Trial document




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  DRKS00004195

Trial Description

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Title

A Structured, manual-based low-level intervention vs. treatment as usual evaluated in a randomized controlled trial for adolescents with extreme obesity, Subproject 2

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Trial Acronym

STEREO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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 (21 years initially) 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.
In February 2013 an amendment was added to the study to include patients up till 24.9 years.

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Brief Summary in Scientific Language

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 (21 years initially) 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.

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Organizational Data

  •   DRKS00004195
  •   2012/08/15
  •   [---]*
  •   yes
  •   Approved
  •   89/12, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1131-4384 
  •   01GI1120B  (BMBF Förderkennzeichen)
  •   DRKS00004172  (Teilprojekt 1 / Subproject 1)
  •   DRKS00004196  (Teilprojekt 3 / Subproject 3)
  •   DRKS00004197  (Teilprojekt 4 / Subproject 4)
  •   DRKS00004198  (longitudinale Beobachtungsstudie / longitudinal observation study)
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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Manual based low key group intervention that focuses 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.
  •   Standardized, manual based routine care focusing on weight loss: In the control group, 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.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Composite of:
a) Compliance rate: Number of regular participants at the time of the 6 months follow up.
b) Changes (randomization-6 months follow up) in the 37 item DISABKIDS questionnaire.

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Secondary Outcome

1. Changes (randomization-6 months follow up) in the 6 subscales of DISABKIDS.
2. Changes (randomization-6 months follow up) in quality of life (via KIDSCREEN-52).
3. Changes (randomization-6 months follow up) in self-esteem (Rosenberg’s scale)
4. Changes (randomization-6 months follow up) in self reported time spent outside the home.
5. Changes (randomization-6 months follow up) in depression symptoms (BDI-2).
6. Changes (randomization-6 months follow up) in perceived stress (Fliege scale).
7. Changes (randomization-6 months follow up) in the self reported attendance of school, apprenticeship, or work.
8. Changes (randomization-6 months follow up) in self reported physician- / and therapist contacts.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/15
  •   350
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   24   Years
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Additional Inclusion Criteria

BMI ≥ 30.0 kg/m2, adequate German language skills

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Exclusion Criteria

Conditions requiring immediate inpatient care (e.g. severe somatic or psychiatric illness), obvious cognitive deficits

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Addresses

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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters LVR-Klinikum Essen Kliniken/Institut der Universität Duisburg-Essen
    • Mr.  Prof. Dr. med.  Johannes  Hebebrand 
    • Wickenburgstr. 21
    • 45147  Essen
    • Germany
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    • Vestische Kinder- und Jugendklinik Universität Witten/Herdecke
    • Mr.  Professor Dr. med.  Thomas  Reinehr 
    • Dr. F. Steiner Str. 5
    • 45711  Datteln
    • Germany
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    • Charité Universitätsmedizin Berlin Ambulantes Adipositas Zentrum Interdisziplinäres SPZ der Kinderklinik
    • Ms.  Dr. med.  Susanne  Wiegand 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Klinik und Poliklinik für Kinder- und Jugendmedizin am Universitätsklinikum Leipzig Universität Leipzig
    • Mr.  Professor Dr. med.  Wieland  Kiess 
    • Liebigstraße 20a
    • 04103  Leipzig
    • Germany
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    • Klinik für Kinder- und Jugendmedizin, Universität Ulm
    • Mr.  Professor Dr. med.  Martin  Wabitsch 
    • Eythstraße 24
    • 89075  Ulm
    • Germany
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    • University of Ulm
    • Mr.  Prof. Dr. med.  Reinhard  Holl 
    • Albert-Einstein-Allee 41
    • 89081  Ulm
    • Germany
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    • Zentrum für klinische Studien Essen
    • Mr.  PD Dr.  André  Scherag 
    • Hufelanstr. 55
    • 45122  Essen
    • Germany
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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters LVR-Klinikum Essen Kliniken/Institut der Universität Duisburg-Essen
    • Mr.  Prof. Dr. med.  Johannes  Hebebrand 
    • Wickenburgstr. 21
    • 45147  Essen
    • Germany
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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters LVR-Klinikum Essen Kliniken/Institut der Universität Duisburg-Essen
    • Mr.  Prof. Dr. med.  Johannes  Hebebrand 
    • Wickenburgstr. 21
    • 45147  Essen
    • Germany
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    • Vestische Kinder- und Jugendklinik Universität Witten/Herdecke
    • Ms.  Anke  Schäfer 
    • Dr. F. Steiner Str. 5
    • 45711  Datteln
    • Germany
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    • Charité Universitätsmedizin Berlin Ambulantes Adipositas Zentrum Interdisziplinäres SPZ der Kinderklinik
    • Ms.  Dr. med.  Annika  Bickenbach 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Klinik und Poliklinik für Kinder- und Jugendmedizin am Universitätsklinikum Leipzig Universität Leipzig
    • Ms.  Annett  Witzmann 
    • Liebigstraße 20a
    • 04103  Leipzig
    • Germany
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    • Klinik für Kinder- und Jugendmedizin, Universität Ulm
    • Ms.  Dr. med.  Belinda  Lennerz 
    • Eythstraße 24
    • 89075  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/11
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Trial Publications, Results and other Documents

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