A study protocol of the adaptation and evaluation by means of a cluster-RCT of an integrated workplace health promotion program based on a European good practice.

BACKGROUND: An integrated workplace health promotion program (WHPP) which targets multiple lifestyle factors at different levels (individual and organizational) is potentially more effective than a single component WHPP. The aim of this study is to describe the protocol of a study to tailor a European good practice of such an integral approach to the Dutch context and to evaluate its effectiveness and implementation. METHODS: This study consists of two components. First, the five steps of the Map of Adaptation Process (MAP) will be followed to tailor the Lombardy WHP to the Dutch context. Both the employers and employees will be actively involved in this process. Second, the effectiveness of the integrated Dutch WHPP will be evaluated in a clustered randomized controlled trial (C-RCT) with measurements at baseline, 6 months and 12 months. Clusters will be composed based on working locations or units - dependent on the organization's structure and randomization within each organization takes place after baseline measurements. Primary outcome will be a combined lifestyle score. Secondary outcomes will be the separate lifestyle behaviors targeted, stress, work-life balance, need for recovery, general health, and well-being. Simultaneously, a process evaluation will be conducted. The study population will consist of employees from multiple organizations in different industry sectors. Organizations in the intervention condition will receive the integrated Dutch WHPP during 12 months, consisting of an implementation plan and a catalogue with activities for multiple lifestyle themes on various domains: 1) screening and support; 2) information and education; 3) adjustments in the social, digital or physical environment; and 4) policy. DISCUSSION: The MAP approach provides an appropriate framework to systematically adapt an existing WHPP to the Dutch context, involving both employers and employees and retaining the core elements, i.e. the catalogue with evidence-based activities on multiple lifestyle themes and domains enabling an integrated approach. The following process and effect evaluation will contribute to further insight in the actual implementation and effectiveness of the integrated WHP approach. TRIAL REGISTRATION: NTR (trialregister.nl ), NL9526. Registered on 3 June 2021.

Long-Term Cost-Effectiveness and Return-on-Investment of a Mindfulness-Based Worksite Intervention: Results of a Randomized Controlled Trial.

OBJECTIVES: The aim of this study was to conduct a cost-effectiveness and return-on-investment analysis comparing a mindfulness-based worksite intervention to usual practice. METHODS: Two hundred fifty-seven governmental research institute employees were randomized to the intervention or control group. Intervention group participants received an eight-week mindfulness training, e-coaching, and supporting elements. Outcomes included work engagement, general vitality, job satisfaction, work ability, and costs. Cost-effectiveness analyses were conducted from the societal and employer's perspective, and a return-on-investment analysis from the employer's perspective. RESULTS: After 12 months, a significant but not clinically relevant adverse effect on work engagement was found (-0.19; 95% confidence interval: -0.38 to -0.01). There were no significant differences in job satisfaction, general vitality, work ability, and total costs. Probabilities of cost-effectiveness were low (≤0.25) and the intervention did not have a positive financial return to the employer. CONCLUSION: The intervention was neither cost-saving nor cost-effective. Poor e-coaching compliance might partly explain this result.

Effect of education on non-specific neck and low back pain: A meta-analysis of randomized controlled trials.

BACKGROUND: Neck and low back pain are significant health problems due to their high prevalence among the general population. Educational intervention commonly aims to reduce the symptoms and risk for additional problems by increasing the participant's knowledge, which in turn will alter the person's behavior. The primary aim of this study was to review randomize controlled trials (RCTs) to gain insights into the effectiveness of education for the prevention and treatment of non-specific neck and low back pain. METHODS: Publications were systematically searched from 1982 to March 2015 in several databases. Relevant RCTs were retrieved and assessed for methodological quality. Meta-analysis was conducted to examine the effectiveness of education for the prevention and treatment of non-specific neck and low back pain. The overall quality of evidence was assessed using the GRADE system. RESULTS: Thirty-six RCTs (30 high-quality studies) were identified. A total of 15 RCTs, which compared education programs to no education program, were included for further analysis. All studies included investigated the effectiveness of education with intermediate- and long-term follow-ups. The results showed that education programs were not effective in preventing and treating neck pain as well as treating low back pain. Conflicting evidence was found for the effectiveness of education on prevention of low back pain. CONCLUSIONS: Evidence suggests that education programs are not recommended in preventing or treating neck pain as well as treating low back pain, unless supplementary high-quality studies provide evidence to the contrary.

