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	https://doi.org/10.1186/ISRCTN60545588
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	VU University Medical Centre (The Netherlands)
Funder	Arbouw Foundation (Stichting Arbouw) (The Netherlands)

Submission date: 22/01/2007
Registration date: 22/01/2007
Last edited: 26/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms I F Groeneveld
Scientific

VU University Medical Center
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 6496
Email	iris.groeneveld@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, controlled, parallel group, single blinded trial
Secondary study design	Randomised controlled trial
Scientific title	The (cost)-effectiveness of a lifestyle intervention for male workers at risk for cardiovascular disease in the contruction industry in The Netherlands
Study objectives	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(s)	Approval received from the Ethics Committee of the VU Medical Centre ('Medisch Ethische Toetseingscommissie VU medisch centrum') on 3rd April 2007 (ref: 2006/291).
Health condition(s) or problem(s) studied	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
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
Key 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
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	700
Key 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)
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009	26/02/2021	Yes	No
Results article	results	31/10/2011	26/02/2021	Yes	No
Protocol article	protocol	03/01/2008		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/02/2021: Publication references added.
06/11/2019: Internal review.