Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Ms I F Groeneveld
ORCID ID
Contact details
VU University Medical Center
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 6496
iris.groeneveld@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular disease
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/04/2007
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
700
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
01/10/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
VU University Medical Centre (The Netherlands)
Sponsor details
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Arbouw Foundation (Stichting Arbouw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18173844
Publication citations
-
Study protocol
Groeneveld IF, Proper KI, van der Beek AJ, van Duivenbooden C, van Mechelen W, Design of a RCT evaluating the (cost-) effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: the health under construction study., BMC Public Health, 2008, 8, 1, doi: 10.1186/1471-2458-8-1.