- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05660330
Well-being at Work: Research Into Happiness at Work
Assessing the Effectiveness of a Holistic Semi-tailormade Well-being Intervention at Work: Study Protocol of a Partially Randomized Preference Trial Design
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eline De Poortere
- Phone Number: +32475702806
- Email: eline.dp@hotmail.com
Study Contact Backup
- Name: Sophie Vandepitte
Study Locations
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Ghent, Belgium, 9000
- Recruiting
- Ghent University
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Contact:
- Braeckman Lutgart
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sufficient knowledge in one of the languages (Dutch, French, English)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Holistic semi-tailormade well-being (intervention) group
They receive the holistic semi-tailormade intervention, consisting of training and workshops in three well-being domains: psychosocial, ergonomic and lifestyle.
In addition to this intervention, they still receive their standard interventions
|
The holistic well-being intervention consists of a mandatory basic package that will take 2 half days and 1 full day to complete.
In the first half day, the conclusion of the baseline measurement will be discussed, as well as the specific outline of the well-being thay.
On the well-being day, three trained professionals from an HR service company, called Liantis, will guide these interventions (consisting of training and workshops) in the workplace.
Only a small proportion of the company employees, called the ambassadors, will attend the well-being day.
In the second half day, the ambassadors will be coached to disseminate the obtained information to the entire workplace.
This information will be personalized according to the problems, needs and context of each company.
Besides the basic package, an optional expertise package will be offered during this second half day.
In the period afterwards, the ambassadors are followed every 2 months by means of a semi-structured interview.
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No Intervention: Standard well-being (control) group
At first, they receive standard well-being interventions.
After six or twelve months, this group can participate in the holistic semi-tailormade well-being intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement
Time Frame: Change from baseline to post-interventional measurement at 6 and 12 months
|
Change in self-reported Utrecht Work Engagement Scale (9 items) from baseline measurement to follow-up measurements at 6 and 12 months
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Change from baseline to post-interventional measurement at 6 and 12 months
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Jobsatisfaction
Time Frame: Change from baseline to post-interventional measurement at 6 and 12 months
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Change in self-reported Jobsatisfaction (1 item) from baseline measurement to follow-up measurements at 6 and 12 months
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Change from baseline to post-interventional measurement at 6 and 12 months
|
Commitment
Time Frame: Change from baseline to post-interventional measurement at 6 and 12 months
|
Change in self-reported COPSOQ subscale 'Commitment' (5 items) from baseline measurement to follow-up measurements at 6 and 12 months
|
Change from baseline to post-interventional measurement at 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Life satisfaction
Time Frame: Change from baseline to post-interventional measurement at 6 and 12 months
|
Change in self-reported life satisfaction, measured with Cantril Ladder, from baseline measurement to follow-up measurements at 6 and 12 months
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Change from baseline to post-interventional measurement at 6 and 12 months
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Affect
Time Frame: Change from baseline to post-interventional measurement at 6 and 12 months
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Change in self-reported positive and negative affect, measured with the PANAS (10 items), from baseline measurement to follow-ups measurements at 6 and 12 months
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Change from baseline to post-interventional measurement at 6 and 12 months
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Basic needs
Time Frame: Change from baseline to post-interventional measurement at 6 and 12 months
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Change in self-reported basic need satisfaction and frustration, measured with the BNSFS (12 items), from baseline measurement to follow-up measurements at 6 and 12 months
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Change from baseline to post-interventional measurement at 6 and 12 months
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Burnout
Time Frame: Change from baseline to post-interventional measurement at 6 and 12 months
|
Change in self-reported burnout, measured with the UBOS (15 items), from baseline measurement to follow-up measurements at 6 and 12 months
|
Change from baseline to post-interventional measurement at 6 and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lutgart Braeckman, University Ghent
- Principal Investigator: Lieven Annemans, University Ghent
Publications and helpful links
General Publications
- Lustria ML, Noar SM, Cortese J, Van Stee SK, Glueckauf RL, Lee J. A meta-analysis of web-delivered tailored health behavior change interventions. J Health Commun. 2013;18(9):1039-69. doi: 10.1080/10810730.2013.768727. Epub 2013 Jun 10. Erratum In: J Health Commun. 2013;18(11):1397.