Evaluation of an mHealth intervention aiming to improve health-related behavior and sleep and reduce fatigue among airline pilots.

OBJECTIVES: The aim of this study was to evaluate the effects of an mHealth intervention (intervention using mobile technology) consisting of tailored advice regarding exposure to daylight, sleep, physical activity, and nutrition, and aiming to improve health-related behavior, thereby reducing sleep problems and fatigue and improving health perception of airline pilots. METHODS: A randomized controlled trial was conducted among 502 airline pilots. The intervention group was given access to both the MORE Energy mobile application (app) with tailored advice and a website with background information. The control group was directed to a website with standard information about fatigue. Health-related behavior, fatigue, sleep, and health perception outcomes were measured through online questionnaires at baseline and at three and six months after baseline. The effectiveness of the intervention was determined using linear and Poisson mixed model analyses. RESULTS: After six months, compared to the control group, the intervention group showed a significant improvement on fatigue (ß= -3.76, P<0.001), sleep quality (ß= -0.59, P=0.007), strenuous physical activity (ß=0.17, P=0.028), and snacking behavior (ß= -0.81, P<0.001). No significant effects were found for other outcome measures. CONCLUSIONS: The MORE Energy mHealth intervention reduced self-reported fatigue compared to a minimal intervention. Some aspects of health-related behavior (physical activity and snacking behavior) and sleep (sleep quality) improved as well, but most did not. The results show offering tailored advice through an mHealth intervention is an effective means to support employees who have to cope with irregular flight schedules and circadian disruption. This kind of intervention might therefore also be beneficial for other working populations with irregular working hours.

Responsiveness of the individual work performance questionnaire.

BACKGROUND: Individual work performance is an important outcome measure in studies in the workplace. Nevertheless, its conceptualization and measurement has proven challenging. To overcome limitations of existing scales, the Individual Work Performance Questionnaire (IWPQ) was recently developed. The aim of the current study was to gain insight into the responsiveness of the IWPQ. METHODS: Data were used from the Be Active & Relax randomized controlled trial. The aim of the trial was to investigate the effectiveness of an intervention to stimulate physical activity and relaxation of office workers, on need for recovery. Individual work performance was a secondary outcome measure of the trial. In total, 39 hypotheses were formulated concerning correlations between changes on the IWPQ scales and changes on similar constructs (e.g., presenteeism) and distinct constructs (e.g., need for recovery) used in the trial. RESULTS: 260 Participants completed the IWPQ at both baseline and 12 months of follow-up. For the IWPQ scales, 23%, 15%, and 38%, respectively, of the hypotheses could be confirmed. In general, the correlations between change scores were weaker than expected. Nevertheless, at least 85% of the correlations were in the expected direction. CONCLUSIONS: Based on results of the current study, no firm conclusions can be drawn about the responsiveness of the IWPQ. Several reasons may account for the weaker than expected correlations. Future research on the IWPQ's responsiveness should be conducted, preferably in other populations and intervention studies, where greater changes over time can be expected.

Effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement and mental health: results of a randomized controlled trial.

OBJECTIVES: The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness. METHODS: In a randomized controlled trial design, 257 workers of two research institutes participated. The intervention group (n = 129) received a targeted mindfulness-related training, followed by e-coaching. The total duration of the intervention was 6 months. Data on work engagement, mental health, need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up. Effects were analyzed using linear mixed effect models. RESULTS: There were no significant differences in work engagement, mental health, need for recovery and mindfulness between the intervention and control group after either 6- or 12-months follow-up. Additional analyses in mindfulness-related training compliance subgroups (high and low compliance versus the control group as a reference) and subgroups based on baseline work engagement scores showed no significant differences either. CONCLUSIONS: This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness after 6 and 12 months. TRIAL REGISTRATION: Netherlands Trial Register NTR2199.

Effectiveness of a worksite mindfulness-based multi-component intervention on lifestyle behaviors.

