- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05866978
An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mette Korshøj, PhD
- Phone Number: 004559489851
- Email: melars@regionsjaelland.dk
Study Contact Backup
- Name: Ole Steen Mortensen, PhD
- Phone Number: 004559489851
- Email: osm@regionsjaelland.dk
Study Locations
-
-
Region Zealand
-
Holbaek, Region Zealand, Denmark, 4300
- Recruiting
- Department of Occupational and Social Medicine
-
Contact:
- Mette Korshøj, PhD
- Phone Number: 004559489851
- Email: melars@regionsjaelland.dk
-
Contact:
- Ole Steen Mortensen, PhD
- Phone Number: 004559489851
- Email: osm@regionsjaelland.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
No Intervention: Reference
Reference: No intervention activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of musculoskeletal disorders from baseline to 6, 9, 12 and 15 months after randomization
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.
|
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.
|
Change of functionality from baseline to 6, 9, 12 and 15 months after randomization
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.
|
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.
|
Change of psychosocial wellbeing from baseline to 6, 9, 12 and 15 months after randomization
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.
|
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.
|
Change of safety culture from baseline to 6, 9, 12 and 15 months after randomization
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.
|
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.
|
Change of body weight (kg) from baseline to 6, 9, 12 and 15 months after randomization
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.
|
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.
|
Change of percent body fat from baseline to 6, 9, 12 and 15 months after randomization
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.
|
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.
|
Change of resting heart rate (beats per minute) from baseline to 6, 9, 12 and 15 months after randomization.
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.
|
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.
|
Change of blood pressure (mmHg) from baseline to 6, 9, 12 and 15 months after randomization.
Time Frame: Blood pressure are collected 3 months after randomization. Additional follow up data are collected 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of sickness absence from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
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.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mette Korshøj, PhD, Holbaek Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R22A547
- SJ-927 (Other Identifier: Ethics Committee in Region Zealand, Denmark)
- REG-034-2021 (Other Identifier: The Danish data protection agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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