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Randomized Controlled Trial
. 2010 Feb 15:10:69.
doi: 10.1186/1471-2458-10-69.

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

Karen Broekhuizen  1 , Mireille N M van Poppel, Lando L J Koppes, Johannes Brug, Willem van Mechelen
Affiliations
Randomized Controlled Trial

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

Karen Broekhuizen et al. BMC Public Health. .

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 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.

Discussion: 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.

Trial registration number: NTR1899.

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Figures

Figure 1
Figure 1
I-Change model 2.0. An integrated model for exploring motivational and behavioural change, used as theoretical framework during the development of the PRO-FIT intervention.
Figure 2
Figure 2
Participant flow. A detailed participant flow chart of the PRO-FIT project.
See this image and copyright information in PMC

References

    1. Kasper DL, Braunwald E, Fauci AS, Hauser SL, Longo DL, Jameson DL, Loscalzo J. Harrison's principles of internal medicine. New York: McGraw-Hill Medical Publishing Division; 2008.
    1. Lansberg PJ, Tuzgol S, van de Ree MA, Defesche JC, Kastelein JJ. Higher prevalence of familial hypercholesterolemia than expected in adult patients of four family practices in Netherlands. Ned Tijdschr Geneeskd. 2000;144:1437–1440. - PubMed
    1. Stichting Opsporing Erfelijke Hypercholesterolemie. Jaarverslag 2007. 2008.
    1. Risk of fatal coronary heart disease in familial hypercholesterolaemia. Scientific Steering Committee on behalf of the Simon Broome Register Group. BMJ. 1991;303:893–896. doi: 10.1136/bmj.303.6807.893. - DOI - PMC - PubMed
    1. Treurniet HF, Hoeymans N, Gijsen R, Poos MJ, van Oers JA, Thien WM. Health status and the challenges for prevention in The Netherlands. Public Health. 2005;119:159–166. doi: 10.1016/j.puhe.2004.05.018. - DOI - PubMed

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