E66.9
Conditions
Interventions
Group 1: Patients with overweight and obesity and increased cardiovascular risk profil were provided the medical device in an one-armed observational study and interrogated with standardised questionn
Sponsors
Praxis
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 95 years 2. Gender: male + female 3. Capacity to consent 4. Signed consent form 5. Failure of a basic program (nutritional, exercise and behavioural therapy) 6. Received medical device 7. at least 2 documented visits after receiving the medical device
Exclusion criteria
Exclusion criteria: 1. Weight reduction > 5% over the last months before inclusion into the study 2. Wasting disease 3. Medication influeincing weight loss 4. Pregnancy or breastfeeding women 5. Mental disorders or non-compliance 6. Incapacity to give informed consent 7. Participation in another therapy program or study 8. Exclsuion by dentist for dental of maxillary joint problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PEP is efficiency (weight reduction) of the medical device. | — |
Secondary
| Measure | Time frame |
|---|---|
| The security of the medical device will be controlled through regular visits and participants have been advised to present immediately if problems occur. Anthropometric measurements will be done and they will be asked to complete two questionnaires during usage of the medical device. Furthermore participants will be followed up through telephone contacts. Detailed informations about the medical device will be given in a separate information brochure. The mode of action will be assessed through questionnaires at the beginning and end of usage of the medical device. | — |
Countries
Germany
Contacts
Public ContactCaroline Schmidt-Lucke
MEDIACC, Medico-academic Consultings
Outcome results
None listed