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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24877

Enrollment

300

Registered

2005-08-16

Start date

2005-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

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 diabe

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

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Contacts

Public ContactLaura M.C. Welschen

VU University Medical Center, EMGO-Institute, Van der Boechorststraat 7

l.welschen@vumc.nl+31 (0)20 4445263

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)