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/NCT05963893</url>
    </required_header>
    <id_info>
      <org_study_id>2023_14_PRI</org_study_id>
      <nct_id>NCT05963893</nct_id>
    </id_info>
    <brief_title>Promoting a Healthy Life Through Gender Equity</brief_title>
    <acronym>Uni4Move</acronym>
    <official_title>Cooperative Planning Process With the University Community to Sit Less, Move More and Improve Mental Health Though a Gendered Enviromental Approach: the Uni4Move Project</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundació Universitària del Bages</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundació Universitària del Bages</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>
        Mental health, understood as the individual or group well-being at an emotional,&#xD;
        psychological, and/or social level, affects up to 35% of university students, of whom only&#xD;
        16.4% seek or receive help from healthcare professionals. Despite this prevalence and its&#xD;
        impact on academic performance and the challenges faced by universities in terms of limited&#xD;
        resources to address this situation, most research tends to focus on primary and/or secondary&#xD;
        education stages. Consequently, there is limited research on the reasons why university&#xD;
        students experience mental health problems and why they do not seek help.&#xD;
  &#xD;
        Physical activity and reducing sedentary behaviour could be protective factors for mental&#xD;
        health in both children and adolescents. In this regard, according to data from the DESK-Uni&#xD;
        at UVic-UCC, university students report engaging in low levels of physical activity, with&#xD;
        female students reporting lower levels than male students. Additionally, adolescent girls&#xD;
        report more mental health problems than boys. Therefore, there is a need for research and&#xD;
        projects that consider the gender bias in health that exists in our society, including&#xD;
        universities. This bias could explain why girls engage in less physical activity or claim to&#xD;
        do so and why they experience more mental health problems. Thus, the purpose of the project&#xD;
        is to improve or reduce gender inequalities within the university community and their impact&#xD;
        on health behaviour (physical activity/sedentary behaviour) and mental health of both&#xD;
        students and staff members.&#xD;
  &#xD;
        Overall, the project aims to decrease the risks of experiencing mental health problems in the&#xD;
        university environment by enhancing identification and promoting health-related behaviours&#xD;
        that act as protective factors (e.g., physical activity). This will be done by considering&#xD;
        the intersectionality of inequality axes present in our society and reproduced within the&#xD;
        university setting. To do it, the Sustainable Development Goals (SDG; 3-4-5) will be taken in&#xD;
        consideration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The university environment is not separate from society, which has experienced an increase in&#xD;
        the prevalence of mental health problems following the COVID-19 pandemic. Similarly, the&#xD;
        university environment is not immune to the gender biases of our society: in fact, the&#xD;
        university itself could help perpetuate and reproduce these biases if not addressed.&#xD;
        Therefore, it is necessary to investigate which social factors, such as gender construction,&#xD;
        can influence aspects of health (mental health problems) and behaviour (engagement in&#xD;
        physical activity or sedentary behaviour) within the university community.&#xD;
  &#xD;
        Generally, the data provided by the university community are self-reported, often estimating&#xD;
        levels of physical activity. Consequently, these low levels of physical activity may be even&#xD;
        higher. Therefore, it is necessary to explore physical activity levels and sedentary&#xD;
        behaviour using accelerometers and qualitatively examine, from a gender perspective, the&#xD;
        reasons, barriers, and facilitators that influence engagement in physical activity and the&#xD;
        improvement of sedentary behaviour among the university community.&#xD;
  &#xD;
        On the other hand, while it is true that the UManresa university offers free psychological&#xD;
        assistance to students (up to three visits per year), the understanding of mental health by&#xD;
        the university community can affect the utilization of this service. For example, in a&#xD;
        society that demands strength from &quot;men,&quot; they may be more resistant to acknowledging their&#xD;
        mental health problems, considering it a sign of weakness, and seeking help. Therefore,&#xD;
        understanding how the university community perceives and interprets mental health is&#xD;
        important: how it socially constructs the meaning of mental health problems and the role that&#xD;
        gender plays in this construction.&#xD;
  &#xD;
        In the face of this situation, the following questions arise: Is there a correlation between&#xD;
        levels of physical activity, sedentary behaviour, and the mental health status of the&#xD;
        university community? What social and gender factors in the university environment can lead&#xD;
        to lower levels of physical activity and more mental health problems? What actions can the&#xD;
        university community take to improve the current situation regarding health behaviours and&#xD;
        mental health of the university community? Additionally, considering that levels of physical&#xD;
        activity are influenced by gender inequity and that mental health problems are partly&#xD;
        influenced by physical activity and sedentary behaviour, it is necessary to study the&#xD;
        relationship between mental health, health behaviours, and gender perspective.&#xD;
  &#xD;
        In fact, the report &quot;Gender perspective in research at the University&quot; (2017), coordinated by&#xD;
        Tània Verge Mestre (Universitat Pompeu Fabra) and Teresa Cabruja Ubach (Universitat de&#xD;
