Condition category
Circulatory System
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
28/01/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.bouwenaangezondheid.nl

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

http://www.vumc.nl/english/

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

  1. 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.

Additional files

Editorial Notes