concept is developed by The
        American Total Worker Health (TWH) and the Australian WorkHealth Improvement Network (WIN)
        program. Recently, the Department of Occupational and Social Medicine (ASMA) at Holbæk
        Hospital tested the WIN concept in a Danish context among adult employees with little or no
        education, and preliminary analyses showed promising results. As the intervention concept is
        very flexible and is based on local adaption, we assume that it is possible to implement in
        two Danish FGU schools or similar settings.
  
        To this date, one FGU and one technical school has expressed willingness to participate in
        the intervention.
  
        The intervention involves three phases:
  
        Phase 1: The needs assessment includes: 1) A systematic review about HL interventions among
        youth in school settings; 2) Individual, semi structured interviews or focus groups with
        local experts (e.g. teachers at FGU schools), who are strategically selected based on their
        knowledge about the organizational structure and experience with the target group, to clarify
        the HL needs from a professional perspective; 3) Two focus groups at each school (in total,
        n=24-28) with the target group, i.e. students, are conducted pre the intervention to clarify
        the HL needs of the students. Qualitative data are analyzed in NVivo software by use of
        thematic network analysis and interpreted by use of social practice theory, which has
        previously been used to analyze complex relationships between intervention elements
        (competencies, materials and meanings) and social context in complex interventions.
  
        Phase 2: Program implementation: The intervention is implemented after adjustment according
        to the needs assessment. The integrated intervention design allows for local adaption, i.e.
        the specific focus point for the intervention activities will be based on issues in the local
        context brought up by the participants themselves. Additionally, the intervention concept
        follows a systematic, participatory approach where participants are supported to develop
        their own HL initiatives. The intervention activities includes:
  
          1. Establishment of a HL committee: A group of students (6-7) and a teacher join a HL
             committee at each school. The HL committee participate in two 3-hours workshops where
             they will be educated and trained in collaborative methodology and WIN concepts
             (particularly in the first workshop).
  
          2. Development of own initiatives: During the workshops, the HL committee will develop own
             initiatives to improve HL among all students at each school.
  
          3. Implementation of initiatives: Between the workshops, the HL committee will test and
             implement their initiatives, e.g. using the Model of Improvement and the
             plan-do-study-act (PDSA) cycle (as described below). In every implementation period, the
             HL Committee at each school meets and discuss the implementation. The students in the HL
             committee will document changes and barriers and facilitators to the implementation by
             taking photos and do an on-going evaluation.
  
        The Model of Improvement consists of a brainstorming part including three key questions
        aiming to guide the assessment of which initiatives to focus on: 1) What are we trying to
        accomplish?, 2) How will we know that a change will lead to an improvement?, and 3) What
        changes can we make that will result in an improvement?). The second part is the "test part",
        which consist of the PDSA cycles: 1) Plan: Thorough planning of the initiative, clarification
        of expectations of outcomes, and agreements on data collection, 2) Do: Implementation of the
        planned actions as well as data collection, 3) Study: Reflection on effect and learning, data
        analysis, and identification of unintended negative and positive consequences, and 4) Act:
        Assessment of either continuation of implementation, adjustments, or testing a new
        initiative. The experiences from each cycle will systematically be transferred to the next.
        Thus, continuous improvements and/or adjustments will be conducted.
  
