Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013011

Trial Description

start of 1:1-Block title

Title

TALENT-Study Obesity and Diabetes risk - A randomized controlled trial to investigate the effectiveness of a lifestyle program (IHM-SEPP) on overweight and type 2 diabetes risk

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

Trial Acronym

TALENT-Study Diabetes risk

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

It is well known that an unfavorable lifestyle affects the type 2 diabetes risk. Risk reduction includes changes in lifestyle such as balanced nutrition, avoidance of overweight and regular physical activity as means of choice. The study, with a duration of 12 months, examines whether there are any differences in overweight people between participating in the lifestyle program IHM-SEPP (Individual Health Management - Sino-European Prevention Program) with access to an internet-based health portal (www.viterio.de) and people in a waiting list group with regard to the change in the body mass index (BMI). Feasible persons with a BMI of 30.0-39.9 are assigned randomly to one of the two groups. During the course of the year, the BMI is measured at intervals of 3 months, further examinations are carried out (e.g. laboratory findings, bioimpedance analysis) and appropriate questionnaires clarify various risk and protection factors.

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

Brief Summary in Scientific Language

Background: Unfavorable lifestyle factors influence the type 2 diabetes risk. In the sense of essential primary prevention, risk reduction includes lifestyle modifications, such as balanced nutrition, avoidance of overweight and regular physical activity as a means of choice.
Issue: The intervention study examines the efficacy of the lifestyle program IHM-SEPP (Individual Health Management - Sino-European Prevention Program) with regard to a risk reduction for the development of type 2 diabetes mellitus against a control group (waiting list group).
Methodology: The study is a controlled, randomized, monocentric trial with an observation duration of 12 months per participant. After a screening phase, feasible persons are checked according to the inclusion and exclusion criteria and are assigned to the intervention or control group. The intervention group receives the lifestyle program IHM-SEPP, the control group receives this program after a waiting period of at least 12 months. The allocation is randomized, with 1/2 of the participants joining the intervention group and 1/2 joining the control group (planned number of cases: 136 participants).
Examinations are conducted at baseline, after 3, 6, 9 and 12 months and include the body mass index (BMI) and e.g. laboratory findings, a bioimpedance analysis (BIA) to measure body composition, measurement of the waist circumference, blood pressure, heart rate, heart rate variability (VNS analysis), TCM diagnostics and specifying of the TCM constitution. From the screening questionnaire findrisk, the risk of developing a type 2 diabetes mellitus can be determined. The study participants also fill out suitable questionnaires to clarify a variety of risk and protection factors.
Interventions: Participants of the intervention group have access to a web-based health portal (www.viterio.de) and join 3 full-day and 10 two-hour training sessions during the first three months. There are 2 different fasting programs for free choice during an intensive training week. During the remaining 9 months, 4 training sessions (refresher) and a weekly monitoring are performed with remote assistance as required. Particular importance is attached to the implementation of the recommendations in everyday life.
Statistics: The confirmatory analysis examines the differences between the two groups with regard to a change in the body mass index (BMI) after 12 months compared to the initial value by means of variance analysis after control of the initial value based on the ITT population. Secondary endpoints are exploratively analyzed.

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

Organizational Data

  •   DRKS00013011
  •   2017/10/06
  •   [---]*
  •   yes
  •   Approved
  •   160/17S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E66.00 -  [generalization E66.0: Obesity due to excess calories]
  •   E66.01 -  [generalization E66.0: Obesity due to excess calories]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Lifestyle program IHM-SEPP (Individual Health Management - Sino-European Prevention Programm): access to a web-based health portal (www.viterio.de) and join of three full-day and 10 2-hour training sessions during the first three months. There are two different fasting programs for free choice during an intensive training week. During the remaining 9 months four refresher trainings and a weekly monitoring are performed with remote assistance as required. Particular importance is attached to the implementation of the recommendations in everyday life.
  •   Waiting list (demand for lifestyle program IHM-SEPP after at least 12 months of waiting time).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Change in body mass index (BMI) after 12 months

