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/NCT05974826</url>
    </required_header>
    <id_info>
      <org_study_id>SHE-003-HC</org_study_id>
      <nct_id>NCT05974826</nct_id>
    </id_info>
    <brief_title>Healthy Communities: A Healthy City Preventive Program on Cardiovascular Health and Well-being (HC)</brief_title>
    <acronym>HC</acronym>
    <official_title>Impact of a Healthy City Preventive Program on Cardiovascular Health and Well-being: a Quasi-Experimental Controlled Longitudinal Community-Based Study (Healthy Communities 2030)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Foundation for Science, Health and Education, Spain</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>La Caixa Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital del Mar Research Institute (IMIM)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Foundation for Science, Health and Education, Spain</source>
    <oversight_info>
      <has_dmc>No</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>
        Healthy Communities is a multidisciplinary health-promotion initiative. The objective of the&#xD;
        present study is to determine whether such an intervention will be efficacious to improve&#xD;
        cardiovascular health compared to the current approach.&#xD;
  &#xD;
        A quasi-experimental controlled longitudinal community-based intervention study will be&#xD;
        carried out comprising approximately 2000 individuals from the age of 12 years from the&#xD;
        cities of Cardona (intervention city) and Sallent (control city), in Spain. The core of the&#xD;
        intervention will be based on the previous health promotion programs developed and evaluated&#xD;
        by the Science, Health and Education (SHE) Foundation: the SI! Program (Salud Integral&#xD;
        -Comprehensive Health) for children, and the Fifty-Fifty Program for adults. Coupled to&#xD;
        infrastructure development, we will promote the understanding of the benefits of active&#xD;
        living to increase awareness on the relevance of healthy lifestyle to improve health and&#xD;
        wellbeing in three consecutive phases (Phase 1- full supervised program; Phase 2- transition&#xD;
        period, and Phase 3- self-community driven program), which will provide full empowerment to&#xD;
        the community.&#xD;
  &#xD;
        The primary outcome will be measured with the validated composite Fuster-BEWAT (Blood&#xD;
        pressure, Exercise/physical activity, body Weight/BMI, Alimentation/diet, and&#xD;
        Tobbaco/smoking) score consisting of a 0-15 scale for behaviors/health risk factors.&#xD;
        Assessments will be performed at baseline, at 2.5 and 5 years. Follow-up assessments will be&#xD;
        conducted to determine the between group differences (intervention vs. control) in the change&#xD;
        of the Fuster-BEWAT score at phase 2 and phase 3.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Healthy Communities is a multidisciplinary health-promotion initiative aiming to improve the&#xD;
        health and wellbeing of individuals using an innovative combination of programs and urban&#xD;
        design to build up a &quot;culture of health&quot;. The main aim is to turn cities and towns into&#xD;
        places where individuals, families, and communities can increase their health and welfare&#xD;
        potential, and where working toward cardiovascular health and wellbeing is everyone's&#xD;
        business.&#xD;
  &#xD;
        The objective of the present study is to determine whether such an intervention will be&#xD;
        efficacious compared to the current approach.&#xD;
  &#xD;
        The hypothesize is that a healthy city will impact positively to their inhabitants by&#xD;
        improving cardiovascular health and physical activity indices, mental health, and wellbeing.&#xD;
        For such a purpose, a controlled longitudinal community-based intervention study will be&#xD;
        carried out on 2000 participants (1000 in the intervention and 1000 in the control towns) 12&#xD;
        years or older over a period of 5 years.&#xD;
  &#xD;
        The core of the intervention will be based on the previous health promotion programs&#xD;
        developed and evaluated by the Science, Health and Education (SHE) Foundation: the SI!&#xD;
        Program for children, and the &quot;Fifty-Fifty&quot; Program for adults. The effect of these&#xD;
        interventions was proven through randomized trials and the results were published in&#xD;
        high-impact journals (Journal of the American College of Cardiology, American Heart Journal,&#xD;
        American Journal of Medicine, etc.).&#xD;
  &#xD;
          -  The &quot;SI!&quot; Program is a school-based intervention aimed at promoting cardiovascular&#xD;
             Health among children aged 3 to 16 years using their proximal environment (school,&#xD;
             teachers, and families). The intervention is designed to instill and develop healthy&#xD;
             behaviors in relation to diet, physical activity, and emotions, all connected to&#xD;
             cardiovascular health.&#xD;
  &#xD;
          -  The &quot;Fifty-Fifty&quot; Program is a peer-group based intervention about topics related to&#xD;
             physical activity, nutrition, and psychological aspects of lifestyle change, which is&#xD;
