Table 2 Inclusion and exclusion criteria
Inclusion criteria |
 o BMI ≥ 30—≤ 45 kg/m2 or ICD-10: E66 |
 o ≥ 18 years and ≤ 65 years |
 o Regular care provided in recruiting research practice |
 o Capacity to consent |
 o No objection to data processing for the purpose of identifying potential study participants (case finding) |
Exclusion criteria (after study-specific informed consent and consent to data processing is signed) |
 o Pregnancy (up to 6 months post-partum) or lactation period |
 o History for or presence of an eating disorder: anorexia, bulimia, binge eating disorder |
 o Presence of uncontrolled hyper-/hypothyroidism |
 o Current presence of an organic or symptomatic mental disorder as assessed by the study physician |
 o Diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin therapy |
Anamnestic evidence for:  o Cardiovascular event within the past 12 months (acute coronary syndrome, cardiac catheterization, bypass surgery, hospitalization due to heart failure, stroke, transient ischemic attack) or uncontrolled arrhythmia  o Active or therapeutically unstable (insufficiently achieved symptom control) or expected risk of worsening of the underlying disease under TRE in diseases from the fields of rheumatology, oncology, hematology, infectiology, gastroenterology, psychiatry, nephrology or endocrinology  o Uncontrolled arterial hypertension  o Current harmful use of illegal substances and/or alcohol  o Performed bariatric surgery  o Current or within the past 6 months use of medications which, according to the assessment of the study physician, favor obesity or influence body weight and affect energy and glucose balance (e.g. steroids, antiepileptic drugs, psychotropic drugs, appetite suppressants) as well as immunosuppressants |
Pathological results of laboratory examination at screening:  o Advanced renal insufficiency (glomerular filtration rate (GFR) < 45 ml/min or assessed or known to be so by study physician)  o Advanced hepatic insufficiency (elevation of transaminases above 3 times normal or assessed or known to be so by study physician)  o Anemia   o Additional laboratory parameters assessed by the study physician as critical for study participation |
 o History of or existing retinal detachment |
 o Presence of any secondary form of obesity (incl. polycystic ovary syndrome, Cushing's syndrome, Prader-Willi syndrome, hypogonadism, Lauren-Moon-Biedl-Bardet syndrome, acromegaly, hypothalamic-pituitary hormone axis disorders) |
 o Physician-ordered other form of diet (e.g. for celiac disease) |
 o Participation in a weight loss program with weight loss of more than 5% body weight in the past 3 months |
 o Lack of suitability for study participation assessed by the study physician |
 o Concurrent participation in another intervention study or participation in another intervention study within the last 3 months |