Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00016856

Trial Description

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Title

Identical twins: Obesity surgery and mental health.

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Trial Acronym

two

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Identical twins are evaluated before and after obesity surgery. Main goal of this study is to find out, what effect obesity surgery has on mental health, including health related quality of life.

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Brief Summary in Scientific Language

Identical twins: what effects has obesity surgery on mental health.

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Organizational Data

  •   DRKS00016856
  •   2019/03/14
  •   [---]*
  •   yes
  •   Approved
  •   18-8450-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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

  •   E66.0 -  Obesity due to excess calories
  •   F50.8 -  Other eating disorders
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Interventions/Observational Groups

  •   Mental health and Quality of life is measured with the following questionniares:

    Three-Factor-Eating-Questionnaire (FEV), Body-Image-Questionnaire (FKB-20), Obesity specific QoL (IWQOL) und Yale food-addiction scale (YFAS), self-efficacy (IE-4), commitment to exercise scale (CES) und impulsivity (BIS/BAS, BIS 15).

    Data is collected at four different times: Right before surgery, 4,12 and 36 weeks after surgery.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Mental health and Quality of life is measured with the following questionniares:

Three-Factor-Eating-Questionnaire (FEV), Body-Image-Questionnaire (FKB-20), Obesity specific QoL (IWQOL) und Yale food-addiction scale (YFAS), self-efficacy (IE-4), commitment to exercise scale (CES) und impulsivity (BIS/BAS, BIS 15).

Data is collected at four different times: Right before surgery, 4,12 and 36 weeks after surgery.

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Secondary Outcome

Right before and 36 weeks after surgery, the weight of the patients is measured.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/01/30
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Identical twins with planned obesity surgery ahead of them.

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Exclusion Criteria

Cognitive inability to fill out the questionnaires.

Patients younger than 18 or older than 99 years.

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen
    • Mr.  Per  Teigelack 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen
    • Mr.  Per  Teigelack 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.