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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00003067 |
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Date of registration:
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30/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of lifestyle coaching in general practice - a cluster randomized controlled pilot study
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Scientific title:
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Effectiveness of lifestyle coaching in general practice - a cluster randomized controlled pilot study - coaching in general practice |
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Date of first enrolment:
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24/05/2011 |
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Target sample size:
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600 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00003067 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: prevention
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Michael
Mehring |
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Address:
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Orleansstr. 47
81667
München
Germany |
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Telephone:
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089614658914 |
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Email:
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michael.mehring@lrz.tum.de |
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Affiliation:
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Institut für Allgemeinmedizin |
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Name:
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Michael
Mehring |
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Address:
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Orleansstr. 47
81667
München
Germany |
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Telephone:
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089614658913 |
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Email:
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michael.mehring@lrz.tum.de |
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Affiliation:
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Institut für Allgemeinmedizin des Klinikums rechts der Isar; Technische Universität München |
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Key inclusion & exclusion criteria
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Inclusion criteria: at least 18 years old; Internet access; sufficient knowledge of the German language; Signed declaration of consent form
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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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E66.9
F17.2
Z73
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Obesity, unspecified
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Problems related to life-management difficulty
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F17.2
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E66.9
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Intervention(s)
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Group 1: 100 Participants in the intervention arm weight reduction with a 12 week support by the HausMed Internet coaching program
Group 2: 100 Participants in the intervention arm
smoking cessation with a 12 week support by the HausMed Internet coaching program
Group 3: 100 Participants in the intervention arm stress reduction with a 12 week support by the HausMed Internet coaching program
Group 4: 100 Participants in the control arm weight reduction with a 12 week usual care
support by the general practitioner
Group 5: 100 Participants in the control arm smoking cessation with a 12 week usual care
support by the general practitioner
Group 6: 100 Participants in the control arm stress reduction with a 12 week usual care
support by the general practitioner
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Primary Outcome(s)
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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(s)
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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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Source(s) of Monetary Support
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HausMed eHealth Services GmbH
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Ethics review
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Status: Approved
Approval date: 19/04/2011
Contact:
ethikkommission@mri.tum.de
Ethikkommission der Fakultät für Medizin der Technischen Universität München
+49-89-41404371
ethikkommission@mri.tum.de
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