<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/NCT01703273</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1131-4384b</org_study_id>
    <secondary_id>DRKS00004195</secondary_id>
    <secondary_id>01GI1120B</secondary_id>
    <nct_id>NCT01703273</nct_id>
  </id_info>
  <brief_title>Low-level Intervention for Adolescents With Extreme Obesity</brief_title>
  <acronym>STEREO</acronym>
  <official_title>Structured Low-level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents With Extreme Obesity, Subproject 2</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>University of Ulm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zentrum für klinische Studien Essen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulm</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      While adolescents with obesity and extreme obesity are at increased risk for health&#xD;
      complications, especially adolescents with extreme obesity rarely seek medical care, and&#xD;
      sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the lack&#xD;
      of adequate treatment options.&#xD;
&#xD;
      In this multicenter study, we aim to test a new, low key group intervention focusing on&#xD;
      improving compliance and psychosocial functioning. The study is a subproject of the Medical&#xD;
      and psychosocial implications of adolescent extreme obesity - acceptance and effects of&#xD;
      structured care, short: &quot;Youth with Extreme obesity Study (YES)&quot;, which aims at improving the&#xD;
      medical care and social support structures for youth with obesity and extreme obesity in&#xD;
      Germany.&#xD;
&#xD;
      Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially&#xD;
      up to 21 years) are eligible to participate. Participants will be asked to complete a series&#xD;
      of questionnaires on their general health, psychosocial situation and wellbeing, and will be&#xD;
      offered a thorough medical evaluation. Individuals who complete the baseline evaluations will&#xD;
      be invited to participate in 6 group sessions over a 3 months period. Group assignment to the&#xD;
      psycho-social intervention vs. routine care group will be at random, like throwing a dice.&#xD;
      After 6 months, participants will complete further questionnaires to evaluate the effects of&#xD;
      the interventions on quality of life and psycho-social functionning.&#xD;
&#xD;
      The study will show the acceptance and effectiveness of a new intervention focusing on&#xD;
      improving compliance and psychosocial functioning in adolescents with extreme obesity, and&#xD;
      thereby inform the development of new treatment and support options for these adolescents. If&#xD;
      interested, participants are invited to participate in additional components of YES, and to&#xD;
      receive medical care and psycho-social support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While obese youth are at high risk for co-morbidities, especially the extremely obese&#xD;
      individuals rarely seek medical care. The underlying reasons are poorly understood, but&#xD;
      patient inherent factors and the lack of adequate treatment options may play a role.&#xD;
&#xD;
      In this multicenter study, we aim to assess the acceptance and effectiveness of a manual&#xD;
      based low key group intervention focusing on improving compliance and psychosocial&#xD;
      functioning in adolescents with morbid obesity (BMI≥35kg/m2), in comparison to routine care.&#xD;
      Youth with more moderate degrees of obesity (BMI 30-34.9kg/m2) will serve as an additional&#xD;
      control group. The study is part of the Medical and psychosocial implications of adolescent&#xD;
      extreme obesity - acceptance and effects of structured care&quot;, short: &quot;Youth with extreme&#xD;
      obesity Study (YES), which also comprises the recruitment and characterization of obese (BMI&#xD;
      30-34.9kg/m2) and extremely obese (BMI ≥ 35kg/m2) youth from different healthcare- and non&#xD;
      healthcare settings, a structured prospective evaluation of adolescent bariatric surgery,&#xD;
      economic assessments of the financial burden of extreme adolescent obesity on the healthcare&#xD;
      system, and a long-term prospective observation study.&#xD;
&#xD;
      Based on the current state of knowledge, we will test the a priori ordered hirarchy of&#xD;
      hypotheses:&#xD;
&#xD;
        1. The compliance rate 6 months after randomization is higher in subjects in the low key&#xD;
           intervention group compared to the standard care group.&#xD;
&#xD;
        2. Covariant-adjusted changes in quality of life (assessed by DISABKIDS scale) between&#xD;
           baseline and the 6 months follow up will be more pronounced in the low key intervention&#xD;
           group compared to the standard care group.&#xD;
&#xD;
      The five participating university centers are distributed across 4 geographic regions in the&#xD;
      North (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. We&#xD;
      will screen a 600 adolescents age 14 to 24.9 years (initially up to 21 years; this was&#xD;
      changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35 kg/m2) and 600&#xD;
      adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. A total of 350 subjects&#xD;
      will be enrolled. Baseline assessments include an array of standardized questionnaires and&#xD;
      validated instruments to assess health, psycho-social situation, psychiatric co-morbidities&#xD;
      and health related quality of life, as well as an in-depth medical evaluation. Individuals&#xD;
      who complete the baseline evaluations will be invited to participate in 6 group sessions over&#xD;
      a 3 months period. Group assignment to the low key intervention vs. standard care group will&#xD;
