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

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

Effectiveness of the blended-care lifestyle intervention 'PerfectFit': A cluster randomised trial in employees at risk for cardiovascular diseases

Background: Web-based lifestyle interventions at the workplace have the potential to promote health and work productivity. However, the sustainability of effects is often small, which could be enhanced by adding face-to-face contacts, so-called 'blended care'. Therefore, this study evaluates the effects of a blended workplace health promotion intervention on health and work outcomes among employees with increased cardiovascular risk. Methods: In this multicentre cluster-randomised controlled trial (PerfectFit), 491 workers in 18 work units from military, police, and a hospital with increased cardiovascular risk were randomised into two intervention groups. The limited intervention (n = 213; 9 clusters) consisted of a web-based Health Risk Assessment with advice. In the extensive intervention (n = 271; 8 clusters), coaching sessions by occupational health physicians using motivational interviewing were added. One cluster dropped out after randomisation but before any inclusion o

Prognostic factors for perceived recovery or functional improvement in non-specific low back pain: secondary analyses of three randomized clinical trials

The objective of this study was to report on secondary analyses of a merged trial dataset aimed at exploring the potential importance of patient factors associated with clinically relevant improvements in non-acute, non-specific low back pain (LBP). From 273 predominantly male army workers (mean age 39 ± 10.5 years, range 20–56 years, 4 women) with LBP who were recruited in three randomized clinical trials, baseline individual patient factors, pain-related factors, work-related psychosocial factors, and psychological factors were evaluated as potential prognostic variables in a short-term (post-treatment) and a long-term logistic regression model (6 months after treatment). We found one dominant prognostic factor for improvement directly after treatment as well as 6 months later: baseline functional disability, expressed in Roland–Morris Disability Questionnaire scores. Baseline fear of movement, expressed in Tampa Scale for Kinesiophobia scores, had also significant prognostic value for long-term improvement. Less strongly associated with the outcome, but also included in our final models, were supervisor social support and duration of complaints (short-term model), and co-worker social support and pain radiation (long-term model). Information about initial levels of functional disability and fear-avoidance behaviour can be of value in the treatment of patient populations with characteristics comparable to the current army study population (e.g., predominantly male, physically active, working, moderate but chronic back problems). Individuals at risk for poor long-term LBP recovery, i.e., individuals with high initial level of disability and prominent fear-avoidance behaviour, can be distinguished that may need additional cognitive-behavioural treatment

Energy Expenditure and Changes in Body Composition During Submarine Deployment-An Observational Study "DasBoost 2-2017"

The present study was designed to objectively assess the effects of 3-months submarine deployment on behavioural and metabolic determinants of metabolic health. In 13 healthy, non-obese volunteers, we using stable isotope dilution, and plasma and urinary biochemistry to characterize metabolic health before and after a 3-month submarine deployment. Volunteers worked in 6-h shifts. After deployment, we observed reduced fat-free mass (mean ± SD, −4.1 ± 3.3 kg, p = 0.003) and increased adiposity (21.9 ± 3.2% fat mass to 24.4 ± 4.7%, p = 0.01). Changes in fat-free mass were positively associated with physical activity (+0.8 kg per 0.1 increase in PAL, p = 0.03). The average physical activity level was 1.64 ± 0.26 and total energy expenditure during deployment was 2937 ± 498 kcal/d, while energy intake was 3158 ± 786 kcal/d. Fasting glucose (p = 0.03), and triglycerides (p = 0.01) declined, whereas fasting free fatty acids increased (p = 0.04). Plasma vitamin D and B12 concentrations decreased (−14%, p = 0.04, and −44%, p = 0.001, respectively), and plasma calcium, and magnesium increased (+51%, p = 0.01, and +5%, p = 0.02). Haemoglobin was unchanged, but haematocrit decreased (−2.2 ± 2.1%, p = 0.005). In conclusion, submarine deployment impairs fat-free mass maintenance and promotes adiposity. High physical activity may prevent the decline in fat-free mass. Our study confirms the need to counteract Vitamin D and B12 deficiencies, and suggests impairments in erythrocyte metabolism

The Effectiveness of Blue-Light-Emitting Glasses in Security Guards Exposed to Night Shift Work on Work-Related and General Fatigue: A Randomised Controlled Cross-Over Study

