Clinical trial NCT05660330: Well-being at Work: Research Into Happiness at Work
Official title: Assessing the Effectiveness of a Holistic Semi-tailormade Well-being Intervention at Work: Study Protocol of a Partially Randomized Preference Trial Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-being at Work
Keywords: Well-being at work
Work-engagement
Workplace intervention
Holistic
Tailor-made
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Liantis
First posted: 2022-12-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Organizations are becoming increasingly aware that employees are an important factor in gaining and maintaining competitive advantage. Based on the current evidence, a holistic approach, in which different well-being factors and different levels are addressed simultaneously, is needed. However, given the scarcity of this approach in studies, a significant gap in knowledge is demonstrated. This paper tries to address these shortcomings. A partially randomised preference trials design is used to evaluate the impact of an intervention package that focusses on both the individual and organizational level and addresses 3 different domains to improve well-being: psychosocial, ergonomic and lifestyle. The data collection of the research outcomes will be conducted at several points in time. Therefore, a online self-administered questionnaire is developed en will be administered before the start of the intervention. Six and twelve months after the intervention, the short and long term impact of the intervention will be measured. The intervention itself consists of a basic intervention package that will be spread over 3 different days that take place over a time period of maximum 2 weeks. Between 20 and 30 companies will be recruited from a data pool with clients from the Flemish side of Belgium. The sample size of the participating employees should be at least 2000. A stratified random sampling method will be used based on sector type while company size (small-medium-large) will be taken into account

Detailed description: Background

Since there's a high prevalence of people with work-related mental health problems and chronic diseases, the literature used to mainly focus on the negative impact on the well-being of individuals and the consequences for the organizations and how to prevent this.

The last decades, developing methods for preventing health problems has been recognized as crucial and should be high on the agenda of workplace health promotion programs. The introduction of a positive psychology approach to well-being highlights not only the prevention of health problems but especially creating a healthy organization with an environment that can promote employee health and safety as well as organizational effectiveness by enhancing individual and organizational resources .

Organizations are becoming increasingly aware that employees are an important factor in gaining and maintaining competitive advantage . Therefore, literature has seen a growth on research on constructs such as engagement or flow, thriving at work, flourishing at work, meaning at work, and purpose in life or personal growth. Engagement has become one of the most significant concepts in the management field in recent years. It yields positive outcomes such as high levels of well-being and performance . Individuals who are engaged in their work have higher levels of energy, are enthusiastic about their work, and are completely immersed in their work activities. Furthermore, well-being at work is not only crucial for the well-being of the individual employee but it also has positive consequences for the organization, such as better work performance, higher levels of employee creativity and engagement. It has also been associated with lower rates of absenteeism at work.

With most adults spending around half of their waking hours at work, the workplace is an important setting to promote health and well-being. Multiple studies, systematic reviews and meta-analyzes have shown that workplace interventions may result in positive effects. Therefore, it is very important to address and enhance determinants of workplace-related well-being. Interventions that enhance well-being can take place on both the individual level and the organizational level. On the individual level, well-being and health can be improved by different intervention domains. Firstly, physical activity can improve a healthy lifestyle and well-being. Secondly, psychosocial interventions, such as engagement interventions, resilience training or burnout preventions increase mental health and well-being. Lastly, ergonomic interventions, such as sitting behavior has an impact on health . For employees who attended well-being interventions, the number of absence days due to stress, anxiety and depression had fallen over the following three years. In addition, they reported improvements in their relationships, improvements in sleep patterns and improvements in happiness when at work. On the organizational level, workplace well-being programs are expected to reduce employee healthcare costs, increase productivity, and provide a positive return on investment. However, today, empirical evidence for organizational interventions remains limited and the effectiveness of organizational level workplace interventions has not been fully examined. Furthermore, only a small number of studies have thus far examined organizational interventions or activities as potential antecedents of engagement.

It is proven that interventions addressing both the individual and organizational level components simultaneously lead to better results than interventions exclusively focusing on an individual, or an organizational component. Interventions at multiple levels are preferred due to the potential synergistic effects on both employee well-being and performance. Not only is it important to include a combination of both individual-level and organizational-level interventions, but also interventions that are addressing different well-being domains at once - such as ergonomic, psychosocial and lifestyle domain - had a higher chance of reporting significant health improvements than those restricted to one well-being intervention domain. A systematic review indicated that a multi-domain intervention combining physical activity, cognitive training and nutrition exerted beneficial effects. Overall, multi-component programs were more effective than single-component interventions .

Although the monetary aspect (productivity) is an essential part for the organizations whether to implement an intervention or not, organizations and workplaces are also a social and psychological context in which people live, work and relate. Therefore, in order to increase productivity, a holistic intervention approach that addresses more than only the financial aspect, but also other well-being aspects (e.g. engagement and health) will be more effective and should be high on the agenda.

Furthermore, literature has shown the importance of tailor-made interventions because this increases the relevance of the intervention for participants. Tailoring well-being programs have an increased likelihood of success when tailored to the special features of each workplace environment. The effects of the tailored interventions were superior to the generic interventions.

Design

A partially randomized preference trial design with waiting list will be used to assess the effectiveness of an intervention package to improve engagement, job satisfaction and commitment at work. The intervention group will consist of employees from different organizational levels receiving a package of different well-being interventions and will be compared to a control group that does not receive this intervention. Comparison between the groups will be done by collecting psychosocial, ergonomic and lifestyle data through an online questionnaire. The study participants are Flemish adults, employed in a company from one of the following sectors: construction, transportation, industry, IT and health care. We aimed to include at least 2000 participants over 20-30 different companies.

Statistical analysis

Descriptive statistics of baseline characteristics will be reported through numbers and proportions. All analyses will be conducted using SPSS software (version 25.0, SPSS Inc., Chicago, Illinois) or R software (version...., R Core Team...) and the level of significance will be set at p \< 0.05 (5%) . T-tests and chi-square tests will be used to compare differences between pre- and post-intervention outcomes and also between intervention participants and non-participants identified at the post-intervention survey.

Eligibility criteria: Inclusion Criteria:

* Sufficient knowledge in one of the languages (Dutch, French, English)

Primary outcomes:
measure: Engagement
timeFrame: Change from baseline to post-interventional measurement at 6 and 12 months
measure: Jobsatisfaction
timeFrame: Change from baseline to post-interventional measurement at 6 and 12 months
measure: Commitment
timeFrame: Change from baseline to post-interventional measurement at 6 and 12 months
Secondary outcomes:
measure: Life satisfaction
timeFrame: Change from baseline to post-interventional measurement at 6 and 12 months
measure: Affect
timeFrame: Change from baseline to post-interventional measurement at 6 and 12 months
measure: Basic needs
timeFrame: Change from baseline to post-interventional measurement at 6 and 12 months
measure: Burnout
timeFrame: Change from baseline to post-interventional measurement at 6 and 12 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Lutgart Braeckman
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Lieven Annemans
role: PRINCIPAL_INVESTIGATOR
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