Trial document




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  DRKS00004197

Trial Description

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Title

Economic aspects of extreme obesity in adolescents, Subproject 4

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Trial Acronym

YES

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Obesity is one of the biggest public health challenges today and in the years to come, particularly due to its rising prevalence in children and adolescents. In addition to the increased health risks for each individual, obesity causes a tremendous economic burden on the healthcare system.
Here, we will investigate the impact of extreme obesity on healthcare utilization, costs, and health related quality of life in adolescents. The study is a subproject of the “Medical and psychosocial implications of adolescent extreme obesity – acceptance and effects of structured care study", 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 complete questionnaires to assess health related quality of life and utilization of healthcare. These questionnaires will be applied at baseline and then every 12 months (initially every 6 months) during health check-ups. As part of the other subprojects of YES, participants will be invited to complete further questionnaires and will be offered a thorough medical examination, medical care and psycho-social support.
We expect to provide valid and up-to-date information on costs and health-related quality of life for obese adolescents. This information will help in the planning of useful and cost effective preventive and therapeutic strategies, and improve the medical care and support structures for obese adolescents.
In February 2013, an amendment was added to the study to include patients up till 24.9 years. To increase patients’ compliance, in a further amendment in December 2014, the number of visits was reduced from biannually to once a year. In addition, the patients will now receive a reimbursement of their travel expenses (30€ per patient).

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Brief Summary in Scientific Language

Obesity is acknowledged as one of the biggest public health challenges today and in the years to come, particularly due to its rising prevalence in children and adolescents. In addition to the physical, mental and social health consequences of the obesity epidemic, a major concern that emanates from overweight and obesity is the related economic burden. Here, we will investigate the impact of extreme obesity on healthcare utilization, costs, and health related quality of life in a cohort of adolescents. 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 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 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 a long-term prospective observation study.

Based on the current state of knowledge, we have formulated the following hypotheses in regards to healthcare utilization, costs, and health related quality of life:

1. Cost induced by utilization of healthcare services of adolescents with extreme obesity (BMI ≥ 35kg/m2) will be significantly higher compared to cost induced by adolescents with obese (BMI 30-34.9kg/m2). In adolescents who undergo bariatric surgery, cost will decrease after the intervention.
2. Adolescents with extreme obesity (BMI ≥ 35) have significantly lower health related quality of life compared to adolescents with obesity (BMI 30-34.9kg/m2). After specific interventions (psycho-social intervention in subproject 2, bariatric surgery in subproject 3), health related quality of life will increase after the intervention.
3. The cost of the surgical intervention will be accompanied by strong positive effects (such as relative weight loss and health related quality of life) Therefore bariatric surgery will be cost-effective.
4. The high costs of bariatric surgery will be amortized by health savings due to decreased utilization of health care services and lower indirect costs in the medium to long term.

We will recruit a total of 600 adolescents age 14 to 24.9 years (initially up till 21 years) 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.
Utilization and healthcare costs associated with extreme obesity in adolescents will be assessed via standardized patient questionnaires. Health related quality of life associated with extreme obesity in adolescents will be assessed with validated instruments at baseline and then every 12 months (initially every 6 months). Cost-effectiveness and cost-utility analyses will be performed.

We expect to provide valid and up-to-date information on healthcare costs and health-related quality of life for this relevant patient group. This information will inform the planning of future preventive and therapeutic strategies.

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Organizational Data

  •   DRKS00004197
  •   2012/06/25
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  •   yes
  •   Approved
  •   89/12, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1131-4384 
  •   01GI1127  (BMBF Förderkennzeichen)
  •   DRKS00004172  (Teilprojekt 1/ Subproject 1)
  •   DRKS00004195  (Teilprojekt 2 / Subproject 2)
  •   DRKS00004196  (Teilprojekt 3 / Subproject 3)
  •   DRKS00004198  (longitudinale Beobachtungsstudie / longitudinal observation study )
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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   youth with extreme obesity (BMI ≥35kg/m2): questionnaire application
  •   youth with obesity (BMI 30-34,9kg/m2): questionnaire application
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Health economics
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Economic burden of adolescent extreme obesity in Germany. We will elicit resource utilization and health care cost at baseline and every 12 months (initially every 6 months) throughout the study period, using a standardized patient questionnaire that was developed and tested by the Helmholtz Center in Munich.

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Secondary Outcome

1. Health related quality of life associated with extreme obesity in adolescents: Via validated patient questionnairs (EQ5D, DISABKIDS), we will elicit health related quality of life at baseline and every 12 months (initially every 6 months) throughout the study period.

2. BMI, assessed at baseline and every 12 months (initially every 6 months).

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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
  •   2012/07/09
  •   1200
  •   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

none

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Addresses

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    • Institut für Gesundheitsökonomie und Management im Gesundheitswesen, Helmholtz Zentrum München
    • Mr.  Professor Dr.   Rolf  Holle 
    • Postfach 1129
    • 85758  Neuherberg
    • 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 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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    • Sektion Pädiatrische Endokrinologie und Diabetologie, 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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    • Klinik für Kinder- und Jugendmedizin, Universität Ulm
    • Mr.  Professor Dr. med.  Martin  Wabitsch 
    • Eythstraße 24
    • 89075  Ulm
    • Germany
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    • Institut für Gesundheitsökonomie und Managment im Gesundheitswesen, Helmholz Zentrum München
    • Mr.  Prof. Dr.  Rolf  Holle 
    • Postfach 1129
    • 85758  Neuherberg
    • Germany
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    • Sektion Pädiatrische Endokrinologie und Diabetologie, Universitätsklinik für Kinder- und Jugendmedizin
    • Ms.  Dr. med.  Belinda  Lennerz 
    • Eythstr. 24
    • 89075  Ulm
    • 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 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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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 continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.