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 |
- 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
Scientific
VU University Medical Center
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 6496 |
|---|---|
| iris.groeneveld@vumc.nl |
Study information
| Study design | Randomised, controlled, parallel group, single blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2007 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 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
1081 BT
Netherlands
Sponsor information
VU University Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8180 |
|---|---|
| emgo@vumc.nl | |
| Website | http://www.vumc.nl/english/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
Arbouw Foundation (Stichting Arbouw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/01/2008 | Yes | No | |
| Results article | results | 01/12/2009 | 26/02/2021 | Yes | No |
| Results article | results | 31/10/2011 | 26/02/2021 | Yes | No |
Editorial Notes
26/02/2021: Publication references added.
06/11/2019: Internal review.
