Work Related StressNCT04633876
Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors, Workability and Subjective Wellbeing
A study testing Individual coaching and Group coaching in people with Work Related Stress and Metabolic Syndrome, run by Aava Medical at 1 site in Finland.
Trial summary
The main purpose of this study is to understand the impact of lifestyle coaching on the risk of future cardiometabolic disease, workability and self-assessed wellbeing. The data gathered during the study helps in the future to better identify different focus groups for more tailored interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Related Stress, Metabolic Syndrome, Lipid Metabolism Disorders
- What is being tested?
- Individual coaching and Group coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFinland
- Study dates
- 15 Feb 2020to Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Age 18 - 65 years
- Male or female with at least 1/3 of each gender
- Adequate Finnish or English* skill to comprehend study-related instructions and questionnaires
Who cannot join
- Suspected high probability to travel for more than one working day a week during the trial period according to the investigator's assessment
- History of a major cardiovascular event (myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, or transient ischemic attack) within the previous 6 months
- Diagnosed type 1 or type 2 diabetes requiring treatment
- History of malignant disease such as cancer within five years prior to recruitment
- Lipid-lowering medication (such as any statin or ezetimibe) or medication for obesity (such as orlistat or liraglutide)
- Pregnancy
- Use of cardiac pacemaker or history of atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors, Workability and Subjective Wellbeing - A Randomized Controlled Study
The main purpose of this study is to understand the impact of lifestyle coaching on the risk of future cardiometabolic disease, workability and self-assessed wellbeing. The data gathered during the study helps in the future to better identify different focus groups for more tailored interventions.
The study consists of two main stages: screening and coaching phase. Screening Aava and the pension will recruit 2000 participants for screening from the employer companies. Screening participants are invited to answer a wellbeing questionnaire (Aava Virta questionnaire, Work Ability Index questionnaire) and give blood samples and physiological measurements, including weight, height, waist circumference, neck circumference and blood pressure. All subjects participating in screening will receive the results from wellbeing questionnaire immediately and they receive the results from blood test within few weeks.
Read more
Of these 2000 screened persons, a total of 300 high-risk (according to ApoB/ApoA1) individuals and 600 medium-risk individuals will be selected to participate in the coaching phase. These participants are randomly split into treatment and control groups, so that eventually 150 high-risk and 300 medium-risk individuals are placed in both groups. Therefore, a total of 900 subjects carry forward to the coaching phase and in 1100 subjects the study ends.
All 900 subjects entering coaching phase receive home a Firstbeat Bodyguard 2 device with instructions for performing Firstbeat wellbeing analysis. After the measurement the device is posted back for analysis according to instructions. The results and feedback from this test is received in the end of the study after the coaching phase.
Stage 2: Coaching phase Within the coaching groups, participants in the high-risk category and treatment group undergo an individual coaching program. Participants in the medium-risk category undergo a group coaching program with similar aims. Both coaching programs last 10 weeks during which there are 8 almost weekly coaching sessions at the subjects worksite or near vicinity. Both coaching programs aim in reducing cardiometabolic risk factors and improving subjective well-being. The topics of the lifestyle coaching are 1) nutrition, 2) physical activity, 3) sleep and stress and 4) the long-term maintenance of lifestyle changes. The aims and methods in each coaching topic is based on Finnish recommendations on the topic. The coaching sessions include mostly discussions but in the sessions focusing more on physical activity there are also sessions including activity.
In the halfway (5 weeks) of coaching phase, a second blood sampling and Aava wellbeing questionnaire are taken from all subjects (both coaching and control groups). In the end of the coaching phase (10 weeks) blood samples, Aava wellbeing questionnaire, Work Ability Index -questionnaire and physiological measurements are taken the last time. At this stage a second Firstbeat analysis is also performed. BBI-15 questionnaire is administered before and after the coaching phase. An open ended questionnaire regarding lifestyle change motivators and experiences before, during and after the coaching phase is administered to all participants. Also, a small subset (20 persons) of subjects takes in interviews to delve more detailed to the experiences during the study.
End of coaching phase and study - start of feedback and analysis After the coaching phase has ended and the subjects (coaching and their control groups) have received all the results (wellbeing questionnaire, blood tests and Firstbeat results) for the study and feedback sessions will be held for all. Willing subjects also receive the results from the gene test in form of PRS scores ie. total genetic risk for three areas of health: heart disease, type 2 diabetes and obesity. THL gene results do not identify single gene variants. After this feedback session the study has ended for the subject.
After all data in the study has been gathered starts the analysing and reporting phase for the researchers. At this stage the researchers can retrieve data from Aava patient records to analyse the effect of earlier diagnoses and findings. The information retrieved relate to ICD-10 diagnosis codes C00-C97 (malignant neoplasms), E00-E89 (endocrine, nutritional and metabolic diseases), F00-F99 (mental, behavioral and neurodevelopmental disorders), I00-I99 (diseases of the circulatory system) and M00-M99 (diseases of the musculoskeletal system and connective tissue) as these diagnostic codes can be important background factors for biomarkers of CVD and Type 2 diabetes risk and to some of the secondary endpoints like workability.
