search
Back to results

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

Primary Purpose

Musculoskeletal Disorder, Mental Health Issue, Work-related Illness

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
Sponsored by
Holbaek Sygehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Disorder focused on measuring total worker health, occupational safety and health, intervention development, cleaning assistants, pain and injury, wellbeing, working conditions, work environment, workhealth improvement network

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Occupational and Social MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

An integrated workplace intervention

Reference

Arm Description

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.

Reference: No intervention activities.

Outcomes

Primary Outcome Measures

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
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/)
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
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)
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).
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).
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).
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).

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2023
Last Updated
May 10, 2023
Sponsor
Holbaek Sygehus
Collaborators
Region Zealand
search

1. Study Identification

Unique Protocol Identification Number
NCT05866978
Brief Title
An Integrated Approach to Health, Wellbeing, and Productivity at Work
Acronym
ITASPA
Official Title
An Integrated Approach to Health, Wellbeing, and Productivity at Work
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holbaek Sygehus
Collaborators
Region Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
An integrated workplace intervention
Arm Type
Other
Arm Description
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.
Arm Title
Reference
Arm Type
No Intervention
Arm Description
Reference: No intervention activities.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of musculoskeletal disorders from baseline to 6, 9, 12 and 15 months after randomization
Description
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.
Title
Change of functionality from baseline to 6, 9, 12 and 15 months after randomization
Description
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.
Title
Change of psychosocial wellbeing from baseline to 6, 9, 12 and 15 months after randomization
Description
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.
Title
Change of safety culture from baseline to 6, 9, 12 and 15 months after randomization
Description
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.
Title
Change of body weight (kg) from baseline to 6, 9, 12 and 15 months after randomization
Description
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.
Title
Change of percent body fat from baseline to 6, 9, 12 and 15 months after randomization
Description
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.
Title
Change of resting heart rate (beats per minute) from baseline to 6, 9, 12 and 15 months after randomization.
Description
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.
Title
Change of blood pressure (mmHg) from baseline to 6, 9, 12 and 15 months after randomization.
Description
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 Outcome Measure Information:
Title
Change of sickness absence from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Korshøj, PhD
Phone
004559489851
Email
melars@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ole Steen Mortensen, PhD
Phone
004559489851
Email
osm@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Korshøj, PhD
Organizational Affiliation
Holbaek Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Occupational and Social Medicine
City
Holbaek
State/Province
Region Zealand
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Korshøj, PhD
Phone
004559489851
Email
melars@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Ole Steen Mortensen, PhD
Phone
004559489851
Email
osm@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs