Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 10
- 主要终点
- Changes in degree of obesity
研究概览
简要总结
This study aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) are compared between usual care (control) and usual care with complementary web-based support system (intervention).
详细描述
In this study children with obesity will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity according to International Obesity Task Force (IOTF)
- •Swedish speaking parents
- •Parents able to use a smart phone
- •Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25
排除标准
- •Diagnosed with or undergoing assessment of neuropsychiatric disorder
- •Hypothalamic obesity
- •Pharmacological treatment that could intervene the obesity treatment
结局指标
主要结局
Changes in degree of obesity
时间窗: 6 and 12 months after baseline
Measured by BMI standard deviation score control vs intervention
次要结局
- Number of physical visits(During the intervention 12 months)
- Time consumption for the health care professionals(During the intervention 12 months)
- Parental experience of treatment(During the intervention 3, 6 and 12 months)
- Physical activity level(During the intervention 12 months)
- Cancelation of physical visits(During the intervention 12 months)
- Health care professional's experiences using the web-based support system(During the intervention 3, 6 and 12 months)
研究者
Pernilla Danielsson
Principal Investigator
Karolinska Institutet