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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04633876
• Other study ID #: Virta1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: September 2021

Study information

• Verified date: November 2020
• Source: Aava Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Individual coaching
Individual coaching on lifestyle change, sleep, nutrition, physical activity and stress management.
• Group coaching
Group coaching on lifestyle change, sleep, nutrition, physical activity and stress management.

Other:
• Control group
Group receives no lifestyle coaching but did get baseline results from assessments which might motivate for lifestyle change.

Locations

Country	Name	City	State
Finland	Aava Medical	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Aava Medical	Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ApoB/ApoA1	Ratio of ApoB to ApoA1 concentration	10 weeks
Primary	hs-CRP	Measure of low-grade inflammation	10 weeks
Primary	TG	Fasting triglyceride levels	10 weeks
Primary	Fasting blood glucose	Fasting blood glucose	10 weeks
Secondary	Workability	Workability assessed by Work Ability Index	10 weeks
Secondary	Work disability	Workability assessed by Work Disablity Prediction Score	10 weeks
Secondary	Blood pressure, both systolic and diastolic	Blood pressure, both systolic and diastolic	10 weeks
Secondary	Waist circumference	Waist circumference	10 weeks
Secondary	Heart Rate Variability	Heart rate variability measurement	10 weeks
Secondary	Virta Index	Self reported data in Virta Index	10 weeks