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

Sponsor
University of Witten/Herdecke (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00435734
Collaborator
(none)
4,000
Enrollment
1
Location
377
Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Behavioral: obesity intervention

Study Design

Study Type:
Observational
Actual Enrollment :
4000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents
Study Start Date :
Jul 1, 1999
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Outcome Measures

Primary Outcome Measures

  1. change of BMI-SDS [20 years]

Secondary Outcome Measures

  1. change of GI hormones [10 years]

  2. change of adipocytokines [10 years]

  3. change of cardiovascualr risk factors [10 years]

  4. change of metabolomics [10 years]

  5. change of psychological variables [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • BMI> 97. percentile for age and gender
Exclusion Criteria:

  • Psychiatric disorders

  • Endocrine disorders

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vestische Children´s Hospital Datteln Germany 45711

Sponsors and Collaborators

  • University of Witten/Herdecke

Investigators

  • Principal Investigator: Thomas Reinehr, Vestische Children´s Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Feb 15, 2007
Last Update Posted:
Nov 5, 2020
Last Verified:
Nov 1, 2020
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Nov 5, 2020