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

Not Applicable

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN60545588
• Lead Sponsor: VU University Medical Centre (The Netherlands)

Brief Summary

2008 protocol in https://pubmed.ncbi.nlm.nih.gov/18173844/ 2009 results in https://pubmed.ncbi.nlm.nih.gov/19951417/ (added 26/02/2021) 2011 results in https://pubmed.ncbi.nlm.nih.gov/22040007/ (added 26/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-22
• Study Completion: 2008-10-01
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 700

Inclusion Criteria

1. Male
2. 18 to 55 years
3. Available for the study for the following 12 months
4. Signed an informed consent form
5. At risk for CVD according to the Framingham risk score, and one or more of the following other risk factors:
a. fulfilling none of the Dutch Physical Activity (PA) standards (Nederlandse Norm Gezond Bewegen [NNGB] and Fitnorm)
c. alcohol use: more than 35 glasses of alcohol per week
d. HbA1c more than 6.5%
e. Body Mass Index (BMI) more than 30 kg/m^2
f. tiredness or stress and/or treated for psychological disorders and/or low motivation to recover
h. shortness of breath and/or suffering from chest pain and/or diagnosed with or treated for CVD or its predictors (e.g. high blood pressure)

Exclusion Criteria

1. Unable to be physically active
2. Not sufficiently capable of using the Dutch language
3. Not having signed an informed consent form

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Dietary intake:<br> a. fruits, vegetables and fish<br> b. snacks, soda, and alcohol intake<br> c. slices of bread, plates for dinner<br> 2. Physical activity:<br> a. fulfilling the NNGB and the Fitnorm<br> b. frequency, duration and intensity of habitual PA in leisure time<br> 3. smoking status: smoker/ non-smoker<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. BMI (kg/ m^2)<br> 2. Systolic and diastolic blood pressure (mmHg)<br> 3. High Density Lipoprotein (HDL)-cholesterol and total cholesterol (mmol/litre)<br> 4. HbA1C (%)<br> 5. Cardio-respiratory fitness<br> 6. Stage of change<br> 7. Behaviour determinants<br> 8. Perceived general health<br> 9. Absenteeism<br> 10. Cost-effectiveness<br>