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临床试验/NCT03854877
NCT03854877Unknown不适用

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

Finnish Institute of Occupational Health2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
2
主要终点
Allostatic load (AL)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Pregnancy
  • Retirement during the intervention

研究组 & 干预措施

Health behaviour intervention

Experimental

Personalised health behaviour e-health intervention. The intervention uses the principles of acceptance-commitment therapy (ACT). It aims to promote health habits. Based on personal needs participants can choose tasks for physical activity, relaxation, healthy eating, sleep etc. They get regular feedback, tasks and support from their personal trainer via phone and computer.

干预措施: Health behaviour intervention (Behavioral)

Control group

No Intervention

Only before and after measurements

结局指标

主要结局

Allostatic load (AL)

时间窗: 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

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Finnish Institute of Occupational Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

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