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

Study acronym: Obeldicks
StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

  1. Primary and study completion dates moved earlier to Dec 2030
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 6000 to confirmed 4000
    • Site details revised
    v9
  2. Site contact updatedv8
  3. 2 versions Re-verified since Dec 3, 2015, no change to tracked fieldsv6-v7
  4. Enrollment target: 6000
    • Primary completion date: Dec 2034
    • Study completion date: Dec 2035
    v5
  5. 3 versions Re-verified since Feb 12, 2009, no change to tracked fieldsv2-v4
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00435734
Lead Sponsor University of Witten/Herdecke
Conditions
(from sponsor)		 Obesity
Related terms Obesity
Enrollment 4,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov