E66
Conditions
Interventions
Group 1: Intervention group: Time restricted eating (TRE) according to the scheme 16:8 over 6 month
Group 2: Control groupt: treatment as usual (TAU) over 6 month
Sponsors
Universitätsklinikum Tübingen, Institut für Allgemeinmedizin und Interprofessionelle Versorgung
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - BMI 30-45 kg/m2, - Regular care through recruiting 'research practice PLUS' - Capacity to consent - No objection to data processing for the purpose of identifying potential study participants (case finding) - Signed study-specific informed consent and consent to data processing
Exclusion criteria
Exclusion criteria: - No regular primary care through 'research practice PLUS' - Objection to data processing for the purpose of identifying potential study participants (case finding) - No capacity to consent Presence of any of the following: 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, i.e. a TSH value outside the target range under hormone replacement or thyrostatic therapy, or newly diagnosed hypo-/hyperthyroidism in the past six months. 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 o Anamnestic evidence for: > 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, i.e. presence of a known brady/tachycardia or history of brady/tachycardia in the past, if applicable, with persistent fail in rhythm/rate control, symptomatic AV block II° type Mobitz I, AV block II° (type Mobitz II)/III°. > 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. > Uncontrolled arterial hypertension, i.e. blood pressure values outside the individual target range under therapy or initial diagnosis of arterial hypertension in the course of the study. > Current harmful use of illegal substances and/or alcohol > Performed bariatric surgery > 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. o Pathological results of laboratory examination at screening: > Advanced renal insufficiency (GFR Advanced hepatic insufficiency (elevation of transaminases above 3 times normal or assessed or known to be so by study physician). > Anemia > 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 Active or recent participation in another 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Goal criteria with focus on implementation - feasibility: - Number of participating practices compared to the target number (n=50) of participating practices - Participation rates at the patient level overall: > Ratio of identified patients via case finding to approached patients > Drop-out rate - Participation rates at the practice level > Participation rate per practice: Target vs. achieved participant rate per practice Ratio of identified patients via case finding to approached patients per practice Ratio of patients addressed to participants Drop-Out rate per practice Goal criterion clinical study on TRE: - Change in body weight/BMI t0 to t2 comparing the two study arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical goal criteria - Change in metabolic parameters from t0 to t2 comparing the two study arms (blood lipids, HbA1c, fasting blood glucose, fasting insulin levels). - Change in insulin resistance (indirectly via HOMA index, calculated from fasting glucose/insulin levels) from t0 to t2 between study arms. - Change in blood pressure t0 to t2 comparing the two study arms. - Change in waist circumference t0 to t2 comparing the two study arms. Patient related goal criteria - Quality of life (EQ5D) t0 to t2 comparing the two study arms. - Sleep quality (Pittsburgh Sleep Quality Index) t0 to t2 comparing the two study arms. - Patient activation (PAM-13) t0 to t2 comparing the two study arms. - Psycho-social distress due to external appearance, body image, expectations of intervention, physical function/discomfort, social participation, body satisfaction (BODY-Q) t0 to t2 comparing the two study arms. - Physical activty (International Physical Activity Questionnaire, patient diary) t0 to t2 comparing the two study arms. - Adherence to TRE (patient diary, documentation of fasting periods), recording study weeks 5, 11, 17, and 23. - Timing of food intake (documentation via patient diary), recording study weeks 5, 11, 17, and 23. - Feeling of hunger (self-developed questionnaire in patient diary), recording study weeks 5, 11, 17, and 23. - Quality of nutrition (Ernährungsmusterindex) t0 to t2 comparing the two study arms. - Increase in knowledge related to obesity (self-developed questionnaire) t0 to t2 comparing the two study arms. - Competence in the fields: Dietary change, time restricted eating (self-developed questionnaire) t0 to t2 comparing the two study arms. Goal criteria on practice level (meso level) - Increased knowledge in the following areas: > Knowledge about obesity > Knowledge of interventions for obesity in general practice > Knowledge of research in your own general practice > Knowledge of how to implement interve | — |
Countries
Germany
Contacts
Public ContactAndreas Polanc
Universitätsklinikum Tübingen, Institut für Allgemeinmedizin und Interprofessionelle Versorgung
Outcome results
None listed