A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial.
BACKGROUND
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. This project focuses on the development and evaluation of an innovative intervention aiming to reduce CVD risk by promoting a healthy lifestyle among people with FH.


METHODS
This project is designed as a randomised 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 counselling 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 behaviour (with regard to smoking, physical activity, dietary pattern and compliance to statin therapy) and psychological correlates and determinants of healthy lifestyle behaviour (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 randomisation. Additionally, a throughout process-evaluation will be conducted to assess and monitor intervention implementation during the trial.


CONCLUSIONS
Results of the PRO-FIT project will 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.


BACKGROUND
NTR1899.
Department of Public and Occupational Health, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands.
Karen
K
Broekhuizen
Mireille N M
MN
van Poppel
Lando L J
LL
Koppes
Johannes
J
Brug
Willem
W
van Mechelen
D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003376:Counseling; D005260:Female; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000150:complications / Q000628:therapy*; D020407:Internet; D008019:Life Style; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012307:Risk Factors; D017216:Telemedicine; D055815:Young Adult