Department of Public and Occupational Health, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands.
BMC Public Health. 2010 Feb 15;10:69. doi: 10.1186/1471-2458-10-69.
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.
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.
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.
NTR1899.
由于家族性高胆固醇血症（FH）患者存在较高的心血管疾病（CVD）风险，因此早期预防心血管疾病对于增进健康和降低成本非常重要。本项目专注于开发和评估一种创新干预措施，旨在通过促进 FH 患者的健康生活方式来降低 CVD 风险。
该项目设计为一项随机对照试验，其中 FH 患者将被随机分配到对照组或干预组。在干预组（n=200）中，参与者将接受个性化干预，该干预结合了基于网络的个性化生活方式建议和生活方式教练的个人咨询。对照组（n=200）将接受常规护理。主要结局指标是 CVD 风险的生物学指标：收缩压、血糖、BMI、腰围和血脂（甘油三酯、总胆固醇、LDL 和 HDL 胆固醇）。次要结局指标是：健康的生活方式行为（关于吸烟、身体活动、饮食模式和他汀类药物治疗的依从性）以及健康生活方式行为的心理相关因素和决定因素（知识、态度、风险感知、社会影响、自我效能、行动线索、意图和自主性）。测量将在基线、随机分组后 3 个月和 12 个月进行。此外，还将进行全面的过程评估，以评估和监测试验期间的干预实施情况。
PRO-FIT 项目的结果将提供有关 FH 患者健康生活方式干预效果和实施的信息。我们在该干预措施方面的经验将表明这种方法对于其他高危人群（如家族性混合型高胆固醇血症（FCH）和糖尿病）的未来干预措施的适用性、可行性和益处。
NTR1899。
