NCT05660330

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

November 30, 2022

Last Update Submit

April 11, 2024

Conditions

Keywords

Well-being at workWork-engagementWorkplace interventionHolisticTailor-made

Outcome Measures

Primary Outcomes (3)

  • Engagement

    Change in self-reported Utrecht Work Engagement Scale (9 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

  • Jobsatisfaction

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

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

  • Commitment

    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 Outcomes (4)

  • Life satisfaction

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

  • Affect

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

  • Basic needs

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

  • Burnout

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

Study Arms (2)

Holistic semi-tailormade well-being (intervention) group

EXPERIMENTAL

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

Behavioral: Holistic semi-tailormade well-being intervention

Standard well-being (control) group

NO INTERVENTION

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.

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.

Holistic semi-tailormade well-being (intervention) group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

RECRUITING

Related Publications (32)

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Study Officials

  • Lutgart Braeckman

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Lieven Annemans

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eline De Poortere

CONTACT

Sophie Vandepitte

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 21, 2022

Study Start

April 1, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations