a tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with familial hypercholesterolemia (fh) design of the pro-fit randomised controlled trial定制的生活方式干预,减少心血管疾病的风险患有家族性高胆固醇血症(fh)成功率随机对照试验的设计.pdfVIP
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a tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with familial hypercholesterolemia (fh) design of the pro-fit randomised controlled trial定制的生活方式干预,减少心血管疾病的风险患有家族性高胆固醇血症(fh)成功率随机对照试验的设计
Broekhuizen et al. BMC Public Health 2010, 10:69
/1471-2458/10/69
STUDY PROTOCOL Open Access
A tailored lifestyle intervention to reduce the
cardiovascular disease risk of individuals with
Familial Hypercholesterolemia (FH): design of the
PRO-FIT randomised controlled trial
1 1,2* 3 4 1,2
Karen Broekhuizen , Mireille NM van Poppel , Lando LJ Koppes , Johannes Brug , Willem van Mechelen
Abstract
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 wi
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