The number of people with cardiovascular disease (CVD) and diabetes mellitus type 2 (T2DM) is growing rapidly throughout the world. To a large extend, this increase is due to lifestyle-dependent risk factors, such as being overweight, reducing physical activity, and following an unhealthy diet. Changing these risk factors has the potential to postpone or prevent the development of T2DM and CVD. Lakerveld and coworkers hypothesized that a cognitive behavioral program (CBP), focused in particular on motivation and self-management in persons who are at high risk for CVD and/or T2DM, would improve their lifestyle behavior and, in turn, reduce their risk of developing T2DM and CVD. They have recruited 12,000 inhabitants, 30-50 years of age living in several municipalities in the semi-rural region of West-Friesland of the Netherlands, who received an invitation from their general practitioner to measure their own waist circumference with a tape measure. People with abdominal obesity (male waist of 102 cm or more, female waist 88 cm or more) were invited to participate in the second step of the screening, which includes obtaining blood pressure readings, a blood sample, and anthropometric measurements. T2DM and CVD risk scores will be calculated according to the ARIC and the SCORE formulae, respectively. People with a score indicating a high risk of developing T2DM and/or CVD will be randomly assigned to the intervention group (n=300) or an untreated control group (n=300). Participants in the intervention group will follow a CBP aimed at modifying their dietary behavior, physical activity, and smoking behavior. The counseling methods that will be used are motivational interviewing (MI) and problem solving treatment (PST), which focus in particular on intrinsic motivation for change and self-management of problems. The CBP will be provided by trained nurse practitioners in the participant's general practice, and will consist of a maximum of six individual sessions of 30 minutes, followed by 3-monthly booster sessions by phone. Participants in the control group will receive brochures containing health guidelines regarding physical activity and diet, and how to stop smoking. The primary outcome measures will be changes in T2DM and CVD risk scores. Secondary outcome measures will be changes in lifestyle behavior and cost-effectiveness and cost-utility ratios. All relevant direct and indirect costs will be measured, and there will followed-up for 24 months.

WHAT THE STUDY MAY MEAN TO YOU AS A HEALTH CARE PROVIDER: Changing behaviors is difficult, requires time, considerable effort and motivation. The authors believe combining the two counseling methods MI and PST, followed by booster sessions, may result in sustained behavioral change.

WHAT THE STUDY MAY MEAN TO YOU AS A PATIENT: The study is noteworthy because of the large number of patient participation. There will, no doubt, be changes between the intervention group and the control group. However, the intervention used in the program is weak for two reasons: First, it likely needs a greater emphasis upon teaching self-management skills and less accentuation of motivational techniques. Second, the aim of a self-management program is to teach patients to take control of their behaviors. Eventually, through the development of self-efficacy, they will not only maintain their performance, but apply self-management skills across time and in different settings. Under these circumstances, booster sessions seem unnecessary given that the follow-up is only for two years.

J Lakerveld et al. Primary prevention of diabetes mellitus type 2 and cardiovascular diseases using a cognitive behavior program aimed at lifestyle changes in people at risk: design of a randomized controlled trial. BMC Endocrine Disorders, 2008;8:6.