             adapted to 3 different aged groups: &quot;Fifty-Action&quot; for young adults aged 17 to 24 years,&#xD;
             &quot;Fifty-Fifty&quot; for people aged 25 to 50 years and &quot;Fifty-Plus&quot; for people over 51 years&#xD;
             of age.&#xD;
  &#xD;
        Coupled to infrastructure development, we will promote the understanding of the benefits of&#xD;
        active living to increase awareness on the relevance of healthy lifestyle to improve health&#xD;
        and wellbeing in three consecutive phases, which will provide full empowerment to the&#xD;
        community.&#xD;
  &#xD;
        During the first phase, a full educational and behavioral change program with specific&#xD;
        actions and activities to engage and promote health and wellbeing in the community will be&#xD;
        implemented; while the second phase will be a transition period where the Cardona inhabitants&#xD;
        will progressively acquire a key role in such implementation under moderate supervision.&#xD;
        Finally, during phase 3, we expect that the community will become totally empowered to drive&#xD;
        their own health and wellbeing promotion program under minimal supervision. A&#xD;
        non-intervention town -Sallent, in the same area- will serve as control group.&#xD;
  &#xD;
        The primary outcome will be measured with the validated composite Fuster-BEWAT score&#xD;
        consisting of a 0-15 scale for behaviors/health risk factors related to Blood pressure,&#xD;
        Exercise, Weight, Alimentation (diet), and Tobacco (smoking). Assessments will be performed&#xD;
        at baseline, at 2.5 and 5 years. Follow-up assessments will be used to calculate the between&#xD;
        group differences (intervention vs. control) for the change in the Fuster-BEWAT score at&#xD;
        midpoint of phase 2 (after the full supervised program and during the transition period), and&#xD;
        at phase 3 (self-community driven program). Each study visit will include clinical interview,&#xD;
        physical examination (height, weight, waist circumference, blood pressure and heart rate),&#xD;
        point-of-care testing of lipid and glucose profile, lifestyle and behavior questionnaires,&#xD;
        assessment of physical activity, evaluation of muscle strength and muscle quality, and&#xD;
        assessment of psychosocial well-being. Trained health personnel will conduct all interviews&#xD;
        and measurements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">October 20, 2021</start_date>
    <completion_date type="Anticipated">December 2030</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes of the Fuster-BEWAT</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>The primary outcome will be the change from baseline in composite Fuster-BEWAT score consisting of a 0-15 scale for the following behaviors/health risk factors (higher scores correspond to healthier lifestyles): Blood pressure (systolic and diastolic blood pressure), Exercise (minutes of vigorous and moderate physical activity), Weight (body mass index calculated as body weight divided by height squared (kg/m2), Alimentation (diet) (fruits and vegetables consumption), and Tobacco (smoking) (smoking status and number of cigarettes) (0-3 points for each domain). Higher scores correspond to healthier lifestyle behaviors. The primary outcome is whether individuals belonging to a lifestyle intervention program (intervention group) demonstrate an improvement of health related behaviors and biological parameters compared to the self-management approach (control group).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes at follow-up visits of individual domains of the Fuster-BEWAT score</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean score and change at follow-up visits for each of the individual domains assimilated in the composite Fuster-BEWAT score (0-3 points for each domain, higher scores correspond to healthier lifestyles): Blood pressure (systolic and diastolic blood pressure), Exercise (minutes of vigorous and moderate physical activity), Weight (body mass index calculated as body weight divided by height squared (kg/m2)), Alimentation (diet) (fruits and vegetables consumption), and Tobacco (smoking) (smoking status and number of cigarettes). Higher scores correspond to higher compliance to lifestyle guidelines.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of blood pressure</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean and change in blood pressure (systolic and diastolic) (mmHg) as assessed with a fully automated blood pressure monitor (OMRON M6 monitor).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of physical activity</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean and change in physical activity as evaluated by self-reported the short version of the Minnesota Leisure Time Physical Activity Questionnaire (REGICOR). The questionnaire calculates energy expenditure from total physical activity, and from light, moderate and vigorous physical activity (minutes per week).