- Conditions
- Work Related Stress, Metabolic Syndrome, Lipid Metabolism Disorders, Lifestyle Risk Reduction, Burnout
- Being tested
- Individual coaching, Group coaching, Control group
- Medical subject headings
- Occupational Stress, Metabolic Syndrome, Lipid Metabolism Disorders, Risk Reduction Behavior, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual coachingBehavioural
Individual coaching on lifestyle change, sleep, nutrition, physical activity and stress management.
Group coachingBehavioural
Group coaching on lifestyle change, sleep, nutrition, physical activity and stress management.
Control groupOther
Group receives no lifestyle coaching but did get baseline results from assessments which might motivate for lifestyle change.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The subjects allocated to this group receive some results from baseline measurements (as do subjects in the intervention) but do not receive lifestyle counselling Receives: Other: Control group |
| Individual coaching | Experimental | These subjects receive individual counselling during the study. Receives: Behavioral: Individual coaching |
| Group coaching | Experimental | These subjects receive individual counselling during the study. Receives: Behavioral: Group coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
ApoB/ApoA1
Ratio of ApoB to ApoA1 concentration
Measured: 10 weeks
hs-CRP
Measure of low-grade inflammation
Measured: 10 weeks
TG
Fasting triglyceride levels
Measured: 10 weeks
Fasting blood glucose
Fasting blood glucose
Measured: 10 weeks
Secondary outcomes (6)
Workability
Workability assessed by Work Ability Index
Measured: 10 weeks
Work disability
Workability assessed by Work Disablity Prediction Score
Measured: 10 weeks
Blood pressure, both systolic and diastolic
Blood pressure, both systolic and diastolic
Measured: 10 weeks
Waist circumference
Waist circumference
Measured: 10 weeks
Heart Rate Variability
Heart rate variability measurement
Measured: 10 weeks
Virta Index
Self reported data in Virta Index
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start15 Feb 2020
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (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 Work Related StressStudies 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
- Factorial
- Model description
- RCT, lifestyle coaching in two arms: individualised coaching and group coaching. No coaching as a control group.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aava Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Eira Roos, PhD, Principal investigator, Aava Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633876
- Sponsor's protocol ID
- Virta1
- Status last verified
- Nov 2020
- First submitted
- 19 May 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Shiri R, Vaananen A, Mattila-Holappa P, Kauppi K, Borg P. The Effect of Healthy Lifestyle Changes on Work Ability and Mental Health Symptoms: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Oct 13;19(20):13206. doi: 10.3390/ijerph192013206.
PubMed 36293787
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors, Workability and Subjective Wellbeing - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04633876
- Acronym / sponsor ID
- Virta1
- Conditions
- Work Related Stress, Metabolic Syndrome, Lipid Metabolism Disorders, Lifestyle Risk Reduction, Burnout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Aava MedicalUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health, University of Helsinki
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Nov 2020 (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 purpose of this study is to understand the impact of lifestyle coaching on the risk of future cardiometabolic disease, workability and self-assessed wellbeing. The data gathered during the study helps in the future to better identify different focus groups for more tailored interventions.
The study consists of two main stages: screening and coaching phase. Screening Aava and the pension will recruit 2000 participants for screening from the employer companies. Screening participants are invited to answer a wellbeing questionnaire (Aava Virta questionnaire, Work Ability Index questionnaire) and give blood samples and physiological measurements, including weight, height, waist circumference, neck circumference and blood pressure. All subjects participating in screening will receive the results from wellbeing questionnaire immediately and they receive the results from blood test within few weeks.
Of these 2000 screened persons, a total of 300 high-risk (according to ApoB/ApoA1) individuals and 600 medium-risk individuals will be selected to participate in the coaching phase. These participants are randomly split into treatment and control groups, so that eventually 150 high-risk and 300 medium-risk individuals are placed in both groups. Therefore, a total of 900 subjects carry forward to the coaching phase and in 1100 subjects the study ends.
All 900 subjects entering coaching phase receive home a Firstbeat Bodyguard 2 device with instructions for performing Firstbeat wellbeing analysis. After the measurement the device is posted back for analysis according to instructions. The results and feedback from this test is received in the end of the study after the coaching phase.
Stage 2: Coaching phase Within the coaching groups, participants in the high-risk category and treatment group undergo an individual coaching program. Participants in the medium-risk category undergo a group coaching program with similar aims. Both coaching programs last 10 weeks during which there are 8 almost weekly coaching sessions at the subjects worksite or near vicinity. Both coaching programs aim in reducing cardiometabolic risk factors and improving subjective well-being. The topics of the lifestyle coaching are 1) nutrition, 2) physical activity, 3) sleep and stress and 4) the long-term maintenance of lifestyle changes. The aims and methods in each coaching topic is based on Finnish recommendations on the topic. The coaching sessions include mostly discussions but in the sessions focusing more on physical activity there are also sessions including activity.
