Trial document




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  DRKS00003067

Trial Description

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Title

Effectiveness of lifestyle coaching in general practice - a cluster randomized controlled pilot study

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Trial Acronym

coaching in general practice

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URL of the Trial

http://www.hausmed.de/studie

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Brief Summary in Lay Language

The aim of this study is to investigate the effectiveness of the three internet-supported coaching programs for weight reduction, smoking cessation and stress reduction in comparison to the conventional lifestyle consultation as usual care in general practice.
The 12 week Internet-supported Coaching program is based on education, motivation, exercise guidance, daily SMS reminder, weekly feedback function via Internet,
active company and monitoring by the general practitioner. The study is addressed to patients with overweight, to smokers or to patients with a high subjective perceived stress.
After completion of the coaching program the results of the intervention arm are to be compared and evaluated with those of the control arm.
Background of the study is that an effective consultation and behavior training for the weight reduction, smoking cessation and stress reduction in general practice is mostly very unsatisfactory practicable and possibly the Internet-supported Coaching program represents a support for this leak.

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Brief Summary in Scientific Language

Cluster-randomized controlled evaluation study in 2 x 40 general practices with 3 x 100 patients in the intervention arm and 3 x 100 patients in the control arm during a twelve week observation period.
Intervention: The participants in the intervention group are informed about the HausMed coaching program by the physician after inclusion into the study. According to the indication the Participants then follow a condition-specific internet-based coaching program (HausMed) during a period of 12 weeks. The internet-supported program is based on education, motivation, exercise guidance, daily memory function by SMS, active monitoring by general practice and a weekly feedback function via Internet. Participants in the control arm are advised and cared under usual care conditions by the general practitioners without the HausMed coaching program.

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Organizational Data

  •   DRKS00003067
  •   2011/05/30
  •   [---]*
  •   no
  •   Approved
  •   4001/11, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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

  •   E66.9 -  Obesity, unspecified
  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
  •   Z73 -  Problems related to life-management difficulty
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Interventions/Observational Groups

  •   100 Participants in the intervention arm weight reduction with a 12 week support by the HausMed Internet coaching program
  •   100 Participants in the intervention arm
    smoking cessation with a 12 week support by the HausMed Internet coaching program
  •   100 Participants in the intervention arm stress reduction with a 12 week support by the HausMed Internet coaching program
  •   100 Participants in the control arm weight reduction with a 12 week usual care
    support by the general practitioner
  •   100 Participants in the control arm smoking cessation with a 12 week usual care
    support by the general practitioner
  •   100 Participants in the control arm stress reduction with a 12 week usual care
    support by the general practitioner
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

Participants fill in questionnaires at study onset and after 12 weeks. Main outcome measures are, according to the respective indication, the change of weight and waist circumference (value at study onset - value after 12 weeks), the proportion of patients with a negative Cotinine-urine test at 12 weeks, and the change of the sum score of the Perceived Stress Questionnaire (score at study onset - score after 12 weeks).

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Secondary Outcome

Weight reduction: food intake behavior as well as physical activity are documented by questionnaires at the beginning and after 12 weeks. Secondary outcome is the portion after 12 weeks who increased physical activety as well as healthier food intake.
Smoking cessation: smoke behavior is documented by questionnaires at the beginning and after 12 weeks. Secondary outcome is the portion who reduced the nicotine consumption more than 50% after 12 weeks as well as the proportion of those who are at least 6, 8 or 10 weeks abstinent.
Also is via the Internet program continuously documented in all groups once a week over 12 weeks on a scale from 1-10 the motivation and condition.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/05/24
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

at least 18 years old; Internet access; sufficient knowledge of the German language; Signed declaration of consent form

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Exclusion Criteria

Younger than 18 years;
No internet access;
German knowledge lacking;
For weight reduction: BMI < 25; type-1-diabetic, hypothyroidism, pregnant or breast feeding woman, dependence on drugs or alcohol, consuming and immunodeficiency illnesses, heavy psychological illnesses, osteoporosis, kidney insufficiency, heart failure, coronary heart illness, eating disorders, cirrhosis of the liver, acute infections, other heavy metabolic illnesses (e.g. gout)
For stress reduction and smoking cessation: Depressive illness, post traumatic stress disorder, schizophrenia, mania or other psychiatric illness

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Addresses

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    • Institut für Allgemeinmedizin des Klinikums rechts der Isar; Technische Universität München
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Orleansstr. 47
    • 81667  München
    • Germany
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    • Institut für Allgemeinmedizin des Klinikums rechts der Isar; Technische Universität München
    • Mr.  Dr. med.  Michael  Mehring 
    • Orleansstr. 47
    • 81667  München
    • Germany
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    • Institut für Allgemeinmedizin
    • Mr.  Dr. med.  Michael  Mehring 
    • Orleansstr. 47
    • 81667  München
    • Germany
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Sources of Monetary or Material Support

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    • HausMed eHealth Services GmbH
    • Schlesische Str. 29/30
    • 10997   Berlin
    • 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.