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临床试验/NCT03380598
NCT03380598已完成不适用

An Evaluation of a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Trial of Childhood Obesity Treatment

Karolinska Institutet3 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
3
主要终点
Familie's experience and feasibility of the treatment

研究概览

简要总结

This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. Changes in BMI standard deviation score 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 were randomized to either usual care according to regular routine (control group) or to usual care plus a web-based support system (intervention group). The system is based on a smartphone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smartphone, where data is presented graphically. The data is transferred to the clinic for support. The system is developed for communication between the clinic and family. The randomization was done at the start of individual treatment and lasted for 6 months. Investigators studied the families and health care professional's experience of using the web-based support system as well as changes in BMI standard deviation score in the control and intervention 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
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
  • •No pharmacological treatment that could intervene the obesity treatment

排除标准

  • •Diagnosed with or undergoing assessment of neuropsychiatric disorder
  • •Structured obesity treatment the past 6 months
  • •Hypothalamic obesity

研究组 & 干预措施

Usual care

Active Comparator

Usual care according to regular treatment routines at the clinic during 6 months.

干预措施: Usual care (Behavioral)

CLOSS

Active Comparator

Usual care plus using a web based support system for self-monitoring weight at physical activity.

干预措施: CLOSS (Behavioral)

结局指标

主要结局

Familie's experience and feasibility of the treatment

时间窗: 6 months after baseline

CLOSS specific questionnaire, control vs intervention

次要结局

  • Health care professional's experience using the web based support system(During the intervention 3 and 6 months)
  • Health care professional's required working time for control vs intervention(During the intervention 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pernilla Danielsson

PhD Pediatric Nurse

Karolinska Institutet

研究点 (3)

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