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


- candidate number6065
- NTR NumberNTR1899
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2009
- Secondary IDs50-50110-96-489 ZonMw
- Public TitleThe effect of individually tailored lifestyle counselling on the cardiovascular disease risk of people with Familial Hypercholesterolemia (FH).
- Scientific TitleA 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).
- ACRONYMPRO-FIT: promoting a healthy lifestyle in people with FH through an individually tailored lifestyle intervention.
- hypothesisBecause of a high cardiovascular disease (CVD) risk in people with FH, prevention of cardiovascular disease in people with FH is important for health gain and cost reduction. This randomised controlled trial (RCT) focuses on CVD risk reduction through promoting a healthy lifestyle among people with Familial Hypercholesterolemia (FH).
- Healt Condition(s) or Problem(s) studiedFamilial hypercholesterolemia (FH), Life style, Cardiovascular disease risk
- Inclusion criteria1. 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 criteriaNone.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-feb-2009
- planned closingdate1-okt-2010
- Target number of participants400
- InterventionsA 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 according to Motivational Interviewing techniques and will focus on nutritional pattern, physical activity, smoking behaviour and adherence to medication.
- Primary outcomeLDL cholesterol.
- Secondary outcome1. 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).
- TimepointsLDL cholesterol and other biological cardiovascular risk indicators;
Timepoints: 0-12 months;
Measures: chronologically, Cholestech LDX analyzer (Cholestech, Hayward, USA), fully automated blood pressure monitor, portable height measure, calibrated weight scales, measuring tape.

Secondary outcomes:
Healthy lifestyle behaviour (smoking): timepoints 0-12 months;
Measure: self-reported measure, asking participants if they are a current smoker, an ex-smoker, or a never smoker, how many years they smoke(d) and how many cigarettes/shag they smoke(d) a day.

Healthy lifestyle behaviour (physical activity): Timepoints: 0-12 months;
Measure: Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH).

Healthy lifestyle behaviour (saturated fat intake, fruit and vegetables intake): Timepoints: 0-12 months;
Measure: the short Dutch questionnaire on total and saturated fat intake and on fruit and vegetable intake.

Healthy lifestyle behaviour (compliance to statin therapy): Timepoints: 0-12 months;
Measure: the five-item Medication Adherence Report Scale (MARS-5) and pharmacy records are used to study the persistence of medication use (period from first prescription to discontinuation) and refill compliance (percentage of prescribed medication that was actually obtained at the pharmacy).

Knowledge, attitude, social influence, self-efficacy, cues to action, intention and autonomy. Timepoints: 0-12 months;
Measure: self-administered questionnaire.

Risk perception. Time points: 0-3-12 months.
Measures: Questions on risk perception were developed from literature and partly based on the brief Illness Perception Questionnaire (IPQ), the revised IPQ (IPQ-R) and questionnaire of Claassen, 2009.
- Trial web sitewww.pro-fitstudy.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Karen Broekhuizen
- CONTACT for SCIENTIFIC QUERIES Karen Broekhuizen
- Sponsor/Initiator VU University Medical Center, Department of Public and Occupational Health, VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBecause of a high cardiovascular disease (CVD) risk in people with FH, prevention of cardiovascular disease in people with FH is important for health gain and cost reduction. This randomised controlled trial (RCT) focuses on CVD risk reduction through promoting a healthy lifestyle among people with Familial Hypercholesterolemia (FH). This project is designed as a RCT in which individuals with FH will be assigned randomly to a control or intervention group. In the intervention group (n=200), participants receive a personalized intervention which is a combination of web-based computer tailored lifestyle advice and personal counselling by a lifestyle coach. The control group (n=200) will not receive this intervention. The participants will be followed for 12 months after randomisation. Primary outcomes are biological indicators of the CVD risk, such as: 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, 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). Additionally, a throughout process-evaluation plan will be followed to assess and monitor intervention implementation during the trial. Results of the PRO-FIT project will provide information about individuals with FH managing their own health and about how they adopt and maintain a healthier lifestyle. Our experiences will be indicative about the suitability and benefits of this personalized multi-channel-approach for future interventions in other high-risk groups.
- Main changes (audit trail)
- RECORD7-jul-2009 - 6-okt-2009


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