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Clinical Trials/NCT03854877
NCT03854877
Unknown
Not Applicable

DagisWork - Improved Health Behaviour and Wellbeing: a Randomized Controlled Workplace Intervention

Finnish Institute of Occupational Health1 site in 1 country300 target enrollmentFebruary 15, 2017
ConditionsHealth Behavior

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Behavior
Sponsor
Finnish Institute of Occupational Health
Enrollment
300
Locations
1
Primary Endpoint
Allostatic load (AL)
Last Updated
7 years ago

Overview

Brief Summary

The main aim of the study is to test effectiveness of a multiple intervention program aimed at making positive changes to health behaviour and stress. Effectiveness of a 4 month workplace intervention, with virtual coaching and co-worker-support, will be assessed as changes in subjective and objective measures of stress, work ability, recovery and health behaviour.

Detailed Description

Consequences of psychosocial stress can be seen in personnel's health such as long lasting imbalance between consumptive and restoring physiological processes (allostatic load, AL) that increase the risk of physical diseases and mental health problems and poor health behaviours. Chronic work stress induces adverse emotional and physical responses, which are triggered by perception of demands that exceed the person's capacity to cope (Folkman et al. 1986). Health behaviour can be improved both by increasing personnel's' resources and removing stress-causing factors (Lamontagne et al. 2007). Mindfulness based cognitive therapy aims at increasing stress resources by developing emotional and behavioral experiences. It combines aspects of cognitive approach including dialectic behavior therapy and Acceptance and Commitment Therapy (ACT). Mindfulness and acceptance-based interventions have positive consequences for physical activity and quality of life (Kangasniemi et al. 2015, Khoury et al. 2015). Novel results suggest that the approach is effective to reduce work stress also (Aikens et al. 2014). A four month intervention with virtual life habit coaching, individualised exercises and mindfulness-based techniques will be performed. The aim is to achieve significant and long lasting changes in life habits and stress of employees. The extensive measurements including both self-evaluated and objective measurements together with multifaceted viewpoint provide profound knowledge of occupational health. They also create a comprehensive picture of preschool setting as an arena for healthy lifestyle and well-being. A new issue is the concert of different kinds of work load factors, and their interacting role in biomarkers for work stress. If proven effective, the health behaviour intervention tested in preschool environment, can be modified to suit also other occupational settings. The health economic evaluation, together with aforementioned measurement, offer information for different stakeholders on whether interventions are economically worthwhile for participating municipalities and occupational health care. The results of study are beneficial also for policy-makers in different sectors. Aims and hypotheses Primary hypotheses 1. The intervention has a positive effects on long-term physiological adaptation to stress, biological health risk factors, recovery, and sickness absences among personnel. 2. The interventions directly enhance personnel's health behavior including eating habits, physical activity and experienced stress. Secondary hypotheses 1. The physiological change in stress regulating systems caused by work related factors (psychosocial, cognitive, and physical) is associated with personnel's change health risk load (AL) and recovery. 2. Subjective psychological and cognitive factors of stress, recovery and even mental health symptoms are individually related to physiological responses, which can be characterized more precisely by the combined assessment of hormonal, neuronal responses and new methods of system biology. 3. The intervention will have positive economic effect (costs and benefits). 4. The intervention will have positive changes in self-efficasy

Registry
clinicaltrials.gov
Start Date
February 15, 2017
End Date
February 28, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Finnish Institute of Occupational Health
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Voluntary
  • Working in municipal city of Espoo or Kouvola in preschool

Exclusion Criteria

  • Pregnancy
  • Retirement during the intervention

Outcomes

Primary Outcomes

Allostatic load (AL)

Time Frame: Change from baseline in stress after four months

Allostatic load (AL) (allostatic load and allostatic overload refers to the cumulative result of an allostatic state) is measured by the following primary and secondary markers: salivary cortisol (µg/dl) heart rate variability measurement \[RMSSD, (ms)\], (hsCRP (mg/l), HbA1c (mmol/mol), triglycerides (mmol/l). Salivary cortisol is the mean of morning and evening samples (Aardal, E.\&Holm, A. 1995), (RMSSD is the value on recovery during sleeping (First_beat Manual 2014). Clinical cutoff values are used for salivary cortisol, hsCRP, HbA1c and triglycerides and age-reference value (HUSLAB Manual 2018). All markers are dichotomized (0 = below the clinical or age-reference; 1= exceeds the clinical or age-reference). Total Allostatic load is calculated as the sum of all measures (range 0 to 5) (Altman et. al.1986). Total Allostatic load we shown before and after the intervention.

Perceived stress

Time Frame: Change from baseline in stress after four months

General Health Questionnaire (GHQ-12). The scale includes 12 items. The four response choices (0 "Not at all", 1 "Same as usual", 2 "Rather more than usual" and 3 "Much more than usual") will be dichotomized as follows: 1=0, 2=1, 3=2, 4=3. GHQ-12 case ≥ 3 points (range 0-36). The higher values indicate higher psychological symptoms. The reference mean value is 10.3 (SD 5.0) points (Holi, Marttunen, Aalberg 2003).

Secondary Outcomes

  • Economic benefits(Sickness absence absence [ (Time Frame: approx. 3 years (from 2016 to 2019) ])
  • Intuitive eating(Change from baseline after four months)
  • Eating habits(Change from baseline after four months.)
  • Measured physical activity(Change from baseline after four months)
  • Work ability(Change from baseline after four months)
  • Cognitive failures at work(Change from baseline after four months)
  • Self-efficacy(Change from baseline after four months)
  • Sleep(Change from baseline after four months)

Study Sites (1)

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