Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence (AGp)

In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. Further it will be investigated to what extent Active pregnancy policy is implemented at the departments and whether it results in higher sense of security and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will be analyzed.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Occupational Exposure; Sickness Absence
• Intervention / Treatment: Behavioral: Active Pregnancy policy

Detailed Description

Background: The majority of Danish women work during their reproductive years. Sickness absence among pregnant women is frequent; more than one third of Danish women are on longterm sick leave during pregnancy. Sick leave has been found associated with occupational exposures and studies have shown that adjustment in exposure can reduce sick leave in pregnancy indicating that there are potential preventive initiatives.

Design and outcomes: In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. It will further be investigated to what extent Active pregnancy policy is implemented at the departments and whether it results in higher sense of security and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will be analyzed.

The study takes place at hospitals in the two regions on Zealand, Denmark (The Capital region of Denmark and Region Zealand) and in the daycare sector in 2 municipalities located in The Capital region of Denmark. The randomization will be at the level of departments, which will be randomized to either intervention or control:

Intervention: The leaders are invited to a 3 hours seminar, where they will be taught in how to implement active pregnancy policy at their department.

Control: as usual

All employees at the involved departments getting pregnant during the year of intervention will be included in the study. They are to answer a questionnaire at 28th week of gestation and their days of sick leave during pregnancy will be recorded. All leaders at the departments are to answer two questionnaires, one before randomization and one after intervention.

The intervention: At the 3 hours seminar the leaders will receive education containing: 1) Updates on evidence on pregnancy and risk of occupational exposures, 2) information about the rules in the area and the leader's responsibilities, 3) Answers and solutions to frequent issues relating pregnant employees at work and 4) Introduction to Active Pregnancy policy.

The content of Active Pregnancy Policy: A congratulation letter to the pregnant employee inviting her to a meeting. At the meeting her job task will be discussed and fears and worries taken hand on. The aim is to adjust the job tasks to the employee and her special need during her pregnancy. During the pregnancy the leader regularly evaluate with the pregnant employee on how it goes and if there are needs for other or further adjustments. A minimum of 3 planned meetings have to be held during the pregnancy. Further the leader shall inform the other employees at the workplace about the arrangements made with the pregnant employee.

• Study Type: Interventional
• Enrollment (Actual): 866
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of occupational and evironmental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnancy during intervention period, employed at one of the included departments/workplaces

Exclusion Criteria:

• not being able to understand, write and read Danish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention, education; Education of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces	Behavioral: Active Pregnancy policy; Education (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places
No Intervention: control; as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy related sick leave	difference in pregnancy related sick leave between the two randomized groups. In days and the proportion of pregnant employee with longterm sick leave (> 4 weeks)	one year (intervention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To what extent Active pregnancy policy is implemented at the departments/workplaces	Difference between the two randomized groups in relation to the proportion of pregnant employees who experienced active pregnancy policy (different parts: Received congratulation letter, had scheduled meetings discussing the possible occupational exposures, adjustment of work tasks)	one year (intervention period)
Wether active pregnancy policy lead to higher sense of security and wellbeing among the pregnant employees	Difference between the two randomized groups in relation to the experience of security and wellbeing among the pregnant employees. Using the WHO-5 and variables concerning the psychosocial work environment	one year
cost effectiveness of the intervention	calculating the costs of the intervention: 1)Holding the seminars (place, salary for teachers, food supply etc.) 2) time used (the leaders salary) attending the seminars, 3) Teaching material and the cost of resources used at the departments (control vs. intervention): 1) time used hiring temporary employees, 2) time used talking with pregnant employees, 3) time used changing the work tasks of the pregnant employee, 4) Salary to hired temporary employees.	one year

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Luise Moelenberg Begtrup, MD, Department of occupational Medicine, Bipspebjerg Hospital

Publications and helpful links

General Publications

• Begtrup LM, Malmros P, Brauer C, Soegaard Toettenborg S, Flachs EM, Hammer PEC, Bonde JP. Manager-oriented intervention to reduce absence among pregnant employees in the healthcare and daycare sector: a cluster randomised trial. Occup Environ Med. 2021 Jan 12:oemed-2020-106794. doi: 10.1136/oemed-2020-106794. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AGp2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No