Trial document




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  DRKS00024978

Trial Description

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Title

Survey of people with severe mental illnesses on attitudes, preferences and experience regarding weight management interventions

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Trial Acronym

GEPSY

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URL of the Trial

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Brief Summary in Lay Language

People with severe mental illness are at increased risk of weight gain and obesity. This is due on the one hand to the drugs prescribed and on the other hand to an often unhealthy lifestyle. Because of this, patients need support in maintaining or achieving a healthy weight. In Germany, there are currently no suitable nutritional programs in the standard care of patients. This study aims to determine the extent to which the patients have already received nutritional training. Additionally, it will be examined which attitudes, preferences and experiences the patients have with regard to such training.
For this purpose, patients between the ages of 18 and 65 years with severe mental illness (schizophrenia and affective disorders) will be included in the study. The survey will be carried out by interview or online survey with a questionnaire developed for this study.
The knowledge gained provides important clues for the development of nutrition training for people with severe mental illness.

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Brief Summary in Scientific Language

People with severe mental illness are particularly vulnerable to excessive weight gain due to their illness, the resulting drug treatment and existing everyday difficulties. In order to improve the patient's quality of life and to reduce the risk of comorbidity, it is important to support the patient in maintaining or achieving a healthy weight. So far, however, there is a lack of suitable, evaluated interventions in standard patient care in Germany. As a preliminary work for the development of a weight management intervention, this study aims to assess the previous utilisation of nutritional training by people with severe mental illness. Additionally, the attitudes, preferences and experiences of people with severe mental illness with regard to nutritional training will be examined.
In-patients, day-patients and out-patients (all genders, 18-65 years of age) with severe mental disorders (ICD-10 -F2x and F3x, ill >2 years, significant functional impairment) will be included in the study. The patient's perspective will be assessed by interview or online survey using a questionnaire developed for this study.
The information obtained is intended to show the needs and preferences of patients with regard to nutritional training. The knowledge gained forms the basis for the development of suitable weight management interventions.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Data that were used for the respective publication will be made available. The data can be requested from the person responsible for the study with appropriate scientific justification.

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Organizational Data

  •   DRKS00024978
  •   2021/07/09
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  •   yes
  •   Approved
  •   211/21, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
  •   F30-F39 -  Mood [affective] disorders
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Interventions/Observational Groups

  •   Patients with severe mental illness (F2 and F3 diagnoses, ICD10) will be asked once with a questionnaire developed for this study about the utilisation of nutritional training and about their experiences, preferences and attitudes regarding nutritional training.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   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

Assessment of the utilisation of nutritional training and the experiences, preferences and attitudes regarding nutritional training of people with severe mental illness (study-specific questionnaire).

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Planned
  •   2021/07/11
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

In-patients, day-inpatients and outpatients; Patients with schizophrenia and schizotype disorders (ICD-10 F2x) or manic and mood disorders (ICD-10 F3x); Duration of illness ≥ 2 years; significant impact on activities of daily living.

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Exclusion Criteria

Patients who are unable to give consent; Patients who cannot answer the questions.

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Addresses

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    • Universität Ulm, Klinik für Psychatrie und Psychotherapie II, BKH Günzburg
    • Lindenallee 2
    • 89312  Günzburg
    • Germany
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    • Universität Ulm, Klinik für Psychiatrie und Psychotherapie II, BKH Günzburg
    • Ms.  Dr.  Johanna  Breilmann 
    • Lindenallee 2
    • 89312  Günzburg
    • Germany
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    • Universität Ulm, Klinik für Psychiatrie und Psychotherapie II, BKH Günzburg
    • Ms.  Julia  Wilfert 
    • Lindenallee 2
    • 89312  Günzburg
    • Germany
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Sources of Monetary or Material Support

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    • Universität Ulm, Klinik für Psychiatrie und Psychotherapie II, BKH Günzburg
    • Lindenallee 2
    • 89312  Günzburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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