INTRODUCTION: Overweight and obesity are associated with an increased risk of morbidity. Mindfulness training could be an effective strategy to optimize lifestyle behaviors related to body weight gain. The aim of this study was to evaluate the effectiveness of a worksite mindfulness-based multi-component intervention on vigorous physical activity in leisure time, sedentary behavior at work, fruit intake and determinants of these behaviors. The control group received information on existing lifestyle behavior- related facilities that were already available at the worksite. METHODS: In a randomized controlled trial design (n = 257), 129 workers received a mindfulness training, followed by e-coaching, lunch walking routes and fruit. Outcome measures were assessed at baseline and after 6 and 12 months using questionnaires. Physical activity was also measured using accelerometers. Effects were analyzed using linear mixed effect models according to the intention-to-treat principle. Linear regression models (complete case analyses) were used as sensitivity analyses. RESULTS: There were no significant differences in lifestyle behaviors and determinants of these behaviors between the intervention and control group after 6 or 12 months. The sensitivity analyses showed effect modification for gender in sedentary behavior at work at 6-month follow-up, although the main analyses did not. CONCLUSIONS: This study did not show an effect of a worksite mindfulness-based multi-component intervention on lifestyle behaviors and behavioral determinants after 6 and 12 months. The effectiveness of a worksite mindfulness-based multi-component intervention as a health promotion intervention for all workers could not be established.

Mindful "Vitality in Practice": an intervention to improve the work engagement and energy balance among workers; the development and design of the randomised controlled trial.

BACKGROUND: Modern working life has become more mental and less physical in nature, contributing to impaired mental health and a disturbed energy balance. This may result in mental health problems and overweight. Both are significant threats to the health of workers and thus also a financial burden for society, including employers. Targeting work engagement and energy balance could prevent impaired mental health and overweight, respectively. METHODS/DESIGN: The study population consists of highly educated workers in two Dutch research institutes. The intervention was systematically developed, based on the Intervention Mapping (IM) protocol, involving workers and management in the process. The workers' needs were assessed by combining the results of interviews, focus group discussions and a questionnaire with available literature. Suitable methods and strategies were selected resulting in an intervention including: eight weeks of customized mindfulness training, followed by eight sessions of e-coaching and supporting elements, such as providing fruit and snack vegetables at the workplace, lunch walking routes, and a buddy system. The effects of the intervention will be evaluated in a RCT, with measurements at baseline, six months (T1) and 12 months (T2). In addition, cost-effectiveness and process of the intervention will also be evaluated. DISCUSSION: At baseline the level of work engagement of the sample was "average". Of the study population, 60.1% did not engage in vigorous physical activity at all. An average working day consists of eight sedentary hours. For the Phase II RCT, there were no significant differences between the intervention and the control group at baseline, except for vigorous physical activity. The baseline characteristics of the study population were congruent with the results of the needs assessment. The IM protocol used for the systematic development of the intervention produced an appropriate intervention to test in the planned RCT. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NTR): NTR2199.

A process evaluation of a worksite vitality intervention among ageing hospital workers.

BACKGROUND: The process evaluation of the Vital@Work intervention was primary aimed at gaining insight into the context, dose delivered, fidelity, reach, dose received, and participants' attitude. Further, the differences between intervention locations were evaluated. METHODS: Eligible for this study were 730 workers, aged ≥ 45 years, from two academic hospitals. Workers randomised to the intervention group (n = 367) received a 6-months intervention consisting a Vitality Exercise Programme (VEP) combined with three visits to a Personal Vitality Coach (PVC), aimed at goal setting, feedback, and problem solving. The VEP consisted of a guided yoga session, a guided workout session, and aerobic exercising without direct face-to-face instruction, all once a week. Data were collected by means of a questionnaire after the intervention, attendance registration forms (i.e. attendance at guided VEP group sessions), and coaching registration forms (filled in by the PVCs). RESULTS: The dose delivered of the yoga and workout sessions were 72.3% and 96.3%. All PVC visits (100%) were offered. The reach for the yoga sessions, workout sessions and PVC visits was 70.6%, 63.8%, and 89.6%, respectively. When taken these three intervention components together, the reach was 52%. This differed between the two locations (59.2% versus 36.8%). The dose received was for the yoga 10.4 sessions/24 weeks and for the workout 11.1 sessions/24 weeks. The attendance rate, defined as the mean percentage of attended group sessions in relation to the total provided group sessions, for the yoga and workout sessions was 51.7% and 44.8%, respectively. For the yoga sessions this rate was different between the two locations (63.2% versus 46.5%). No differences were found between the locations regarding the workout sessions and PVC visits. Workers attended on average 2.7 PVC visits. Overall, workers were satisfied with the intervention components: 7.5 for yoga sessions, 7.8 for workout sessions, and 6.9 for PVC visits. CONCLUSIONS: The implementation of the intervention was accomplished as planned with respect to the dose delivered. Based on the reach, most workers were willing to attend the guided group sessions and the PVC visits, although there were differences between the locations and between intervention components. Overall, workers were positive about the intervention. TRIAL REGISTRATION: Trial registration NTR1240.