      be at random. The effects of the interventions on health related quality of life and&#xD;
      psycho-social functioning will be assessed via questionnaires after 6 months. Subsequently,&#xD;
      subjects will be invited to participate in additional components of YES.&#xD;
&#xD;
      The project will reveal the effectiveness and safety of a manual based low key group&#xD;
      intervention focusing on improving compliance and psychosocial functioning in adolescents&#xD;
      with morbid obesity, and thereby inform the development of new treatment and support options&#xD;
      for these adolescents in Germany.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life.</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>a) Number of regular participants at 6 months follow up will be divided by number of participants at baseline. b) Changes (randomization - 6 months follow up) in the 37 item DISABKIDS questionnaire will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the 6 subscales of DISABKIDS</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>The 37 item DISABKIDS questionnaire will be applied twice, and the score difference in each of the 6 subscales will be calculated for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>The 52 item KIDSCREEN-52 questionnaire will be applied twice, and the score difference will be calculated for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-esteem</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>The Rosenberg's scale patient questionnaire will be applied twice, and the score difference will be calculated for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self reported time spent outside the home</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>The time spent outside the home will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in depression symptoms</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>The Becks Depression Inventory 2 questionnaire will be applied twice, and the score difference will be calculated for each subject. Answers will be reviewed immediately to identify and treat subjects at risk for self harm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in perceived stress</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>The Fliege scale questionnaire will be applied twice, and the score difference will be calculated for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the self reported attendance of school, apprenticeship, or work</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>The attendance of school, apprenticeship, or work will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self reported physician- / and therapist contacts</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Physician- / and therapist contacts will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the difference will be calculated for each subject.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Obesity</condition>
  <condition>Extreme Obesity</condition>
  <arm_group>
    <arm_group_label>low key intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>routine care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>manual based low key group intervention (innovation)</intervention_name>
    <description>6 sessions offered over the course of 3-6 months focus on improvement of quality of life and psychosocial functioning . Topics covered are: 1) social competencies, 2) body image, 3) coping with mobbing and anger, 4) coping with stress, 5) life satisfaction, and 6) psychological well being. The planned intervention does not primarily focus on weight loss.</description>
    <arm_group_label>low key intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>standardized, manual based routine care</intervention_name>
    <description>6 sessions offered over the course of 3-6 months with a focus on weight loss. The topics 1) causes, consequences and treatment options of obesity, 2) nutrition, 3) eating behaviors and problem solving strategies, 4) self esteem and emotional eating, 5) exercise, and 6) use of media, will be covered.</description>
    <arm_group_label>routine care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥30kg/m2&#xD;
&#xD;
          -  sufficient German language skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Circumstances that require immediate inpatient care (e.g. severe somatic or&#xD;
             psychiatric illness)&#xD;
&#xD;
          -  obvious cognitive disability&#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>Principal Investigator</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>Study Chair</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>
  <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>Center for Clinical Trials Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <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>June 2018</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>June 12, 2018</last_update_submitted>
  <last_update_submitted_qc>June 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2018</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>Prof. Dr. med</investigator_title>
  </responsible_party>
  <keyword>Extreme Obesity Keywords: obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life</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/NCT01703273
org study id: U1111-1131-4384b
secondary id: DRKS00004195
secondary id: 01GI1120B
nct id: NCT01703273
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
While adolescents with obesity and extreme obesity are at increased risk for health
      complications, especially adolescents with extreme obesity rarely seek medical care, and
      sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the lack
      of adequate treatment options.

