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RecruitingNCT05866978ITASPAUpdated May 19, 2023

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

An interventional study of Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA) in Musculoskeletal Disorder, Mental Health Issue and Work-related Illness, sponsored by Holbaek Sygehus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Holbaek Sygehus · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2021, registered Mar 2023).
  • Started Apr 2021; still recruiting 5 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Musculoskeletal Diseases

752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.

This study's planned enrollment of 100 is above the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Holbaek Sygehus is the lead sponsor of 27 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Being pregnant; not being able to understand and speak Danish or English
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    An integrated workplace intervention

    Intervention: A group of employees at each workplace will develop and implement their own project activities at meetings four times during the intervention. Activities are implemented at workplaces for all employees. Employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires.

    Behavioral: Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)

  • No intervention
    Reference

    Reference: No intervention activities.

Interventions

  • BehavioralIntegrated 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Data on musculoskeletal disorders are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.

  2. 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/)

    Time frame: Data on functionality are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.

  3. 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

    Time frame: Data on psychosocial wellbeing are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.

  4. 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)

    Time frame: Data on safety culture are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.

  5. 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).

    Time frame: 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.

  6. 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).

    Time frame: 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.

  7. 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).

    Time frame: Data on heart rate are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.

  8. 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).

    Time frame: Blood pressure are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.

Secondary outcomes

  1. 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

    Time frame: Data on sickness absence are collected from 12 months prior to the randomization and 12 months after the last (15 months) follow up.

07

Study locations

1 of 1 sites recruiting
  • Department of Occupational and Social Medicine
    Holbaek, Region Zealand 4300, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05866978
Lead sponsor
Holbaek Sygehus
Collaborators
Region Zealand
Responsible party
Sponsor
First posted
May 19, 2023
Start date
Apr 1, 2021
Primary completion
Jun 1, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 19, 2023

Study contacts

Mette Korshøj, PhD
Contact
melars@regionsjaelland.dk
004559489851
Ole Steen Mortensen, PhD
Contact
osm@regionsjaelland.dk
004559489851
Mette Korshøj, PhD
principal investigator · Holbaek Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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