An Integrated Approach to Health, Wellbeing, and Productivity at Work

Mental Health Issue Clinical Trial

— ITASPA  

Official title:

An Integrated Approach to Health, Wellbeing, and Productivity at Work

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866978
• Other study ID #: R22A547
• Secondary ID: SJ-927REG-034-20
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Holbaek Sygehus
• Contact: Mette Korshøj, PhD
• Phone: 004559489851
• Email: melars[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue
• Musculoskeletal Diseases
• Musculoskeletal Disorder
• Safety Issues

Intervention

Behavioral:
• Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
The intervention investigates 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.

Locations

Country	Name	City	State
Denmark	Department of Occupational and Social Medicine	Holbaek	Region Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Holbaek Sygehus	Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of musculoskeletal disorders from baseline to 6, 9, 12 and 15 months after randomization	The Short Form of the Örebro Musculoskeletal Pain Screening Questionnaire will be used to measure musculoskeletal disorders	Data on musculoskeletal disorders are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Primary	Change of functionality from baseline to 6, 9, 12 and 15 months after randomization	Functionality will be measured by the ICF-based Work Rehabilitation Questionnaire (WORQ) (https://myworq.org/)	Data on functionality are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Primary	Change of psychosocial wellbeing from baseline to 6, 9, 12 and 15 months after randomization	Psychosocial wellbeing will be measured via the Health Survey SF-12	Data on psychosocial wellbeing are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Primary	Change of safety culture from baseline to 6, 9, 12 and 15 months after randomization	Safety culture will be measured by the Nordic Occupational Safety Climate Questionnaire (NOSACQ-50)	Data on safety culture are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Primary	Change of body weight (kg) from baseline to 6, 9, 12 and 15 months after randomization	Bodyweight will be measured while the participant is wearing light clothes and no shoes. The estimated weight of clothes (1.5 kg) will be subtracted from body weight. Percent body fat will be estimated by bioelectric-impedance-analysis. Both body weight and percent body fat will be measured by a Segmental Body Composition Monitor, Innerscan V, BC545N (TANITA, produced in Japan). If participants have a pacemaker or are pregnant, the analysis of percent body fat will not be made. Body height will be measured on a mobile stadiometer Seca 213 (Seca, produced in China). Body mass index (BMI) will be estimated by the equation of BMI = (body weight (kg)/body height (m)2).	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.
Primary	Change of percent body fat from baseline to 6, 9, 12 and 15 months after randomization	Percent body fat will be measured while the participant is wearing light clothes and no shoes. The estimated weight of clothes (1.5 kg) will be subtracted from body weight. Percent body fat will be estimated by bioelectric-impedance-analysis. Both body weight and percent body fat will be measured by a Segmental Body Composition Monitor, Innerscan V, BC545N (TANITA, produced in Japan). If participants have a pacemaker or are pregnant, the analysis of percent body fat will not be made. Body height will be measured on a mobile stadiometer Seca 213 (Seca, produced in China). Body mass index (BMI) will be estimated by the equation of BMI = (body weight (kg)/body height (m)2).	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.
Primary	Change of resting heart rate (beats per minute) from baseline to 6, 9, 12 and 15 months after randomization.	Resting heart rate will be measured three times on the left arm after 15 minutes of sitting at rest using an Omron Model M3, automatic upper arm BP monitor (Omron healthcare, produced in Vietnam).	Data on heart rate are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Primary	Change of blood pressure (mmHg) from baseline to 6, 9, 12 and 15 months after randomization.	Blood pressure will be measured three times on the left arm after 15 minutes of sitting at rest using an Omron Model M3, automatic upper arm BP monitor (Omron healthcare, produced in Vietnam).	Blood pressure are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Secondary	Change of sickness absence from 12 months prior to the randomization and 12 months after the last (15 months) follow up.	Information on sickness absence is provided by the administration at workplaces	Data on sickness absence are collected from 12 months prior to the randomization and 12 months after the last (15 months) follow up.