E66.9
Conditions
Interventions
Group 1: Patients will be randomised into 2 groups referring to the start of the use of the medical device (MD). The MP is compareable to a modified splint. The first set of patients will start immedi
Sponsors
Praxis Dr. von Seck
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 95 years 2.Gender: Männer und Frauen 3.BMI between 25 and 29.9 with concomitant obesity-related health disorders, an abdominal fat distribution pattern, diseases which are aggravated by obesity or a high degree of psychosocial pressure. 4.BMI = 30 kg / m2 5.Capacity to consent 6.Signed consent form 7.Desire to reduce weight 8.Failure of a basic program (nutritional, exercise and behavioural therapy), i. e. less than 5% weight reductiom / 3 to 6 months or weight regain
Exclusion criteria
Exclusion criteria: 1.Weight reduction > 5% over the last months before inclusion into the study 2.Individuals with denture, esp. worn with implants or pivot teeth 3.Less than 10 teeth / joint, teeth with maximally mild to moderate paradontal Zähne pro Kiefer mit maximal leichter bis mittelschwerer paradontal defects 4.Craniomandibular problems 5.Wasting diseases 6.Clinical diagnosis of an eating disorder 7.Medication with substances influencing weight or appetite (i. e. steroids, psyotropic drugs, diuretics) 8.Major surgical interventions durign the last 3 months 9.Pregnancy or breastfeeding women 10.Mental disorders or non-compliance 11.Inability to take in meals on a regularly 12.Incapacity to give informed consent 13.Secondary causes of obesity, i.e. der Adipositas, wie hypothyrodism, cushings syndrome, hypogonadism, hypothalimic tumors, or metabolic decompensation in diabetes mellitus 14.Newly diagnosed diabetes mellitus during the last 6 months before inclusion 15.HbA1C > 9% in diabetics 16.Uncontrolled arterial hypertension 17.Initiation / change of medication for a chronic disease during the last 3 months before inclusion 18.Participation in another clinical trial 19.Participation in another weight reduction program in the last 3 months 20.Unintended weight loss in the last 3 months 21.Participation in another therapy program during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight reduction at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of the medical device (standardised questionnaire, after 1 + 3 months, standardised interview by phone, immediate feedback in case of problems) 2. Therapeutic effect of the medical device on anthropometric parameters (weight control, BIAS, standardised questionnaire at 1, 3, 6,12, 18, 24,36, 60 and 120 months; monthly indication of weight until month 12; comparison to control) 3. Evidence for changes in behaviour (intra-individual comparison of parameters mentioned under 3. at the beginning and after 3 months of the observation period) 4. Weight reduction in high-risk patients (subgroup of grade III obesity; diabetes type 2, metabolic syndrome (IDF), increased waist circumference and waist-hip-ratio; ight control, BIAS, standardised questionnaire at 1, 3, 6,12, 18, 24,36, 60 and 120 months; monthly indication of weight until month 12; comparison to control) | — |
Countries
Germany
Contacts
Public ContactPeter von Seck
Praxis Dr. med. von Seck
Outcome results
None listed