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

Tessa A Kouwenhoven-Pasmooij,M G Myriam Hunink,Alex Burdorf,Bosiljka Djikanovic,Suzan J W Robroek,Pieter Helmhout

doi:10.1186/s12889-015-2059-9

Abstract

BackgroundThe 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.MethodsPerfectFit 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.DiscussionAdditional 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 registrationDutch Trial Register by registration number NTR4894, 14/11/2014.

Highlights

Background life expectancy has significantly increased over the past decades in many countries worldwide, the prevalence of unhealthy lifestyles, preventable chronic diseases and disabilities is rising [1,2,3]
The number of missings ranged from n = 1 to n = 40
The PerfectFit study aims to establish whether adding motivational interviewing (MI) to a web-based health risk assessment (HRA) is a key-factor for improving effectiveness in changing unhealthy lifestyles and reducing risk factors for chronic diseases

Summary

Introduction

Background life expectancy has significantly increased over the past decades in many countries worldwide, the prevalence of unhealthy lifestyles, preventable chronic diseases and disabilities is rising [1,2,3]. Major risk factors for their well-being are adverse lifestyle habits, such as physical inactivity, unhealthy diet, smoking, alcohol and stress. These lifestyle behaviors are associated with chronic diseases, and among them, the most common are cardiovascular disease (CVD) and diabetes. 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. 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

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