Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Qualitative interviews in focus groups interviews |
Qualitative assessment will be carried out in 45-minute focus group interviews in 12 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis. |
16 weeks after inclusion |
|
| Primary |
Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months |
Composite score including waist wircumference, blood pressure, fasting blood glucose, tryglycerids, HDL-cholesterin Range 0-100, lower score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks |
|
| Secondary |
Bio-electrical Impedance Analysis (BIA) |
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Bio-electrical Impedance analysis (BIA) |
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Change from baseline systolic blood pressure at 2 months |
Average of 24h measurement |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Change from baseline diastolic blood pressure at 2 months |
Average of 24h measurement |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Fasting glucose (mmol/l) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Blood lipids |
Triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Insulin (µU/ml) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Glycated hemoglobin (HbA1c) (%) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Fructosamin (µmol/l) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Homeostatic model assessment (HOMA-IR) |
Index calculated from Insulin (µU/ml) x fasting glucose (mmol/l) / 22,5 |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Ferritin (µg/l) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Liver enzymes |
Hepatic transaminases (GPT, GOT in U/L) and Gamma glutamyl transpeptidase (y-GT in U/L) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Folic acid (ng/ml) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Uric Acid (mg/dl) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Complete Blood Count |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Holotranscobalamin (pmol/L) |
|
Date of inclusion (baseline), after 16 weeks |
|
| Secondary |
Trimethylamine N-oxide (mg/dl) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Quality of Life questionnaire (WHO-5) |
Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Stress questionnaire (Cohen Perceived Stress Scale, CPSS) |
Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress. |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
General Self-efficacy Short Scale (ASKU) |
Assessing full scale, range 3-15, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Hospital Anxiety and Depression Scale (HADS) |
Assessing full scale, range 0-42, lower score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Medical Outcomes Study Short Form (MOS SF-12) |
Assessing full scale, range 0-100, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Zerssen symptom list (B-LR and B-LR') |
Assessing full scale, range 20-80, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Intuitive Eating Scale 2 (IES-2) |
Assessing full scale, range 23-115, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Flourishing Scale (FS-D) |
Assessing full scale, range 8-56, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
International Physical Activity Questionnaire (IPAQ ) |
MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Body weight (kg) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Body Mass Index (kg/m2) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Waist circumference (cm) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Wrist Circumference (cm) |
|
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Ambulatory Blood Pressure Monitoring (ABPM) |
Measuring systolic and diastolic blood pressure in 20-minute-intervals for 24h with "Spacelabs" devices |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Dietary Behaviour |
Nutritional history via dietary weight record (each for 3 days) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Daily nutrition protocol |
Via the App 'Calorie Counter - Fddb Extender' |
Daily throughout the entire survey period |
|
| Secondary |
Medication intake |
Name of medication and dosage |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Cardio Vascular Risc Profile |
Cardio Vascular Risc in % with following scores: SCORE-Deutschland/PROCAM/arriba/WHO-ISH Charts/BEWAT-Score |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Gut microbiome |
16S rRNA Sequencing / Shotgun Sequencing |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Blood Oxygenization |
24h measuring by Biovotion Everion (upper arm) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Skin Temperature |
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Heart Rate (HR) |
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Heart Rate Variability (HRV) |
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Interbeat Interval (IBI) |
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Respiration Rate |
24h measuring by Biovotion Everion device |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Blood Volume Pulse |
24h measuring by Empatica E4 device (wrist) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Electrodermal Activity (Galvanic Skin Response) |
24h measuring by Biovotion Everion device and Empatica E4 (upper arm/wrist) devices |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Number of Steps per 24 hours |
24h measuring by Biovotion Everion device (upper arm) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Sociodemographic Measurements |
Age, gender, education level, household income, employment status, marital status, language spoken, complete family history, current and previous illness and co-morbidities, and current medications |
Date of inclusion (baseline) |
|
| Secondary |
Oral Health Qualitative Interviews |
using the German version of the "Oral Health Impact Profile" with 21 questions, score ranges from 0 to 21, high score Shows a low Quality of oral health, low score Shows a high Quality of life |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Evaluation of inflammatory oral conditions |
bleeding index (gingival bleeding index, bleeding on probing) in percentage, ranges from 0 to 100 %, optimal is less then 15 % |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Evaluation of teeth related conditions |
dental findings (attrition, bruxism, caries, dental implants, dentures, missing teeth, erosions, restorations (all classes)) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Evaluation of Oral Fluids |
crevicular fluid rate, salivary flow (stimulated, unstimulated) |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Evaluation of periodontal attachment level |
probing pocket depth, recessions, measuring in mm on 6 sites per tooth |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Evaluation of oral hygiene |
Plaque Index in %, ranges from 0 to 100%, less then 15 % Shows an optimal oral hygiene |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
| Secondary |
Evaluation of periodontal status |
measuring with periodontal Screening index, ranges from 0 to 4, code 0 - oral health, 1-2 Gingivitis, 3-4 Periodontitis, additional findings as furcation involvement and loosening are documented |
Date of inclusion (baseline), after 8 weeks, after 16 weeks |
|