        Phase 3: Process- and effect evaluation: Pre-, during (x2), and post the intervention,
        questionnaire data are collected among all students at the schools. Until baseline,
        participants function as their own controls as in a RCT design. Questionnaire data are
        analyzed in linear mixed models that take into account repeated measurements as well as
        inter- and intra-effect differences among the participants. Focus groups with 6 students at
        each school are conducted to evaluate the implementation of the intervention and its
        feasibility by use of a realist evaluation approach.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  intervention model description: Using a stepped-wedge design, participants at the enrolled schools function as their own control. Thus, the effect of the intervention is evaluated as in an RCT design. All participants are asked to indicate whether they want to participate in the scientific evaluation of the intervention. Those who wish to participate are invited to the data collection containing: Signing of consent and answering questionnaires. No preparation is required of the participants before data collection begins. Smaller groups of students and teachers participate in focus groups as part of the process evaluation. All intervention activities take place at the participants' school. Calculation, analysis and interpretation of data will take place at the Department of Occupational and Social Medicine, Holbæk Hospital.
  The intervention activities are developed by a student commitee, accoording to a participatory approach and following the Work Health Improvements Network concept.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Health Literacy
  time frame: Data on health literacy are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: Change of health literacy level measured by HLS19-Q12 (Danish version), ranging from 1-4, with higher scores indicating a higher level of health literacy, from baseline to 3 and 6 months after randomization.
  measure: Self-perceived health
  time frame: Data on self-perceived health are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire participants are asked: "All in all, how do you think your health is?". Change of self-perceived health (SF-36, Danish version, by Bjørner et al. 1997), ranging from 0-5 with a higher scores indicating a worse health outcome, from baseline to 3 and 6 months after randomization.
  measure: Life satisfaction
  time frame: Data on life satisfaction are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire participants are asked: "How satisfied are you with your life?". Change of life satisfaction, ranging from 0-10, with higher numbers indicating a higher life satisfaction, from baseline to 3 and 6 months after randomization.
  measure: Mental health
  time frame: Data on mental health are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire participants are asked to indicate their mental health by answereing to what degree they agree with four statements: 1) I was happy last week, 2) I felt my friends were not freindly and did not want to spend time with me, 3) I felt sad, 4) It was not easy to get started this week. Change of mental health, ranging from 1-4, with higher numbers indicating worse mental health, from baseline to 3 and 6 months after randomization.
  measure: Self efficacy
  time frame: Data on self efficacy are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire participants are asked to indicate to what degree they agree with three statements: 1) Your are good at solve unexpected problems, 2) You can solve most problems, if you really want to, 3) despite what happens in your life, you feel like you will be able to solve it. Change of self efficacy, ranging from 1-5, with higher numbers indicating worse outcome, from baseline to 3 and 6 months after randomization.
  measure: Ressources for health promotion
  time frame: Data on ressources for health promotion are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire, participants are asked about access to healthy food and physical activity facilities. Change in ressources for health promotion, ranging from 1-4, with higher numbers indicating better outcome, from baseline to 3 and 6 months after randomization.
  measure: Leisure time physical activity
  time frame: Data on leisure time physical activity are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire, participants are asked about their level of physical activity in leisure time. Change in leisure time physical activity, ranging from 1-6, with higher numbers indicating a better outcome, from baseline to 3 and 6 months after randomization.
  measure: Alcohol consumption
  time frame: Data on alcohol consumption are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire, participants are asked about their alcohol consumption. Change in alcohol consumption ranging from 1-7, with higher numbers indicating a worse outcome, from baseline to 3 and 6 months after randomization.
  measure: Nicotine and weed consumption
  time frame: Data on nicotine/weed consumption are collected at baseline and follow up data are collected 3 and 6 months after randomization.
  description: In a questionnaire, participants are asked about their nicotine and weed consumption. Change in nicotine/weed consumption ranging from 1-4, with higher numbers indicating a worse outcome, from baseline to 3 and 6 months after randomization.
  arm group label: An integrated health literacy intervention
  arm group type: Other
  description: Intervention: A group of students at each school will develop and implement their own project activities at meetings two times during the intervention. Activities are implemented in schools for all students.
  arm group label: Reference
  arm group type: No Intervention
  description: No intervention activities
  intervention type: Behavioral
  intervention name: An integrated health literacy intervention
  description: The intervention investigates the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish contexts among students at risk of poorer health outcomes compared to their peers with stronger literacy skills.
  arm group label: An integrated health literacy intervention
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vivian Rueskov Poulsen
  role: Principal Investigator
  affiliation: Holbæk Sygehus
  last name: Vivian Rueskov Poulsen
  phone: 004559489851
  email: vivp@regionsjaelland.dk
  last name: Ole Steen Mortensen
  phone: 004559489851
  email: osm@regionsjaelland.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: We do not plan to share any individual participant data with other researchers.