Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital, Tübingen, Germany.
Department of Psychology, Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.
J Eat Disord. 2014 Mar 10;2:7. doi: 10.1186/2050-2974-2-7. eCollection 2014.
Obesity in adults and children is increasing worldwide at alarming rates. Obese children and adolescents are likely to become obese adults with increased risk of a number of comorbidities. In addition to preventing the development of obesity at young age, it is necessary to individualize the therapy of already obese children and adolescents in order to increase the likelihood of weight loss and maintenance. Therefore, the aim of this study is to identify predictors which play a significant role in successful weight loss and weight loss maintenance in children and adolescents.
METHODS/DESIGN: Over a one year period, 60 obese children and adolescents between 9 to 17 years of age shall be recruited at an inpatient children rehabilitation facility in Germany. They will be investigated twice within a few days following admission and prior to discharge. The study will be an integrated component of an established inpatient weight-loss and in part psychosomatic therapy. The collected data can be grouped into four clusters: 1) demographic, sociometric and psychometric data, 2) objective and subjective parameters of body condition, 3) autonomic nervous system regulated functions and 4) objective and subjective parameters for eating behavior. Primary outcome is the change of the body mass index standard deviation score (BMI-SDS). In order to evaluate the data appropriately, all examinations will be also conducted in a normal-weight reference group, matched for age and gender.
For some of the collected parameters the time span between measures may be too short. Therefore, a 6 months, 1 year and 2 year follow-up will be performed for evaluating the different predictors and their influence in regard to a successful intervention. Further middle- and long-term follow-up studies are planned.
The study protocol was approved by the Ethics Committee of the University Hospital Tübingen, Germany. This study is registered at the German Clinical Trials Register (DRKS) with the clinical trial number DRKS00005122.
肥胖在全球范围内的成年人和儿童中以惊人的速度增长。肥胖的儿童和青少年很可能成为肥胖的成年人，患多种合并症的风险增加。除了在年轻时预防肥胖的发展外，还需要对已经肥胖的儿童和青少年进行个体化治疗，以增加减肥和维持体重的可能性。因此，本研究的目的是确定在儿童和青少年成功减肥和维持体重方面起重要作用的预测因素。
方法/设计：在一年的时间内，将在德国的一家住院儿童康复机构招募 60 名 9 至 17 岁的肥胖儿童和青少年。他们将在入院后几天内和出院前接受两次调查。该研究将作为既定住院减肥治疗的一个组成部分，部分是心身治疗。收集的数据可分为四个组：1）人口统计学、社会计量学和心理计量学数据，2）身体状况的客观和主观参数，3）自主神经系统调节功能和 4）客观和主观的饮食行为参数。主要结果是体重指数标准差评分（BMI-SDS）的变化。为了适当评估数据，所有检查也将在年龄和性别匹配的正常体重参考组中进行。
对于一些收集的参数，测量之间的时间间隔可能太短。因此，将进行 6 个月、1 年和 2 年的随访，以评估不同的预测因素及其对成功干预的影响。还计划进行中期和长期随访研究。
该研究方案已获得德国图宾根大学医院伦理委员会的批准。该研究在德国临床试验注册处（DRKS）注册，注册号为 DRKS00005122。
