E65-E68
Conditions
Interventions
Group 1: Participation in DocWeight2.3 (without meal replacement)
DocWeight 2.3 is divided into a start phase, which takes place 8 to 2 weeks before the start of the course, three therapy phases (orie
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - BMI of 30 - 50 kg/m² - Sufficient German language skills - Written declaration of consent - Performance of an ergometry (bicycle or treadmill) with a load capacity of at least 75 W for at least 2 min.
Exclusion criteria
Exclusion criteria: - Participation in another weight loss program, including use of prescribed weight loss apps (DiGAs) - Severe (acute or chronic) medical condition a. Type 1 diabetes mellitus, pancreopriver diabetes mellitus without residual pancreatic function b. Type 2 diabetes mellitus with intensified insulin therapy (type 2 diabetes mellitus with oral therapy only, with GLP-1 analog therapy (without change in dosage in the last 3 months), or with BOT (basal-assisted oral therapy with long-acting insulin) is not an exclusion criterion) c. Inadequately controlled hypertension (RR >160/95 mmHg; if this threshold is exceeded in the screening examination, a 24 h RR measurement can be performed and if here the mean RR over 24 h is 3-fold above the upper reference range) g. Alcohol dependence and current use of other drugs (e.g., cannabis, cocaine, crystal, etc.) h. acute infection i. untreated endocrine disease (e.g., hypothyroidism). - Severe or untreated psychiatric illness that makes regular participation in the program impossible - New prescription or dose change of weight-increasing or weight-lowering medications within the 3 months prior to study inclusion; if this occurs after inclusion during the study intervention already in progress, subjects will be excluded from the analysis - Significant limitation in physical mobility, such that participation in exercise classes is limited or not possible at all - Major weight change (=10% of body weight) in the previous 3 months - Participation in another clinical trial - Existing pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in body weight after 12 months (in kg and % of initial weight). The weight is collected without shoes, but clothed. 1 kg is deducted for clothing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference, cardiovascular risk factors, quality of life, body composition, physical performance ability, nutritional behavior | — |
Countries
Germany
Contacts
Public ContactSarah Victoria Frenzel
Universität Leipzig
Outcome results
None listed