Trial document




drksid header

  DRKS00008856

Trial Description

start of 1:1-Block title

Title

Multicentre, prospective, randomised, blinded, placebo-controlled study to evaluate a novel medical device for long-lasting weight loss in overweight and obesity.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Prevalence of the chronic disease overweight is around 35% and of that of obesity around 11%. This epidemic disease with serious health problems such as impaired well-being, quality of life, serious secondary diseases, early retirement and increased mortality continues to grow.
It is well known that slow intake of food increases pleasure and satiety. However, our current lifestyle prevents healthy diet with the consequence of steady weight gain of the individual and growing portions of the population.
Current evidence-based programs for weight reduction are characterised by weight regain after an initial weight loss period. Dropout rates of weight reduction programs are around 50% with the inevitable and notorious rapid rebound (yo-yo effect) with the known adverse health effects.
Aim of this clinical trial will be to prove effectiveness safety and added-value of a novel medical device to permanently reduce weight in overweight and obesity with the highest scientific standards. This clinical trial will assess the effect of the novel medical device on long-term weight reduction, improvement of body composition (fat / muscle mass). Furthermore, we will investigate the mechanism of action.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Prevalence of the chronic disease overweight is around 35% and of that of obesity around 11%. This epidemic disease with serious health problems such as impaired well-being, quality of life, serious secondary diseases, early retirement and increased mortality continues to grow.
It is well known that slow intake of food increases pleasure and satiety. However, our current lifestyle prevents healthy diet with the consequence of steady weight gain of the individual and growing portions of the population.
Current evidence-based programs for weight reduction are characterised by weight regain after an initial weight loss period. Dropout rates of weight reduction programs are around 50% with the inevitable and notorious rapid rebound (yo-yo effect) with the known adverse health effects.
Aim of this clinical trial will be to prove effectiveness safety and added-value of a novel medical device to permanently reduce weight in overweight and obesity in a multicentre, randomised, placebo-controlled, single and partially double-blinded confirmatory study design.
This clinical trial is design to test the primary hypothesis that usage of the novel medical device will lead to a long-term weight reduction at 12 months. Further hypotheses address improvement of anthropometric measures, longer follow-up periods and assessment of the mechanism of action.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008856
  •   2015/07/28
  •   [---]*
  •   yes
  •   Approved
  •   FF56/2015, Ethikkommission der Landesärztekammer Hessen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   DRKS00008922  ((DRKS-ID Studienteil 2/study part 2))
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E66.9 -  Obesity, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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 immediately, the second after 3 months. Body weight and composition will be quantified. Individual evaluation of the MD, change of behaviour and quality of life will be recorded with questionnaires. Initially, recording will be carried out monthly, later every 3, 6 and 12 months. To record long-term variables, patients will be contacted after 5 and 10 years.
  •   waiting control group (3 months)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Control group receives no treatment
  •   Treatment
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

weight reduction at 12 months

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/11/09
  •   170
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   95   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Praxis Dr. von Seck
    • Mr.  Dr. med.  Peter  von Seck 
    • Rheinstraße 31
    • 65186  Wiesbaden
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Medical Center Kurfürstendamm/ MVZ
    • Mr.  Prof. Dr. med.  J. André  Schmidt-Lucke 
    • Kurfürstendamm 182
    • 10707   Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Vivantes Netzwerk für Gesundheit GmbHHumboldt-KlinikumAkademisches Lehrkrankenhaus der Charité
    • Mr.  Prof. Dr. med.  J. André  Schmidt-Lucke 
    • Am Nordgraben 2
    • 13509   Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • MEDIACC, Medico-academic Consultings
    • Ms.  PD Dr. med.  Caroline  Schmidt-Lucke 
    • Gneiststr. 4
    • 14193  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Praxis Dr. med. von Seck
    • Mr.  Dr. med.  Peter  von Seck 
    • Rheinstraße 31
    • 65186  Wiesbaden
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Praxis Dr. med. von Seck
    • Mr.  Dr. med.  Peter  von Seck 
    • Rheinstraße 31
    • 65186  Wiesbaden
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.