<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/NCT01662271</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1131-4384e</org_study_id>
    <secondary_id>DRKS00004172</secondary_id>
    <secondary_id>01GI1120A</secondary_id>
    <nct_id>NCT01662271</nct_id>
  </id_info>
  <brief_title>Course of Obesity and Extreme Obesity in Adolescents</brief_title>
  <acronym>YES</acronym>
  <official_title>Course of Obesity and Extreme Obesity in Adolescents, in the Context of Different Treatment Options - a Longitudinal Prospective Observation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Martin Wabitsch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Witten/Herdecke</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universität Duisburg-Essen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helmholtz Zentrum München</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulm</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life,&#xD;
      psychosocial situation, and health of the affected youth. However, as few of these&#xD;
      adolescents seek medical care, little is known about the longitudinal course of adolescent&#xD;
      extreme obesity.&#xD;
&#xD;
      In this study, the investigators aim to provide structured care for adolescents with obesity&#xD;
      and extreme obesity over a prolonged period of time, and to gain information on the course of&#xD;
      obesity and the success of different treatment options. The study is a subproject of the&#xD;
      &quot;Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects&#xD;
      of structured care&quot;, short: &quot;Youth with Extreme obesity Study (YES)&quot;, which aims at improving&#xD;
      the medical care and social support structures for youth with obesity and extreme obesity in&#xD;
      Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years&#xD;
      (initially up to 21 years) are eligible to participate. Participants will have a physical&#xD;
      check-up every 12 months (initially every 6 months), complete questionnaires on their health,&#xD;
      socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to&#xD;
      assess comorbidities. Participants are offered support and guidance for social and vocational&#xD;
      integration. The study will evaluate and inform treatment and support options for adolescents&#xD;
      with extreme obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Little is known about the longitudinal course of adolescent extreme obesity. In this&#xD;
      multicenter study, the investigators aim to enroll adolescents with extreme obesity (BMI ≥&#xD;
      35kg/m2) in a 9 year longitudinal, prospective observation that will reveal information on&#xD;
      the course of obesity and the success of different treatment options. Adolescents with more&#xD;
      moderate degrees of obesity (BMI 30-34,9kg/m2) will serve as a control group. The project&#xD;
      builds on the Consortium &quot;Medical and psychosocial implications of adolescent extreme obesity&#xD;
      - acceptance and effects of structured care&quot;, short: &quot;Youth with extreme obesity Study&#xD;
      (YES)&quot;, which comprises the recruitment and characterization of obese youth from different&#xD;
      healthcare- and non healthcare settings, a randomized controlled trial to investigate a novel&#xD;
      intervention targeted at improving quality of life and social functioning of extremely obese&#xD;
      adolescents, a structured prospective evaluation of adolescent bariatric surgery, and&#xD;
      economic assessments of the financial burden of extreme adolescent obesity on the healthcare&#xD;
      system.&#xD;
&#xD;
      Based on the current state of knowledge, the investigators have formulated the following a&#xD;
      priori hypotheses in regards to the longitudinal observation study:&#xD;
&#xD;
        1. Youth with extreme obesity (BMI ≥ 35kg/m2) achieve lower adherence with the structured&#xD;
           care program compared to adolescents with more moderate degrees of obesity (BMI&#xD;
           30-34,9kg/m2).&#xD;
&#xD;
        2. Youth with extreme obesity (BMI ≥ 35kg/m2) are less likely to achieve and sustain weight&#xD;
           loss over a prolonged period of time, compared to adolescents with more moderate degrees&#xD;
           of obesity (BMI 30-34,9kg/m2).&#xD;
&#xD;
        3. Youth with extreme obesity (BMI ≥ 35kg/m2) are harder to integrate in the job market&#xD;
           compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).&#xD;
&#xD;
        4. Youth with extreme obesity (BMI ≥ 35kg/m2) have higher incidence and severity of&#xD;
           co-morbidities compared to youth with more moderate degrees of obesity (BMI&#xD;
           30-34,9kg/m2).&#xD;
&#xD;
      The investigators aim to recruit a total of 600 adolescents age 14 to 24.9 years (initial age&#xD;
      up to 21 years; changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35&#xD;
      kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. The five&#xD;
      participating university centers are distributed across 4 geographic regions in the North&#xD;
      (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of&#xD;
      Germany, and will therefore render data that are representative of Germany as a whole.&#xD;
      Adolescent will be examined annually (initially examinations were biannually, this was&#xD;
      changed in an amendment in December 2014), and testing will include an array of standardized&#xD;
      questionnaires and validated instruments to assess health, psycho-social situation,&#xD;
      psychiatric co-morbidities and health related quality of life, as well as a physical&#xD;
      examination, laboratory tests, and screenings for orthopedic co-morbidities and sleep apnea.&#xD;
      Participants are offered support and guidance in regards to social and vocational integration&#xD;
      with the aim of improving self esteem and social functioning. Data will be entered in an&#xD;
      extended version of the &quot;German National Register for Longitudinal Research on Childhood&#xD;
      Obesity&quot;. We will perform sub-analyses based on the treatment options these youths have&#xD;
      followed The project will reveal the acceptance and outcomes of a structured healthcare&#xD;
      program for adolescents with extreme obesity and provide unique information on the medical&#xD;
      and psychosocial development of adolescents with extreme obesity in Germany.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>adherence with structured care</measure>
    <time_frame>12 months after subject inclusion</time_frame>
