The (cost-) effectiveness of a lifestyle intervention for male workers at risk for cardiovascular disease in the construction industry in The Netherlands.

Conditions: Elevated risk for cardiovascular disease.
10082206
10003216

Registration Number: NL-OMON30635

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 865

Inclusion Criteria

Male, aged 18-55, working in construction industry
Signed an informed consent form
Elevated risk of cardiovascular disease based on:
The Framingham Risk Score AND one or more of the following:
BMI ><= 30 kg/m2; HbA1c > 6.5%; Alcohol abstinence or > 35 consumptions per week; Psychological complaints, Cardiovascular complaints; Not fulfilling both Dutch physical activity norms (NNGB and Fitnorm). Also see section 4.1, page 13-14 in the protocol.

Exclusion Criteria

Inable to be physically active;
Not sufficiently capable of using the Dutch language;
Not having signed an informed consent form

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Lifestyle factors:<br /><br><br /><br>Physical activity: Frequency, duration and intensity of PA in leisure time.<br /><br>Fulfilling Dutch PA norms (NNGB and Fitnorm)<br /><br><br /><br>Diet: Intake of fruit, vegetables, fish<br /><br>Intake of sodas, snacks, alcohol, sugar,<br /><br>Amount of bread, number of portions<br /><br><br /><br>Smoking: yes/ no</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Biomedical variables:<br /><br><br /><br>BMI (kg/m2)<br /><br>Total cholesterol (mmol/l),<br /><br>HDL-cholesterol (mmol/l)<br /><br>Systolic blood pressure (mmHg),<br /><br>Diastolic blood pressure mmHg),<br /><br>HbA1c (%)<br /><br><br /><br>Other factors:<br /><br><br /><br>Fitness (deduced from resting heart rate, BMI, age and self reported PA)<br /><br><br /><br>Stage of change<br /><br><br /><br>Perceived general health<br /><br><br /><br>Absenteeism<br /><br><br /><br>Cost-effectiveness<br /><br><br /><br><br /><br></p><br>