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Well-being at WorkNCT05660330

Well-being at Work: Research Into Happiness at Work

A study testing Holistic semi-tailormade well-being intervention in people with Well-being at Work, run by University Ghent at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Well-being at Work
What is being tested?
Holistic semi-tailormade well-being intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteBelgium
Study dates
1 Apr 2022to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Eline De Poortere contact

+32475702806

eline.dp@hotmail.com

Sophie Vandepitte contact

Belgium1 site, 1 recruiting
  • Ghent University

    Ghent, 9000

    Braeckman Lutgart

    Recruiting

Other trials in Belgium

About this study

Official title: Assessing the Effectiveness of a Holistic Semi-tailormade Well-being Intervention at Work: Study Protocol of a Partially Randomized Preference Trial Design

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

Read the 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.

Being tested
Holistic semi-tailormade well-being intervention
Keywords
Well-being at work, Work-engagement, Workplace intervention, Holistic, Tailor-made

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Holistic semi-tailormade well-being interventionBehavioural

    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.

Study groups in NCT05660330
Study groupRoleWhat they receive
Holistic semi-tailormade well-being (intervention) groupExperimentalThey 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
Receives: Behavioral: Holistic semi-tailormade well-being intervention
Standard well-being (control) groupNo interventionAt first, they receive standard well-being interventions. After six or twelve months, this group can participate in the holistic semi-tailormade well-being intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Engagement

    Change in self-reported Utrecht Work Engagement Scale (9 items) from baseline measurement to follow-up measurements at 6 and 12 months

    Measured: Change from baseline to post-interventional measurement at 6 and 12 months

  2. Jobsatisfaction

    Change in self-reported Jobsatisfaction (1 item) from baseline measurement to follow-up measurements at 6 and 12 months

    Measured: Change from baseline to post-interventional measurement at 6 and 12 months

  3. Commitment

    Change in self-reported COPSOQ subscale 'Commitment' (5 items) from baseline measurement to follow-up measurements at 6 and 12 months

    Measured: Change from baseline to post-interventional measurement at 6 and 12 months

Secondary outcomes (4)
  1. Life satisfaction

    Change in self-reported life satisfaction, measured with Cantril Ladder, from baseline measurement to follow-up measurements at 6 and 12 months

    Measured: Change from baseline to post-interventional measurement at 6 and 12 months

  2. Affect

    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

    Measured: Change from baseline to post-interventional measurement at 6 and 12 months

  3. Basic needs

    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

    Measured: Change from baseline to post-interventional measurement at 6 and 12 months

  4. Burnout

    Change in self-reported burnout, measured with the UBOS (15 items), from baseline measurement to follow-up measurements at 6 and 12 months

    Measured: Change from baseline to post-interventional measurement at 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start1 Apr 2022
  3. Primary completion31 Aug 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660330
Sponsor's protocol ID
BC10608
Status last verified
Apr 2024
First submitted
30 Nov 2022
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29751224
  • 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.

    PubMed 34261376
  • 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.

    PubMed 29321942
  • 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.

    PubMed 28974935
  • 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.

    PubMed 31861812
  • 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.

    PubMed 32849134
  • 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.

    PubMed 26238744
  • 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.

    PubMed 19467822
  • 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.

    PubMed 26990220
  • 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.

    PubMed 31547516

Questions about this trial

What is this clinical trial studying?

A study testing Holistic semi-tailormade well-being intervention in people with Well-being at Work, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eline De Poortere (+32475702806, eline.dp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engagement (time frame: Change from baseline to post-interventional measurement at 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05660330, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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