    <description>The percentage of subjects that comply with the structured follow up program will be calculated once a year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>percentage of subjects that can be integrated into the job-market or into an apprenticeship training position</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>The percentage of subjects who can be integrated into the job-market or into an apprenticeship training position will be determined via standardized questionnaire (modified after KIGGS and TeenLABS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of subjects that undergo the recommended diagnostic procedures</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Medically appropriate diagnostic procedures will be recommended to the patients, and the percentage of subjects that undergo the recommended diagnostic procedures will be documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in somatic co-morbidities</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Incidences and changes of somatic co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires (modified after KIGGS and TeenLABS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in psychiatric co-morbidities</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Incidences and changes of psychiatric co-morbidities will be assessed via validated patient questionnaires once a year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compliance with treatment of somatic co-morbidities</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Appropriate treatment of the diagnosed somatic co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compliance with treatment of psychiatric co-morbidities</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Appropriate treatment of the diagnosed psychiatric co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in health related quality of life</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Assessed via validated questionnaires (EQ5D, DISABKIDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in socio-economic status</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Assessed via standardized questionnaires (modified after KIGGS and TeenLABS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of extreme obesity</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>The incidence of extreme obesity (BMI ≥35kg/m2) will be determined in the group of adolescents with moderate obesity (BMI 30-34.9kg/m2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in BMI-SDS</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Height and weight will be measured with standardized instruments and BMI-SDS will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>predictors of the above outcomes</measure>
    <time_frame>every 12 months for 9 years</time_frame>
    <description>Psycho-social, psychiatric, and medical variables will be assessed via standardized physical examination, laboratory and apparative tests, standardized patient questionnaires (modified after KIGGS and TeenLABS), and validated psychiatric instruments once a year, and correlation with the outcome variable will be assessed via multiple regression analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adherence with structured care</measure>
    <time_frame>every 12 months from 2-9 years post enrollment</time_frame>
    <description>The percentage of subjects that comply with the structured follow up program will be calculated once a year.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">429</enrollment>
  <condition>Obesity</condition>
  <condition>Extreme Obesity</condition>
  <arm_group>
    <arm_group_label>adolescents with extreme obesity</arm_group_label>
    <description>BMI ≥35kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>adolescents with obesity</arm_group_label>
    <description>BMI 30-34.9kg/m2</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples of fasting plasma, serum, DNA, and urine will be retained.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the general population through different healthcare- and&#xD;
        non healthcare settings to ascertain the inclusion of treatment-seeking and non&#xD;
        treatment-seeking individuals. Healthcare settings include university based obesity&#xD;
        clinics, physician offices and health insurance agencies. Non-healthcare settings include&#xD;
        schools, job centers, and employment agencies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 30kg/m2&#xD;
&#xD;
          -  sufficient German language skills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Wabitsch, Prof. Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>University of Ulm</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susanna Wiegand, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Reinehr, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Witten/Herdecke</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Johannes Hebebrand, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universität Duisburg-Essen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wieland Kiess, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leipzig</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Reinhard Holl, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulm</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ambulatory Obesity Program, Charité University, Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vestische Kinderklinik, University of Witten/Herdecke</name>
      <address>
        <city>Datteln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Duisburg-Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic</name>
      <address>
        <city>Ulm</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.adipositasforschung-ulm.de/index.php?id=69</url>
    <description>study homepage</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulm</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Martin Wabitsch</investigator_full_name>
    <investigator_title>Division Chief Pediatric Endocrinology and Diabetology</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>adiposity</keyword>
  <keyword>psychosocial</keyword>
  <keyword>healthcare</keyword>
  <keyword>co-morbidities</keyword>
  <keyword>youth with extreme obesity</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT01662271
org study id: U1111-1131-4384e
secondary id: DRKS00004172
secondary id: 01GI1120A
nct id: NCT01662271
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life,
      psychosocial situation, and health of the affected youth. However, as few of these
      adolescents seek medical care, little is known about the longitudinal course of adolescent
      extreme obesity.

      In this study, the investigators aim to provide structured care for adolescents with obesity
      and extreme obesity over a prolonged period of time, and to gain information on the course of
      obesity and the success of different treatment options. The study is a subproject of the
      "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects
      of structured care", short: "Youth with Extreme obesity Study (YES)", which aims at improving
      the medical care and social support structures for youth with obesity and extreme obesity in
      Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years
      (initially up to 21 years) are eligible to participate. Participants will have a physical
      check-up every 12 months (initially every 6 months), complete questionnaires on their health,
      socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to
      assess comorbidities. Participants are offered support and guidance for social and vocational
      integration. The study will evaluate and inform treatment and support options for adolescents
      with extreme obesity.
Little is known about the longitudinal course of adolescent extreme obesity. In this
      multicenter study, the investigators aim to enroll adolescents with extreme obesity (BMI ≥
      35kg/m2) in a 9 year longitudinal, prospective observation that will reveal information on
      the course of obesity and the success of different treatment options. Adolescents with more
      moderate degrees of obesity (BMI 30-34,9kg/m2) will serve as a control group. The project
      builds on the Consortium "Medical and psychosocial implications of adolescent extreme obesity
      - acceptance and effects of structured care", short: "Youth with extreme obesity Study
      (YES)", which comprises the recruitment and characterization of obese youth from different
      healthcare- and non healthcare settings, a randomized controlled trial to investigate a novel
      intervention targeted at improving quality of life and social functioning of extremely obese
      adolescents, a structured prospective evaluation of adolescent bariatric surgery, and
      economic assessments of the financial burden of extreme adolescent obesity on the healthcare
      system.