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of body mass index</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean and change in body mass index (kg/m2). Body height as measured using a stadiometer (Seca 213). Body weight as measured using the OMRON BF511 electronic scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of Mediterranean diet adherence</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Change in the adherence to a Mediterranean diet as evaluated by a self-reported the Short Diet Quality Screener (SDQS) questionnaire. Score range=0-36 (higher scores correspond to highest healthy diet).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of smoking status</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean and change in smoking status as evaluated by self-reported the average number of cigarettes products consumed daily.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of blood glucose and lipid profile</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean total, LDL- and HDL-cholesterol (mg/dL), and blood glucose (mg/dL) and change at follow-up visits as evaluated by point-of-care testing. Blood glucose and lipid profile were measured using a CardioCheck Plus device and PTS-Panels test strips in capillary blood sampled with a lancet in fasting status.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of body fat composition</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean and change in body fat mass and body lean mass as measured by bioelectrical impedance.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of muscle strength</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Mean and change in muscle strength evaluated by the hand-grip test (kg)</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of psychosocial wellbeing</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Change in psychosocial wellbeing as evaluated by self-reported questionnaire about perceived happiness (Pemberton Happiness Index), Score range=0-10 (higher scores correspond to highest psychosocial wellbeing).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of perceived stress</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Change in perceived stress as evaluated by self-reported questionnaire Perceived Stress Scale (14-items PSS). Score range=0-56 (higher scores correspond to highest perceived stress).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of social support</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Change in social support as evaluated by self-reported questionnaire Spanish-translated ENRICHD Social Support Instrument. Score range=0-21 (higher scores correspond to highest social support).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of resilience</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Change in resilience as evaluated by self-reported questionnaire Spanish-adaptation of Brief Resilience Coping Scale. Score range=4-20 (higher scores correspond to highest resilience).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of self-esteem</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Change in self-esteem as evaluated by self-reported questionnaire Child Health and Illness Profile-Adolescent Edition (CHIP-AE). Score range=1-20 (higher scores correspond to highest self-esteem).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes at follow-up visits of mood</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Change in mood as evaluated by self-reported a Spanish questionnaire design by Vazquez-Fernandez ME et al 2013. Score range=0-6 (scoring ≥3 means mood is negative).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in the proportion of participants with any positive modifications in behavior</measure>
      <time_frame>baseline, 3 and 5 years</time_frame>
      <description>Changes in the proportion of participants with any positive modifications in behavior</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Heart Disease Risk Factors</condition>
    <condition>Healthy Lifestyle</condition>
    <condition>Health Behavior</condition>
    <arm_group>
      <arm_group_label>Community Intervention (town: Cardona)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The interventions aim to encourage a healthy lifestyle, including diet education, physical activity, and wellbeing.&#xD;
  The SI! Program for Secondary Schools: a four-year specially designed educational program for adolescents is applied.&#xD;
  The Fifty-Fifty Program implies two stages: 1) Training period; 2) a Peer-group intervention, designed to make the subjects participate actively in their healthcare</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Community Control (town: Sallent)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The participants on the control group only receive general health recommendation at the end of each assessment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>the SI! Program for Secondary Schools (NCT03504059)</intervention_name>
      <description>The SI! Program is implemented from 1st to 4th grade of Secondary Schools. A total of 12 hours of classroom intervention per academic year, organized through three educational units, and with active and participative methodologies, and complementary intervention in the family setting, at school and on teachers.</description>
      <arm_group_label>Community Intervention (town: Cardona)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>the Fifty-Fifty Program (NCT02367963)</intervention_name>
      <description>Training stage: the focus is on improving individual health, through workshops (given in person by experts), and on the challenges of changing habits supervised and supported by the SHE Foundation&#xD;