        Girona), found that the effective incorporation of a gender perspective in university&#xD;
        teaching remained a pending challenge, despite the existing European regulatory framework.&#xD;
        Therefore, social inequalities may continue to persist and reproduce within the university&#xD;
        setting. In this sense, this project aims to incorporate a gender perspective to improve the&#xD;
        quality of teaching and the social relevance of knowledge, technologies, and innovations&#xD;
        (re)produced. Firstly, this perspective aims to improve mental health through levels of&#xD;
        physical activity and sedentary behaviour in the university community, both of which are&#xD;
        associated with gender biases. On the other hand, it aims to provide students with new tools&#xD;
        to identify gender stereotypes, norms and roles to contribute to their critical thinking and&#xD;
        acquire competencies that will enable them to avoid gender blindness in their future&#xD;
        professional practice. Likewise, the gender perspective allows faculty and all university&#xD;
        staff to pay attention to gender dynamics within the learning environment and take measures&#xD;
        to ensure that the diversity of students is addressed, thereby impacting the mental health&#xD;
        and potential health behaviours of the entire community.&#xD;
  &#xD;
        Furthermore, it is necessary to explore both physical activity and sedentary behaviour using&#xD;
        accelerometers and how these levels are linked to mental health problems and social&#xD;
        determinants that influence the adoption or non-adoption of a healthy lifestyle and the&#xD;
        social construction of gender and mental illness. Secondly, it is important to&#xD;
        collaboratively develop an action plan among all stakeholders at the university level to&#xD;
        implement the research project's findings. Finally, the action plan should be implemented&#xD;
        from a gender perspective to reduce sedentary behaviour, improve levels of physical activity,&#xD;
        and consequently reduce mental health problems. The results should be evaluated annually&#xD;
        throughout the entire trajectory of the students.&#xD;
  &#xD;
        The overall objective of the project is to co-create and implement an action plan at the&#xD;
        university level from a gender perspective to improve levels of physical activity, reduce&#xD;
        sedentary behaviour, and consequently decrease the risk of mental health problems among&#xD;
        members of the university community.&#xD;
  &#xD;
        The specific objectives include:&#xD;
  &#xD;
          -  Explore the acceptability and feasibility of implementing an action plan at the&#xD;
             university level among different stakeholders from a gender perspective.&#xD;
  &#xD;
          -  Determine the levels of physical activity and sedentary behaviour among the university&#xD;
             community and their correlation with mental health problems.&#xD;
  &#xD;
          -  Explore the experiences and factors (i.e gender inequity) that may influence the&#xD;
             engagement in physical activity and sedentary behaviour, as well as the perception of&#xD;
             mental health, among the university community.&#xD;
  &#xD;
          -  Create a gender-inclusive guide for university teaching that addresses the needs for&#xD;
             improving levels of physical activity, reducing sedentary behaviour, and addressing&#xD;
             mental health problems within the university community.&#xD;
  &#xD;
        Each of the specific objectives will help confirm or refute the hypothesis posed. Broadly&#xD;
        speaking, they can be categorized into two distinct types: those focusing on quantitative and&#xD;
        biological outcomes (correlation between physical activity, sedentary behaviour, and mental&#xD;
        health problems) and those interpreting, applying, or seeking to transfer the results through&#xD;
        changes and actions in the daily life of the university community.&#xD;
  &#xD;
        The study follows a mixed-methods approach using a Cooperative Planning Process (CPP) model.&#xD;
        The CPP is a participatory approach that helps create dynamic social spaces to improve change&#xD;
        processes in healthcare and health promotion in a fair and equitable manner. Additionally,&#xD;
        participatory interventions aim to increase the fit (adaptation) of programs within the&#xD;
        real-life contexts of the individuals involved (university community). In this sense, the CPP&#xD;
        has been frequently used in promoting physical activity over the past decades. The CPP is a&#xD;
        participatory intervention strategy that brings together stakeholders involved in the change&#xD;
        process through egalitarian decision-making to plan, develop, and implement programs that&#xD;
        align with the demands and needs of the target population. Therefore, the CPP addresses&#xD;
        essential principles for interventions such as the multi-dimensionality of interventions&#xD;
        (socioecological perspective), context-specific interventions (action plan), and the&#xD;
        reciprocal adjustment between science and clinical practice.&#xD;
  &#xD;
        To carry out the CPP, the project will be divided into different phases: i) Identification of&#xD;
        the target population members and the needs of the stakeholders. ii) Development of an action&#xD;
        plan to address the identified needs, including co-creation of the action plan for promoting&#xD;
        physical activity, reducing sedentary behaviour, and raising awareness of mental health&#xD;
        within the university community. iii) Establishing the feasibility and acceptability of the&#xD;
        co-created action plan and adapting it based on the emerging needs through an initial&#xD;
        application within the university community. iv) Implementation of the action plan through&#xD;
        close collaboration with the target population and stakeholders. v) Evaluation of the success&#xD;
        of the action plan and making necessary adaptations to ensure long-term sustainability.&#xD;
  &#xD;
        By following this approach, the study aims to actively involve the university community and&#xD;