      Based on the current state of knowledge, the investigators have formulated the following a
      priori hypotheses in regards to the longitudinal observation study:

        1. Youth with extreme obesity (BMI ≥ 35kg/m2) achieve lower adherence with the structured
           care program compared to adolescents with more moderate degrees of obesity (BMI
           30-34,9kg/m2).

        2. Youth with extreme obesity (BMI ≥ 35kg/m2) are less likely to achieve and sustain weight
           loss over a prolonged period of time, compared to adolescents with more moderate degrees
           of obesity (BMI 30-34,9kg/m2).

        3. Youth with extreme obesity (BMI ≥ 35kg/m2) are harder to integrate in the job market
           compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).

        4. Youth with extreme obesity (BMI ≥ 35kg/m2) have higher incidence and severity of
           co-morbidities compared to youth with more moderate degrees of obesity (BMI
           30-34,9kg/m2).

      The investigators aim to recruit a total of 600 adolescents age 14 to 24.9 years (initial age
      up to 21 years; changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35
      kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. The five
      participating university centers are distributed across 4 geographic regions in the North
      (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of
      Germany, and will therefore render data that are representative of Germany as a whole.
      Adolescent will be examined annually (initially examinations were biannually, this was
      changed in an amendment in December 2014), and testing will include an array of standardized
      questionnaires and validated instruments to assess health, psycho-social situation,
      psychiatric co-morbidities and health related quality of life, as well as a physical
      examination, laboratory tests, and screenings for orthopedic co-morbidities and sleep apnea.
      Participants are offered support and guidance in regards to social and vocational integration
      with the aim of improving self esteem and social functioning. Data will be entered in an
      extended version of the "German National Register for Longitudinal Research on Childhood
      Obesity". We will perform sub-analyses based on the treatment options these youths have
      followed The project will reveal the acceptance and outcomes of a structured healthcare
      program for adolescents with extreme obesity and provide unique information on the medical
      and psychosocial development of adolescents with extreme obesity in Germany.
observational model: Cohort
time perspective: Prospective
measure: adherence with structured care
time frame: 12 months after subject inclusion
description: The percentage of subjects that comply with the structured follow up program will be calculated once a year.
measure: percentage of subjects that can be integrated into the job-market or into an apprenticeship training position
time frame: every 12 months for 9 years
description: The percentage of subjects who can be integrated into the job-market or into an apprenticeship training position will be determined via standardized questionnaire (modified after KIGGS and TeenLABS).
measure: percentage of subjects that undergo the recommended diagnostic procedures
time frame: every 12 months for 9 years
description: Medically appropriate diagnostic procedures will be recommended to the patients, and the percentage of subjects that undergo the recommended diagnostic procedures will be documented.
measure: changes in somatic co-morbidities
time frame: every 12 months for 9 years
description: Incidences and changes of somatic co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires (modified after KIGGS and TeenLABS).
measure: changes in psychiatric co-morbidities
time frame: every 12 months for 9 years
description: Incidences and changes of psychiatric co-morbidities will be assessed via validated patient questionnaires once a year.
measure: compliance with treatment of somatic co-morbidities
time frame: every 12 months for 9 years
description: Appropriate treatment of the diagnosed somatic co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS).
measure: compliance with treatment of psychiatric co-morbidities
time frame: every 12 months for 9 years
description: Appropriate treatment of the diagnosed psychiatric co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS).
measure: changes in health related quality of life
time frame: every 12 months for 9 years
description: Assessed via validated questionnaires (EQ5D, DISABKIDS).
measure: changes in socio-economic status
time frame: every 12 months for 9 years
description: Assessed via standardized questionnaires (modified after KIGGS and TeenLABS).
measure: incidence of extreme obesity
time frame: every 12 months for 9 years
description: The incidence of extreme obesity (BMI ≥35kg/m2) will be determined in the group of adolescents with moderate obesity (BMI 30-34.9kg/m2).
measure: changes in BMI-SDS
time frame: every 12 months for 9 years
description: Height and weight will be measured with standardized instruments and BMI-SDS will be calculated.
measure: predictors of the above outcomes
time frame: every 12 months for 9 years
description: Psycho-social, psychiatric, and medical variables will be assessed via standardized physical examination, laboratory and apparative tests, standardized patient questionnaires (modified after KIGGS and TeenLABS), and validated psychiatric instruments once a year, and correlation with the outcome variable will be assessed via multiple regression analyses.
measure: adherence with structured care
time frame: every 12 months from 2-9 years post enrollment
description: The percentage of subjects that comply with the structured follow up program will be calculated once a year.
arm group label: adolescents with extreme obesity
description: BMI ≥35kg/m2
arm group label: adolescents with obesity
description: BMI 30-34.9kg/m2
Samples of fasting plasma, serum, DNA, and urine will be retained.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Wabitsch, Prof. Dr. med.
role: Study Chair
affiliation: University of Ulm
last name: Susanna Wiegand, Dr. med.
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
last name: Thomas Reinehr, Prof. Dr. med.
role: Principal Investigator
affiliation: University of Witten/Herdecke
last name: Johannes Hebebrand, Prof. Dr. med.
role: Principal Investigator
affiliation: Universität Duisburg-Essen
last name: Wieland Kiess, Prof. Dr. med.
role: Principal Investigator
affiliation: University of Leipzig
last name: Reinhard Holl, Prof. Dr. med.
role: Principal Investigator
affiliation: University of Ulm
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: http://www.adipositasforschung-ulm.de/index.php?id=69
description: study homepage
responsible party type: Sponsor-Investigator
investigator affiliation: University of Ulm
investigator full name: Prof. Dr. Martin Wabitsch
investigator title: Division Chief Pediatric Endocrinology and Diabetology
mesh term: Obesity