Trial document





This trial has been registered retrospectively.
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  DRKS00005956

Trial Description

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Title

CHIP-Germany- A scientifically supported type 2 diabetes prevention project

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Trial Acronym

CHIP Germany

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Type 2 Diabetes mellitus is a chronic metabolic disorder. Besides genetic factors its developement is mainly caused by unfavourable lifestyle habits. Untreated, Diabetes mellitus often causes severe sequelae including coronary heart disease, chronic kidney disease, ischaemic stroke and diabetic foot syndrome. The majority of type 2 diabetes cases could be prevented by the adoption of a healthier lifestyle (e.g. increase of physical activity, weight loss and change in eating habits).

CHIP („CHampions In Prevention“) Germany is a comprehensive coaching lifestyle intervention program for the prevention of type 2 diabetes and cardiovascular diseases.

Initially, participants were assigned either to the intervention group (receives the lifestyle intervention program CHIP) or to the control group (does not receive the lifestyle intervention program CHIP; participants of the control group are treated as usual by their general practitioners).

For participants of the intervention group, the 12-months study initially comprises an 8-week lifestyle intervention program, followed by a 10-months follow-up period. The program’s emphasis is placed on the reduction of metabolic and cardiovaskular risk factors by providing profound knowledge and skills about a health-affirming lifestyle. The CHIP program therefore includes health education, weight reduction by means of a special diet, physical training (walking courses), cooking classes and dietitian-guided grocery shopping tours.
In order to assess the intervention program's efficacy, laboratory and anthropometric parameters (serum lipids, serum glucose, body weight, body mass index and waist circumference) were measured in both groups after 8 weeks and after 6 and 12 months. The risk score FINDRISK is applied as an additional screening instrument for the assessment of the long-term diabetes risk.

During the follow-up period, monthly alumni-meetings are hold, providing group support and further knowledge contributing to the consolidation of new behavioural habits.

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Brief Summary in Scientific Language

CHIP Germany, based on the American Comprehensive Health Improvement Project (CHIP) (Diehl, 1998), is designed as a randomized controlled and comparative trial for the primary and secondary prevention of
pre-diabetes, type 2 diabetes and/or cardiovascular diseases. The study is conducted in a primary care setting in Hannover, Germany. The 8-week coaching lifestyle intervention is followed by a 10-months follow-up period.

The CHIP intervention provides profound knowledge and skills to make healthier lifestyle choices like changes in eating habits and increase of physical activity (participants meet twice a week for 2.5 hours). Moreover the program provides physical training (walking courses), cooking classes and dietitian-guided grocery shopping tours.

During the follow-up period, monthly alumni-meetings are hold, providing group support and further knowledge contributing to the consolidation of new behavioural habits.

Primary outcome parameters include:

- significant reduction of body weight in overweight/obese persons after 8 weeks and after 6 and 12 months;

-significant improvements of blood glucose values after 8 weeks and after 6 and 12 months;

-significant long-term improvements of the diabetes risk assessed by means of the diabetes risk score FINDRISK.

Secondary outcome parameters include:

-significant improvements of blood lipids, blood pressures, waist circumference and body mass index after 8 weeks and after 6 and 12 months;

-significant improvements of (mental) wellbeing and health-related quality of life
after 8 weeks and after 6 and 12 months.

Inclusion criteria:
participants either suffer from pre-diabetes, type 2 diabetes or are at high risk of developing diabetes (FINDRISK°>11) and/or cardiovascular diseases.

The control group is treated “as usual” by their general practitioners.

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Organizational Data

  •   DRKS00005956
  •   2014/03/06
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  •   yes
  •   Approved
  •   EA1/151/05, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1153-9957 
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Health Condition or Problem studied

  •   E11.9 -  Non-insulin-dependent diabetes mellitus; Without complications
  •   I51.6 -  Cardiovascular disease, unspecified
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Interventions/Observational Groups

  •   Intervention group: Participation in an 8-week lifestyle intervention program: participants meet twice a week for 2.5 hours.The curriculum includes the following main topics: lifestyle and health, pathogenesis of diseases (cardiovascular diseases, diabetes mellitus, hypertension, hyperlipidaemia), behavioural change, overweight and obesity, diet, change in eating habits, physical activity (the CHIP intervention advocates exercise of moderate intensity for at least 30 minutes per day) and coping strategies.
    Participants further have access to guided walkingcourses. Workshops like dietitian-guided grocery shopping tours and cooking classes are offered.

    -The 8 week intervention is followed by a 10-months follow-up period. During this follow-up period, monthly educational alumni-meetings are hold.

    -Assessment of anthropometric and laboratory parameters (body weight, body mass index, blood pressure, blood lipid- and blood glucose values) after 8 weeks and after 6 and 12 months.
    -Completion of questionnaires (addressing levels physical activity, eating habits, coping strategies, health-related quality of life, wellbeing) at baseline, after 8 weeks and after 6 and 12 months.





  •  
    The control group is treated “as usual” by their general practitioners.

    -Assessment of anthropometric and laboratory parameters, questionnaires filled out at baseline, after 8 weeks and after 6 and 12 months.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Intervention group:

-Body weight at baseline, after 8 weeks and after 6 and 12 months, compared to controls;

-Blood glucose values at baseline, after 8 weeks and after 6 and 12 months, compared to controls;

-Long-term improvement of the diabetes risk (risk score FINDRISK) at baseline and after 12 months, compared to controls.

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Secondary Outcome


Intervention group:
blood lipids, body mass index,waist circumference, systolic and diastolic blood pressure, eating habits (questionnaire, 3-day food log), level of physical activity (questionnaire),
mental wellbeing (wellbeing questionnaire), health-related quality of life (SF-12) and self-efficacy (questionnaire) at baseline, after 8 weeks and after 6 and 12 months, compared to controls.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2010/09/09
  •   152
  •   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

- participants either suffer from pre-diabetes, type 2 diabetes or are at high risk of developing diabetes (FINDRISK°>11) and/or cardiovascular diseases (being overweight/obese, being affected by hypertension, elevated blood lipid- and glucose levels, unfavourable nutrition habits, physical inactivity and smoking);

- persons 18 years of age and older;

- persons who are physically and mentally able to participate in the study;

- written informed consent.

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Exclusion Criteria


-persons with severe acute or chronic diseases who are not able to participate in the study at the discretion of their treating physician;

-minors under the age of 18 years.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Fachhochschule Münster, Fachbereich Oecotrophologie
    • Ms.  Prof. Dr. oec.troph.  Heike  Englert 
    • Corrensstraße 25
    • 48149  Münster
    • Germany
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    • Fachhochschule Münster, Fachbereich Oecotrophologie
    • Ms.  Prof. Dr. oec.troph.  Heike  Englert 
    • Corrensstraße 25
    • 48149  Münster
    • Germany
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    • Vinzenzkrankenhaus Hannover
    • Ms.  Katharina  Wennehorst 
    • Lange-Feld-Strasse 31
    • 30559  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Diabetes-Stiftung
    • Staffelseestraße 6
    • 81477  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/10/07
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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.