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/NCT05966051</url>
    </required_header>
    <id_info>
      <org_study_id>IRFMN-8979</org_study_id>
      <secondary_id>F13C22001210007</secondary_id>
      <nct_id>NCT05966051</nct_id>
    </id_info>
    <brief_title>MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood</brief_title>
    <acronym>LIVELY</acronym>
    <official_title>MuLtidimensional School-based and Family Involved interVentions, to Promote a hEalthy and Sustainable LifestYle for the Childhood Obesity Primary Prevention: the LIVELY Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mario Negri Institute for Pharmacological Research</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pavia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mario Negri Institute for Pharmacological Research</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>
        Childhood obesity condition has increased 10 times in the last 40 years, representing one of&#xD;
        the most important public health challenges of our century.&#xD;
  &#xD;
        The overweight and obesity in children are conditions associated with several determinants,&#xD;
        mostly related to dietary habits, physical activity, and environmental behavior.&#xD;
  &#xD;
        To counteract childhood obesity, several prevention programs have been promoted, however&#xD;
        evidence concerning their efficacy was contrasting, especially among the younger population&#xD;
        and in the long term.&#xD;
  &#xD;
        Moreover, due to the wide variety of interventions administered it is not clear which&#xD;
        specific strategy (or combinations of strategies) was the most effective.&#xD;
  &#xD;
        The LIVELY study aims 1) to assess the prevalence and the factors associated to childhood&#xD;
        overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood&#xD;
        obesity by involving families and recognizing the role of schools as an environment for&#xD;
        raising awareness on healthy and sustainable dietary patterns and lifestyle.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        LIVELY is a study with a one group pre-test - post-test design (without control). The study&#xD;
        will be conducted in the primary schools of the Istituto Luigi Cadorna in Milano (Lombardy&#xD;
        Region, Northern Italy). The study population will involve children (6-11 years) belonging to&#xD;
        different socioeconomic status and ethnic groups, attending classes of the school whose&#xD;
        teachers will accept to participate.&#xD;
  &#xD;
        The educational interventions will consist in:&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Investigate prevalence of childhood overweight and/or obesity</measure>
      <time_frame>Baseline</time_frame>
      <description>Weight and height will be combined to report BMI in kg/m^2</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Investigation on adherence to Mediterranian diet</measure>
      <time_frame>Baseline</time_frame>
      <description>Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the consumption of ultra-processed food by children</measure>
      <time_frame>Baseline</time_frame>
      <description>NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Investigation of family lifestyles</measure>
      <time_frame>Baseline</time_frame>
      <description>Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Feasibility of multidimensional school-based educational interventions</measure>
      <time_frame>6 months</time_frame>
      <description>Perception of usefulness of the interventions: appreciation questionnaires to investigate the satisfaction of the implemented activities; organization of the interventions and usefulness of the educational interventions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Investigation of changes in adherence to Mediterranian diet</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <description>Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of changes of the consumption of ultra-processed food by children</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <description>NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Investigation of changes of family lifestyles</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <description>Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Childhood Obesity</condition>
    <arm_group>
      <arm_group_label>Children attending primary school</arm_group_label>
      <description>In this study will be included children 6-11 years and their families, whose parents will provide written consent to participate,</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Educational interventions</intervention_name>
      <description>The educational interventions will consist in:</description>
      <arm_group_label>Children attending primary school</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will involve children 6-11 years old, attending the primary school&#xD;
          Istituto Luigi Cadorna in Milano (Lombardy Region -Northern Italy) and their families.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  children 6-11 years&#xD;
  &#xD;
            -  children whose parents will provide written consent to participate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children who do not have inclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Carlotta Franchi, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mario Negri Institute for Pharmacological Research</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Marta Baviera, PharmDr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mario Negri Institute for Pharmacological Research</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Maria Vittoria Conti, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pavia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carlotta Franchi, PhD</last_name>
      <phone>+39 0239014</phone>
      <phone_ext>580</phone_ext>
      <email>carlotta.franchi@marionegri.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marta Baviera, PharmDr</last_name>
      <phone>+39 023901 4</phone>
      <phone_ext>633</phone_ext>
      <email>marta.baviera@marionegri.it</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Childhood Obesity Prevention</keyword>
    <keyword>Childhood Obesity determinants</keyword>
    <keyword>Educational Interventions</keyword>
    <keyword>Primary schools</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05966051
  org study id: IRFMN-8979
  secondary id: F13C22001210007
  nct id: NCT05966051
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Childhood obesity condition has increased 10 times in the last 40 years, representing one of
        the most important public health challenges of our century.
  
