Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in sleep length |
Measured using smartbands with sleep trackers: length (in hours) |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Other |
Change in sleep quality |
Measured using smartbands with sleep trackers: with metrics specific to the selected model (score). |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Other |
Change in cardiorespiratory fitness |
Oxygen consumption (VO2) measured using ergospirometer CORTEX MetaMax 3b (ml oxygen/kg of body weight/minute). VO2 max is the maximum amount of oxygen the body can utilize during exercise. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Other |
Change in physical activity level |
Measured using smartbands with pedometers (number of daily steps) |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Other |
Participant's satisfaction with treatment upon completion |
Satisfaction with treatment: DSat-28 questionnaire (10.1002/osp4.299) |
after 8 weeks |
|
Other |
Change in dietary behaviours |
Dietary habits will be assessed using KomPAN questionnaire (https://doi.org/10.3390/nu10121845) |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Primary |
Change in glucose homeostasis |
Change in fasting glucose concentration [mg/dL]. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas Integra 400 plus analyzer. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in total cholesterol (TC) |
The blood serum concentration of total cholesterol (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas Integra 400 plus analyzer. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in high-density lipoprotein (HDL) cholesterol |
The blood serum concentration of high-density lipoprotein cholesterol (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas Integra 400 plus analyzer. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in low-density lipoprotein (LDL) cholesterol |
The blood serum concentration of low-density lipoprotein cholesterol (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on Cobas Integra 400 plus analyzer. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in serum triglycerides (TG) |
The concentration of serum triglycerides (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on Cobas Integra 400 plus analyzer. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in body weight |
Body weight (in kg) will be measured using a digital medical scale witl stadiometer. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in body mass index (BMI) |
The measured values of body height and weight will be used for the calculation of body mass index (in kg/m^2). |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in body fat mass percentage |
Determination of body fat percentage will be performed using SECA® mBCA 515 analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in waist circumference |
Waist circumference measuring (in cm) will be performed using a non-strechable measuring tape. |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in waist-to-hip ratio |
The waist-to-hip ratio will be calculated from the measured values of waist and hip circumferences: waist circumference (cm) / hip circumference (cm). |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in visceral adipose tissue (VAT) |
Determination of abdominal fat volume will be measured in litres and performed using SECA® mBCA 515 analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in inflammatory markers-1 |
interleukin-6 [pg/mL] - COBAS e411 analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in inflammatory markers-2 |
C-reactive protein (CRP) [mg/L] - COBAS Integra 400 Plus analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in nutrition markers-1 |
Homocysteine [µmol/L] - COBAS Integra 400 Plus analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in nutrition markers-2 |
Vitamin B12 [pg/mL] - COBAS e411 analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in insulin concentration |
Insulin [units/mL] - COBAS e411 analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in haemoglobin glycosylated (HbA1c) concentration |
HbA1c [mmol/l] - COBAS e411 analyser |
baseline, after 8 weeks and after 20 weeks from baseline |
|
Secondary |
Change in systolic and diastolic blood pressure |
The assessment of blood pressure (in mmHg) will be performed prior to and immediately after the intervention using electronic monitor (Omron M3 Intellisense Automatic Blood Monitor, Omron Healthcare, Mannheim, Germany). |
baseline, after 8 weeks and after 20 weeks from baseline |
|