        stakeholders in the planning, development, and implementation of interventions, ultimately&#xD;
        promoting sustainable changes in physical activity, sedentary behaviour, and mental health&#xD;
        throughout a gender perspective.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS at 2 years</measure>
      <time_frame>Change from baseline at 2 years</time_frame>
      <description>The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. At individual level 'minimum detectable change' has been calculated using different recommended methods giving results of 3 and 8 points. A change of 3 points means that scores on three items have improved or worsened by 1 point, or scores on one item have improved or worsened by 3 points. This suggests that the lower threshold of 3 points can be taken to represent 'meaningful change' between measurement points in individuals.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Levels</measure>
      <time_frame>Seven days a year during four years</time_frame>
      <description>Levels of light, medium and vigorous physical activity weekly in minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sedentary behavior time</measure>
      <time_frame>Seven days a year during four years</time_frame>
      <description>Number of total time in minutes of sedentary behavior</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sedentary behavior breaks</measure>
      <time_frame>Seven days a year during four years</time_frame>
      <description>Number of breaks (sit-to-stand transitions)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sedentary behavior bouts</measure>
      <time_frame>Seven days a year during four years</time_frame>
      <description>Duration of bouts in minutes (&gt;30, 30-60, &lt;60).</description>
    </secondary_outcome>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Mental Health Wellness 1</condition>
    <condition>Physical Inactivity</condition>
    <condition>Sedentary Behavior</condition>
    <condition>Gender Discrimination</condition>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Uni4Move to sit less and move more</intervention_name>
      <description>Co-create and implement an action plan to move more and sit less in the university context</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The population will consist of healthy individuals from the university community who have&#xD;
          no contraindications for engaging in physical activity and have no difficulties in&#xD;
          understanding Spanish or Catalan.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals involved in the university community, including students and staff&#xD;
               members.&#xD;
  &#xD;
            -  No contraindication for participating in physical activity.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lack of a B2 proficiency level in either Catalan or Spanish language (as determined by&#xD;
               an official exam).&#xD;
  &#xD;
            -  Failure to provide informed consent to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guillem Jabardo Camprubí, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Health Science at Manresa</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guillem Jabardo Camprubí, PhD</last_name>
      <phone>691145828</phone>
      <email>gjabardo@umanresa.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pau Farrés Godayol, PhD</last_name>
      <email>pau.farres@uvic.cat</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Vic-Central University of Catalunya</name>
        <address>
          <city>Manresa</city>
          <state>Barcelona</state>
          <zip>08242</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Guillem Jabardo Camprubí, PhD</last_name>
        <phone>691145828</phone>
        <email>gjabardo@umanresa.cat</email>
      </contact>
      <contact_backup>
        <last_name>Pau Farrés Godayol, PhD</last_name>
        <email>pau.farres@uvic.cat</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Bruffaerts R, Mortier P, Kiekens G, Auerbach RP, Cuijpers P, Demyttenaere K, Green JG, Nock MK, Kessler RC. Mental health problems in college freshmen: Prevalence and academic functioning. J Affect Disord. 2018 Jan 1;225:97-103. doi: 10.1016/j.jad.2017.07.044. Epub 2017 Jul 25.</citation>
      <PMID>28802728</PMID>
    </reference>
    <reference>
      <citation>Smith PJ, Merwin RM. The Role of Exercise in Management of Mental Health Disorders: An Integrative Review. Annu Rev Med. 2021 Jan 27;72:45-62. doi: 10.1146/annurev-med-060619-022943. Epub 2020 Nov 30.</citation>
      <PMID>33256493</PMID>
    </reference>
    <reference>
      <citation>Schuch FB, Vancampfort D. Physical activity, exercise, and mental disorders: it is time to move on. Trends Psychiatry Psychother. 2021 Jul-Sep;43(3):177-184. doi: 10.47626/2237-6089-2021-0237. Epub 2021 Apr 21.</citation>
      <PMID>33890431</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mental health</keyword>
    <keyword>Physical activity</keyword>
    <keyword>Sedentary behavior</keyword>
    <keyword>Gender equity</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We plan to share the results of the study throughout posters, oral communications, webinars and publications in cientific journals</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Results will be share once a year</ipd_time_frame>
      <ipd_access_criteria>Through out posters, communications, webinars and publications</ipd_access_criteria>
    </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/NCT05963893
  org study id: 2023_14_PRI
  nct id: NCT05963893
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Mental health, understood as the individual or group well-being at an emotional,
        psychological, and/or social level, affects up to 35% of university students, of whom only
        16.4% seek or receive help from healthcare professionals. Despite this prevalence and its
        impact on academic performance and the challenges faced by universities in terms of limited
        resources to address this situation, most research tends to focus on primary and/or secondary
        education stages. Consequently, there is limited research on the reasons why university
        students experience mental health problems and why they do not seek help.
  