        The overweight and obesity in children are conditions associated with several determinants,
        mostly related to dietary habits, physical activity, and environmental behavior.
  
        To counteract childhood obesity, several prevention programs have been promoted, however
        evidence concerning their efficacy was contrasting, especially among the younger population
        and in the long term.
  
        Moreover, due to the wide variety of interventions administered it is not clear which
        specific strategy (or combinations of strategies) was the most effective.
  
        The LIVELY study aims 1) to assess the prevalence and the factors associated to childhood
        overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood
        obesity by involving families and recognizing the role of schools as an environment for
        raising awareness on healthy and sustainable dietary patterns and lifestyle.
  LIVELY is a study with a one group pre-test - post-test design (without control). The study
        will be conducted in the primary schools of the Istituto Luigi Cadorna in Milano (Lombardy
        Region, Northern Italy). The study population will involve children (6-11 years) belonging to
        different socioeconomic status and ethnic groups, attending classes of the school whose
        teachers will accept to participate.
  
        The educational interventions will consist in:
  observational model: Cohort
  time perspective: Prospective
  measure: Investigate prevalence of childhood overweight and/or obesity
  time frame: Baseline
  description: Weight and height will be combined to report BMI in kg/m^2
  measure: Investigation on adherence to Mediterranian diet
  time frame: Baseline
  description: Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.
  measure: Assessment of the consumption of ultra-processed food by children
  time frame: Baseline
  description: NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)
  measure: Investigation of family lifestyles
  time frame: Baseline
  description: Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.
  measure: Feasibility of multidimensional school-based educational interventions
  time frame: 6 months
  description: Perception of usefulness of the interventions: appreciation questionnaires to investigate the satisfaction of the implemented activities; organization of the interventions and usefulness of the educational interventions
  measure: Investigation of changes in adherence to Mediterranian diet
  time frame: Baseline, 6 and 12 months
  description: Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.
  measure: Assessment of changes of the consumption of ultra-processed food by children
  time frame: Baseline, 6 and 12 months
  description: NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)
  measure: Investigation of changes of family lifestyles
  time frame: Baseline, 6 and 12 months
  description: Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.
  arm group label: Children attending primary school
  description: In this study will be included children 6-11 years and their families, whose parents will provide written consent to participate,
  intervention type: Behavioral
  intervention name: Educational interventions
  description: The educational interventions will consist in:
  arm group label: Children attending primary school
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 11 Years
  last name: Carlotta Franchi, PhD
  role: Principal Investigator
  affiliation: Mario Negri Institute for Pharmacological Research
  last name: Marta Baviera, PharmDr
  role: Principal Investigator
  affiliation: Mario Negri Institute for Pharmacological Research
  last name: Maria Vittoria Conti, MSc
  role: Principal Investigator
  affiliation: University of Pavia
  last name: Carlotta Franchi, PhD
  phone: +39 0239014
  phone ext: 580
  email: carlotta.franchi@marionegri.it
  last name: Marta Baviera, PharmDr
  phone: +39 023901 4
  phone ext: 633
  email: marta.baviera@marionegri.it
  responsible party type: Sponsor
  mesh term: Obesity
  mesh term: Pediatric Obesity
  sharing ipd: Undecided