Health Behavior Clinical Trial
— DagisWorkOfficial title:
DagisWork - Improved Health Behaviour and Wellbeing: a Randomized Controlled Workplace Intervention
Verified date | August 2018 |
Source | Finnish Institute of Occupational Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 68 Years |
Eligibility |
Inclusion Criteria: - Voluntary - Working in municipal city of Espoo or Kouvola in preschool Exclusion Criteria: - Pregnancy - Retirement during the intervention |
Country | Name | City | State |
---|---|---|---|
Finland | Finnish Institute of Occupational Health | Helsinki | Uusimaa |
Lead Sponsor | Collaborator |
---|---|
Finnish Institute of Occupational Health | Helsinki University, University of Jyvaskyla |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Allostatic load (AL) | 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. | Change from baseline in stress after four months | |
Primary | Perceived stress | 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). | Change from baseline in stress after four months | |
Secondary | Economic benefits | Length (1-365 days/year) of sickness absence and frequency of sickness absence episodes (i.e. frequency of all sickness absence periods within year) obtained from employer records, including dates of absence due to sickness without medical cause information. | Sickness absence absence [ (Time Frame: approx. 3 years (from 2016 to 2019) ] | |
Secondary | Intuitive eating | The Intuitive Eating Scale, 21-items. All items are rated on a five point Likert-scale (1 totally disagree, 5 totally agree). The sum of all items indicates the level of eating habits. Higher values indicate better eating habits. | Change from baseline after four months | |
Secondary | Eating habits | The three factor eating questionnaire-R 18 (TFEQ-18). All items of the three factors (cognitive restraint, uncontrolled eating, emotional eating) are rated on a four point Likert- scale (1 definitely true, 4 definitely false). Higher values indicate higher cognitive restraint, uncontrolled eating and emotional eating. | Change from baseline after four months. | |
Secondary | Measured physical activity | Accelerometer. Average number of steps per week, at least five days and 10 hours data/day. The program counts the physical activity time in different levels (inactive, light, moderate and heavy). The higher number of steps indicate higher physical activity as well as the moderate or heavy activity. | Change from baseline after four months | |
Secondary | Work ability | Question on the current Work Ability (WA) compared with the lifetime best is assessed using one item with a response scale from 0 not able to work at all to 10, my best work ability ever. The result are reported as mean and classification. The higher value is better work ability (Seitsamo et al. 2011). | Change from baseline after four months | |
Secondary | Cognitive failures at work | Workplace cognitive failure scale (WCFS) (Wallace & Chen, 2005). The 15 items of the scale are rated on a 5-point scale (1 =never to 5=several times per day) and sum up to total WCF. All items are summed -up to total WCFS. The higher value indicates more cognitive failures. | Change from baseline after four months | |
Secondary | Self-efficacy | The Self-efficacy beliefs questionnaire (Scharzer & Renner 2000). External and internal attribute. The scale are rated on a 5-point scale (1 =never to 5=several times per day). All items are summed-up. | Change from baseline after four months | |
Secondary | Sleep | The Jenkins sleep questionnaire. Four items of the scale are rated on a 6-point scale (1= never to 6 = every night). All items are summed-up. The higher value means more problems in sleeping (Jenkins et al 1988). | Change from baseline after four months |
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