- Noar SM, Benac CN, Harris MS. Does tailoring matter? Meta-analytic review of tailored print health behavior change interventions. Psychol Bull. 2007 Jul;133(4):673-93. doi: 10.1037/0033-2909.133.4.673.
- Abdin S, Welch RK, Byron-Daniel J, Meyrick J. The effectiveness of physical activity interventions in improving well-being across office-based workplace settings: a systematic review. Public Health. 2018 Jul;160:70-76. doi: 10.1016/j.puhe.2018.03.029. Epub 2018 May 16.
- Ahn S, Chung JW, Crane MK, Bassett DR Jr, Anderson JG. The Effects of Multi-Domain Interventions on Cognition: A Systematic Review. West J Nurs Res. 2022 Dec;44(12):1134-1154. doi: 10.1177/01939459211032272. Epub 2021 Jul 14.
- Frogeli E, Rudman A, Ljotsson B, Gustavsson P. Preventing stress-related ill health among newly registered nurses by supporting engagement in proactive behaviors: development and feasibility testing of a behavior change intervention. Pilot Feasibility Stud. 2018 Jan 8;4:28. doi: 10.1186/s40814-017-0219-7. eCollection 2018.
- Di Fabio A. The Psychology of Sustainability and Sustainable Development for Well-Being in Organizations. Front Psychol. 2017 Sep 19;8:1534. doi: 10.3389/fpsyg.2017.01534. eCollection 2017.
- Nielsen, K., Nielsen, M. B., Ogbonnaya, C., Känsälä, M., Saari, E., & Isaksson, K. (2017). Workplace resources to improve both employee well-being and performance: A systematic review and meta-analysis. Work & Stress, 31(2), 101-120.
- Bakker, A. B., & Albrecht, S. (2018). Work engagement: current trends. Career Development International.
- Garcia-Buades ME, Peiro JM, Montanez-Juan MI, Kozusznik MW, Ortiz-Bonnin S. Happy-Productive Teams and Work Units: A Systematic Review of the 'Happy-Productive Worker Thesis'. Int J Environ Res Public Health. 2019 Dec 20;17(1):69. doi: 10.3390/ijerph17010069.
- Bailey, C., Madden, A., Alfes, K., & Fletcher, L. (2017). The meaning, antecedents and outcomes of employee engagement: A narrative synthesis. International Journal of Management Reviews, 19(1), 31-53.
- Tandler N, Krauss A, Proyer RT. Authentic Happiness at Work: Self- and Peer-Rated Orientations to Happiness, Work Satisfaction, and Stress Coping. Front Psychol. 2020 Aug 7;11:1931. doi: 10.3389/fpsyg.2020.01931. eCollection 2020.
- Kivimaki M, Kawachi I. Work Stress as a Risk Factor for Cardiovascular Disease. Curr Cardiol Rep. 2015 Sep;17(9):630. doi: 10.1007/s11886-015-0630-8.
- Vanhove, A. J., Herian, M. N., Perez, A. L., Harms, P. D., & Lester, P. B. (2016). Can resilience be developed at work? A meta-analytic review of resilience-building programme effectiveness. Journal of Occupational and Organizational Psychology, 89(2), 278-307.
- Awa WL, Plaumann M, Walter U. Burnout prevention: a review of intervention programs. Patient Educ Couns. 2010 Feb;78(2):184-90. doi: 10.1016/j.pec.2009.04.008. Epub 2009 May 20.
- Chu AH, Ng SH, Tan CS, Win AM, Koh D, Muller-Riemenschneider F. A systematic review and meta-analysis of workplace intervention strategies to reduce sedentary time in white-collar workers. Obes Rev. 2016 May;17(5):467-81. doi: 10.1111/obr.12388. Epub 2016 Mar 15.
- Isham, A., Mair, S., & Jackson, T. (2020). Wellbeing and productivity: a review of the literature.
- Pieper C, Schroer S, Eilerts AL. Evidence of Workplace Interventions-A Systematic Review of Systematic Reviews. Int J Environ Res Public Health. 2019 Sep 23;16(19):3553. doi: 10.3390/ijerph16193553.
