Trial document




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  DRKS00013535

Trial Description

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Title

Evaluation of a rehabilitation program for metabolic syndrome patients in the Drei-Burgen-Clinic - A research project of the Rehabilitation Research Network Freiburg

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Trial Acronym

META

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URL of the Trial

http://www.imbi.uni-freiburg.de/SEVERA/Projekte/aktuell/meta

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Brief Summary in Lay Language

In Germany, between 20% and 23% of adults between 18 and 79 years of age are estimated to be affected by the so-called metabolic syndrome that is characterized by overweight in combination with elevated blood pressure, elevated levels of blood sugar, and/or elevated or diminished levels of specfic blood lipids. It is generally assumed that life style factors like nutrition and exercise contribute to the development and perpetuation of this syndrome. Therefore, treatment of the metabolic syndrome attempts to initiate life style changes in these areas with the ultimate goal of weight reduction or weight stabilization.

The so-called META-program of the Drei-Burgen-Klinik in Bad Kreuznach makes extensive use of these components of metabolic syndrome treatment. The present study aims at an evaluation of this program with respect to its effects in these life style domains. It analyzes changes in clinical outcomes like weight and blood pressure as well as in psychosocial outcomes like eating behavior and psychological health at the end of the program and three months later. In addition, patients' satisfaction with the program and patient reported attainmement of personal rehab goals will be analyzed.

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Brief Summary in Scientific Language

In Germany, the prevalence of the metabolic syndrome is estimated to lie between 20% and 23% of adults between 18 and 79 years of age. The development and perpetuation of this syndrome is generally considered to be influenced by psychosocial factors like eating behaviors or exercise. Therefore, strategies for the treatment of this syndrome typically include attempts to inititate life style changes in these domains with the ultimate goal of reducing or stabilizing the patients' weight.

Based on this conception, the Drei-Burgen-Klinik in Bad Kreuznach has implemented the so-called META-program that applies life style interventions in the treatment of the Metabolic Syndrome. The present study aims at evaluating effects of this program with respect to clinical outcomes like weight and blood pressure as well as psychosocial outcomes like eating behavior and psychological health at the end of the program and three months later. In addition, patients' satisfaction with the program as well as their self-reported attainment of their individual rehab goals will be included in the analyses.

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Organizational Data

  •   DRKS00013535
  •   2018/05/14
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  •   yes
  •   Approved
  •   31/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1208-1601 
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Health Condition or Problem studied

  •   Metabolic Syndrom
  •   E66 -  Obesity
  •   E78.5 -  Hyperlipidaemia, unspecified
  •   E88.9 -  Metabolic disorder, unspecified
  •   E11.5 -  Type 2 diabetes mellitus; With peripheral circulatory complications
  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   The program META is offered by the Drei-Burgen-Clinic as a special attempt to provide inpatient rehabilitation for patients suffering from the metabolic syndrome. The program is conducted in a closed group format with up to 15 patients over a period of five weeks. It consists of various treatment modules that include e.g. patient education in the fields of nutrition, exercise, and management of blood sugar leveL, as well as self-management and coping with obesity.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Health behavior, mental health and health competencies at the second (T2) and third (T3) measurement point as measured via questionnaires (AD-EVA, Ardelt-Gattinger & Meindl 2010; HEAHLT-49, Rabung et al. 2009; HELP, Farin et al. 2013; Brief-IPQ, Rief unpublished; and additional single items developed by the research team)

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Secondary Outcome

Subjective attainment of personal rehab-goals and satisfaction with the rehab-program measured by questionnaires

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/04/30
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Metabolic Syndrom

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Exclusion Criteria

Acute psychiatric disease

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Addresses

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    • Sektion Versorgungsforschung und Rehabilitationsforschung (SEVERA)
    • 79106  Freiburg
    • Germany
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    • Drei-Burgen-Klinik
    • Ms.  Dr.  Ute  Dederichs-Masius 
    • Zum Wacholder 2
    • 55  Bad Kreuznach
    • Germany
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    • Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinik Freiburg,
    • Ms.  Dr.  Manuela  Glattacker 
    • Hugstetter Str. 49
    • 79106  Freiburg
    • Germany
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    • Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinik Freiburg,
    • Mr.  Dr.  Jürgen M.  Giesler 
    • Hugstetter Str. 49
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • DRV Rheinland-Pfalz
    • Eichendorffstraße 4-6
    • 67346  Speyer
    • 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.