  Peer-to-peer support group sessions: It is designed to make the subjects participate actively in their healthcare. Along the sessions subjects propose assumable health goals. Participants will be able to view videos with key messages from the workshops to continue the sustainability of the changes made, and the development of new ones. Peer-to-peer support group sessions have two phases: a) leaders will receive support from the Foundation; b) participants will become agents of change with the people around them, and also in their municipality with specific actions to promote health. The role of Foundation's will only be to monitor and resolve possible doubts.</description>
      <arm_group_label>Community Intervention (town: Cardona)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age greater than or equal to 12 years&#xD;
  &#xD;
            -  Registered in the local census of the selected towns (Cardona or Sallent)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 12 years&#xD;
  &#xD;
            -  Residency out of the selected towns (Cardona or Sallent)&#xD;
  &#xD;
            -  Unable/unwilling to provide informed consent&#xD;
  &#xD;
            -  Severe diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>In order to try to equate groups in a quasi-experimental design, a normative age range- and sex- group equivalence matching approach will be used to select a comparison group that has approximately equivalent characteristics to the treatment group&#xD;
  The recruitment will be stratified by sex and age-groups and a minimum of 75 and a maximum of 100 individuals in each strata will be recruited.</gender_description>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Valentín Fuster</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mount Sinaí Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Foundation for Science, Health and Education</name>
        <address>
          <city>Madrid</city>
          <zip>28001</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <link>
      <url>https://fundacionshe.org/</url>
      <description>Web of the SHE Foundation</description>
    </link>
    <link>
      <url>https://fundacionshe.org/healthycommunities2030/</url>
      <description>web of the Healthy Communities Program</description>
    </link>
    <reference>
      <citation>Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.</citation>
      <PMID>31277052</PMID>
    </reference>
    <reference>
      <citation>Fernandez-Alvira JM, Fuster V, Pocock S, Sanz J, Fernandez-Friera L, Laclaustra M, Fernandez-Jimenez R, Mendiguren J, Fernandez-Ortiz A, Ibanez B, Bueno H. Predicting Subclinical Atherosclerosis in Low-Risk Individuals: Ideal Cardiovascular Health Score and Fuster-BEWAT Score. J Am Coll Cardiol. 2017 Nov 14;70(20):2463-2473. doi: 10.1016/j.jacc.2017.09.032.</citation>
      <PMID>29145946</PMID>
    </reference>
    <reference>
      <citation>Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9. Erratum In: J Am Coll Cardiol. 2016 Mar 22;67(11):1385.</citation>
      <PMID>26562047</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Healthy Lifestyle</keyword>
    <keyword>Community health promotion</keyword>
    <keyword>Peer-group</keyword>
    <keyword>School-based intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator.</ipd_description>
      <ipd_time_frame>Starting 9 months after publication</ipd_time_frame>
      <ipd_access_criteria>the de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator.&#xD;
  Email: estudio@fundacionshe.org</ipd_access_criteria>
      <ipd_url>https://fundacionshe.org/healthycommunities2030/</ipd_url>
    </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/NCT05974826
  org study id: SHE-003-HC
  nct id: NCT05974826
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Healthy Communities is a multidisciplinary health-promotion initiative. The objective of the
        present study is to determine whether such an intervention will be efficacious to improve
        cardiovascular health compared to the current approach.
  
        A quasi-experimental controlled longitudinal community-based intervention study will be
        carried out comprising approximately 2000 individuals from the age of 12 years from the
        cities of Cardona (intervention city) and Sallent (control city), in Spain. The core of the
        intervention will be based on the previous health promotion programs developed and evaluated
        by the Science, Health and Education (SHE) Foundation: the SI! Program (Salud Integral
        -Comprehensive Health) for children, and the Fifty-Fifty Program for adults. Coupled to
        infrastructure development, we will promote the understanding of the benefits of active
        living to increase awareness on the relevance of healthy lifestyle to improve health and
        wellbeing in three consecutive phases (Phase 1- full supervised program; Phase 2- transition
        period, and Phase 3- self-community driven program), which will provide full empowerment to
        the community.
  
        The primary outcome will be measured with the validated composite Fuster-BEWAT (Blood
        pressure, Exercise/physical activity, body Weight/BMI, Alimentation/diet, and
        Tobbaco/smoking) score consisting of a 0-15 scale for behaviors/health risk factors.
