A randomised controlled trial on the effects of an individual tailored lifestyle intervention to minimise the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH)

A randomised controlled trial on the effects of an individual tailored lifestyle intervention to minimise the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH) - The PRO-FIT study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33700

Enrollment

400

Registered

2008-08-27

Start date

2009-01-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Type III hyperlipidemia

Interventions

The intervention consists of counselling a health lifestyle which is a combination of web-based counselling, face-to-face counselling (1 session), brochures and telephone booster sessions (3 session

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: People are included if* -FH is diagnosed by standard StOEH procedures between january 2007 and march 2009 -aged 18-70 years old -living in 150 km radius of Amsterdam -sufficiently fluent in Dutch -given informed consent -being able to be moderately physically active

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
1. LDL cholesterol	—

Secondary

Measure	Time frame
2. Biological cardiovascular risk indicators: blood pressure, glucose, body mass index (BMI), waist circumference, triglycerides, LDL cholesterol, blood total cholesterol (TC), HDL cholesterol and TC/HDL ratio. 3. Lifestyle intentions and behaviours (non-smoking, > 30 minutes of daily physical activity, a prudent nutritional pattern, and compliance to FH-related medication); 4. Psychological correlates and determinants of a healthy lifestyle: motivational factors (attitude, self-efficacy, social influences) and awareness factors (knowledge, cues to action, risk perception)?;	—

Measure

Time frame

2. Biological cardiovascular risk indicators: blood pressure, glucose, body mass index (BMI), waist circumference, triglycerides, LDL cholesterol, blood total cholesterol (TC), HDL cholesterol and TC/HDL ratio. 3. Lifestyle intentions and behaviours (non-smoking, > 30 minutes of daily physical activity, a prudent nutritional pattern, and compliance to FH-related medication); 4. Psychological correlates and determinants of a healthy lifestyle: motivational factors (attitude, self-efficacy, social influences) and awareness factors (knowledge, cues to action, risk perception)?;

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)