Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 主要终点
- BMI z-score
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of an educational therapeutic intervention in treating obesity in a pediatric population.
It aims to verify the differences between the experimental group (group-based program) and the control group (individual program) in respect to the BMI z-score values between baseline measurement (beginning of treatment), final measurement (end of treatment) and 18 months follow-up.
详细描述
One of the aim of this clinical trial is to verify that the direct management of the emotional and relational aspects of patients and family plays an important role in maintaining the weight changes achieved in the long term.
The potential added value of the present study concerns the better understanding of the role of psychological and emotional aspects in the treatment of childhood obesity and in maintaining results in the long term.
The clinical trial aims to recruit 300 obese children randomized in two groups: experimental group and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity (>= 95th percentile);
- •No organic causes of obesity;
- •Sufficient understanding and production of Italian language;
- •Age between 7 and 17 years old;
- •Absence of neuropsychiatric diagnosis;
- •Subscription of the Informed Consent from both parents (or legal guardian).
排除标准
- •Degree of obesity< 95th percentile;
- •Organic causes of obesity;
- •Insufficient understanding and production of Italian language;
- •Age <7 or >17;
- •Presence of neuropsychiatric diagnosis;
- •One parent (or legal guardian) refuses to subscribe the Informed Consent.
结局指标
主要结局
BMI z-score
时间窗: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
BMI z-score variation from baseline to 18 months after the and of treatment
次要结局
- Biohumoral exams from blood sample: Thyroid-stimulating hormone(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- healthy dietary habits(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- unhealthy dietary habits(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Cholesterol(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Psychological questionnaire CBCL (Child Behaviour Checklist)(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Drop-out(measurement at end of treatment i.e approximately 24 months after baseline measurements)
- Biohumoral exams from blood sample: Uric acid(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Transaminases(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Glycemia(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Insulin(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Glycated hemoglobin(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Triglycerides(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Psychological questionnaire PEDSQL (Pediatric Quality of life)(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)