In the halfway (5 weeks) of coaching phase, a second blood sampling and Aava wellbeing questionnaire are taken from all subjects (both coaching and control groups). In the end of the coaching phase (10 weeks) blood samples, Aava wellbeing questionnaire, Work Ability Index -questionnaire and physiological measurements are taken the last time. At this stage a second Firstbeat analysis is also performed. BBI-15 questionnaire is administered before and after the coaching phase. An open ended questionnaire regarding lifestyle change motivators and experiences before, during and after the coaching phase is administered to all participants. Also, a small subset (20 persons) of subjects takes in interviews to delve more detailed to the experiences during the study.
End of coaching phase and study - start of feedback and analysis After the coaching phase has ended and the subjects (coaching and their control groups) have received all the results (wellbeing questionnaire, blood tests and Firstbeat results) for the study and feedback sessions will be held for all. Willing subjects also receive the results from the gene test in form of PRS scores ie. total genetic risk for three areas of health: heart disease, type 2 diabetes and obesity. THL gene results do not identify single gene variants. After this feedback session the study has ended for the subject.
After all data in the study has been gathered starts the analysing and reporting phase for the researchers. At this stage the researchers can retrieve data from Aava patient records to analyse the effect of earlier diagnoses and findings. The information retrieved relate to ICD-10 diagnosis codes C00-C97 (malignant neoplasms), E00-E89 (endocrine, nutritional and metabolic diseases), F00-F99 (mental, behavioral and neurodevelopmental disorders), I00-I99 (diseases of the circulatory system) and M00-M99 (diseases of the musculoskeletal system and connective tissue) as these diagnostic codes can be important background factors for biomarkers of CVD and Type 2 diabetes risk and to some of the secondary endpoints like workability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- RCT, lifestyle coaching in two arms: individualised coaching and group coaching. No coaching as a control group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupThe subjects allocated to this group receive some results from baseline measurements (as do subjects in the intervention) but do not receive lifestyle counselling |
| Individual coaching | Experimental | Behavioral: Individual coachingThese subjects receive individual counselling during the study. |
| Group coaching | Experimental | Behavioral: Group coachingThese subjects receive individual counselling during the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Age 18 - 65 years
- Male or female with at least 1/3 of each gender
- Adequate Finnish or English* skill to comprehend study-related instructions and questionnaires
Key exclusion criteria (7 listed)
- Suspected high probability to travel for more than one working day a week during the trial period according to the investigator's assessment
- History of a major cardiovascular event (myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, or transient ischemic attack) within the previous 6 months
- Diagnosed type 1 or type 2 diabetes requiring treatment
- History of malignant disease such as cancer within five years prior to recruitment
- Lipid-lowering medication (such as any statin or ezetimibe) or medication for obesity (such as orlistat or liraglutide)
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 |
|---|---|---|
| Individual coachingIndividual coaching on lifestyle change, sleep, nutrition, physical activity and stress management. | Behavioural | Individual coaching |
| Group coachingGroup coaching on lifestyle change, sleep, nutrition, physical activity and stress management. | Behavioural | Group coaching |
| Control groupGroup receives no lifestyle coaching but did get baseline results from assessments which might motivate for lifestyle change. | Other | Control group |
Primary outcome
ApoB/ApoA1
Time frame: 10 weeks
Ratio of ApoB to ApoA1 concentration
hs-CRP
Time frame: 10 weeks
Measure of low-grade inflammation
TG
Time frame: 10 weeks
Fasting triglyceride levels
Fasting blood glucose
Time frame: 10 weeks
Fasting blood glucose
6 secondary outcomes
Workability
Time frame: 10 weeks
Work disability
Time frame: 10 weeks
Blood pressure, both systolic and diastolic
Time frame: 10 weeks
Waist circumference
Time frame: 10 weeks
Heart Rate Variability
Time frame: 10 weeks
Virta Index
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 36293787Shiri R, Vaananen A, Mattila-Holappa P, Kauppi K, Borg P. The Effect of Healthy Lifestyle Changes on Work Ability and Mental Health Symptoms: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Oct 13;19(20):13206. doi: 10.3390/ijerph192013206.
- Individual participant dataSharing planned: Yes
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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.
Eira Roos, PhD principal investigator
Aava Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual coaching and Group coaching in people with Work Related Stress and Metabolic Syndrome, run by Aava Medical 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 4 inclusion and 7 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 18 Nov 2020. 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?
ApoB/ApoA1 (time frame: 10 weeks). The study lists 4 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 NCT04633876, 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 18 Nov 2020.