Effectiveness of lifestyle coaching in general practice - a cluster randomized controlled pilot study
Organizational Data
- DRKS-ID:
- DRKS00003067
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2011-05-30
- Last update in DRKS:
- 2012-01-04
- Registration type:
- Retrospective
Acronym/abbreviation of the study
coaching in general practice
URL of the study
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.
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.
Health condition or problem studied
- ICD10:
- E66.9 - Obesity, unspecified
- ICD10:
- F17.2
- ICD10:
- Z73 - Problems related to life-management difficulty
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 100 Participants in the intervention arm weight reduction with a 12 week support by the HausMed Internet coaching program
- Arm 2:
- 100 Participants in the intervention arm smoking cessation with a 12 week support by the HausMed Internet coaching program
- Arm 3:
- 100 Participants in the intervention arm stress reduction with a 12 week support by the HausMed Internet coaching program
- Arm 4:
- 100 Participants in the control arm weight reduction with a 12 week usual care support by the general practitioner
- Arm 5:
- 100 Participants in the control arm smoking cessation with a 12 week usual care support by the general practitioner
- Arm 6:
- 100 Participants in the control arm stress reduction with a 12 week usual care support by the general practitioner
Endpoints
- 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).
- 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.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- No Entry
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2011-05-24
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 600
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Institut für Allgemeinmedizin des Klinikums rechts der Isar; Technische Universität MünchenProf. Dr. med. Antonius SchneiderOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089614658913
- Fax:
- 089614658915
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Institut für Allgemeinmedizin des Klinikums rechts der Isar; Technische Universität MünchenDr. med. Michael MehringOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089614658913
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Institut für AllgemeinmedizinDr. med. Michael MehringOrleansstr. 4781667 MünchenGermany
- Telephone:
- 089614658914
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- HausMed eHealth Services GmbHSchlesische Str. 29/3010997 BerlinGermany
- Telephone:
- 030-60989867-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.hausmed.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Fakultät für Medizin der Technischen Universität MünchenIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- +49-89-41404371
- Fax:
- +49-89-41404199
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2011-02-28
- Ethics committee number:
- 4001/11
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2011-04-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry