CClinicalTrials.gg
Status unknownNCT04633876Updated Nov 18, 2020

Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors, Workability and Subjective Wellbeing

An interventional study of Individual coaching and Group coaching in Work Related Stress, Metabolic Syndrome and Lipid Metabolism Disorders, sponsored by Aava Medical. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Aava Medical · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2020, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Work Related Stress
  • Metabolic Syndrome
  • Lipid Metabolism Disorders
  • Lifestyle Risk Reduction
  • Burnout
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

This is the only study on the registry with Aava Medical as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Signed written informed consent
  2. Age 18 - 65 years
  3. Male or female with at least 1/3 of each gender
  4. Adequate Finnish or English* skill to comprehend study-related instructions and questionnaires

Exclusion criteria

Exclusion Criteria:

  1. Suspected high probability to travel for more than one working day a week during the trial period according to the investigator's assessment
  2. 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
  3. Diagnosed type 1 or type 2 diabetes requiring treatment
  4. History of malignant disease such as cancer within five years prior to recruitment
  5. Lipid-lowering medication (such as any statin or ezetimibe) or medication for obesity (such as orlistat or liraglutide)
  6. Pregnancy
  7. Use of cardiac pacemaker or history of atrial fibrillation.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Active comparator
    Control group

    The subjects allocated to this group receive some results from baseline measurements (as do subjects in the intervention) but do not receive lifestyle counselling

    Other: Control group

  • Experimental
    Individual coaching

    These subjects receive individual counselling during the study.

    Behavioral: Individual coaching

  • Experimental
    Group coaching

    These subjects receive individual counselling during the study.

    Behavioral: Group coaching

Interventions

  • BehavioralIndividual coaching

    Individual coaching on lifestyle change, sleep, nutrition, physical activity and stress management.

  • BehavioralGroup coaching

    Group coaching on lifestyle change, sleep, nutrition, physical activity and stress management.

  • OtherControl group

    Group receives no lifestyle coaching but did get baseline results from assessments which might motivate for lifestyle change.

06

What researchers measure

Primary outcomes

  1. ApoB/ApoA1

    Ratio of ApoB to ApoA1 concentration

    Time frame: 10 weeks

  2. hs-CRP

    Measure of low-grade inflammation

    Time frame: 10 weeks

  3. TG

    Fasting triglyceride levels

    Time frame: 10 weeks

  4. Fasting blood glucose

    Fasting blood glucose

    Time frame: 10 weeks

Secondary outcomes

  1. Workability

    Workability assessed by Work Ability Index

    Time frame: 10 weeks

  2. Work disability

    Workability assessed by Work Disablity Prediction Score

    Time frame: 10 weeks

  3. Blood pressure, both systolic and diastolic

    Blood pressure, both systolic and diastolic

    Time frame: 10 weeks

  4. Waist circumference

    Waist circumference

    Time frame: 10 weeks

  5. Heart Rate Variability

    Heart rate variability measurement

    Time frame: 10 weeks

  6. Virta Index

    Self reported data in Virta Index

    Time frame: 10 weeks

07

Study locations

1 site
  • Aava Medical
    Helsinki, 00100, Finland
08

References and documents

Study documents

  • Informed consent form · Mar 15, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04633876
Lead sponsor
Aava Medical
Collaborators
Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health, University of Helsinki
Responsible party
Sponsor
First posted
Nov 18, 2020
Start date
Feb 15, 2020
Primary completion
Jun 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Nov 18, 2020

Study contacts

Eira Roos, PhD
principal investigator · Aava Medical

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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