This study aimed to evaluate the effectiveness of glasses that emit blue light in reducing the need for recovery, general fatigue, and stress levels in security guards who work night shifts. Light manipulation is seen as a promising strategy to mitigate complaints related to shift work, such as sleepiness and impaired cognitive performance. In a randomized controlled cross-over study design, 86 Dutch security guards used light-emitting glasses (exposure duration: 30 min) during night shifts in a five week period versus a five week control period without glasses. Measurements (Need for Recovery Scale; Checklist Individual Strength; stress level assessed by a fitness tracker) were performed at baseline, at five weeks, and again at 11 weeks. The chronotype was measured at baseline as a potential covariate. A mixed model for repeated measure analyses showed no significant reduction in the need for recovery, nor a reduction in general fatigue scores, during the intervention period. Paired Samples T-Test analyses showed no significant changes in stress levels for the intervention period. Conclusively, blue light exposure using light-emitting glasses for security guards during night shifts showed no directly measurable effect on the reduced need for recovery, overall fatigue, and stress levels

The Effectiveness of Blue-Light-Emitting Glasses in Security Guards Exposed to Night Shift Work on Work-Related and General Fatigue: A Randomised Controlled Cross-Over Study

This study aimed to evaluate the effectiveness of glasses that emit blue light in reducing the need for recovery, general fatigue, and stress levels in security guards who work night shifts. Light manipulation is seen as a promising strategy to mitigate complaints related to shift work, such as sleepiness and impaired cognitive performance. In a randomized controlled cross-over study design, 86 Dutch security guards used light-emitting glasses (exposure duration: 30 min) during night shifts in a five week period versus a five week control period without glasses. Measurements (Need for Recovery Scale; Checklist Individual Strength; stress level assessed by a fitness tracker) were performed at baseline, at five weeks, and again at 11 weeks. The chronotype was measured at baseline as a potential covariate. A mixed model for repeated measure analyses showed no significant reduction in the need for recovery, nor a reduction in general fatigue scores, during the intervention period. Paired Samples T-Test analyses showed no significant changes in stress levels for the intervention period. Conclusively, blue light exposure using light-emitting glasses for security guards during night shifts showed no directly measurable effect on the reduced need for recovery, overall fatigue, and stress levels

A high-intensity lumbar extensor strengthening program is little better than a low-intensity program or a waiting list control group for chronic low back pain: a randomised clinical trial

QuestionIs eight weeks of high-intensity strengthening of the isolated lumbar extensors more effective than low-intensity strengthening or no strengthening? Are any gains maintained 16 weeks later?DesignRandomised, three-arm trial with concealed allocation, assessor blinding, and intention-to-treat-analysis. Participants in the waiting list control group were randomised again, after the first 8 weeks, to either the high-intensity or the low-intensity strengthening program.ParticipantsSixty-five army personnel with non-specific chronic low back pain.InterventionThe high-intensity training group received 10 sessions of 15 to 20 repetitions for the isolated lumbar extensor muscles. The low-intensity training group received a nonprogressive, low-intensity resistance protocol.Outcome measuresPrimary outcomes were global perceived effect and disability. Secondary outcomes were health-related quality of life, fear of movement/(re-)injury, and isometric lumbar extensor muscle strength. Measures were taken before and after the training and 16 weeks later.ResultsAt eight weeks, SF-36 overall score was on average 7% (95% CI 1 to 13) greater in the high-intensity training group compared with the low-intensity training group and the waiting list control group, and self-assessed decrease of back symptoms was on average 39% (95% CI 14 to 64) greater in the high-intensity training group compared with the waiting list control group. There was no difference in improvement between the groups for any other outcome at 8 weeks or 24 weeks.ConclusionsAlthough some beneficial effects were found, the results of this high-intensity strengthening program of the isolated lumbar extensor muscles do not clearly support the generally-claimed beneficial influence of exercise for chronic non-specific low back pain

Additional file 2: of Effectiveness of the blended-care lifestyle intervention ‘PerfectFit’: a cluster randomised trial in employees at risk for cardiovascular diseases

Table S3. Characteristics of non-responders at 6 or 12 months follow-up (n = 109). (DOCX 22 kb