The effectiveness of an intervention, including a very low calorie diet, cognitive behavioural therapy and maintenance contract, regarding weight and weight regain, diabetes management, cardiovasculair risk, depression and quality of life in overweight patients with type 2 diabetes mellitus, after 2 year follow-up.
Completed
- Conditions
- diabetesOverweight1001265310024450
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Diabetes mellitus type 2
Overweight: Body Mass Index (BMI) > 25 kg/m2
Age >18 years
Exclusion Criteria
Pregnancy/lactation
Inadequate knowledge of the Dutch language/Inability to fill in questionnaires
Inability to lose 5% of body weight during very low calorie diet
Severe psychiatric problems
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measures are weight (kg) and weight regain.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Other outcome measures are Body Mass Index (BMI = weight (kg) / length (m)2),<br /><br>HbA1c (%), waist circumference (cm), systolic blood pressure (mmHg), lipid<br /><br>levels (LDL, HDL, TG (mmol/l)en chol/HDL), antidiabetic agents en doses,<br /><br>cardiovascular risk (UKPDS), lifestyle and quality of life (EuroQol). A smaal<br /><br>amount of hair will be collected at 3 timepoints during te study to measure<br /><br>haircortisol. Psychosocial parameters like depression, self-esteem, relational<br /><br>functioning and fear for negative appearance evaluation are studied, as<br /><br>secondary outcome as well as determinant for weight loss.<br /><br>In this unique population we want to collect DNA-material to study the genetic<br /><br>factors associated with succeeding of the intervention.<br /><br>Last but not least we want to conduct an analysis of the cost effectiveness of<br /><br>the intervention as compared to usual care.</p><br>