Cost-effectiveness of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders: design of a randomised controlled trial.

BACKGROUND: Within the working population there is a vulnerable group: workers without an employment contract and workers with a flexible labour market arrangement, e.g. temporary agency workers. In most cases, when sick-listed, these workers have no workplace/employer to return to. Also, for these workers access to occupational health care is limited or even absent in many countries. For this vulnerable working population there is a need for tailor-made occupational health care, including the presence of an actual return-to-work perspective. Therefore, a participatory return-to-work program has been developed based on a successful return-to-work intervention for workers, sick-listed due to low back pain.The objective of this paper is to describe the design of a randomised controlled trial to study the (cost-)effectiveness of this newly developed participatory return-to-work program adapted for temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders, compared to usual care. METHODS/DESIGN: The design of this study is a randomised controlled trial with one year of follow-up. The study population consists of temporary agency workers and unemployed workers sick-listed between 2 and 8 weeks due to musculoskeletal disorders. The new return-to-work program is a stepwise program aimed at making a consensus-based return-to-work implementation plan with the possibility of a (therapeutic) workplace to return-to-work. Outcomes are measured at baseline, 3, 6, 9 and 12 months. The primary outcome measure is duration of the sickness benefit period after the first day of reporting sick. Secondary outcome measures are: time until first return-to-work, total number of days of sickness benefit during follow-up; functional status; intensity of musculoskeletal pain; pain coping; and attitude, social influence and self-efficacy determinants. Cost-benefit is evaluated from an insurer's perspective. A process evaluation is part of this study. DISCUSSION: For sick-listed workers without an employment contract there can be gained a lot by improving occupational health care, including return-to-work guidance, and by minimising the 'labour market handicap' by creating a return-to-work perspective. In addition, reduction of sickness absence and work disability, i.e. a reduction of disability claims, may result in substantial benefits for the Dutch Social Security System. TRIAL REGISTRATION NUMBER: NTR1047.

The Vital@Work Study. The systematic development of a lifestyle intervention to improve older workers' vitality and the design of a randomised controlled trial evaluating this intervention.

BACKGROUND: A major contributor of early exit from work is a decline in health with increasing age. As healthy lifestyle choices contribute to better health outcomes, an intervention aimed at an improved lifestyle is considered a potentially effective tool to keep older workers healthy and vital, and thereby to prolong labour participation. METHODS: Using the Intervention Mapping (IM) protocol, a lifestyle intervention was developed based on information obtained from 1) literature, 2) a short lifestyle questionnaire aimed at identifying the lifestyle behaviours among the target group, and 3) focusgroup (FG) interviews among 36 older workers (aged 45+ years) aimed at identifying: a) key determinants of lifestyle behaviour, b) a definition of vitality, and c) ideas about how vitality can be improved by lifestyle.The main lifestyle problems identified were: insufficient levels of physical activity and insufficient intake of fruit and vegetables. Using information from both literature and FG interviews, vitality consists of a mental and a physical component. The interviewees suggested to improve the mental component of vitality by means of relaxation exercises (e.g. yoga); physical vitality could be improved by aerobic endurance exercise and strength training.The lifestyle intervention (6 months) consists of three visits to a Personal Vitality Coach (PVC) combined with a Vitality Exercise Programme (VEP). The VEP consists of: 1) once a week a guided yoga group session aimed at relaxation exercises, 2) once a week a guided aerobic workout group session aimed at improving aerobic fitness and increasing muscle strength, and 3) older workers will be asked to perform once a week for at least 45 minutes vigorous physical activity without face-to-face instructions (e.g. fitness). Moreover, free fruit will be offered at the group sessions of the VEP. The lifestyle intervention will be evaluated in a RCT among older workers of two major academic hospitals in the Netherlands. At baseline, after 6 and 12 months, measurements (primary: lifestyle and vitality, and secondary: work-engagement and productivity) will take place. DISCUSSION: The lifestyle programme is developed specifically tailored to the needs of the older workers and which is aimed at improving their vitality. TRIAL REGISTRATION: NTR1240.