Primary prevention of diabetes mellitus type two and cardiovascular diseases using a cognitive behaviour programme aimed at lifestyle changes in people with abdominal obesity
Completed
- Conditions
- Diabetes Mellitus type two (DM2), cognitive behaviour treatment, lifestyle, prevention, cardiovascular diseaseNutritional, Metabolic, EndocrineDiabetes, and cardiovasucalr disease
- Registration Number
- ISRCTN59358434
- Lead Sponsor
- VU University Medical Centre (VUMC) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. Persons aged 30 to 50 years
2. With a moderate or high risk of CVD (as calculated according to the Systematic COronary Risk Evaluation [SCORE]-project)
3. Or a high risk of DM2 (as calculated according to the risk function of the Atherosclerosis Risk In Communities [ARIC] Study)
Exclusion Criteria
1. Having diabetes
2. Previous CVD
3. Pregnancy
4. Current malignant disease
5. (Severe) mobility problems
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Changes in cardiovascular risk score (risk function developed by the SCORE-project)<br>2. Changes in diabetes risk calculation (risk function from data of the ARIC Study)
- Secondary Outcome Measures
Name Time Method 1. Changes in lifestyle factors:<br>1.1. Dietary behaviour<br>1.2. Physical activity<br>1.3. Smoking behaviour<br>2. Changes in perceived health<br>3. Changes in medical care utilisation<br>4. Changes in waist circumference<br>5. Cost effectiveness and cost-utility (cost diary and Euroqol questionnaire)