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The (cost)-effectiveness of a lifestyle intervention for male workers at risk for cardiovascular disease in the contruction industry in The Netherlands
ISRCTN ISRCTN60545588
DOI 10.1186/ISRCTN60545588
ClinicalTrials.gov identifier
EudraCT number
Public title The (cost)-effectiveness of a lifestyle intervention for male workers at risk for cardiovascular disease in the contruction industry in The Netherlands
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis Participants in the intervention group, receiving an individual lifestyle intervention, will improve lifestyle and Cardiovascular Disease (CVD)-risk related biomedical outcome values at the short (six months) and the longer (12 months) term, whereas in the control group these variables will remain the same as at baseline.
Lay summary
Ethics approval Approval received from the Ethics Committee of the VU Medical Centre ('Medisch Ethische Toetseingscommissie VU medisch centrum') on 3rd April 2007 (ref: 2006/291).
Study design Randomised, controlled, parallel group, single blinded trial
Countries of recruitment Netherlands
Disease/condition/study domain Cardiovascular disease
Participants - 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)
Participants - 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
Anticipated start date 01/04/2007
Anticipated end date 01/10/2008
Status of trial Completed
Patient information material
Target number of participants 700
Interventions Intervention:
Individual counselling about improving the energy balance (diet and physical activity) or smoking cessation, in the form of Motivational Interviewing, with the stages of change as a basis.

Duration is six months, in which three face to face contacts at the Occupational Health Service and four telephone contacts with a professional health counsellor (OP or nurse) will take place. Additional written information about a healthy lifestyle will also be provided.

Control:
Care as usual.
Primary outcome measure(s) 1. Dietary intake:
a. fruits, vegetables and fish
b. snacks, soda, and alcohol intake
c. slices of bread, plates for dinner
2. Physical activity:
a. fulfilling the NNGB and the Fitnorm
b. frequency, duration and intensity of habitual PA in leisure time
3. smoking status: smoker/ non-smoker
Secondary outcome measure(s) 1. BMI (kg/ m^2)
2. Systolic and diastolic blood pressure (mmHg)
3. High Density Lipoprotein (HDL)-cholesterol and total cholesterol (mmol/litre)
4. HbA1C (%)
5. Cardio-respiratory fitness
6. Stage of change
7. Behaviour determinants
8. Perceived general health
9. Absenteeism
10. Cost-effectiveness
Sources of funding Arbouw Foundation (Stichting Arbouw) (The Netherlands)
Trial website http://www.bouwenaangezondheid.nl
Publications Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18173844
Contact name Ms  I F  Groeneveld
  Address VU University Medical Center
EMGO-Institute
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 444 6496
  Fax +31 (0)20 444 8387
  Email iris.groeneveld@vumc.nl
Sponsor VU University Medical Centre (The Netherlands)
  Address EMGO-Institute
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 444 8180
  Fax +31 (0)20 444 8181
  Email emgo@vumc.nl
  Sponsor website: http://www.vumc.nl/english/
Date applied 22/01/2007
Last edited 28/01/2008
Date ISRCTN assigned 22/01/2007
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