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ISRCTN
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ISRCTN12666286
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ClinicalTrials.gov identifier
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Public title
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The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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A cognitive behaviour intervention is more effective in achieving behavioural changes and therefore changes in lifestyle and cardiovascular risk profile than usual care in patients with type two diabetes.
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Lay summary
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Ethics approval
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Approved by the Medical Ethical Committee of the VU University Medical Center Amsterdam.
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Study design
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Randomised, active controlled, factorial, single blinded trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Diabetes Mellitus type II (DM type II)
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Participants - inclusion criteria
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1. Patients with type two diabetes from general practices with the support of a practice nurse
2. Age 40 to 70 years
3. Written informed consent
4. Capable to fill in questionnaires
5. Understanding of Dutch language
6. HbA1c more than 7.0 % and/or Body Mass Index (BMI) more than 27.0 kg/m^2 and/or smoking
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Participants - exclusion criteria
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1. Unstable endocrine disorders, with the exception of diabetes
2. Malignant disease
3. Treatment with corticosteroids
4. Serious mental impairment, i.e. preventing to understand the study protocol
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Anticipated start date
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01/09/2005
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300
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Interventions
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Intervention group:
A Cognitive Behavioural Therapy (CBT) which consist of a Motivational Interviewing phase and a Problem Solving Treatment phase. The CBT will be performed by dieticians and diabetes nurses and includes six individual sessions of 30 minutes. This sessions will be performed within a period of 16 weeks.
Usual care group:
Usual care by general practitioner/practice nurse and an annual check-up Diabetes Research Centre as is usual in the optimal care system where the study will be performed.
Both groups will be measured at baseline, at six and at 12 months. Measurements include: demographic patient characteristics, patients' history, diabetes care, clinical patients' characteristics (weight, height, waist circumference, foot inspection, blood pressure, fasting plasma glucose, HbA1c, total cholesterol, High Density Lipoprotein [HDL]-cholesterol) and questionnaires.
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Primary outcome measure(s)
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1. Differences between intervention and usual care groups in changes in diet, physical activity and smoking behaviour according to the ASE-model, a health behaviour model that assumes that behaviour is determined by attitude (A), social influences (S) and self-efficacy (E)
2. Changes in cardiovascular risk score based on the Oxford Risk Engine (algorithm that includes: age at diagnosis, duration of diabetes, sex, ethnicity, smoking status, systolic blood pressure, HbA1c, total cholesterol, HDL-cholesterol). A risk reduction of 5% is clinical relevant.
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Secondary outcome measure(s)
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1. Quality of life
2. Patient satisfaction
3. Changes in medication use, adherence to prescribed medication
4. Proportion of patients reaching treatment targets according to the guidelines of the Dutch College of General practitioners
5. Adherence to the 3-monthly visit to the general practitioner
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Sources of funding
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EMGO Institute (The Netherlands) - internal funding
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Trial website
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Publications
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Study protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17488511
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Contact name
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Ms
Corina
van den Hurk
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Address
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Zernikestraat 29
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City/town
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Eindhoven
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Zip/Postcode
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5612 HZ
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Country
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Netherlands
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Sponsor
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VU University Medical Centre (The Netherlands)
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Address
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EMGO-Institute
Van der Boechorststraat 7
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City/town
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Amsterdam
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Zip/Postcode
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1081 BT
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Country
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Netherlands
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Tel
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+31 (0)20 444 8180
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Fax
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+31 (0)20 444 8181
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Email
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emgo@vumc.nl
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Sponsor website:
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http://www.emgo.nl/
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Date applied
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12/09/2005
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Last edited
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14/05/2007
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Date ISRCTN assigned
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12/09/2005
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