Trial document





This trial has been registered retrospectively.
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  DRKS00005122

Trial Description

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Title

PreDictor Research in Obesity during Medical care - weight Loss in children and adolescents during an INpatient rehabilitation- the DROMLIN study

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Trial Acronym

DROMLIN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Obesity is increasing worldwide at alarming rates in adults and children with epidemic levels having been reached in Western industrialized societies. Obese children/adolescents are very likely to be also obese in adulthood which increases the risk of developing a number of comorbidities such as type 2 diabetes, cardiovascular disease, structural problems with joints, malignancies and psychosocial problems. The costs for the treatment of obesity associated diseases are enormous for the health care systems and are rising further rapidly. Besides the prevention of obesity in childhood and adolescence it is unequivocally necessary to individually adapt the therapy of already obese children/adolescents in order to achieve better results. Therefore, it is important to find predictors which play a significant role in successful weight loss and weight loss maintenance in children and adolescents. The aim of the project is to find such predictors on the basis of new hypotheses.
60 obese children and adolescents (8 to 17 years old) with an indication for hospitalization with the purpose of weight loss, will be recruited at the children rehabilitation facility in Wangen. Children with severe psychiatric comorbidities, with linguistic or intellectual limitations, type-1 diabetes, tumors, systemic disorders, or severe cardiovascular diseases are excluded from participation.. The average duration of stay of the children and adolescents in this rehabilitation facility is 42 days. The study will bi an integrative component of an established therapy at a rehabilitation facility in Wangen in close cooperation with the parents, children and the health care professionalists. The examinations to be investigated can be grouped into four clusters: 1. objective and subjective parameters for eating behaviour, 2. objective and subjective parameters for body condition, 3. regulation of the autonomic nervous system and 4. psychometry and sociometry. Data of the clinical routine with weight-related importance will also be used for the analyses. In order to verify the success of the therapy we will additionally assess besides the body weight, the body composition and the physical fitness. A follow-up is performed. In order to evaluate the data appropriately, the examinations are also investigated in 30 participants of a normal weight reference group, matched for age and gender.

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Brief Summary in Scientific Language

Obesity is increasing worldwide at alarming rates in adults and children with epidemic levels having been reached in Western industrialized societies. Obese children/adolescents are very likely to be also obese in adulthood which increases the risk of developing a number of comorbidities such as type 2 diabetes, cardiovascular disease, structural problems with joints, malignancies and psychosocial problems. The costs for the treatment of obesity associated diseases are enormous for the health care systems and are rising further rapidly. Besides the prevention of obesity in childhood and adolescence it is unequivocally necessary to individually adapt the therapy of already obese children/adolescents in order to achieve better results. Therefore, it is important to find predictors which play a significant role in successful weight loss and weight loss maintenance in children and adolescents. The aim of the project is to find such predictors on the basis of new hypotheses.
60 obese children and adolescents (8 to 17 years old) with an indication for hospitalization with the purpose of weight loss, will be recruited at the children rehabilitation facility in Wangen. Children with severe psychiatric comorbidities, with linguistic or intellectual limitations, type-1 diabetes, tumors, systemic disorders, or severe cardiovascular diseases are excluded from participation.. The average duration of stay of the children and adolescents in this rehabilitation facility is 42 days. The study will bi an integrative component of an established therapy at a rehabilitation facility in Wangen in close cooperation with the parents, children and the health care professionalists. The examinations to be investigated can be grouped into four clusters: 1. objective and subjective parameters for eating behaviour, 2. objective and subjective parameters for body condition, 3. regulation of the autonomic nervous system and 4. psychometry and sociometry. Data of the clinical routine with weight-related importance will also be used for the analyses. In order to verify the success of the therapy we will additionally assess besides the body weight, the body composition and the physical fitness. A follow-up is performed. In order to evaluate the data appropriately, the examinations are also investigated in 30 participants of a normal weight reference group, matched for age and gender.

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Organizational Data

  •   DRKS00005122
  •   2013/07/03
  •   [---]*
  •   yes
  •   Approved
  •   429/2011BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Obesity in childhood and adolescence
  •   E65-E68 -  Obesity and other hyperalimentation
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Interventions/Observational Groups

  •   Children and adolescents (8 to 17 years old) with an indication for hospitalization with the purpose of weight loss will be recruited for a series of investigations. The examinations are performed upon admission, and the same prior to discharge. The examinations to be investigated can be grouped into four clusters: 1. objective and subjective parameters for eating behaviour, 2. objective and subjective parameters for body condition, 3. regulation of the autonomic nervous system and 4. psychometry and sociometry. On the basis of these data and new hypotheses, we want to identify potential predictors for successful weight loss
    and weight loss maintenance
  •   The same examinations will be performed once in normal weight children and adolescents matched for gender and age
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Characteristics

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

Primary outcome is the change of the body mass index standard deviation score (BMI-SDS). Body weight and body height are assessed upon admission, and prior to discharge using calibrated instruments.

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Secondary Outcome

Secondary Outcomes are 1) the change of body composition, assessed upon admission and prior to discharge using a lipometer and 2) the change of motor performance assessed upon admission and prior to discharge using the Dordel-Koch-Test



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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/02/20
  •   87
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   17   Years
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Additional Inclusion Criteria

Children and adolescents with an indication for hospitalization with the purpose of weight loss - as set by their responsible primary or secondary care physicians - and with a BMI scoring higher than the 97th, resp. of the age and sex specific percentile were included. The reference group has normal weight and is matched for sex and age

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Exclusion Criteria

Children with severe psychiatric comorbidities, with linguistic or intellectual limitations, type-1 diabetes, tumors, systemic disorders, or severe cardiovascular diseases are excluded from participation. If written informed consent is not provided bei either the child and/or the legal quardian, this is also an exclusion criterion. For the reference group, overweight is also an exclusion criterion.

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Addresses

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    • Universitäsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr.  Isabelle  Mack 
    • Frondsbergstr. 23
    • 72070  Tübingen
    • Germany
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    • Fachkliniken Wangen, Rehabilitationsklinik für Kinder und Jugendliche mit Atemwegserkrankungen, Allergien und psychosomatischen Beschwerden
    • Mr.  Dr.  Dirk  Dammann 
    • Am Vogelherd 14
    • 88239  Wangen
    • Germany
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    • Landeshauptstadt Stuttgart Abteilung für Kinder-, Jugend- und Zahngesundheit, Soziale Dienste, Gesundheitsamt der Stadt Stuttgart 53-3
    • Mr.  Dr.  Stefan  Ehehalt 
    • Bismarckstr. 3
    • 70176  Stuttgart
    • Germany
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    • Pädiatrische Endokrinologie und Adipositas, Universitätsklinik für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr.  Gerhard  Binder 
    • Hoppe-Seyler-Str. 1
    • 72076  Tübingen
    • Germany
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    • Universitäsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr.  Paul  Enck 
    • Frondsbergstr. 23
    • 72070  Tübingen
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr.  Isabelle  Mack 
    • Frondsbergstr. 23
    • 72070  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr.  Isabelle  Mack 
    • Frondsbergstr. 23
    • 72070  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Else Kröner-Fresenius-Stiftung
    • 61288  Bad Homburg
    • Germany
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    •   [---]*
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    • Universitätsklinikum Tübingen, Innere Medizin VI Psychosomatische Medizin und Psychotherapie
    • Osianderstr. 5
    • 72076  Tübingen
    • 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.