<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/NCT01688453</url>
  </required_header>
  <id_info>
    <org_study_id>C11-46</org_study_id>
    <nct_id>NCT01688453</nct_id>
  </id_info>
  <brief_title>Overweight Management and Social Inequalities</brief_title>
  <acronym>PRALIMAP-INES</acronym>
  <official_title>Reduction of Inequalities in Overweight and Obesity Management Care Access Among High School Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The prevalence of overweight and obesity continues to increase in socially less&#xD;
      advantaged populations but is stabilizing even is decreasing in socially more advantaged&#xD;
      populations. The PRALIMAP trial highlighted the effectiveness of structured screening and&#xD;
      care management in decreasing the prevalence of overweight and obesity in high school&#xD;
      adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened&#xD;
      care management (CM) for socially less advantaged adolescents in school in the short and long&#xD;
      term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and&#xD;
      obesity among socially advantaged adolescents.&#xD;
&#xD;
      Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight&#xD;
      and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35&#xD;
      state-run schools of the Vosges department (northeastern France) for the academic years&#xD;
      2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as&#xD;
      advantaged are allocated to the standard-CM and those less advantaged are randomized to&#xD;
      standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr&#xD;
      each performed in high school and supervised by a healthcare mobile team specialised in&#xD;
      overweight and obesity care management for adolescents. The strengthened-CM consists of 5&#xD;
      collective sessions with the same standard operating procedure as the standard-CM with&#xD;
      supplementary interventions between each session: strengthened solicitation with the&#xD;
      adolescent and the family, peer-led educational sessions, motivational interviews, financial&#xD;
      support for physical activity practice, cooking classes and multidisciplinary consultation&#xD;
      meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are&#xD;
      collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end&#xD;
      of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after&#xD;
      the intervention=T2). Process evaluation data are also collected during the trial.&#xD;
&#xD;
      Expected results: To confirm the effectiveness of overweight CM for adolescents in a school&#xD;
      setting and to highlight or not the effectiveness of specific strengthened interventions&#xD;
      adapted for socially less advantaged adolescents to maintain social equality in access to&#xD;
      overweight care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The prevalence of overweight and obesity continues to increase in socially less&#xD;
      advantaged populations but is stabilizing even is decreasing in socially more advantaged&#xD;
      populations. The PRALIMAP trial confirmed major social inequalities in overweight and obesity&#xD;
      frequency in adolescents in grade 10. The trial highlighted the effectiveness of structured&#xD;
      screening and care management in decreasing the prevalence of overweight and obesity in high&#xD;
      school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a&#xD;
      strengthened care management strategy for socially less advantaged adolescents in school in&#xD;
      the short and long term (just after the intervention and 1 year later) has an equivalent&#xD;
      effect as a standard-care management strategy on decreasing the prevalence of overweight and&#xD;
      obesity among socially advantaged adolescents.&#xD;
&#xD;
      Hypothesis: A strengthened overweight and obesity care management strategy for overweight and&#xD;
      obesity (risk factors of cancer) can improve care access for socially less advantaged&#xD;
      adolescents and maintain social equality in terms of overweight and obesity prevalence.&#xD;
&#xD;
      Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial (one randomised part&#xD;
      and one non-randomised part) of 1,250 overweight and obese adolescents aged 13 to 18 years&#xD;
      who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department&#xD;
      (northeastern France) for the academic years 2012-2013, 2013-2014 and 2014-2015. After a&#xD;
      session to detect overweight and obese adolescents, the social status of included adolescents&#xD;
      as &quot;advantaged&quot; or &quot;less advantaged&quot; is determined. Adolescents classified as advantaged are&#xD;
      allocated to the standard-care management and those less advantaged are randomized to&#xD;
      standard-care management or strengthened-care management. The standard-care management&#xD;
      consists of 5 collective sessions of 2 hr each performed in high school and supervised by a&#xD;
      healthcare mobile team specialised in overweight and obesity care management for adolescents.&#xD;
      The team consists of physicians, dietitians, psychologists and sports educators from the AVRS&#xD;
      Association. The content of sessions was validated in the PRALIMAP trial. The&#xD;
      strengthened-care management consists of 5 collective sessions with the same standard&#xD;
      operating procedure as the standard-care management with supplementary interventions between&#xD;
      each session: strengthened solicitation with the adolescent and the family, peer-led&#xD;
      educational sessions, motivational interviews, financial support for physical activity&#xD;
      practice, cooking classes and multidisciplinary consultation meetings (adjusting the care&#xD;
      management according to the social status). Data on sociodemographics, anthropometrics,&#xD;
      physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10&#xD;
      (before the intervention = T0), at the end of grade 9 or 10 (at the end of the intervention =&#xD;
