Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- change of BMI-SDS
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •percentile for age and gender
排除标准
- •Psychiatric disorders
- •Endocrine disorders
结局指标
主要结局
change of BMI-SDS
时间窗: 20 years
次要结局
- 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)
研究者
Thomas Reinehr
Head of Department of Pediatric Endocrinology Diabetes and Nutrition Medicine
University of Witten/Herdecke
