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

Primary Purpose

Work Related Stress, Metabolic Syndrome, Lipid Metabolism Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Individual coaching
Group coaching
Control group
Sponsored by
Aava Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Work Related Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aava Medical

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

Individual coaching

Group coaching

Arm Description

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

These subjects receive individual counselling during the study.

These subjects receive individual counselling during the study.

Outcomes

Primary Outcome Measures

ApoB/ApoA1
Ratio of ApoB to ApoA1 concentration
hs-CRP
Measure of low-grade inflammation
TG
Fasting triglyceride levels
Fasting blood glucose
Fasting blood glucose

Secondary Outcome Measures

Workability
Workability assessed by Work Ability Index
Work disability
Workability assessed by Work Disablity Prediction Score
Blood pressure, both systolic and diastolic
Blood pressure, both systolic and diastolic
Waist circumference
Waist circumference
Heart Rate Variability
Heart rate variability measurement
Virta Index
Self reported data in Virta Index

Full Information

First Posted
May 19, 2020
Last Updated
November 16, 2020
Sponsor
Aava Medical
Collaborators
Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT04633876
Brief Title
Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors, Workability and Subjective Wellbeing
Official Title
Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors, Workability and Subjective Wellbeing - A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aava Medical
Collaborators
Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health, University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work Related Stress, Metabolic Syndrome, Lipid Metabolism Disorders, Lifestyle Risk Reduction, Burnout

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
RCT, lifestyle coaching in two arms: individualised coaching and group coaching. No coaching as a control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The subjects allocated to this group receive some results from baseline measurements (as do subjects in the intervention) but do not receive lifestyle counselling
Arm Title
Individual coaching
Arm Type
Experimental
Arm Description
These subjects receive individual counselling during the study.
Arm Title
Group coaching
Arm Type
Experimental
Arm Description
These subjects receive individual counselling during the study.
Intervention Type
Behavioral
Intervention Name(s)
Individual coaching
Intervention Description
Individual coaching on lifestyle change, sleep, nutrition, physical activity and stress management.
Intervention Type
Behavioral
Intervention Name(s)
Group coaching
Intervention Description
Group coaching on lifestyle change, sleep, nutrition, physical activity and stress management.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Group receives no lifestyle coaching but did get baseline results from assessments which might motivate for lifestyle change.
Primary Outcome Measure Information:
Title
ApoB/ApoA1
Description
Ratio of ApoB to ApoA1 concentration
Time Frame
10 weeks
Title
hs-CRP
Description
Measure of low-grade inflammation
Time Frame
10 weeks
Title
TG
Description
Fasting triglyceride levels
Time Frame
10 weeks
Title
Fasting blood glucose
Description
Fasting blood glucose
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Workability
Description
Workability assessed by Work Ability Index
Time Frame
10 weeks
Title
Work disability
Description
Workability assessed by Work Disablity Prediction Score
Time Frame
10 weeks
Title
Blood pressure, both systolic and diastolic
Description
Blood pressure, both systolic and diastolic
Time Frame
10 weeks
Title
Waist circumference
Description
Waist circumference
Time Frame
10 weeks
Title
Heart Rate Variability
Description
Heart rate variability measurement
Time Frame
10 weeks
Title
Virta Index
Description
Self reported data in Virta Index
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eira Roos, PhD
Organizational Affiliation
Aava Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aava Medical
City
Helsinki
ZIP/Postal Code
00100
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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