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Obesity Intervention "Obeldicks" for Obese Children, Adolescents and Their Parents (Obeldicks)

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ClinicalTrials.gov Identifier: NCT00435734
Recruitment Status : Recruiting
First Posted : February 15, 2007
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Reinehr, University of Witten/Herdecke

Brief Summary:
The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.

Condition or disease Intervention/treatment
Obesity Behavioral: obesity intervention

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents
Study Start Date : July 1999
Estimated Primary Completion Date : December 2034
Estimated Study Completion Date : December 2035



Primary Outcome Measures :
  1. change of BMI-SDS [ Time Frame: 20 years ]

Secondary Outcome Measures :
  1. change of GI hormones [ Time Frame: 10 years ]
  2. change of adipocytokines [ Time Frame: 10 years ]
  3. change of cardiovascualr risk factors [ Time Frame: 10 years ]
  4. change of metabolomics [ Time Frame: 10 years ]
  5. change of psychological variables [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
clinic based study of obese children
Criteria

Inclusion Criteria:

  • BMI> 97. percentile for age and gender

Exclusion Criteria:

  • Psychiatric disorders
  • Endocrine disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435734


Contacts
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Contact: Thomas Reinehr ++49 2363 975 229 T.Reinehr@kinderklinik-datteln.de

Locations
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Germany
Vestische Children´s Hospital Recruiting
Datteln, Germany, 45711
Contact: Thomas Reinehr    ++49 2363 975 229    t.reinehr@kinderklinik-datteln.de   
Contact       t.reinehr@kinderklinik-datteln.de   
Principal Investigator: Thomas Reinehr         
Sponsors and Collaborators
University of Witten/Herdecke
Investigators
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Principal Investigator: Thomas Reinehr Vestische Children´s Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Reinehr, Head of Department of Pediatric Endocrinology Diabetes and Nutrition Medicine, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT00435734    
Other Study ID Numbers: GFEL011174506
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms