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.
Approved by the Medical Ethical Committee of the VU University Medical Center Amsterdam.
Randomised, active controlled, factorial, single blinded trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Diabetes Mellitus type II (DM type II)
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.
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
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
Target number of participants
Participant exclusion criteria
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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
EMGO Institute (The Netherlands) - internal funding
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Welschen LM, van Oppen P, Dekker JM, Bouter LM, Stalman WA, Nijpels G, The effectiveness of adding cognitive behavioural therapy aimed at changing lifestyle to managed diabetes care for patients with type 2 diabetes: design of a randomised controlled trial., BMC Public Health, 2007, 7, 74, doi: 10.1186/1471-2458-7-74.