        Assessments will be performed at baseline, at 2.5 and 5 years. Follow-up assessments will be
        conducted to determine the between group differences (intervention vs. control) in the change
        of the Fuster-BEWAT score at phase 2 and phase 3.
  Healthy Communities is a multidisciplinary health-promotion initiative aiming to improve the
        health and wellbeing of individuals using an innovative combination of programs and urban
        design to build up a "culture of health". The main aim is to turn cities and towns into
        places where individuals, families, and communities can increase their health and welfare
        potential, and where working toward cardiovascular health and wellbeing is everyone's
        business.
  
        The objective of the present study is to determine whether such an intervention will be
        efficacious compared to the current approach.
  
        The hypothesize is that a healthy city will impact positively to their inhabitants by
        improving cardiovascular health and physical activity indices, mental health, and wellbeing.
        For such a purpose, a controlled longitudinal community-based intervention study will be
        carried out on 2000 participants (1000 in the intervention and 1000 in the control towns) 12
        years or older over a period of 5 years.
  
        The core of the intervention will be based on the previous health promotion programs
        developed and evaluated by the Science, Health and Education (SHE) Foundation: the SI!
        Program for children, and the "Fifty-Fifty" Program for adults. The effect of these
        interventions was proven through randomized trials and the results were published in
        high-impact journals (Journal of the American College of Cardiology, American Heart Journal,
        American Journal of Medicine, etc.).
  
          -  The "SI!" Program is a school-based intervention aimed at promoting cardiovascular
             Health among children aged 3 to 16 years using their proximal environment (school,
             teachers, and families). The intervention is designed to instill and develop healthy
             behaviors in relation to diet, physical activity, and emotions, all connected to
             cardiovascular health.
  
          -  The "Fifty-Fifty" Program is a peer-group based intervention about topics related to
             physical activity, nutrition, and psychological aspects of lifestyle change, which is
             adapted to 3 different aged groups: "Fifty-Action" for young adults aged 17 to 24 years,
             "Fifty-Fifty" for people aged 25 to 50 years and "Fifty-Plus" for people over 51 years
             of age.
  
        Coupled to infrastructure development, we will promote the understanding of the benefits of
        active living to increase awareness on the relevance of healthy lifestyle to improve health
        and wellbeing in three consecutive phases, which will provide full empowerment to the
        community.
  
        During the first phase, a full educational and behavioral change program with specific
        actions and activities to engage and promote health and wellbeing in the community will be
        implemented; while the second phase will be a transition period where the Cardona inhabitants
        will progressively acquire a key role in such implementation under moderate supervision.
        Finally, during phase 3, we expect that the community will become totally empowered to drive
        their own health and wellbeing promotion program under minimal supervision. A
        non-intervention town -Sallent, in the same area- will serve as control group.
  
        The primary outcome will be measured with the validated composite Fuster-BEWAT score
        consisting of a 0-15 scale for behaviors/health risk factors related to Blood pressure,
        Exercise, Weight, Alimentation (diet), and Tobacco (smoking). Assessments will be performed
        at baseline, at 2.5 and 5 years. Follow-up assessments will be used to calculate the between
        group differences (intervention vs. control) for the change in the Fuster-BEWAT score at
        midpoint of phase 2 (after the full supervised program and during the transition period), and
        at phase 3 (self-community driven program). Each study visit will include clinical interview,
        physical examination (height, weight, waist circumference, blood pressure and heart rate),
        point-of-care testing of lipid and glucose profile, lifestyle and behavior questionnaires,
        assessment of physical activity, evaluation of muscle strength and muscle quality, and
        assessment of psychosocial well-being. Trained health personnel will conduct all interviews
        and measurements.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Changes of the Fuster-BEWAT
  time frame: baseline, 3 and 5 years
  description: The primary outcome will be the change from baseline in composite Fuster-BEWAT score consisting of a 0-15 scale for the following behaviors/health risk factors (higher scores correspond to healthier lifestyles): Blood pressure (systolic and diastolic blood pressure), Exercise (minutes of vigorous and moderate physical activity), Weight (body mass index calculated as body weight divided by height squared (kg/m2), Alimentation (diet) (fruits and vegetables consumption), and Tobacco (smoking) (smoking status and number of cigarettes) (0-3 points for each domain). Higher scores correspond to healthier lifestyle behaviors. The primary outcome is whether individuals belonging to a lifestyle intervention program (intervention group) demonstrate an improvement of health related behaviors and biological parameters compared to the self-management approach (control group).
  measure: Changes at follow-up visits of individual domains of the Fuster-BEWAT score
  time frame: baseline, 3 and 5 years
  description: Mean score and change at follow-up visits for each of the individual domains assimilated in the composite Fuster-BEWAT score (0-3 points for each domain, higher scores correspond to healthier lifestyles): Blood pressure (systolic and diastolic blood pressure), Exercise (minutes of vigorous and moderate physical activity), Weight (body mass index calculated as body weight divided by height squared (kg/m2)), Alimentation (diet) (fruits and vegetables consumption), and Tobacco (smoking) (smoking status and number of cigarettes). Higher scores correspond to higher compliance to lifestyle guidelines.
  measure: Changes at follow-up visits of blood pressure
  time frame: baseline, 3 and 5 years
  description: Mean and change in blood pressure (systolic and diastolic) (mmHg) as assessed with a fully automated blood pressure monitor (OMRON M6 monitor).
  measure: Changes at follow-up visits of physical activity
  time frame: baseline, 3 and 5 years
  description: Mean and change in physical activity as evaluated by self-reported the short version of the Minnesota Leisure Time Physical Activity Questionnaire (REGICOR). The questionnaire calculates energy expenditure from total physical activity, and from light, moderate and vigorous physical activity (minutes per week).
  measure: Changes at follow-up visits of body mass index
  time frame: baseline, 3 and 5 years
  description: Mean and change in body mass index (kg/m2). Body height as measured using a stadiometer (Seca 213). Body weight as measured using the OMRON BF511 electronic scale.
  measure: Changes at follow-up visits of Mediterranean diet adherence
  time frame: baseline, 3 and 5 years
  description: Change in the adherence to a Mediterranean diet as evaluated by a self-reported the Short Diet Quality Screener (SDQS) questionnaire. Score range=0-36 (higher scores correspond to highest healthy diet).
  measure: Changes at follow-up visits of smoking status
  time frame: baseline, 3 and 5 years
  description: Mean and change in smoking status as evaluated by self-reported the average number of cigarettes products consumed daily.
  measure: Changes at follow-up visits of blood glucose and lipid profile
  time frame: baseline, 3 and 5 years
  description: Mean total, LDL- and HDL-cholesterol (mg/dL), and blood glucose (mg/dL) and change at follow-up visits as evaluated by point-of-care testing. Blood glucose and lipid profile were measured using a CardioCheck Plus device and PTS-Panels test strips in capillary blood sampled with a lancet in fasting status.
  measure: Changes at follow-up visits of body fat composition
  time frame: baseline, 3 and 5 years
  description: Mean and change in body fat mass and body lean mass as measured by bioelectrical impedance.
  measure: Changes at follow-up visits of muscle strength
  time frame: baseline, 3 and 5 years
  description: Mean and change in muscle strength evaluated by the hand-grip test (kg)
  measure: Changes at follow-up visits of psychosocial wellbeing
  time frame: baseline, 3 and 5 years
  description: Change in psychosocial wellbeing as evaluated by self-reported questionnaire about perceived happiness (Pemberton Happiness Index), Score range=0-10 (higher scores correspond to highest psychosocial wellbeing).
  measure: Changes at follow-up visits of perceived stress
  time frame: baseline, 3 and 5 years
  description: Change in perceived stress as evaluated by self-reported questionnaire Perceived Stress Scale (14-items PSS). Score range=0-56 (higher scores correspond to highest perceived stress).
  measure: Changes at follow-up visits of social support
  time frame: baseline, 3 and 5 years
  description: Change in social support as evaluated by self-reported questionnaire Spanish-translated ENRICHD Social Support Instrument. Score range=0-21 (higher scores correspond to highest social support).
  measure: Changes at follow-up visits of resilience
  time frame: baseline, 3 and 5 years
  description: Change in resilience as evaluated by self-reported questionnaire Spanish-adaptation of Brief Resilience Coping Scale. Score range=4-20 (higher scores correspond to highest resilience).
  measure: Changes at follow-up visits of self-esteem
  time frame: baseline, 3 and 5 years
  description: Change in self-esteem as evaluated by self-reported questionnaire Child Health and Illness Profile-Adolescent Edition (CHIP-AE). Score range=1-20 (higher scores correspond to highest self-esteem).
  measure: Changes at follow-up visits of mood
  time frame: baseline, 3 and 5 years
  description: Change in mood as evaluated by self-reported a Spanish questionnaire design by Vazquez-Fernandez ME et al 2013. Score range=0-6 (scoring ≥3 means mood is negative).
  measure: Changes in the proportion of participants with any positive modifications in behavior
  time frame: baseline, 3 and 5 years
  description: Changes in the proportion of participants with any positive modifications in behavior
  arm group label: Community Intervention (town: Cardona)
  arm group type: Experimental
  description: The interventions aim to encourage a healthy lifestyle, including diet education, physical activity, and wellbeing.
  The SI! Program for Secondary Schools: a four-year specially designed educational program for adolescents is applied.
  The Fifty-Fifty Program implies two stages: 1) Training period; 2) a Peer-group intervention, designed to make the subjects participate actively in their healthcare
  arm group label: Community Control (town: Sallent)
  arm group type: No Intervention
  description: The participants on the control group only receive general health recommendation at the end of each assessment.
  intervention type: Behavioral
  intervention name: the SI! Program for Secondary Schools (NCT03504059)
  description: The SI! Program is implemented from 1st to 4th grade of Secondary Schools. A total of 12 hours of classroom intervention per academic year, organized through three educational units, and with active and participative methodologies, and complementary intervention in the family setting, at school and on teachers.
  arm group label: Community Intervention (town: Cardona)
  intervention type: Behavioral
  intervention name: the Fifty-Fifty Program (NCT02367963)
  description: Training stage: the focus is on improving individual health, through workshops (given in person by experts), and on the challenges of changing habits supervised and supported by the SHE Foundation
  Peer-to-peer support group sessions: It is designed to make the subjects participate actively in their healthcare. Along the sessions subjects propose assumable health goals. Participants will be able to view videos with key messages from the workshops to continue the sustainability of the changes made, and the development of new ones. Peer-to-peer support group sessions have two phases: a) leaders will receive support from the Foundation; b) participants will become agents of change with the people around them, and also in their municipality with specific actions to promote health. The role of Foundation's will only be to monitor and resolve possible doubts.
  arm group label: Community Intervention (town: Cardona)
  criteria: 
  gender: All
  gender based: Yes
  gender description: In order to try to equate groups in a quasi-experimental design, a normative age range- and sex- group equivalence matching approach will be used to select a comparison group that has approximately equivalent characteristics to the treatment group
  The recruitment will be stratified by sex and age-groups and a minimum of 75 and a maximum of 100 individuals in each strata will be recruited.
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Valentín Fuster
  role: Principal Investigator
  affiliation: Mount Sinaí Hospital
  facility: 
  country: Spain
  url: https://fundacionshe.org/
  description: Web of the SHE Foundation
  url: https://fundacionshe.org/healthycommunities2030/
  description: web of the Healthy Communities Program
  citation: Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.
  PMID: 31277052
  citation: Fernandez-Alvira JM, Fuster V, Pocock S, Sanz J, Fernandez-Friera L, Laclaustra M, Fernandez-Jimenez R, Mendiguren J, Fernandez-Ortiz A, Ibanez B, Bueno H. Predicting Subclinical Atherosclerosis in Low-Risk Individuals: Ideal Cardiovascular Health Score and Fuster-BEWAT Score. J Am Coll Cardiol. 2017 Nov 14;70(20):2463-2473. doi: 10.1016/j.jacc.2017.09.032.
  PMID: 29145946
  citation: Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9. Erratum In: J Am Coll Cardiol. 2016 Mar 22;67(11):1385.
  PMID: 26562047
  responsible party type: Sponsor
  mesh term: Heart Diseases
  sharing ipd: Yes
  ipd description: The de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator.
  ipd time frame: Starting 9 months after publication
  ipd access criteria: the de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator.
  Email: estudio@fundacionshe.org
  ipd url: https://fundacionshe.org/healthycommunities2030/