Trial document




drksid header

  DRKS00016677

Trial Description

start of 1:1-Block title

Title

The Quality of Life for Obesity Surgery-Revised (QOLOS-R) questionnaire for the assessment of health-related quality of life prior to and following bariatric surgery

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

QOLOS-R

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://n/a

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study will be addressing the psychometric evaluation of the revised version of the Quality of Life for Obesity Surgery questionnaire (QOLOS-R). Using a longitudinal design, reliability (internal consistency, retest reliability) and validity (dimenionality, convergent and discriminant validity, sensitivity to Change) will be assessed.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Psychometric evaluation of the revised version of the Quality of Life for Obesity Surgery questionnaire.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016677
  •   2019/02/11
  •   [---]*
  •   yes
  •   Approved
  •   8133_BO_S_2018, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E66.02 -  [generalization E66.0: Obesity due to excess calories]
  •   F50.9 -  Eating disorder, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   This prospective longitudinal study will be addressing the specific health-related quality of life of patients with grade 2/3 obesity undergoing bariatric surgery (Roux-en-Y gastric bypass, omega-loop gastric bypass, sleeve gastrectomy, gastric banding). Assessments will be conducted at 4 measurement points: t0 = prior to surgery, t1 = 6 months following surgery, t2 = 12 months following surgery, and t3 = 24 months following sugery.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Bariatric surgery specific health-related quality of life (HRQoL) using the Quality of Life for Obesity Surgery-Revised questionnaire (QOLOS-R); 4 assessments: t0 = prior to surgery, t1 = 6 months following surgery, t2 = 12 months following surgery, t3 = 24 months following surgery

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Symptoms of eating disorders (Eating Disorder Examination-Questionnaire, EDE-Q), Food addiction (Yale Food Addiction Scale 2.0, YFAS 2.0), anxiety and Depression (Hospital Anxiety and Depression Scale, HADS), self-harm (Self Harm Inventory, SHI), alcohol use disorder (Alcohol Use Disorders Identification Test, AUDIT), dumping (Sigstad Dumping Score)
4 assessments:
t0 = prior to surgery
t1 = 6 months following surgery
t2 = 12 months following surgery
t3 = 24 months following surgery

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/04/08
  •   600
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Adult bariatric surgery candidates with grad 2/3 obesity, 18 years or older

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

insufficient German language skills, cognitive impairments, psychosis

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover Klinik für Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr. med. Dr. phil.  Astrid  Müller 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • KRH Klinikum Neustadt, Adipositaszentrum
    • Mr.  Prof. Dr. med.  Julian  Mall 
    • Haltenhoffstr. 41
    • 30167  Hannover
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Herzogin Elisabeth Hospital, Adipositaszentrum
    • Mr.  Dr. med.  Hinrich  Köhler 
    • Leipziger Str. 24
    • 38124  Braunschweig
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • DRK-Krankenhaus Clementinenhaus, Adipositaszentrum
    • Ms.  Dr.  Ruth  Wunder 
    • Lützerodestraße 1
    • 30161  Hannover
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • AMC WolfartKlinik Gräfelfing, Adipositaszentrum
    • Mr.  PD Dr. med.  G.  Meyer 
    • Ruffiniallee 17
    • 82166  Gräfelfing
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Chirurgische Klinik München-Bogenhausen, Adipositaszentrum
    • Mr.  Prof. Dr. med.  Thomas  Hüttl 
    • Denninger Str. 44
    • 81679   München
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Else Kröner-Fresenius-Zentrum Institut für Ernährungsmedizin, Klinikum rechts der Isar, Technische Universität München
    • Ms.  Dr.  Christina  Holzapfel 
    • Weihenstephaner Berg 1
    • 85354  Freising
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Medizinische Hochschule Hannover Klinik für Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr. med. Dr. phil.  Astrid  Müller 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medizinische Hochschule Hannover Klinik für Psychosomatik und Psychotherapie
    • Ms.  Melanie  Pommnitz 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Psychosomatik und Psychotherapie, Medizinische Hochschule Hannover
    • Ms.  Prof.  Astrid  Müller 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.