        Physical activity and reducing sedentary behaviour could be protective factors for mental
        health in both children and adolescents. In this regard, according to data from the DESK-Uni
        at UVic-UCC, university students report engaging in low levels of physical activity, with
        female students reporting lower levels than male students. Additionally, adolescent girls
        report more mental health problems than boys. Therefore, there is a need for research and
        projects that consider the gender bias in health that exists in our society, including
        universities. This bias could explain why girls engage in less physical activity or claim to
        do so and why they experience more mental health problems. Thus, the purpose of the project
        is to improve or reduce gender inequalities within the university community and their impact
        on health behaviour (physical activity/sedentary behaviour) and mental health of both
        students and staff members.
  
        Overall, the project aims to decrease the risks of experiencing mental health problems in the
        university environment by enhancing identification and promoting health-related behaviours
        that act as protective factors (e.g., physical activity). This will be done by considering
        the intersectionality of inequality axes present in our society and reproduced within the
        university setting. To do it, the Sustainable Development Goals (SDG; 3-4-5) will be taken in
        consideration.
  The university environment is not separate from society, which has experienced an increase in
        the prevalence of mental health problems following the COVID-19 pandemic. Similarly, the
        university environment is not immune to the gender biases of our society: in fact, the
        university itself could help perpetuate and reproduce these biases if not addressed.
        Therefore, it is necessary to investigate which social factors, such as gender construction,
        can influence aspects of health (mental health problems) and behaviour (engagement in
        physical activity or sedentary behaviour) within the university community.
  
