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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 : Active, not recruiting
First Posted : February 15, 2007
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Reinehr, University of Witten/Herdecke

Tracking Information
First Submitted Date February 14, 2007
First Posted Date February 15, 2007
Last Update Posted Date November 5, 2020
Study Start Date July 1999
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2014)
change of BMI-SDS [ Time Frame: 20 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: December 3, 2014)
  • change of GI hormones [ Time Frame: 10 years ]
  • change of adipocytokines [ Time Frame: 10 years ]
  • change of cardiovascualr risk factors [ Time Frame: 10 years ]
  • change of metabolomics [ Time Frame: 10 years ]
  • change of psychological variables [ Time Frame: 10 years ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obesity Intervention "Obeldicks" for Obese Children, Adolescents and Their Parents
Official Title Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
frozen Serum probes
Sampling Method Non-Probability Sample
Study Population clinic based study of obese children
Condition Obesity
Intervention Behavioral: obesity intervention
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 3, 2020)
4000
Original Enrollment Not Provided
Estimated Study Completion Date December 2030
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • BMI> 97. percentile for age and gender

Exclusion Criteria:

  • Psychiatric disorders
  • Endocrine disorders
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00435734
Other Study ID Numbers GFEL011174506
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thomas Reinehr, University of Witten/Herdecke
Study Sponsor University of Witten/Herdecke
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Reinehr Vestische Children´s Hospital
PRS Account University of Witten/Herdecke
Verification Date November 2020