Trial document




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  DRKS00017584

Trial Description

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Title

Tackling malnutrition in nursing home residents - an individualized multimodal intervention study

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Trial Acronym

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URL of the Trial

https://www.enable-cluster.de/forschung/mangelernaehrung-im-alter/bewaeltigung-von-mangelernaehrung-und-dehydratation

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Brief Summary in Lay Language

Nutritional care is a particular challenge in nursing homes. Due to decreasing appetite and changing in taste as well as the fact that food and drinks can no longer be chewed or swallowed properly, nutrition is sometimes inadequate. This in turn results in a loss of body weight and/or muscle or an increased frailty and need for help. This study implements a nutritional concept to increase dietary intake of residents at risk of malnutrition or with malnutrition in nursing homes, which consists of three elements: (1) protein drink, (2) energy- and protein-enriched meals, and (3) pureed and reshaped energy- and protein-enriched meals. In order to select the elements of the dietary intervention appropriately, individual nutritional problems and needs of the residents are assessed. The aim of the study is to investigate whether this nutritional concept has a positive effect on energy and protein intake, body weight, quality of life and handgrip strength of the nursing home residents. It is planned to include 55 nursing home residents with (risk of) malnutrition.

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Brief Summary in Scientific Language

Nursing home residents are often affected by malnutrition. Due to the multifactorial etiology of malnutrition with different individual causes, individualized intervention strategies are necessary to ensure sufficient dietary intake. The aim of this pre-post-study is to investigate the effects of an individualised multimodal nutritional intervention compared to usual care on energy and protein intake, body weight, handgrip strength and quality of life in 55 nursing home residents with (risk of) malnutrition. The intervention concept consists of 3 modules, (1) a protein drink, (2) energy and protein enriched meals and (3) pureed and reformed energy and protein enriched meals that can be individually combined according to nutritional problems and needs. The study is conducted over a period of 18 weeks and is divided into a six-week phase of usual care, a six-week intervention phase and an equally long follow-up.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017584
  •   2019/09/10
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  •   yes
  •   Approved
  •   71_19 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   Malnutrition
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Interventions/Observational Groups

  •   individualized multimodal nutritional care intervention, 6 weeks
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Characteristics

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

Energy intake

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Secondary Outcome

Protein intake, body weight, quality of life, handgrip strength

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/09/30
  •   55
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Malnutrition (according to Mini Nutritional Assessment-Short Form (MNA-SF)) or risk of malnutrition (according to MNA-SF and/ or receiving texture modified diet), for those at risk at least one nutrition related factor according to MNA-SF (MNA-A=0 or 1; MNA-B=0, 1 or 2; MNA-D=0; MNA-F=0, 1 or 2)

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Exclusion Criteria

enteral or parenteral nutrition, terminal life stage, acute illness, BMI ≥ 30 kg/m2

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Addresses

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    • Institut für Biomedizin des Alterns, Friedrich-Alexander Universität Erlangen-Nürnberg
    • Mr.  Prof. Dr.  Cornel  Sieber 
    • Kobergerstr. 60
    • 90408  Nürnberg
    • Germany
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    • Institut für Biomedizin des Alterns, Friedrich-Alexander-Universität Erlangen-Nürnberg
    • Ms.  Prof. Dr.  Dorothee  Volkert 
    • Kobergerstr. 60
    • 90408  Nürnberg
    • Germany
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    • Institut für Biomedizin des Alterns, Friedrich-Alexander Universität Erlangen-Nürnberg
    • Ms.  Dr.  Eva  Kiesswetter 
    • Kobergerstr. 60
    • 90408  Nürnberg
    • Germany
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    • Institut für Biomedizin des Alterns, Friedrich-Alexander-Universität Erlangen-Nürnberg
    • Ms.  Johanna  Seemer 
    • Kobergerstr. 60
    • 90408  Nürnberg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/02/21
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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.