A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>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 developmen...

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Main Authors: Brug Johannes, Koppes Lando LJ, van Poppel Mireille NM, Broekhuizen Karen, van Mechelen Willem
Format: Article
Language:English
Published: BMC 2010-02-01
Series:BMC Public Health
Online Access:http://www.biomedcentral.com/1471-2458/10/69
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author Brug Johannes
Koppes Lando LJ
van Poppel Mireille NM
Broekhuizen Karen
van Mechelen Willem
author_facet Brug Johannes
Koppes Lando LJ
van Poppel Mireille NM
Broekhuizen Karen
van Mechelen Willem
author_sort Brug Johannes
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration number</p> <p>NTR1899</p>
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spelling doaj.art-df8a3d3844fa41439a5a4a77996475e12022-12-22T02:48:55ZengBMCBMC Public Health1471-24582010-02-011016910.1186/1471-2458-10-69A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trialBrug JohannesKoppes Lando LJvan Poppel Mireille NMBroekhuizen Karenvan Mechelen Willem<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration number</p> <p>NTR1899</p>http://www.biomedcentral.com/1471-2458/10/69
spellingShingle Brug Johannes
Koppes Lando LJ
van Poppel Mireille NM
Broekhuizen Karen
van Mechelen Willem
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
title A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial
title_full A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial
title_fullStr A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial
title_full_unstemmed A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial
title_short A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial
title_sort tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with familial hypercholesterolemia fh design of the pro fit randomised controlled trial
url http://www.biomedcentral.com/1471-2458/10/69
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