Condition category
Not Applicable
Date applied
10/11/2016
Date assigned
15/11/2016
Last edited
05/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Organizational workplace interventions to improve employee health aim to reduce health hazards and enhance health promoting working conditions. In particular, organizational workplace interventions which involve participation of workers may have a positive impact on employees’ health, since these types of interventions draw on workers’ deep knowledge of the working procedures and because they are likely to improve employees’ job control. This study is looking at a programme designed to improve the work environment by focusing on improving the performance of core job tasks. It is expected that focusing on core job tasks will reduce work stress, and that reduced work stress will result in favorable outcomes with regard to job satisfaction, exhaustion, sleep disturbances, short term sickness absence, and parents’ satisfaction. Results from organizational workplace intervention studies are, however, inconsistent, and only few studies have used a strong research design. Therefore, the aim of this study is to use a strong research design to examine whether a workplace intervention focusing on employees' work tasks can increase employees' well-being, reduce their short-term sickness absence, and increase parents’ satisfaction.

Who can participate?
Male and female employees in all age and job groups employed in one of the 78 participating pre-schools.

What does the study involve?
Participating workplaces (pre-schools) are randomly allocated to one of two groups. Workplaces in the first group continue to work as normal for the duration of the study. Workplaces in the second group take part in the workplace intervention. The program consists of seminars and workshops. Based on consultants implementation support, seminars, and workshops, local intervention activities were developed and implemented in workplaces. A work environment consultant being assigned to all workplaces for the full implementation period.

What are the possible benefits and risks of participating?
If successful, the intervention would result in an increased level of job satisfaction, decreased levels of exhaustion and sleep disturbances, lower risk of short-term sickness absence, and increase parent satisfaction. The intervention was not expected to pose any risks on participants.

Where is the study run from?
The study is run by The Children and Youth Administration and takes place in 78 pre-schools within the Children and Youth Administration of the Municipality of Copenhagen, (Denmark)

When is study starting and how long is it expected to run for?
September 2010 to September 2013

Who is funding the study?
1. The Danish Working Environment Research Fund (Denmark)
2. The Danish Prevention Fund (Denmark)

Who is the main contact?
Associate Professor Ole Henning Sørensen
ohs@business.aau.dk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ole Henning Sørensen

ORCID ID

http://orcid.org/0000-0002-1782-1660

Contact details

Aalborg Universitet København
A. C. Meyers Vænge 15
Copenhagen
DK-2450 SV
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

28-2010-03

Study information

Scientific title

Process-supported work environment efforts with a focus on the core task

Danish: "Processtøttede arbejdsmiljøindsatser med kerneopgaven i centrum"

Acronym

Study hypothesis

1. The workplace intervention, a participatory organizational-level occupational health intervention aiming to improve the working environment by focusing on core job tasks, will lead to increased job satisfaction and reduced exhaustion and sleep disturbances in the intervention group compared to the control group
2. The workplace intervention, a participatory organizational-level occupational health intervention aiming to improve the working environment by focusing on core job tasks, will lead to a lower risk of short-term sickness absence in the intervention group compared to the control group
3. The workplace intervention, a participatory organizational-level occupational health intervention aiming to improve the working environment by focusing on core job tasks, will lead to higher user satisfaction among parents in the intervention group compared to the control group

Ethics approval

According to Danish law, research studies that solely use questionnaire and register data do not need approval from the National Committee on Health Research Ethics (Den Nationale Videnskabetiske Komité).

Study design

Interventional cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Employment

Intervention

78 workplaces (pre-schools) will be randomized to either intervention group or control group by a statistician at The Danish National Research Centre for the Working Environment using a random number generator.

Control group: Workplaces will continue to work as usual for the duration of the study (25 months)

Intervention group: A working environment consultant will be assigned to each pre-school in the intervention group. Further, a steering group in each intervention group pre-school will receive implementation support from the working environment consultant for the full implementation period. The intervention consists of intervention activities for all steering group members, i.e. seminars and workshops focusing on how to develop and implement intervention activities tailored their own workplace using a participatory approach, change management training, workplace culture, and tools to evaluate achievements. Based on seminars, workshops, and consultants’ implementation support, the steering groups will develop and implement intervention activities tailored their own workplace involving all employees.

The total duration of the intrvention is 25 months. The total duration of follow-up is 2 years for self-reported employee measures, 31 months for register-based employee measures and finally, 1 year for self-reported parents’ measures.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Job satisfaction is measured using one item from the second version of the Copenhagen Psychosocial Questionnaire at baseline and 2 years
2. Exhaustion is measured using one item from the Major Depression Inventory at baseline and 2 years
3. Sleep disturbances are measured using one item from the Major Depression Inventory at baseline and 2 years
4. Parents’ satisfaction is measured using an 11 items web based survey developed for the project at baseline and 1 year

Secondary outcome measures

Long-term sickness absence is measured by employer register with individual, monthly updates on number of days with long-term sickness absence throughout the 2 year study period.

Overall trial start date

01/09/2010

Overall trial end date

30/09/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years and over of either gender
2. Employed at one of the 78 participating pre-schools during time of intervention

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

78 workplaces with 20 employees - minimum of 1560 unique participants.

Participant exclusion criteria

Workplace exclusion criteria:
1. Less than 10 employees
3. Assessed by district management as not being ready for the intervention

Recruitment start date

01/03/2011

Recruitment end date

01/06/2011

Locations

Countries of recruitment

Denmark

Trial participating centre

The Children and Youth Administration
Municipality of Copenhagen
Copenhagen
DK-1599 V
Denmark

Sponsor information

Organisation

The Danish National Research Centre for the Working Environment

Sponsor details

Lersø Parkallé 105
Copenhagen
DK-2100
Denmark
+45 3916 5200
nfa@arbejdsmiljoforskning.dk

Sponsor type

Research organisation

Website

http://www.arbejdsmiljoforskning.dk/en

Funders

Funder type

Research organisation

Funder name

The Danish Working Environment Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Prevention Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/11/2017

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27899101

Publication citations

Additional files

Editorial Notes

05/12/2016: Publication reference added.