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

Secondary Outcome

fasting glucose, laboratory findings, bioimpedance analysis (BIA), waist circumference, blood pressure, heart rate, heart rate variability, tcm constitution, tcm diagnosis, diabetes risk (screening questionnaire findrisk), hypertension risk, metabolic syndrom index, fatty liver index, comprehensive medical history, motivation and willingness to change, life satisfaction (FLZ), Tedium Measure, psycho-vegetative test, severity of mood state in general (VAS), stresses and strains, WHO-5-well-being, cardiovascular and metabolic risk factors, self-efficacy, optimism and pessimism (SWOP), 3-level-stresstest, nutrition index, moving index, physical power, The body`s defenses, Sense of coherence (SOC-13), social support (SSS). Examinations are conducted at month 0, 3, 6, 9 and 12.

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

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/07/03
  •   136
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

- Authorized insurants of the AOK-Bayern in the catchment area of the IGM-Präventionszentrum SINOCUR in Bad Kötzting: Cham, Regen, Deggendorf, Dingolfing-Landau, Freyung-Grafenau, Regensburg (east county), Schwandorf, Straubing-Bogen
- body mass index (BMI): 30.0-39.9
- increased diabetes risk, defined as findrisk-score > 11 (probability of at least 17% to develop diabetes over the next 10 years)
- informed consent

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

Exclusion Criteria

- being unable to consent for themself
- insufficient skills in German language
- no private access to internet
- known hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) with or without medication
- known hypotension (systolic blood pressure ≤ 70 mmHg or diastolic blood pressure ≤ 50 mmHg)
- Tedium-Measure (=Burnout Scale) ≥ 3,20
- known diabetes mellitus (type 1 or 2)
- known psychiatric disease including addiciton and eating disorder
- known heart disease (like CHD, arrhythmia, valvular heart defect, cardiac insufficiency)
- known gastric or duodenal ulcers
- known diseases of the liver or kidneys
- known diseases of the eyes (e.g. retinal detachment)
- known disease of the thyroid gland or taking of thyroid hormones
- known disease-related impairments preventing a participation in the lifestyle program (e.g. arthrosis)
- known therapeutic conditions that are due to risiks/side effects not compatible with participation in the lifestyle program
- known pregnancy (or lactation) or planned in the next year
- participation in another currently cinical trial or during the last 6 months

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum rechts der Isar der Technischen Universität München
    • Ismaninger Str. 22
    • 81675  München
    • 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
    • AOK Bayern - Die Gesundheitskasse
    • Carl-Wery-Str. 28
    • 81739   München
    • 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
    • Technische Hochschule Deggendorf - Fakultät für Angewandte Gesundheitswissenschaften
    • Dieter-Görlitz-Platz 1
    • 94469  Deggendorf
    • 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
    • TCM-Klinik Bad Kötzting
    • Ludwigstr. 2
    • 93444  Bad Kötzting
    • 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
    • Kompetenzzentrum für Komplementärmedizin und Naturheilkunde (KoKoNat), Klinikum rechts der Isar der Technischen Universität München
    • Mr.  Prof. Dr. med.  Dieter  Melchart 
    • Kaiserstr. 9
    • 80801  München
    • 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
    • Kompetenzzentrum für Komplementärmedizin und Naturheilkunde (KoKoNat), Klinikum rechts der Isar der Technischen Universität München
    • Ms.  Dipl. Psych.  Kristina  Wifling 
    • Kaiserstr. 9
    • 80801  München
    • 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
    • Kompetenzzentrum für Komplementärmedizin und Naturheilkunde (KoKoNat), Klinikum rechts der Isar der Technischen Universität München
    • Kaiserstr. 9
    • 80801  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address materialSupport
    • Institut für Kurortmedizin und Gesundheitsförderung (IKOM) am Bayerischen Landesamt für Gesundheit und Lebensmittelsicherheit
    • Münchner Str. 5
    • 97688  Bad Kissingen
    • 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.