Primary prevention through a change in lifestyle Not Applicable
Conditions
Interventions
Participants are stratified according to BMI and level of exercise and randomly assigned using a computer-based age- and gender-stratified block randomisation into groups of four subjects each to one
EXC: sports scientists with a Bachelor's degree in sports science and experience in health and prevention sports and individual training
and, WB: psychologists with a Master's or at least Bachelor's degree in Psychology.
For the IF group, the subjects undergo a 16:8 IF regime (i.e., 16 hours of fasting versus 8 hours of eating per day
the subjects can decide when in the period from 6 am to 4 pm to include the 8 hours eating interval) for 6 days per week. Participants who are randomised into the EXC group receive a training programm
each 2 months apart) in a face-to-face meeting. For the EXC intervention after the first fac
Sponsors
Tirol Kliniken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years old 2. Motivated to initiate a change in lifestyle 3. In possession of a smartphone and familiar with its use
Exclusion criteria
Exclusion criteria: 1. Current and/or past relevant previous diseases: 1.1.Malignant cancers (exception: non-melanocytic skin cancer) 1.2. Cardiac disease 1.3. Severe metabolic diseases, particularly diabetes mellitus (type 1 and type 2) 1.4. Serious psychiatric illnesses 2. Current pregnancy or breastfeeding period 3. BMI = 40 kg/m2 4. Smoker or smoking cessation < 6 months previously 5. Concurrent participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reaching the planned number of participants (n=600) within 6 months, used as an indirect measure of the acceptance of lifestyle interventions measured using study records from baseline to 6 months recruiting time. 2. Proportion of participants who adhere to the intervention (> 80 %) measured using study records at baseline and eight months after the start of the study for each participant. 3. Change in quality of life measured using the WHO quality of life questionnaire (WHOQOL) at baseline and 2, 4, 6 and 8 months after the start of the study, comparing between the randomized groups per stratum and across stratum, including change from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Longitudinal effectiveness: change in the following parameters assessed at the intervention-free run-in phase in the first two months within the five intervention groups (IF, EXC, WB, IF+EXC, IF+WB) and at the end of the study (8 months after entry), using both per-protocol and intention to treat analyses: 1.1. Sleep duration and quality measured using the Pittsburgh Sleep Quality Index (PSQI) 1.2. Blood pressure and pulse measured using the device Boso Medicus X (Bosch + Sohn) 1.3. Stress measured using the stress measurement tool (heart rate variability) of a fitness tracker (Garmin vívosmart® 4) and the Perceived Stress Scale (PSS-10) 1.4. Laboratory parameters (blood count and differential blood count, LDL, HDL, HbA1c, creatinine, CRP): All laboratory parameters are measured using CE-IVD test systems and ISO9001:2015 procedures: Blood count and differential blood count are measured by flow cytometry on a Sysmex XN-3000 module. CRP, HDL and LDL are measured by immunologic methods (CLIA) using a Roche Cobas 801 module. HbA1c is measured by an immunologic method (TINIA) using a Roche Cobas 513 analyzer and Creatinine is measured by an enzymatic method using a Roche Cobas c702 analyzer. 1.5. Bioelectrical impedance measured using the device BIA Corpus RX4004M (Medical) 1.6. Vascular elasticity measured using the device Vicorder® 1.7. Epigenetic markers using buccal and cervical/vaginal smears and blood: epigenetic ageing signatures (WID-SOLA, relative epithelial and immunological age), and other WID indices associated with disease (e.g. WID-BC, WID-OC) measured using DNA methylation analysis. 2. Effectiveness in group comparison: comparison of the effectiveness of the five interventions comparing the adherence to the interventions, changes in quality of life and sleep, sleep duration, blood pressure and pulse, stress, laboratory parameters (blood count and differential blood count, LDL, HDL, HbA1c, creatinine, CRP), bioelectrical impedance, vascular elasticity an | — |
Countries
Austria
Contacts
Public ContactSandra Plaikner
Outcome results
None listed