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

NCT05866978 | Unknown DMC

• 3 other identifiers: R22A547SJ-927REG-034-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Change of sickness absence from 12 months prior to the randomization and 12 months after the last (15 months) follow up.

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

Study Arms (2)

An integrated workplace intervention

OTHER

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)

Reference

NO INTERVENTION

Reference: No intervention activities.

Interventions

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

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.

An integrated workplace intervention

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Holbaek Sygehus: lead
• Region Zealand: collaborator

Study Sites (1)

Department of Occupational and Social Medicine

Holbæk, Region Sjælland, 4300, Denmark

RECRUITING

Related Publications (1)

• Korshoj M, Poulsen VR, Skold MB, Autrup SK, Oldenburg B, Mortensen OS. An integrated approach to health, wellbeing, and productivity at work: a design of a stepped wedge worksite intervention study. BMC Public Health. 2023 Jun 2;23(1):1057. doi: 10.1186/s12889-023-16014-x.

  PMID: 37268907 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Occupational Stress; Pain; Wounds and Injuries

Interventions

Health

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Mette Korshøj, PhD

  Holbaek Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Korshøj, PhD

CONTACT

004559489851; melars@regionsjaelland.dk

Ole Steen Mortensen, PhD

CONTACT

004559489851; osm@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 19, 2023
• Study Start: April 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)