Trial document




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  DRKS00004198

Trial Description

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Title

Course of obesity and extreme obesity in adolescents, in the context of different treatment options - a longitudinal prospective observation study

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Trial Acronym

YES

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URL of the Trial

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Brief Summary in Lay Language

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, we aim to provide structured care for adolescents with obesity and extreme obesity over a prolongued 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, socio-economic status and wellbeing, and are offered blood test and diagnostic procedures to assess co-morbidities. 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.
In February 2013, an amendment was added to the study to include patients up till 24.9 years. Furthermore, in an amendment in December 2014, the number of visits was reduced from biannually to once a year. In addition, the patients will receive a reimbursement of their travel expenses (30€ per patient).

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Brief Summary in Scientific Language

The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life, psychosocial situation, and health of the affected youth.
In this multicenter study, we 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, we 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).

We will recruit a total of 300 adolescents age 14 to 24.9 years (initially up till 21 years) with extreme obesity (BMI ≥ 35 kg/m2) and 300 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 biannually), 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.

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Organizational Data

  •   DRKS00004198
  •   2012/07/20
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  •   yes
  •   Approved
  •   89/12, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1131-4384 
  •   01GI1120A  (BMBF Förderkennzeichen)
  •   DRKS00004172  (Teilprojekt 1 / Subproject 1)
  •   DRKS00004195  (Teilprojekt 2 / Subproject 2)
  •   DRKS00004196  (Teilprojekt 3 / Subproject 3)
  •   DRKS00004197  (Teilprojekt 4 / Subproject 4)
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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Adolescents with extreme obesity (BMI ≥35kg/m2). Adolescent will be examined annually (initially biannually), 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.
  •   Adolescents with obesity (BMI 30-34,9kg/m2). Adolescent will be examined annually (initially biannually), 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.
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Characteristics

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

Adherence with structured care. The percentage of subjects that comply with the structured follow up program will be calculated once a year.

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Secondary Outcome

1. Percentage of subjects that can be integrated into the job-market or into an apprenticeship training position. Integration into the job marked or educational programs will be determined via standardized questionnaire (modified after KIGGS and TeenLABS) once a year.
2. Percentage of subjects that undergo the recommended diagnostic procedures. Medically appropriate diagnostic procedures will be recommended to the patients, and the percentage of subjects that undergo all procedures will be determined at each follow up.
3. Incidences and changes of somatic co-morbidities. Presence and severity of somatic co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires (modified after KIGGS and TeenLABS) at each follow up.
4. Incidences and changes of psychiatric co-morbidities. Presence and severity of psychiatric co-morbidities will be assessed via validated patient questionnaires once a year.
5. Compliance with treatment of somatic co-morbidities. 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) at each follow up.
6. Compliance with treatment of psychiatric co-morbidities. 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) at each follow up.
7. Health related quality of life. Health related quality of life will be assessed via validated questionnaires (EQ5D, DISABKIDS) once a year.
8. Socio-economic status. Socio-economic status will be assessed via standardized questionnaires (modified after KIGGS and TeenLABS) once a year.
9. The incidence of extreme obesity (BMI ≥35kg/m2) will be determined in the group of adolescents with moderate obesity (BMI 30-34.9kg/m2).
10. BMI-SDS. The BMI-SDS will be calculated and changes documented at each follow up.
11. Predictors of the above outcomes. 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 vie multiple regression analyses.

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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
  •   2012/07/23
  •   600
  •   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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    • 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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    • 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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    • 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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