Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04633876
Other study ID # Virta1
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A