- Grant, A. M. (2012). ROI is a poor measure of coaching success: towards a more holistic approach using a well-being and engagement framework. Coaching: An International Journal of Theory, Research and Practice, 5(2), 74-85.
- Shi Y, Sears LE, Coberley CR, Pope JE. The association between modifiable well-being risks and productivity: a longitudinal study in pooled employer sample. J Occup Environ Med. 2013 Apr;55(4):353-64. doi: 10.1097/JOM.0b013e3182851923.
- De Cocker K, De Bourdeaudhuij I, Cardon G, Vandelanotte C. The Effectiveness of a Web-Based Computer-Tailored Intervention on Workplace Sitting: A Randomized Controlled Trial. J Med Internet Res. 2016 May 31;18(5):e96. doi: 10.2196/jmir.5266.
- Brewin CR, Bradley C. Patient preferences and randomised clinical trials. BMJ. 1989 Jul 29;299(6694):313-5. doi: 10.1136/bmj.299.6694.313. No abstract available.
- Ivandic I, Freeman A, Birner U, Nowak D, Sabariego C. A systematic review of brief mental health and well-being interventions in organizational settings. Scand J Work Environ Health. 2017 Mar 1;43(2):99-108. doi: 10.5271/sjweh.3616. Epub 2017 Jan 2.
- Varekamp I, van Dijk FJ. Workplace problems and solutions for employees with chronic diseases. Occup Med (Lond). 2010 Jun;60(4):287-93. doi: 10.1093/occmed/kqq078.
- Woodhouse E, Homewood KM, Beauchamp E, Clements T, McCabe JT, Wilkie D, Milner-Gulland EJ. Guiding principles for evaluating the impacts of conservation interventions on human well-being. Philos Trans R Soc Lond B Biol Sci. 2015 Nov 5;370(1681):20150103. doi: 10.1098/rstb.2015.0103.
- Knight C, Patterson M, Dawson J. Building work engagement: A systematic review and meta-analysis investigating the effectiveness of work engagement interventions. J Organ Behav. 2017 Jul;38(6):792-812. doi: 10.1002/job.2167. Epub 2016 Dec 13.
- Astrella JA. Return on Investment: Evaluating the Evidence Regarding Financial Outcomes of Workplace Wellness Programs. J Nurs Adm. 2017 Jul/Aug;47(7-8):379-383. doi: 10.1097/NNA.0000000000000499.
- Montano D, Hoven H, Siegrist J. Effects of organisational-level interventions at work on employees' health: a systematic review. BMC Public Health. 2014 Feb 8;14:135. doi: 10.1186/1471-2458-14-135.
- Knight, C., Patterson, M., & Dawson, J. (2019). Work engagement interventions can be effective: a systematic review. European Journal of Work and Organizational Psychology, 28(3), 348-372.
- DeChant PF, Acs A, Rhee KB, Boulanger TS, Snowdon JL, Tutty MA, Sinsky CA, Thomas Craig KJ. Effect of Organization-Directed Workplace Interventions on Physician Burnout: A Systematic Review. Mayo Clin Proc Innov Qual Outcomes. 2019 Sep 26;3(4):384-408. doi: 10.1016/j.mayocpiqo.2019.07.006. eCollection 2019 Dec.
- Hoek RJA, Havermans BM, Houtman ILD, Brouwers EPM, Heerkens YF, Zijlstra-Vlasveld MC, Anema JR, van der Beek AJ, Boot CRL. Stress Prevention@Work: a study protocol for the evaluation of a multifaceted integral stress prevention strategy to prevent employee stress in a healthcare organization: a cluster controlled trial. BMC Public Health. 2017 Jul 17;18(1):26. doi: 10.1186/s12889-017-4585-0. Erratum In: BMC Public Health. 2017 Sep 22;17 (1):736.
- Kröll, C., Doebler, P., & Nüesch, S. (2017). Meta-analytic evidence of the effectiveness of stress management at work. European Journal of Work and Organizational Psychology, 26(5), 677-693.
- Proper KI, van Oostrom SH. The effectiveness of workplace health promotion interventions on physical and mental health outcomes - a systematic review of reviews. Scand J Work Environ Health. 2019 Nov 1;45(6):546-559. doi: 10.5271/sjweh.3833. Epub 2019 May 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BC10608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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