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

Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors, Workability and Subjective Wellbeing - A Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04633876
Enrollment
2000
Registered
2020-11-18
Start date
2020-02-15
Completion date
2021-09-30
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

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.

Sponsors

Finnish Institute for Health and Welfare
CollaboratorOTHER_GOV
Finnish Institute of Occupational Health
CollaboratorOTHER
University of Helsinki
CollaboratorOTHER
Aava Medical
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

RCT, lifestyle coaching in two arms: individualised coaching and group coaching. No coaching as a control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
ApoB/ApoA110 weeksRatio of ApoB to ApoA1 concentration
hs-CRP10 weeksMeasure of low-grade inflammation
TG10 weeksFasting triglyceride levels
Fasting blood glucose10 weeksFasting blood glucose

Secondary

MeasureTime frameDescription
Heart Rate Variability10 weeksHeart rate variability measurement
Workability10 weeksWorkability assessed by Work Ability Index
Virta Index10 weeksSelf reported data in Virta Index
Work disability10 weeksWorkability assessed by Work Disablity Prediction Score
Blood pressure, both systolic and diastolic10 weeksBlood pressure, both systolic and diastolic
Waist circumference10 weeksWaist circumference

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026