Health BehaviorDagisWorkNCT03854877
DagisWork-a Workplace Health Behaviour E-intervention
A study testing Health behaviour intervention in people with Health Behavior, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Health behaviour intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 15 Feb 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary
- Working in municipal city of Espoo or Kouvola in preschool
Who cannot join
- Pregnancy
- Retirement during the intervention
Trial locations and contacts
1 site in 1 country.
Finland1 site
Finnish Institute of Occupational Health
Helsinki, Uusimaa, 00250
About this study
Official title: DagisWork - Improved Health Behaviour and Wellbeing: a Randomized Controlled Workplace Intervention
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.
Read the 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
- The intervention has a positive effects on long-term physiological adaptation to stress, biological health risk factors, recovery, and sickness absences among personnel.
- The interventions directly enhance personnel's health behavior including eating habits, physical activity and experienced stress.
Secondary hypotheses
- 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.
- 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.
- The intervention will have positive economic effect (costs and benefits).
- The intervention will have positive changes in self-efficasy
- Conditions
- Health Behavior
- Being tested
- Health behaviour intervention
- Keywords
- Health behaviour, Work place intervention, Stress, Physical activity, Nutrition, e-health, Mindfulness
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health behaviour interventionBehavioural
The intervention uses the principles of acceptance-commitment therapy (ACT). It aims to increase healthy eating and good sleep. Based on personal needs participants can choose task for physical activity, relaxation, healthy eating, sleep eg. Their get regular feedback and support from their personal trainer via phone and computer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health behaviour intervention |
| Control group | No intervention | Only before and after measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in stress after four months
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).
Measured: Change from baseline in stress after four months
Secondary outcomes (8)
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.
Measured: Sickness absence absence [ (Time Frame: approx. 3 years (from 2016 to 2019) ]
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.
Measured: Change from baseline after four months
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.
Measured: Change from baseline after four months.
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.
Measured: Change from baseline after four months
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).
Measured: Change from baseline after four months
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.
Measured: Change from baseline after four months
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.
Measured: Change from baseline after four months
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).
Measured: Change from baseline after four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start15 Feb 2017
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized two group behavioral intervention
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, University of Jyvaskyla
- Responsible party
- Sponsor
- Investigators
- Sampsa Puttonen, PhD, Principal investigator, Finnish Institute of Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854877
- Sponsor's protocol ID
- FinnishIOH
- Acronym
- DagisWork
- Status last verified
- Aug 2018
- First submitted
- 14 Sep 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karihtala T, Puttonen S, Valtonen AM, Kautiainen H, Hopsu L, Heinonen A. Role of physical activity in the relationship between recovery from work and insomnia among early childhood education and care professionals: a cross-sectional study. BMJ Open. 2024 Mar 19;14(3):e079746. doi: 10.1136/bmjopen-2023-079746.
PubMed 38508638
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DagisWork - Improved Health Behaviour and Wellbeing: a Randomized Controlled Workplace Intervention
- ClinicalTrials.gov ID
- NCT03854877
- Acronym / sponsor ID
- DagisWork / FinnishIOH
- Conditions
- Health Behavior
- Keywords
- Health behaviour, Work place intervention, Stress, Physical activity, Nutrition, e-health, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- University of Helsinki, University of Jyvaskyla
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The intervention has a positive effects on long-term physiological adaptation to stress, biological health risk factors, recovery, and sickness absences among personnel.
- The interventions directly enhance personnel's health behavior including eating habits, physical activity and experienced stress.
Secondary hypotheses
- 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.
- 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.
- The intervention will have positive economic effect (costs and benefits).
- The intervention will have positive changes in self-efficasy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized two group behavioral intervention
| Arm | Type | Receives |
|---|---|---|
| Health behaviour intervention | Experimental | Behavioral: Health behaviour interventionPersonalised 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. |
| Control group | No intervention | –Only before and after measurements |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Voluntary
- Working in municipal city of Espoo or Kouvola in preschool
Key exclusion criteria (2 listed)
- Pregnancy
- Retirement during the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health behaviour interventionThe intervention uses the principles of acceptance-commitment therapy (ACT). It aims to increase healthy eating and good sleep. Based on personal needs participants can choose task for physical activity, relaxation, healthy eating, sleep eg. Their get regular feedback and support from their personal trainer via phone and computer. | Behavioural | Health behaviour intervention |
Primary outcome
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).
8 secondary outcomes
Economic benefits
Time frame: Sickness absence absence [ (Time Frame: approx. 3 years (from 2016 to 2019) ]
Intuitive eating
Time frame: Change from baseline after four months
Eating habits
Time frame: Change from baseline after four months.
Measured physical activity
Time frame: Change from baseline after four months
Work ability
Time frame: Change from baseline after four months
Cognitive failures at work
Time frame: Change from baseline after four months
Self-efficacy
Time frame: Change from baseline after four months
Sleep
Time frame: Change from baseline after four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Derived from this study: PubMed 38508638Karihtala T, Puttonen S, Valtonen AM, Kautiainen H, Hopsu L, Heinonen A. Role of physical activity in the relationship between recovery from work and insomnia among early childhood education and care professionals: a cross-sectional study. BMJ Open. 2024 Mar 19;14(3):e079746. doi: 10.1136/bmjopen-2023-079746.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sampsa Puttonen, PhD principal investigator
Finnish Institute of Occupational Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health behaviour intervention in people with Health Behavior, run by Finnish Institute of Occupational Health at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allostatic load (AL) (time frame: Change from baseline in stress after four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03854877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019; AzTrials last refreshed its copy on 28 Oct 2026.