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van CCT (UK)

van CCT (UK)


- candidate number20922
- NTR NumberNTR4894
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2014
- Secondary IDsMEC-2012-459 METC Erasmus Medisch Centrum
- Public TitlePerfectFit
- Scientific TitleCost-effectiveness of a lifestyle intervention on health and sustainable employability among workers of 40 years and older with high physical work demands: a randomized controlled trial
- ACRONYMPerfectFit
- hypothesis
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Work ability, E-health, Cardiovascular disease risk, Employability
- Inclusion criteriaAge 40 years or older and at least one of the following risk factors are present:
- BMI>30 kg/m2 and / or waist circumference >= 102 cm (men, >= 88 cm ( women)
- Hypertension (diastolic >90 mm Hg or a systolic value >140 mm Hg)
- Use of hypertensive drugs
- Self-reported diabetes or random glucose >= 11.1 mmol/l
- Dyslipidemia (total cholesterol, LDL cholesterol >= 2.5 mmol; triglycerides >=1.7 mmol/l; HDL-cholesterol <= 1.0 mmol/l
- Angina or myocardial infarction in first degree relative
- Physical activity less than 30 minutes daily for 5 days per week or comparable effort
- Smoking
- Exclusion criteria- Manifest CVD (history of myocardial infarction, heart failure, or cerebrovascular accident)
- Terminal illness
- A history of psychosis
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-dec-2012
- planned closingdate1-sep-2015
- Target number of participants650
- InterventionsIntervention group A ("control") is offered a standard health intervention program. The standard health intervention program consists of the following modules: 1. oral advise from the occupational health physician, based on the cardiovascular risk profile (=usual care), with refer to a medical specialist when indicated (usual care) 2. a web-based health risk assessment with tailored and personalised feedback Intervention group B (=intervention) is additionally offered 7 coaching-sessions (using the technique motivational interviewing) and has access to a part of the webportal which includes more personalised advise.
- Primary outcomeGeneral health (from SF-36)
- Secondary outcomeWork ability
CVD-risk score
physical activity
quality of life
work conditions
individual characteristics
socio-economic determinants
total cost (direct and indirect costs)
- Timepointsbaseline
6 months
12 months
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES T.A. Kouwenhoven-Pasmooij
- CONTACT for SCIENTIFIC QUERIES T.A. Kouwenhoven-Pasmooij
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)21-dec-2014: Note: this trial has been registered after patient-inclusion finished! - AB
- RECORD14-nov-2014 - 27-dec-2014

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