Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Change in degree of obesity
研究概览
简要总结
This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.
详细描述
Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.
In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.
The present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period.
The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity according to International Obesity Task Force (IOTF)
排除标准
- 未提供
结局指标
主要结局
Change in degree of obesity
时间窗: From start of treatment to three years follow-up
Measured by BMI standard deviation score. Digi-physical group vs. control group
次要结局
- Number of physical visits(From start of treatment to three years follow-up)
- The use of the support system - weighings(From start of treatment to three years follow-up)
- The use of the support system - text messages(From start of treatment to three years follow-up)
- Number of cancelation of physical visits(From start of treatment to three years follow-up)
- Number of patients not showing up to physical visit(From start of treatment to three years follow-up)
研究者
Pernilla Danielsson
Principal Investigator
Karolinska Institutet