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

Not Applicable

Recruiting

• Conditions: E66.00; E66.01

• Registration Number: DRKS00013011
• Lead Sponsor: Klinikum rechts der Isar der Technischen Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 136

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in body mass index (BMI) after 12 months

Secondary Outcome Measures

Name	Time	Method
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.