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01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Public Health 1/2015

Design and baseline characteristics of the PerfectFit study: a multicenter cluster-randomized trial of a lifestyle intervention in employees with increased cardiovascular risk

Zeitschrift:
BMC Public Health > Ausgabe 1/2015
Autoren:
Tessa A. Kouwenhoven-Pasmooij, Bosiljka Djikanovic, Suzan J. W. Robroek, Pieter Helmhout, Alex Burdorf, M. G. Myriam Hunink
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

TK contributed to the design and implementation of the study and drafted the article. BD contributed to the analyses of the baseline characteristics and draft of the article. SR, AB and MH contributed to the conception and design of the study, provided critical revision of the article, and obtained the grant from ZonMW (grant number: 208030007). TK and MH obtained an additional grant from Erasmus Medical Center (grant number: 2013–13110). BD received an Erasmus Mundus–Western Balkans (ERAWEB) scholarship for academic mobility. MH was principal investigator. TK was project leader. All authors provided final approval of the version to be published.

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.

Discussion

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.

Trial registration

Dutch Trial Register by registration number NTR4894, 14/11/2014.
Literatur
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