The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR92
• Date of registration: 16/08/2005
• Primary sponsor: VU University Medical Center, EMGO-Institute
• Public title: The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system.
• Scientific title: The effectiveness of adding a cognitive behavioural therapy aimed at changing lifestyle to an optimal diabetes care system. - N/A
• Date of first enrolment: 1/9/2005
• Target sample size: 300
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=92
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Laura M.C. Welschen

• Name: Giel Nijpels

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes from general practices with the support of a practice nurse;

2. Age 40-70 years;

3. Written informed consent;

4. Capable to fill in questionnaires;

5. Understanding of Dutch language;

6. HbA1c > 7.0 % and/or BMI > 27.0 kg/m2 and/or smoking.
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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Diabetes Mellitus type 2 (DM type II)

Intervention(s)

1. 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 6 individual sessions of 30 minutes. This sessions will be performed within a period of 16 weeks;

2. Usual care group: usual care by general practitioner/practice nurse and an annual check-up Diabetes Research Center as is usual in the optimal care system where the study will be performed.



Both groups will be measured at baseline, at 6 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, HDL-cholesterol) and questionnaires.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

ISRCTN12666286

N/A

Source(s) of Monetary Support

EMGO Institute internal funding