        Generally, the data provided by the university community are self-reported, often estimating
        levels of physical activity. Consequently, these low levels of physical activity may be even
        higher. Therefore, it is necessary to explore physical activity levels and sedentary
        behaviour using accelerometers and qualitatively examine, from a gender perspective, the
        reasons, barriers, and facilitators that influence engagement in physical activity and the
        improvement of sedentary behaviour among the university community.
  
        On the other hand, while it is true that the UManresa university offers free psychological
        assistance to students (up to three visits per year), the understanding of mental health by
        the university community can affect the utilization of this service. For example, in a
        society that demands strength from "men," they may be more resistant to acknowledging their
        mental health problems, considering it a sign of weakness, and seeking help. Therefore,
        understanding how the university community perceives and interprets mental health is
        important: how it socially constructs the meaning of mental health problems and the role that
        gender plays in this construction.
  
        In the face of this situation, the following questions arise: Is there a correlation between
        levels of physical activity, sedentary behaviour, and the mental health status of the
        university community? What social and gender factors in the university environment can lead
        to lower levels of physical activity and more mental health problems? What actions can the
        university community take to improve the current situation regarding health behaviours and
        mental health of the university community? Additionally, considering that levels of physical
        activity are influenced by gender inequity and that mental health problems are partly
        influenced by physical activity and sedentary behaviour, it is necessary to study the
        relationship between mental health, health behaviours, and gender perspective.
  
        In fact, the report "Gender perspective in research at the University" (2017), coordinated by
        Tània Verge Mestre (Universitat Pompeu Fabra) and Teresa Cabruja Ubach (Universitat de
        Girona), found that the effective incorporation of a gender perspective in university
        teaching remained a pending challenge, despite the existing European regulatory framework.
        Therefore, social inequalities may continue to persist and reproduce within the university
        setting. In this sense, this project aims to incorporate a gender perspective to improve the
        quality of teaching and the social relevance of knowledge, technologies, and innovations
        (re)produced. Firstly, this perspective aims to improve mental health through levels of
        physical activity and sedentary behaviour in the university community, both of which are
        associated with gender biases. On the other hand, it aims to provide students with new tools
        to identify gender stereotypes, norms and roles to contribute to their critical thinking and
        acquire competencies that will enable them to avoid gender blindness in their future
        professional practice. Likewise, the gender perspective allows faculty and all university
        staff to pay attention to gender dynamics within the learning environment and take measures
        to ensure that the diversity of students is addressed, thereby impacting the mental health
        and potential health behaviours of the entire community.
  
        Furthermore, it is necessary to explore both physical activity and sedentary behaviour using
        accelerometers and how these levels are linked to mental health problems and social
        determinants that influence the adoption or non-adoption of a healthy lifestyle and the
        social construction of gender and mental illness. Secondly, it is important to
        collaboratively develop an action plan among all stakeholders at the university level to
        implement the research project's findings. Finally, the action plan should be implemented
        from a gender perspective to reduce sedentary behaviour, improve levels of physical activity,
        and consequently reduce mental health problems. The results should be evaluated annually
        throughout the entire trajectory of the students.
  
        The overall objective of the project is to co-create and implement an action plan at the
        university level from a gender perspective to improve levels of physical activity, reduce
        sedentary behaviour, and consequently decrease the risk of mental health problems among
        members of the university community.
  
        The specific objectives include:
  
          -  Explore the acceptability and feasibility of implementing an action plan at the
             university level among different stakeholders from a gender perspective.
  
          -  Determine the levels of physical activity and sedentary behaviour among the university
             community and their correlation with mental health problems.
  
          -  Explore the experiences and factors (i.e gender inequity) that may influence the
             engagement in physical activity and sedentary behaviour, as well as the perception of
             mental health, among the university community.
  
          -  Create a gender-inclusive guide for university teaching that addresses the needs for
             improving levels of physical activity, reducing sedentary behaviour, and addressing
             mental health problems within the university community.
  
        Each of the specific objectives will help confirm or refute the hypothesis posed. Broadly
        speaking, they can be categorized into two distinct types: those focusing on quantitative and
        biological outcomes (correlation between physical activity, sedentary behaviour, and mental
        health problems) and those interpreting, applying, or seeking to transfer the results through
        changes and actions in the daily life of the university community.
  
        The study follows a mixed-methods approach using a Cooperative Planning Process (CPP) model.
        The CPP is a participatory approach that helps create dynamic social spaces to improve change
        processes in healthcare and health promotion in a fair and equitable manner. Additionally,
        participatory interventions aim to increase the fit (adaptation) of programs within the
        real-life contexts of the individuals involved (university community). In this sense, the CPP
        has been frequently used in promoting physical activity over the past decades. The CPP is a
        participatory intervention strategy that brings together stakeholders involved in the change
        process through egalitarian decision-making to plan, develop, and implement programs that
        align with the demands and needs of the target population. Therefore, the CPP addresses
        essential principles for interventions such as the multi-dimensionality of interventions
        (socioecological perspective), context-specific interventions (action plan), and the
        reciprocal adjustment between science and clinical practice.
  
        To carry out the CPP, the project will be divided into different phases: i) Identification of
        the target population members and the needs of the stakeholders. ii) Development of an action
        plan to address the identified needs, including co-creation of the action plan for promoting
        physical activity, reducing sedentary behaviour, and raising awareness of mental health
        within the university community. iii) Establishing the feasibility and acceptability of the
        co-created action plan and adapting it based on the emerging needs through an initial
        application within the university community. iv) Implementation of the action plan through
        close collaboration with the target population and stakeholders. v) Evaluation of the success
        of the action plan and making necessary adaptations to ensure long-term sustainability.
  
        By following this approach, the study aims to actively involve the university community and
        stakeholders in the planning, development, and implementation of interventions, ultimately
        promoting sustainable changes in physical activity, sedentary behaviour, and mental health
        throughout a gender perspective.
  observational model: Cohort
  time perspective: Prospective
  measure: Change from Baseline Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS at 2 years
  time frame: Change from baseline at 2 years
  description: The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. At individual level 'minimum detectable change' has been calculated using different recommended methods giving results of 3 and 8 points. A change of 3 points means that scores on three items have improved or worsened by 1 point, or scores on one item have improved or worsened by 3 points. This suggests that the lower threshold of 3 points can be taken to represent 'meaningful change' between measurement points in individuals.
  measure: Physical Activity Levels
  time frame: Seven days a year during four years
  description: Levels of light, medium and vigorous physical activity weekly in minutes
  measure: Sedentary behavior time
  time frame: Seven days a year during four years
  description: Number of total time in minutes of sedentary behavior
  measure: Sedentary behavior breaks
  time frame: Seven days a year during four years
  description: Number of breaks (sit-to-stand transitions)
  measure: Sedentary behavior bouts
  time frame: Seven days a year during four years
  description: Duration of bouts in minutes (>30, 30-60, <60).
  intervention type: Behavioral
  intervention name: Uni4Move to sit less and move more
  description: Co-create and implement an action plan to move more and sit less in the university context
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Guillem Jabardo Camprubí, PhD
  role: Principal Investigator
  affiliation: Faculty of Health Science at Manresa
  last name: Guillem Jabardo Camprubí, PhD
  phone: 691145828
  email: gjabardo@umanresa.cat
  last name: Pau Farrés Godayol, PhD
  email: pau.farres@uvic.cat
  facility: 
  contact: 
  contact backup: 
  country: Spain
  citation: Bruffaerts R, Mortier P, Kiekens G, Auerbach RP, Cuijpers P, Demyttenaere K, Green JG, Nock MK, Kessler RC. Mental health problems in college freshmen: Prevalence and academic functioning. J Affect Disord. 2018 Jan 1;225:97-103. doi: 10.1016/j.jad.2017.07.044. Epub 2017 Jul 25.
  PMID: 28802728
  citation: Smith PJ, Merwin RM. The Role of Exercise in Management of Mental Health Disorders: An Integrative Review. Annu Rev Med. 2021 Jan 27;72:45-62. doi: 10.1146/annurev-med-060619-022943. Epub 2020 Nov 30.
  PMID: 33256493
  citation: Schuch FB, Vancampfort D. Physical activity, exercise, and mental disorders: it is time to move on. Trends Psychiatry Psychother. 2021 Jul-Sep;43(3):177-184. doi: 10.47626/2237-6089-2021-0237. Epub 2021 Apr 21.
  PMID: 33890431
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: We plan to share the results of the study throughout posters, oral communications, webinars and publications in cientific journals
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Results will be share once a year
  ipd access criteria: Through out posters, communications, webinars and publications