Comparison of Day Hospitalization and Full-Time Hospitalization in the Treatment of Severe Adolescent Obesity (MAROSA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 主要终点
- hange in BMI z-score
研究概览
简要总结
This multicenter prospective quasi-experimental study aims to compare the effectiveness of day hospitalization versus full-time hospitalization for adolescents with severe obesity. The primary outcome is the change in BMI z-score measured six months after the end of treatment.
详细描述
This study evaluates two healthcare delivery models for adolescents with severe obesity: day hospitalization and full-time hospitalization. It examines clinical, biological, psychological, and social outcomes, as well as patient satisfaction and predictors of response. The objective is to identify patient profiles that benefit most from each treatment modality to optimize care pathways
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 12-20 years
- •Severe obesity (IOTF > 30)
- •Admitted to participating centers
- •Covered by health insurance
- •Signed informed consent (participant or legal guardian)
排除标准
- •Acute psychiatric disorder requiring hospitalization
- •Secondary obesity due to endocrine disorders
- •Age < 12 or > 20 years
- •Inability to provide consent Emergency situation Refusal to participate
研究组 & 干预措施
Day Hospitalization (DH)
Multidisciplinary day hospital program for adolescents with severe obesity, including medical follow-up, nutritional counseling, physical activity, and psychological support, provided during daytime without overnight stay.
干预措施: Day Hospital Multidisciplinary Care (Other)
Full-Time Hospitalization (FTH)
Multidisciplinary full-time hospitalization program for adolescents with severe obesity, including medical follow-up, nutritional counseling, physical activity, and psychological support, provided with continuous inpatient care.
干预措施: Full-Time Inpatient Multidisciplinary Care (Other)
结局指标
主要结局
hange in BMI z-score
时间窗: From date of admission (baseline, T0) until the first occurrence of [event of interest], assessed up to 9 months after inclusion.
BMI z-score calculated based on weight, height, sex, and age
次要结局
- Pain intensity assessed using Visual Analog Scale (VAS)(Baseline and end of treatment (3 months))
- Quality of life assessed using the SF-36 questionnaire(Baseline and end of treatment (3 months))
- Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)(Baseline and end of treatment (3 months))
- Fatigue assessed using the Fatigue Severity Scale (FSS)(Baseline and end of treatment (3 months))