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临床试验/NCT03270423
NCT03270423已完成不适用

PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers

Ostschweizer Kinderspital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月30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
发起方
入组人数
40
试验地点
1
主要终点
Body Mass Index

研究概览

简要总结

Randomised controlled trial in overweight adolescents using a health App.

详细描述

Problem In Switzerland, 20% of children are overweight and novel methods are urgently needed to control the epidemic. Foundations of chronic diseases develop during childhood and track into adulthood obesity in more than 75% of patients, contributing to a significant increase in public health costs.

Multi-professional programs combining physical activity, nutritional and behavioral components have positive effects on therapy outcomes and co-morbidities, but these interventions induce high costs and are time-consuming for health providers, patients and families, in particular those living in rural regions. In fact, less than 0.2% of overweight children can participate in these programs. Thus, health information systems (HIS) have not only the potential to improve outcomes of obesity therapy but also to reduce health costs and increase access to health care in remote regions. Most HIS have indeed not been evaluated in this regard.

Preparation work In the PathMate project (SNF grant #135552), a mobile HIS has been developed for teenagers to support therapy and to prevent obesity in accordance with state-of-the-art multiprofessional programs and, in contrast to commercially available IT applications, with a high standard of data protection and safety. The IS effects of this HIS have been successfully evaluated in first longitudinal studies. In parallel, the impact of multi-professional therapies in Swiss children as well as potential confounders have been established in several longitudinal cohort studies with up to two-years follow-up.

Objectives

The overall goal of PathMate2 is to assess the impact of HIS services on the degree of obesity measured by the body mass index (BMI) incl. other health outcomes. Individual and shared understanding between patients and therapists are assessed as mediating factors. Specific goals are:

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
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •obesity, BMI > P. 97 (Jenni et al., 2011) or overweight, BMI >P.90, plus risk factors or co-morbidity
  • •ability and parent's permission to use pre-configured study smartphones handed out to the children
  • •readiness to use the personal smartphone number and to spend the sum allocated exclusively for the study SMS during the 6 months of intervention

排除标准

  • •major somatic or psychiatric disease without adequate treatment,
  • •weight-relevant medication (antiepileptic drugs, methylphenhydate and similar medication),
  • •inability or lack of parent's or caregivers' permission to use a study smartphone with a mobile phone contract,
  • •lack of informed consent from children and parents and
  • •undue consumption of the amount allocated for study SMS for non-study purposes,
  • •overuse of smartphone e.g. without night beak for at least 8 hours.

研究组 & 干预措施

Control SG

No Intervention

Therapy during 6 months with usual care. 10 therapy visits over 6 months

Intervention SG

Active Comparator

Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months

干预措施: PathMate2 (Device)

Intervention VD

Active Comparator

Adapted sport session 1h/week + PathMate-S during 6 months

干预措施: PathMateS (Device)

Control VD

No Intervention

Adapted sport session 1h/week during 6 months

结局指标

主要结局

Body Mass Index

时间窗: 12 months

Main outcome parameter is Body Mass Index, as BMI-SDS adjusted for gender \& age. Group size of 4\*20 was based on an expected decrease by -0.23±0.02 (SDS, Mean±SD) after 1 year, from initially 2.88±0.7.

次要结局

  • stress and arousal(12 months)
  • stress and arousal, biophysical measure(12 months)
  • well-being(12 months)
  • waist circumference(12 months)
  • fitness / physical activity(12 months)
  • stress reduction, biological measure(12 months)
  • reduction of chronic stress(12 months)
  • fitness / physical capability(12 months)

研究者

发起方
Ostschweizer Kinderspital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dagmar l'Allemand

Prof. Dr. med.

Ostschweizer Kinderspital

研究点 (1)

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