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NCT Number: NCT00435734

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestische Children´s Hospital

Datteln, 45711, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI> 97. percentile for age and gender

Exclusion criteria

  • Psychiatric disorders
  • Endocrine disorders

Treatment and study plan

obesity intervention

Behavioral

Primary outcomes

  1. change of BMI-SDS

    Time frame: 20 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Registry information

Official study title

Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents

Acronym: Obeldicks

Important dates

Study start
1999
Primary completion
2030
Study completion
2030
First posted
Feb 15, 2007
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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