Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633876
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2020-05-19
Brief Title:
Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors Workability and Subjective Wellbeing
Sponsor:
Aava Medical
Organization:
Aava Medical
Study Overview
Official Title:
Effects of 10 Weeks of Lifestyle Coaching on Cardiometabolic Risk Factors Workability and Subjective Wellbeing - A Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ApoBApoA1 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
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 ApoBApoA1 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None