Trial document




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  DRKS00006736

Trial Description

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Title

TALENT Study weight reduction - A randomized controlled trial to investigate the effectiveness of 'Individual Health Management' for weight reduction

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Trial Acronym

TALENT-WR

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URL of the Trial

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Brief Summary in Lay Language

It is well known that overweight is a risk factor for cardiovascular and metabolic diseases. People with overweight are recommended to reduce weight by lifestyle modifications. The 1-year study examines whether there are any differences between two intervention strategies regarding changes of weight in overweight persons. Feasible persons with a Body-Mass-Index of 28 to 35 are assigned randomly to one of two intervention programs: A) comprehensive lifestyle modification program (Individual Health Management IGM), B) written information with advice for healthy food habits. Body weight is measured at baseline, after 3, 6, 9 and 12 months. Examinations also include laboratory findings and an analysis to measure body composition.

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Brief Summary in Scientific Language

Overweight is considered an important risk factor for diseases in the context of metabolic syndrome. Lifestyle modifications are the means of choice to reduce weight in persons with a BMI of 28 to 35.
The study examines whether there are any differences between two intervention strategies regarding weight reduction in overweight persons.
The study is a multicenter randomized controlled trial with observation duration of 12 months. Feasible persons are checked according to inclusion and exclusion criteria and after given informed consent are assigned randomly to one of two intervention programs: A)intervention group: comprehensive lifestyle modification program (Individual Health Management IGM), B) control group: written information with advice for healthy food habits. Randomization ratio is 2:1, total sample size is 150. Examinations are conducted at baseline, after 3, 6, 9 and 12 months. Examinations include body weight, waist circumference, blood pressure, laboratory findings and a bioimpedance analysis to measure body composition. Primary outcome is change of body weight after 12 months.
Participants of the IGM group have access to a web-based health portal (www.viterio.de) and join two full-day and 10 2-hour training sessions during the first 3 months. During the remaining nine months three refresher trainings will be performed. There are three different diet strategies (fasting, 2-day diet, meal replacement) for free choice. Participants of the control group are provided with acknowledged rules for healthy food according the German Nutrition Society (DGE).
Statistical analysis of the primary outcome is based on ITT population including analysis of variance of the weight differences between month 0 and 12 with the factors ‘group’, ‘baseline value’ and ‘study center’. Secondary outcomes will be analyzed exploratively.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006736
  •   2014/09/29
  •   [---]*
  •   yes
  •   Approved
  •   97/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Overweight, Obesity degree I
  •   E66.9 -  Obesity, unspecified
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Interventions/Observational Groups

  •   Lifestyle program 'Individual Health Management': access to a web-based health portal (www.viterio.de) and join two full-day and 10 2-hour training sessions during the first 3 months. During the remaining nine months three refresher trainings will be performed. There are three different diet strategies (fasting, 2-day diet, meal replacement) for free choice.
  •   Written information: participants are provided with a leaflet containing 10 acknowledged rules for healthy food according the German Nutrition Society (DGE).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Change in body weight after 12 months

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Secondary Outcome

waist circumference, Body-Mass-Index, laboratory findings, blood pressure, pulse frequency, distribution of bodily fat with examinations at month 0, 3, 6, 9 and 12

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/10/07
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   67   Years
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Additional Inclusion Criteria

men and women, age 18 to 67 years, with Body-Mass-Index of 28.0 to 35.0 and informed consent

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Exclusion Criteria

not legally competent, insufficient skills in German language, no private access to internet, already known pregnancy, known psychiatric disease including eating disorder or addiction, known diseases of the eyes, known diabetes, hypertension with/without medication, known heart disease, known gastric or duodenal ulcers, diseases of the liver or kidneys, disease-related impairments hampering certain elements of the lifestyle program, therapeutic conditions not compatible with lifestyle modifications

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Addresses

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Kompetenzzentrum für Komplementärmedizin und Naturheilkunde (KoKoNat), Klinikum rechts der Isar, TU München
    • Mr.  Univ.-Prof. Dr. med.  Dieter  Melchart 
    • Kaiserstrasse 9
    • 80801  München
    • Germany
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    • Kompetenzzentrum für Komplementärmedizin und Naturheilkunde (KoKoNat), Klinikum rechts der Isar, TU München
    • Mr.  Dr.phil. Dr.rer.biol.hum.  Wolfgang  Weidenhammer 
    • Kaiserstrasse 9
    • 80801  München
    • Germany
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Sources of Monetary or Material Support

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    • Bayer. Gesundheitsagentur am Bayer. Landesamt für Gesundheit und Lebensmittelsicherheit
    • Eggenreuther Weg 43
    • 91058  Erlangen
    • Germany
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    • Kompetenzzentrum für Komplementärmedizin und Naturheilkunde (KoKoNat), Klinikum rechts der Isar, TU München
    • Mr.  Univ.-Prof. Dr. med.  Dieter  Melchart 
    • Kaiserstrasse 9
    • 80801  München
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Status

  •   Recruiting complete, follow-up complete
  •   2016/03/10
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Trial Publications, Results and other Documents

  •   Melchart D, Doerfler W, Eustachi A, Wellenhofer-Li Y, Weidenhammer W. The Talent study: a multicentre randomized controlled trial assessing the impact of a 'tailored lifestyle self-management intervention' (talent) on weight reduction. BMC Obesity 2015; 2:38.
  •   Open access to full-text
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* This entry means the parameter is not applicable or has not been set.