Because of a high cardiovascular disease (CVD) risk in people with Familial Hypercholesterolemia (FH), early prevention of cardiovascular disease is important for health gain and cost reduction. Broekhuizen and colleagues focused on the development and evaluation of an innovative intervention aiming to reduce CVD risk by promoting a healthy lifestyle among people with FH. The project is designed as a randomized controlled trial in which individuals with FH will be assigned randomly to a control or intervention group. In the intervention group (n=200), participants will receive a personalized intervention, which is a combination of web-based tailored lifestyle advice and personal counseling by a lifestyle coach. The control group (n=200) will receive care as usual. Primary outcomes are biological indicators of CVD risk: systolic blood pressure, glucose, BMI, waist circumference and lipids (triglycerides, total, LDL and HDL cholesterol). Secondary outcomes are: healthy lifestyle behavior (with regard to smoking, physical activity, dietary pattern and compliance to statin therapy) and psychological correlates, and determinants of healthy lifestyle behavior (knowledge, attitude, risk perception, social influence, self-efficacy, cues to action, intention, and autonomy). Measurement will take place at baseline, and at 3 and 12 months after randomization. In addition, a throughout process-evaluation will be conducted to assess and monitor intervention implementation during the trial.

WHAT THE STUDY COULD MEAN TO YOU AS A HEALTH CARE PROVIDER: The investigators concluded that results of the PRO-FIT project would provide information about the effects and implementation of a healthy lifestyle intervention for individuals with FH. Our experiences with this intervention will be indicative about the suitability, feasibility and benefits of this approach for future interventions in other high-risk groups, such as Familial Combined Hypercholesterolemia (FCH) and diabetes.

WHAT THE STUDY COULD MEAN TO YOU AS A PATIENT: The description of the study is fine. However, a 12-month follow-up is too short a period to determine if the program is effective with a chronic illness such as familial hypercholesterolemia.

K Broekhuizen et al. A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial. BMC Public Health, 2010;10:69.