Clinical trial NCT05866978: An Integrated Approach to Health, Wellbeing, and Productivity at Work
Official title: An Integrated Approach to Health, Wellbeing, and Productivity at Work
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Disorder
Mental Health Issue
Work-related Illness
Safety Issues
Work Environment Adverse Effects
Keywords: total worker health
occupational safety and health
intervention development
cleaning assistants
pain and injury
wellbeing
working conditions
work environment
workhealth improvement network
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Region Zealand
First posted: 2023-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Using a stepped-wedge design, participants at the enrolled worksites function as their own control. Thus, the effect of the intervention is evaluated as in an RCT design. All employees are asked to complete a short screening questionnaire. Those who wish to participate are invited to the data collection containing: Signing of consent, measurements of height, body weight, fat percentage and blood pressure and answering a questionnaire. No preparation is required of the participants before data collection begins. All intervention activities and health checks take place at the participants' workplace during paid working hours. Calculation, analysis and interpretation of data will take place at the Department of Occupational and Social Medicine, Holbæk Hospital.

The intervention activities are developed by a local commitee including participants and managers, acoording a participatory approach and following the Work Health Improvements Network concept.
Primary purpose: PREVENTION

Brief summary: The goal of the workplace intervention study 'An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' is to examine the effect of the Australian WorkHealth Improvement Network (WIN) program in a Danish context among blue-collar workers. The project is evaluated via its effect on: 1) Musculoskeletal disorders (MSD), 2) Functionality, 3) Psychosocial wellbeing, and 4) Safety culture. Based on identified work health challenges at the included workplace, a group of employees at each worksite will develop and implement their own health promoting activities. Remaining employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. All intervention activities and health checks take place at the participants' workplace during paid working hours. In our study design, participants will be compared to themselves and their previous measurements. Furthermore, we will compare the worksites.

Detailed description: The aim of the 'Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' project is to investigate the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish context among blue-collar workers. The project is evaluated via its effect on: 1) Musculoskeletal disorders (MSD), 2) Functionality, 3) Psychosocial wellbeing, and 4) Safety culture. In addition, we evaluate the intervention effect on BMI, heart rate, and blood pressure. Furthermore, the ITASPA project aims to examine the degree of implementation of the initiated initiatives and identify barriers and facilitating factors for implementation. This contributes to the knowledge about what characterizes best practices for the implementation of integrated workplace interventions.

Based on identified work health challenges at the included worksites, a group of employees at each workplace will develop and implement their own project activities. Remaining employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. All intervention activities and health checks take place at the participants' workplace during paid working hours.

ITASPA is a workplace intervention, conducted in a stepped wedge design. The stepped wedge design are assumed to increase the willingness to participate as it allows all workers to receive the intervention. The workers function as their own control and thereby, the stepped wedge design allows for an effect-evaluation, mimicking an RCT design.

To increase the transferring of the WIN program to a broad variety of Danish worksites, both public and private worksites are aimed to be enrolled. The worksites will be enrolled on basis of their willingness to perform the ITASPA activities during paid worktime and participation in the scientific evaluation of the ITASPA project.

The ITASPA project will be organized by a steering group consisting of the ITASPA project managers, representatives from the senior management at the enrolled worksites, and the ITASPA facilitators from the Department of Occupational and Social Medicine at Holbæk Hospital, Denmark. Moreover, the steering group includes an advisory board consisting of the developers of the WIN program and TWH concept. The advisory board will provide information about international experiences with integrated workplace interventions to assist the development of workplace health interventions in Denmark.

Eligibility criteria: Inclusion Criteria:

* Employed at one of the enrolled worksites ≥ 20 hours/week, providing an informed signed consent prior to participation.

Exclusion Criteria:

* Being pregnant; not being able to understand and speak Danish or English

Primary outcomes:
measure: Change of musculoskeletal disorders from baseline to 6, 9, 12 and 15 months after randomization
timeFrame: Data on musculoskeletal disorders are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
measure: Change of functionality from baseline to 6, 9, 12 and 15 months after randomization
timeFrame: Data on functionality are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
measure: Change of psychosocial wellbeing from baseline to 6, 9, 12 and 15 months after randomization
timeFrame: Data on psychosocial wellbeing are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
measure: Change of safety culture from baseline to 6, 9, 12 and 15 months after randomization
timeFrame: Data on safety culture are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
measure: Change of body weight (kg) from baseline to 6, 9, 12 and 15 months after randomization
timeFrame: Data on body weight (kg) are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
measure: Change of percent body fat from baseline to 6, 9, 12 and 15 months after randomization
timeFrame: Data on percent body fat are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
measure: Change of resting heart rate (beats per minute) from baseline to 6, 9, 12 and 15 months after randomization.
timeFrame: Data on heart rate are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
measure: Change of blood pressure (mmHg) from baseline to 6, 9, 12 and 15 months after randomization.
timeFrame: Blood pressure are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Secondary outcomes:
measure: Change of sickness absence from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
timeFrame: Data on sickness absence are collected from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Department of Occupational and Social Medicine
state: Region Zealand
Study officials:
affiliation: Holbaek Hospital
name: Mette Korshøj, PhD
role: PRINCIPAL_INVESTIGATOR
References: