<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/NCT03233425</url>
  </required_header>
  <id_info>
    <org_study_id>EKSG 08/023</org_study_id>
    <secondary_id>09.004211/204.0001/-629</secondary_id>
    <secondary_id>l'Allemand, 20110901</secondary_id>
    <nct_id>NCT03233425</nct_id>
  </id_info>
  <brief_title>Evaluation of Multiprofessional Group Programs for Paediatric Obesity Therapy</brief_title>
  <acronym>KIDSSTEP</acronym>
  <official_title>Evaluation of Therapy for Overweight Children and Adolescents in Switzerland: Therapy in Multiprofessional Group Programs - Part 2, Collection and Analysis of Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostschweizer Kinderspital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>akj, Fachverband Adipositas im Kindes- und Jugendalter, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal Office of Public Health, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ostschweizer Kinderspital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this pilot project is to disseminate multiprofessional group programs (*MGP*) for&#xD;
      therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based&#xD;
      behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and&#xD;
      family behaviours, after the intensive phase (*T1*), at 1 and 2 years after start (*T2*,&#xD;
      *T3*). MGP costs are reimbursed in Switzerland: 1) if 116 sessions are provided by experts in&#xD;
      physical activity, nutrition and psychology; 2) if parents are included and if their&#xD;
      adherence is higher than 85%. In the nationwide &quot;Evaluation of Multiprofessional Group&#xD;
      Programs for Paediatric Obesity Therapy&quot; (*KIDSSTEP*) study, multiple psychosocial and&#xD;
      physical parameters were assessed at T0, T2 and T3 . Out of 33 certified centers, 25 were&#xD;
      active and only 19 were re-certified in 2013/2014. Obese children suffer from major&#xD;
      co-morbidities and therefore, only one third of referred patients can be treated in MGPs and&#xD;
      their beneficial effects on obesity as well as physical and mental health outcomes are&#xD;
      sustained over 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Switzerland, the number of overweight children &lt;18 years is estimated to 80'000 and&#xD;
      related cardiovascular, osteoarticular and other complications are already present in&#xD;
      approximately in 50% of these youth. Controlled studies demonstrated that multiprofessional&#xD;
      treatment programs can reduce adiposity and improve health risk factors. To pre-empt the&#xD;
      deterioration of obesity and co-morbidities in adult life, the Swiss Department of the&#xD;
      Interior (EDI) approved in 2007 the reimbursement of treatment of overweight children by&#xD;
      health insurances , if conducted in certified multi-professional family-based group programs.&#xD;
      All programs have to participate in a scientific evaluation study supported by the Federal&#xD;
      Office of Public Health (FOPH) in order to determine nationwide outcomes in clinical&#xD;
      practice. The goal of this study is to evaluate individual changes of physical activity,&#xD;
      nutrition, behaviours, quality of life, co-morbidities and adiposity during therapy and to&#xD;
      identify predictors of positive or negative changes.&#xD;
&#xD;
      During 5 years, the investigators will recruit about 200 children and adolescents aged 6 to&#xD;
      18 years every year. Patients must have a Body Mass Index (BMI), fat mass or waist&#xD;
      circumference above the 97th percentile, or a BMI above the 90th percentile plus a&#xD;
      co-morbidity. Together with their parents they will be enrolled in an intensive group therapy&#xD;
      program for 6 to 12 months, with 12 months of follow up. To date, in 25 certified centres,&#xD;
      physicians, nutrition and physical activity specialists as well as psychologists can provide&#xD;
      a multiprofessional standardized care, the costs of participation being reimbursed after&#xD;
      regular presence. At start, after 1 year and 2 years, standardized instruments validated in&#xD;
      Swiss or European children will be used to document changes during therapy. Questionnaires&#xD;
      will assess motivation, weight of parents, personal and family history, quality of life,&#xD;
      child and family lifestyle, parenting skills, eating or psychological disorders, and&#xD;
      satisfaction. Other investigations will include medical examination, blood tests, and&#xD;
      European Fitness (*Eurofit*)-test for physical fitness and capacities. Anonymised data will&#xD;
      be recorded centrally in an electronic database, after controlling for completeness and&#xD;
      plausibility. Informed consent and positive votes of local ethical committees will be&#xD;
      obtained. Reports on cross-sectional and longitudinal descriptive statistics and benchmarking&#xD;
      will be provided once yearly. A comprehensive multivariate analysis of complex associations&#xD;
      between predictors and health-related outcomes will be completed. Statistical analyses will&#xD;
      be performed by specialists in each field and will be supervised by public health scientists.&#xD;
      To guarantee meaningful analyses, the last patients will be included in December 2013.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body mass index - standard deviation score (*SDS*), (*BMI-SDS*)</measure>
    <time_frame>2 years</time_frame>
    <description>Age- and sex-adjusted BMI according to World Health Organisation (*WHO*) charts used in Switzerland</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by Quality of life questionnaires for children and adolescents (*KIDSSCREEN*) with 52 questions</measure>
    <time_frame>2 years</time_frame>
    <description>Outcome Measure is a Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eurofit - Test</measure>
    <time_frame>2 years</time_frame>
    <description>Outcome measure is a score on physical fitness and sport activity of children and adolescents</description>
  </secondary_outcome>
  <enrollment type="Actual">1152</enrollment>
  <condition>Overweight</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>multiprofessional group therapy</intervention_name>
    <description>Behavioural therapy of lifestyle including activity, family and eating habits</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Overweight children &lt; 18 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI above the 97th percentile, or in second line waist circumference or fat mass above&#xD;
             the nor-mal range, or BMI above the 90th percentile associated with the presence of&#xD;
             co-morbidities&#xD;
&#xD;
          -  Medical examination is a pre-requisite&#xD;
&#xD;
          -  Motivation of the patient and support by the family are pre-requisites&#xD;
&#xD;
          -  Psychiatric diseases or severe psychosocial restraints must be adequately tackled.&#xD;
&#xD;
          -  Informed consent of patients and parents to the participation in an anonymous&#xD;
             evaluation,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  healthy child&#xD;
&#xD;
          -  no motivation for therapy, as assessed by interview and questionnaires to Patient and&#xD;
             Family&#xD;
&#xD;
          -  psychiatric disease without adequate treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dagmar lAllemand, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ostschweizer Kinderspital, St. Gallen, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ostschweizer Kinderspital</name>
      <address>
        <city>St. Gallen</city>
        <zip>9006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>March 4, 2015</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ostschweizer Kinderspital</investigator_affiliation>
    <investigator_full_name>Dagmar l'Allemand</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Child</keyword>
  <keyword>adolescent</keyword>
  <keyword>co-morbidity</keyword>
  <keyword>psychology</keyword>
  <keyword>motivation</keyword>
  <keyword>physical activity</keyword>
  <keyword>eating disorders</keyword>
  <keyword>quality of life</keyword>
  <keyword>therapy</keyword>
  <keyword>predictors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03233425
org study id: EKSG 08/023
secondary id: 09.004211/204.0001/-629
secondary id: l'Allemand, 20110901
nct id: NCT03233425
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this pilot project is to disseminate multiprofessional group programs (*MGP*) for
      therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based
      behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and
      family behaviours, after the intensive phase (*T1*), at 1 and 2 years after start (*T2*,
      *T3*). MGP costs are reimbursed in Switzerland: 1) if 116 sessions are provided by experts in
      physical activity, nutrition and psychology; 2) if parents are included and if their
      adherence is higher than 85%. In the nationwide "Evaluation of Multiprofessional Group
      Programs for Paediatric Obesity Therapy" (*KIDSSTEP*) study, multiple psychosocial and
      physical parameters were assessed at T0, T2 and T3 . Out of 33 certified centers, 25 were
      active and only 19 were re-certified in 2013/2014. Obese children suffer from major
      co-morbidities and therefore, only one third of referred patients can be treated in MGPs and
      their beneficial effects on obesity as well as physical and mental health outcomes are
      sustained over 2 years.
In Switzerland, the number of overweight children <18 years is estimated to 80'000 and
      related cardiovascular, osteoarticular and other complications are already present in
      approximately in 50% of these youth. Controlled studies demonstrated that multiprofessional
      treatment programs can reduce adiposity and improve health risk factors. To pre-empt the
      deterioration of obesity and co-morbidities in adult life, the Swiss Department of the
      Interior (EDI) approved in 2007 the reimbursement of treatment of overweight children by
      health insurances , if conducted in certified multi-professional family-based group programs.
      All programs have to participate in a scientific evaluation study supported by the Federal
      Office of Public Health (FOPH) in order to determine nationwide outcomes in clinical
      practice. The goal of this study is to evaluate individual changes of physical activity,
      nutrition, behaviours, quality of life, co-morbidities and adiposity during therapy and to
      identify predictors of positive or negative changes.

      During 5 years, the investigators will recruit about 200 children and adolescents aged 6 to
      18 years every year. Patients must have a Body Mass Index (BMI), fat mass or waist
      circumference above the 97th percentile, or a BMI above the 90th percentile plus a
      co-morbidity. Together with their parents they will be enrolled in an intensive group therapy
      program for 6 to 12 months, with 12 months of follow up. To date, in 25 certified centres,
      physicians, nutrition and physical activity specialists as well as psychologists can provide
      a multiprofessional standardized care, the costs of participation being reimbursed after
      regular presence. At start, after 1 year and 2 years, standardized instruments validated in
      Swiss or European children will be used to document changes during therapy. Questionnaires
      will assess motivation, weight of parents, personal and family history, quality of life,
      child and family lifestyle, parenting skills, eating or psychological disorders, and
      satisfaction. Other investigations will include medical examination, blood tests, and
      European Fitness (*Eurofit*)-test for physical fitness and capacities. Anonymised data will
      be recorded centrally in an electronic database, after controlling for completeness and
      plausibility. Informed consent and positive votes of local ethical committees will be
      obtained. Reports on cross-sectional and longitudinal descriptive statistics and benchmarking
      will be provided once yearly. A comprehensive multivariate analysis of complex associations
      between predictors and health-related outcomes will be completed. Statistical analyses will
      be performed by specialists in each field and will be supervised by public health scientists.
      To guarantee meaningful analyses, the last patients will be included in December 2013.
observational model: Case-Only
time perspective: Prospective
measure: Body mass index - standard deviation score (*SDS*), (*BMI-SDS*)
time frame: 2 years
description: Age- and sex-adjusted BMI according to World Health Organisation (*WHO*) charts used in Switzerland
measure: Quality of life as assessed by Quality of life questionnaires for children and adolescents (*KIDSSCREEN*) with 52 questions
time frame: 2 years
description: Outcome Measure is a Scale
measure: Eurofit - Test
time frame: 2 years
description: Outcome measure is a score on physical fitness and sport activity of children and adolescents
intervention type: Behavioral
intervention name: multiprofessional group therapy
description: Behavioural therapy of lifestyle including activity, family and eating habits
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Dagmar lAllemand, Pr
role: Principal Investigator
affiliation: Ostschweizer Kinderspital, St. Gallen, Switzerland
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Ostschweizer Kinderspital
investigator full name: Dagmar l'Allemand
investigator title: Prof. Dr. med.
mesh term: Overweight
sharing ipd: No