      In this multicenter study, we aim to test a new, low key group intervention focusing on
      improving compliance and psychosocial functioning. 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 be asked to complete a series
      of questionnaires on their general health, psychosocial situation and wellbeing, and will be
      offered a thorough medical evaluation. Individuals who complete the baseline evaluations will
      be invited to participate in 6 group sessions over a 3 months period. Group assignment to the
      psycho-social intervention vs. routine care group will be at random, like throwing a dice.
      After 6 months, participants will complete further questionnaires to evaluate the effects of
      the interventions on quality of life and psycho-social functionning.

      The study will show the acceptance and effectiveness of a new intervention focusing on
      improving compliance and psychosocial functioning in adolescents with extreme obesity, and
      thereby inform the development of new treatment and support options for these adolescents. If
      interested, participants are invited to participate in additional components of YES, and to
      receive medical care and psycho-social support.
While obese youth are at high risk for co-morbidities, especially the extremely obese
      individuals rarely seek medical care. The underlying reasons are poorly understood, but
      patient inherent factors and the lack of adequate treatment options may play a role.

      In this multicenter study, we aim to assess the acceptance and effectiveness of a manual
      based low key group intervention focusing on improving compliance and psychosocial
      functioning in adolescents with morbid obesity (BMI≥35kg/m2), in comparison to routine care.
      Youth with more moderate degrees of obesity (BMI 30-34.9kg/m2) will serve as an additional
      control group. The study is part of the Medical and psychosocial implications of adolescent
      extreme obesity - acceptance and effects of structured care", short: "Youth with extreme
      obesity Study (YES), which also comprises the recruitment and characterization of obese (BMI
      30-34.9kg/m2) and extremely obese (BMI ≥ 35kg/m2) youth from different healthcare- and non
      healthcare settings, a structured prospective evaluation of adolescent bariatric surgery,
      economic assessments of the financial burden of extreme adolescent obesity on the healthcare
      system, and a long-term prospective observation study.

      Based on the current state of knowledge, we will test the a priori ordered hirarchy of
      hypotheses:

        1. The compliance rate 6 months after randomization is higher in subjects in the low key
           intervention group compared to the standard care group.

        2. Covariant-adjusted changes in quality of life (assessed by DISABKIDS scale) between
           baseline and the 6 months follow up will be more pronounced in the low key intervention
           group compared to the standard care group.

      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. We
      will screen a 600 adolescents age 14 to 24.9 years (initially up to 21 years; this was
      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. A total of 350 subjects
      will be enrolled. Baseline assessments 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 an in-depth medical evaluation. Individuals
      who complete the baseline evaluations will be invited to participate in 6 group sessions over
      a 3 months period. Group assignment to the low key intervention vs. standard care group will
      be at random. The effects of the interventions on health related quality of life and
      psycho-social functioning will be assessed via questionnaires after 6 months. Subsequently,
      subjects will be invited to participate in additional components of YES.

      The project will reveal the effectiveness and safety of a manual based low key group
      intervention focusing on improving compliance and psychosocial functioning in adolescents
      with morbid obesity, and thereby inform the development of new treatment and support options
      for these adolescents in Germany.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life.
time frame: baseline and 6 months
description: a) Number of regular participants at 6 months follow up will be divided by number of participants at baseline. b) Changes (randomization - 6 months follow up) in the 37 item DISABKIDS questionnaire will be assessed.
measure: Changes in the 6 subscales of DISABKIDS
time frame: baseline and 6 months
description: The 37 item DISABKIDS questionnaire will be applied twice, and the score difference in each of the 6 subscales will be calculated for each subject.
measure: Changes in quality of life
time frame: baseline and 6 months
description: The 52 item KIDSCREEN-52 questionnaire will be applied twice, and the score difference will be calculated for each subject.
measure: Changes in self-esteem
time frame: baseline and 6 months
description: The Rosenberg's scale patient questionnaire will be applied twice, and the score difference will be calculated for each subject.
measure: Changes in self reported time spent outside the home
time frame: baseline and 6 months
description: The time spent outside the home will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject.
measure: Changes in depression symptoms
time frame: baseline and 6 months
description: The Becks Depression Inventory 2 questionnaire will be applied twice, and the score difference will be calculated for each subject. Answers will be reviewed immediately to identify and treat subjects at risk for self harm.
measure: Changes in perceived stress
time frame: baseline and 6 months
description: The Fliege scale questionnaire will be applied twice, and the score difference will be calculated for each subject.
measure: Changes in the self reported attendance of school, apprenticeship, or work
time frame: baseline and 6 months
description: The attendance of school, apprenticeship, or work will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject.
measure: Changes in self reported physician- / and therapist contacts
time frame: baseline and 6 months
description: Physician- / and therapist contacts will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the difference will be calculated for each subject.
arm group label: low key intervention
arm group type: Experimental
arm group label: routine care
arm group type: Active Comparator
intervention type: Behavioral
intervention name: manual based low key group intervention (innovation)
description: 6 sessions offered over the course of 3-6 months focus on improvement of quality of life and psychosocial functioning . Topics covered are: 1) social competencies, 2) body image, 3) coping with mobbing and anger, 4) coping with stress, 5) life satisfaction, and 6) psychological well being. The planned intervention does not primarily focus on weight loss.
arm group label: low key intervention
intervention type: Behavioral
intervention name: standardized, manual based routine care
description: 6 sessions offered over the course of 3-6 months with a focus on weight loss. The topics 1) causes, consequences and treatment options of obesity, 2) nutrition, 3) eating behaviors and problem solving strategies, 4) self esteem and emotional eating, 5) exercise, and 6) use of media, will be covered.
arm group label: routine care
criteria: 
gender: All
minimum age: 14 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Wabitsch, Prof. Dr. med.
role: Principal Investigator
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: Study Chair
affiliation: Universität Duisburg-Essen
last name: Wieland Kiess, Prof. Dr. med.
role: Principal Investigator
affiliation: University of Leipzig
facility: 
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: Prof. Dr. med
mesh term: Obesity