Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 4,000
- Locations
- 1
- Primary Endpoint
- change of BMI-SDS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •percentile for age and gender
Exclusion Criteria
- •Psychiatric disorders
- •Endocrine disorders
Outcomes
Primary Outcomes
change of BMI-SDS
Time Frame: 20 years
Secondary Outcomes
- change of GI hormones(10 years)
- change of adipocytokines(10 years)
- change of cardiovascualr risk factors(10 years)
- change of metabolomics(10 years)
- change of psychological variables(10 years)
Investigators
Thomas Reinehr
Head of Department of Pediatric Endocrinology Diabetes and Nutrition Medicine
University of Witten/Herdecke