Trial document





This trial has been registered retrospectively.
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  DRKS00006585

Trial Description

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Title

Early recognition and preventive care for persons being at risk for type 2 diabetes in community pharmacies in Bavaria, Germany

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Trial Acronym

GLICEMIA

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URL of the Trial

http://www.wipig.de/ueber-uns/wissenschaft/wissenschaftliche-projekte/item/glicemia

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Brief Summary in Lay Language

The trial has two aims: On the one hand, we want to analyze the feasibility of the lifestyle intervention program GLICEMIA in community pharmacies. On the other hand, we conduct this study to evaluate the effectiveness of the program in comparison to standard information.
Participants of the GLICEMIA group (intervention group) take part in five group-based lectures and receive three individual counselling sessions.
Participants of the standard information group (control group) receive written information and were informed about their diabetes risk factors at three appointments.
The diabetes risk is assessed using the questionnaire FINDRISC.
Participants are at least 35 years old and have an increased diabetes risk (FINDRISC score greater than six points).
In this trial the feasibility and the effectiveness of the lifestyle intervention program in community pharmacies are analyzed.
Therefore, the change of the FINDRISC score after 12 months is compared between the groups.

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Brief Summary in Scientific Language

To analyze the feasibility and effectiveness of the lifestyle intervention program GLICEMIA in community pharmacies, we conducted this clusterrandomized, controlled trial.
Participants of the intervention group take part in the lifestyle intervention program GLICEMIA consisting of five group-based lectures and three individual counselling sessions. The program promotes weight loss, physical activity and smoking cessation.
Participants of the control group receive written information regarding healthy lifestyle. Their lifestyle risk factors are assessed at three appointments.
Primary outcome is the difference of the change of the FINDRISC score between the two groups after 12 months.

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Organizational Data

  •   DRKS00006585
  •   2014/09/17
  •   [---]*
  •   yes
  •   Approved
  •   012/1630, Freiburger Ethik-Kommission International
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Secondary IDs

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

  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Subjects, who have an increased risk for diabetes (at least 7 points in the diabetes risk questionnaire FINDRISC), participate in a structured lifestyle intervention program (three individual counseling sessions and five group-based lectures regarding healthy diet, weight reduction, dialy physical activity and smoking cessation). Moreover, they received written information about nutrition, physical activity and - if they need - smoking cessation.
  •   Subjects, who have an increased risk for diabetes (at least 7 points in the diabetes risk questionnaire FINDRISC) take part in three assessements of their diabetes risk factors. They receive written information regarding nutrition, physical activity and - if they need - smoking cessation. They receive no further counseling.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

FINDRISC score: Is there a significant difference of the change of the FINDRISC score between the intervention and the control group after 12 months?

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Secondary Outcome

1) Weight loss (e.g., of at least 5% after 12 months in case of overweight at baseline)
2) Change of the capillary blood glucose level after 12 months
3) Change of the systolic and diastolic blood pressure after 12 months (non-invasive measurement)
4) Change of the physical activity after 12 months
5) Change of the quality of life after 12 months (SF-12 questionnaire)

For every secondary endpoint the comparison between the groups was analyzed.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/10/01
  •   1112
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

increased risk for diabetes (FINDRISC score at least 7 points), ability to give written informed consent

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Exclusion Criteria

diabetes, cancer, pregnancy, participation in a clinical trial 30 days prior to enrollment

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Addresses

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    • WIPIG - Wissenschaftliches Institut für Prävention im Gesundheitswesen der Bayerischen Landesapothekerkammer
    • Maria-Theresia-Str. 28
    • 81675  München
    • Germany
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    • Johannes-Gutenberg-Universität, Professur für Pharmakologie und Toxikologie, Fachbereich für Biochemie und Pharmazie
    • Ms.  Prof.  Kristina  Friedland 
    • Staudinger Weg 5
    • 55128  Mainz
    • Germany
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    • WIPIG - Wissenschaftliches Institut für Prävention im Gesundheitswesen der Bayerischen Landesapothekerkammer
    • Ms.  Karin   Schmiedel 
    • Maria-Theresia-Str. 28
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Bayerisches Staatsministerium für Gesundheit und Pflege, "Gesund.Leben.Bayern.", Leitstelle Prävention im Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
    • Eggenreuther Weg 43
    • 91058  Erlangen
    • Germany
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    •   [---]*
    •   [---]*
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    • Dr. August und Dr. Anni Lesmüller-Stiftung
    • Maria-Theresia-Str. 28
    • 81675  München
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/01/14
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* This entry means the parameter is not applicable or has not been set.