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The effect of individually tailored lifestyle counselling on the cardiovascular disease risk of people with Familial Hypercholesterolemia (FH).

A randomised controlled trial on the (cost-)effects of an individually tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22727
Enrollment
400
Registered
2009-07-07
Start date
2009-02-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial hypercholesterolemia (FH) is an autosomal dominant disorder of the lipoprotein metabolism. Due to a defect of the low density lipoprotein (LDL) receptor gene, plasma concentrations of LDL cholesterol (LDL-C) are elevated. In the Netherlands, approximately one in 300 people is affected with the heterozygous type of FH. A national cascade screening project to detect people with FH was introduced in 2003 by the Ministry of Health, Welfare, and Sports. The project is run by the Foundation

Interventions

A personalised health counselling intervention which is a combination of computer tailored web-based counselling, face-to-face counselling and telephone booster sessions. Counseling will be done accor

Sponsors

Department of Public and Occupational Health, EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. FH is diagnosed by standard StOEH procedures; 2. Aged 18-65 years old; 3. Sufficiently fluent in Dutch; 4. Given informed consent; 5. Able to be moderately physically active.

Exclusion criteria

Exclusion criteria: None.

Design outcomes

Primary

MeasureTime frame
LDL cholesterol.

Secondary

MeasureTime frame
1. Other biological cardiovascular risk indicators (glucose, blood pressure, body mass index (BMI), waist circumference, triglycerides, LDL cholesterol, total cholesterol (TC), HDL cholesterol and TC/HDL ratio); 2. Healthy lifestyle behaviour (with regard to smoking, physical activity, nutritional pattern and compliance to statin therapy) and psychological correlates and determinants of healthy lifestyle (knowledge, attitude, risk perception, social influence, self-efficacy, cues to action, intention and autonomy).

Contacts

Public ContactKaren Broekhuizen

Dpt. of Public and Occupational Health Van der Boechorststraat 7

k.broekhuizen@vumc.nl+ 31 (0) 20 4449685

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)