      T1) and at the end of grade 10 or 11 (1 year after the intervention = T2). T1 measurement&#xD;
      allows for evaluating the short-term effect of the intervention and T2, the long-term effect&#xD;
      of a 1-year break from the intervention. Data on participation and from questionnaires, as&#xD;
      well as focus group and activity reports, necessary for evaluation, are collected during the&#xD;
      trial.&#xD;
&#xD;
      Expected results: With this trial, the investigators expect to confirm the effectiveness of&#xD;
      overweight and obesity care management for adolescents in a school setting and to highlight&#xD;
      or not the effectiveness of specific strengthened interventions adapted for socially less&#xD;
      advantaged adolescents to maintain social equality in access to overweight and obesity care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Mass Index from to baseline to 1 and 2 years</measure>
    <time_frame>0-1-2 years</time_frame>
    <description>BMI is measured at baseline(on grade 10 entry) and after 1 and 2 follow up years(at the end of grades 10 and 11).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in overweight and obesity status according to IOTF norms</measure>
    <time_frame>up to 2 years</time_frame>
    <description>overweight and obesity status is calculated from BMI at each measurement time according to the IOTF norms for age and sex</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in BMI Z score from baseline to one and two years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>BMI Z score is calculated from BMI at each time measurement using WHO reference and SAS macro</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>2 years</time_frame>
    <description>waist circumference is measured two times at each measurement point by trained nurses and validated by a practitioner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in eating attitude score from baseline to 1 and 2 years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Eating attitudes are measured at each measurement point using then EAT40 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety and depression scores from baseline to 1 and 2 years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>HAD questionnaire is used to measure score at each follow-up point</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Nutritional behavior from baseline to 1 and 2 years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Nutritional behavior is measured through self administered questionnaires which allow to assess the compliance to French national recommendations</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1689</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Group 1:</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Socially advantaged overweight or obese adolescents are allocated to the standard care management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Socially less advantaged overweight or obese adolescents are allocated to the standard care management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Socially less advantaged overweight or obese adolescents are allocated to the strengthened care management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard care management</intervention_name>
    <description>The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.</description>
    <arm_group_label>Group 1:</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The strengthened care management</intervention_name>
    <description>The strengthened care management is the addition of the standard care management and of additional interventions.&#xD;
The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.&#xD;
The additional interventions are strengthened solicitation and accompaniment, peer-led education, motivational interview, financial support for physical activity practice, cooking classes and meetings of multidisciplinary consultation.</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Attending grade 9 or 10 in one of the 35 state-run school of the Vosges department and&#xD;
             be in a general, technological or vocational course,&#xD;
&#xD;
          -  Aged ≤ 18 years old,&#xD;
&#xD;
          -  not giving written refusal to participate in the trial,&#xD;
&#xD;
          -  able to complete a questionnaire,&#xD;
&#xD;
          -  overweight or obese according to the IOTF criteria (for BMI) and the McCarthy criteria&#xD;
             (for waist circumference) and/or have a high eating disorder score, and/or express the&#xD;
             need for management of excess weight,&#xD;
&#xD;
          -  confirmed as corresponding to the 4 previous inclusion criteria by the physician, with&#xD;
             elimination of adolescents with false-positive BMI (particularly athletic&#xD;
             adolescents),&#xD;
&#xD;
          -  agree to an overweight and obesity care management program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serge Briançon, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lorraine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School</name>
      <address>
        <city>Vosges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>overweight/obesity</keyword>
  <keyword>adolescence</keyword>
  <keyword>care management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688453
org study id: C11-46
nct id: NCT01688453
lead sponsor: 
has dmc: Yes
Background: The prevalence of overweight and obesity continues to increase in socially less
      advantaged populations but is stabilizing even is decreasing in socially more advantaged
      populations. The PRALIMAP trial highlighted the effectiveness of structured screening and
      care management in decreasing the prevalence of overweight and obesity in high school
      adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened
      care management (CM) for socially less advantaged adolescents in school in the short and long
      term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and
      obesity among socially advantaged adolescents.

      Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight
      and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35
      state-run schools of the Vosges department (northeastern France) for the academic years
      2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as
      advantaged are allocated to the standard-CM and those less advantaged are randomized to
      standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr
      each performed in high school and supervised by a healthcare mobile team specialised in
      overweight and obesity care management for adolescents. The strengthened-CM consists of 5
      collective sessions with the same standard operating procedure as the standard-CM with
      supplementary interventions between each session: strengthened solicitation with the
      adolescent and the family, peer-led educational sessions, motivational interviews, financial
      support for physical activity practice, cooking classes and multidisciplinary consultation
      meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are
      collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end
      of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after
      the intervention=T2). Process evaluation data are also collected during the trial.

      Expected results: To confirm the effectiveness of overweight CM for adolescents in a school
      setting and to highlight or not the effectiveness of specific strengthened interventions
      adapted for socially less advantaged adolescents to maintain social equality in access to
      overweight care.
Background: The prevalence of overweight and obesity continues to increase in socially less
      advantaged populations but is stabilizing even is decreasing in socially more advantaged
      populations. The PRALIMAP trial confirmed major social inequalities in overweight and obesity
      frequency in adolescents in grade 10. The trial highlighted the effectiveness of structured
      screening and care management in decreasing the prevalence of overweight and obesity in high
      school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a
      strengthened care management strategy for socially less advantaged adolescents in school in
      the short and long term (just after the intervention and 1 year later) has an equivalent
      effect as a standard-care management strategy on decreasing the prevalence of overweight and
      obesity among socially advantaged adolescents.

      Hypothesis: A strengthened overweight and obesity care management strategy for overweight and
      obesity (risk factors of cancer) can improve care access for socially less advantaged
      adolescents and maintain social equality in terms of overweight and obesity prevalence.

      Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial (one randomised part
      and one non-randomised part) of 1,250 overweight and obese adolescents aged 13 to 18 years
      who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department
      (northeastern France) for the academic years 2012-2013, 2013-2014 and 2014-2015. After a
      session to detect overweight and obese adolescents, the social status of included adolescents
      as "advantaged" or "less advantaged" is determined. Adolescents classified as advantaged are
      allocated to the standard-care management and those less advantaged are randomized to
      standard-care management or strengthened-care management. The standard-care management
      consists of 5 collective sessions of 2 hr each performed in high school and supervised by a
      healthcare mobile team specialised in overweight and obesity care management for adolescents.
      The team consists of physicians, dietitians, psychologists and sports educators from the AVRS
      Association. The content of sessions was validated in the PRALIMAP trial. The
      strengthened-care management consists of 5 collective sessions with the same standard
      operating procedure as the standard-care management with supplementary interventions between
      each session: strengthened solicitation with the adolescent and the family, peer-led
      educational sessions, motivational interviews, financial support for physical activity
      practice, cooking classes and multidisciplinary consultation meetings (adjusting the care
      management according to the social status). Data on sociodemographics, anthropometrics,
      physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10
      (before the intervention = T0), at the end of grade 9 or 10 (at the end of the intervention =
      T1) and at the end of grade 10 or 11 (1 year after the intervention = T2). T1 measurement
      allows for evaluating the short-term effect of the intervention and T2, the long-term effect
      of a 1-year break from the intervention. Data on participation and from questionnaires, as
      well as focus group and activity reports, necessary for evaluation, are collected during the
      trial.

      Expected results: With this trial, the investigators expect to confirm the effectiveness of
      overweight and obesity care management for adolescents in a school setting and to highlight
      or not the effectiveness of specific strengthened interventions adapted for socially less
      advantaged adolescents to maintain social equality in access to overweight and obesity care.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Body Mass Index from to baseline to 1 and 2 years
time frame: 0-1-2 years
description: BMI is measured at baseline(on grade 10 entry) and after 1 and 2 follow up years(at the end of grades 10 and 11).
measure: Change in overweight and obesity status according to IOTF norms
time frame: up to 2 years
description: overweight and obesity status is calculated from BMI at each measurement time according to the IOTF norms for age and sex
measure: Change in BMI Z score from baseline to one and two years
time frame: up to 2 years
description: BMI Z score is calculated from BMI at each time measurement using WHO reference and SAS macro
measure: Change in waist circumference
time frame: 2 years
description: waist circumference is measured two times at each measurement point by trained nurses and validated by a practitioner
measure: change in eating attitude score from baseline to 1 and 2 years
time frame: up to 2 years
description: Eating attitudes are measured at each measurement point using then EAT40 questionnaire
measure: Change in anxiety and depression scores from baseline to 1 and 2 years
time frame: up to 2 years
description: HAD questionnaire is used to measure score at each follow-up point
measure: Change in Nutritional behavior from baseline to 1 and 2 years
time frame: up to 2 years
description: Nutritional behavior is measured through self administered questionnaires which allow to assess the compliance to French national recommendations
arm group label: Group 1:
arm group type: Active Comparator
description: Socially advantaged overweight or obese adolescents are allocated to the standard care management.
arm group label: Group 2
arm group type: Experimental
description: Socially less advantaged overweight or obese adolescents are allocated to the standard care management.
arm group label: Group 3
arm group type: Experimental
description: Socially less advantaged overweight or obese adolescents are allocated to the strengthened care management.
intervention type: Behavioral
intervention name: Standard care management
description: The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.
arm group label: Group 1:
arm group label: Group 2
intervention type: Behavioral
intervention name: The strengthened care management
description: The strengthened care management is the addition of the standard care management and of additional interventions.
The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.
The additional interventions are strengthened solicitation and accompaniment, peer-led education, motivational interview, financial support for physical activity practice, cooking classes and meetings of multidisciplinary consultation.
arm group label: Group 3
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Serge Briançon, Pr
role: Principal Investigator
affiliation: University of Lorraine
facility: 
country: France
responsible party type: Sponsor
mesh term: Overweight