title: Design and baseline characteristics of the PerfectFit study: a multicenter cluster-randomized trial of a lifestyle intervention in employees with increased cardiovascular risk.
abstract: BACKGROUND
  The prevalence of unhealthy lifestyles and preventable chronic diseases is high. They lead to disabilities and sickness absence, which might be reduced if health promotion measures were applied. Therefore, we developed the PerfectFit health promotion intervention with a "blended care"-approach, which consists of a web-based health risk assessment (HRA) including tailored and personalized advice, followed by motivational interviewing (MI). We hypothesize that adding MI to a web-based HRA leads to better health outcomes. The objective is to describe the design and baseline characteristics of the PerfectFit study, which is being conducted among employees with high cardiovascular risk in the military workforce, the police organization and an academic hospital.
  
  
  METHODS
  PerfectFit is a cluster randomized controlled trial, consisting of two arms. Based on cardiovascular risk profiling, done between 2012 and 2014, we included employees based on one or more risk factors and motivation to participate. One arm is the 'limited' health program (control) that consists of: (a) an HRA as a decision aid for lifestyle changes, including tailored and personalized advice, and pros and cons of the options, and (b) a newsletter every 3 months. The other arm is the 'extensive' program (intervention), which is additionally offered MI-sessions by trained occupational physicians, 4 face-to-face and 3 by telephone, and is offered more choices of health promotion activities in the HRA. During the follow-up period, participants choose the health promotion activities they personally prefer. After six and twelve months, outcomes will be assessed by online questionnaires. After twelve months the cardiovascular risk profiling will be repeated. The primary outcome is self-reported general health. Secondary outcomes are self-reported work ability, CVD-risk score, sickness absence, productivity loss at work, participation in health promotion activities, changes in lifestyle (smoking, alcohol consumption, physical activity, stress management) and body mass index. Furthermore, a process evaluation and an economic analysis will be performed.
  
  
  CONCLUSIONS
  Additional coaching using MI is expected to be a key factor for success of the web-based HRA in employees with increased cardiovascular risk. This "blended care"-approach may be an essential strategy for effective health promotion activities.
  
  
  BACKGROUND
  Dutch Trial Register by registration number NTR4894 , 14/11/2014.
authors.affiliation: Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands. t.kouwenhoven@erasmusmc.nl.|Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands. t.kouwenhoven@erasmusmc.nl.|Department of Occupational Health, Erasmus Medical Center, Rotterdam, The Netherlands. t.kouwenhoven@erasmusmc.nl.
authors.forename: Tessa A
authors.initials: TA
authors.lastname: Kouwenhoven-Pasmooij
authors.affiliation: Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.|Institute of Social medicine, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.|Centre - School of Public Health, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Bosiljka
authors.initials: B
authors.lastname: Djikanovic
authors.affiliation: Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Suzan J W
authors.initials: SJ
authors.lastname: Robroek
authors.affiliation: Staff Joint Health Care Division, Command Service Center, Ministry of Defense, Utrecht, The Netherlands.
authors.forename: Pieter
authors.initials: P
authors.lastname: Helmhout
authors.affiliation: Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Alex
authors.initials: A
authors.lastname: Burdorf
authors.affiliation: Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands.|Department of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands.|Center for Health Decision Sciences, Harvard T.H. Chan School of Public Health, Boston, USA.
authors.forename: M G Myriam
authors.initials: MG
authors.lastname: Hunink
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003376:Counseling / Q000379:methods; D005260:Female; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D020407:Internet; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009042:Motivation; D062405:Motivational Interviewing / Q000379:methods*; D009786:Occupational Health Services / Q000458:organization & administration*; D012307:Risk Factors; D011795:Surveys and Questionnaires