PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers (PM2)
研究概览
详细说明
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:
- to assess the effects of a child-friendly IT-mediated low-threshold intervention under the supervision of primary care providers and obesity experts, compared to expensive on-site consultations in highly specialized pediatric obesity centers
- to automatically capture and process obesity-related biosignals by smart sensors and use results for immediate feedback for the patients and medical providers based on permissions and communication patterns and
- to design evidence-based selfregulation interventions for teenager in their everyday life by coupling Neuro Information Systems (NeuroIS) services with Smart Health Sensors (SHS).
Methods HIS services are collaboratively developed by design-science research and evaluated by medical experts, patients, IS researcher and computer scientists. First, HIS services from PathMate are enhanced with SHS enabling real-time data analytics on mobile devices and results can be seen by both therapists and patients. Second, a randomized controlled trial (RCT) is conducted by a physician in a specialized pediatric obesity center in St. Gall with the goal to evaluate the effects of the re-designed and improved HIS services on adherence to therapy of the patient and his parents as well as on BMI and other health outcomes; a second RCT is conducted in parallel to assess the effects of these services in a community setting in the French-speaking part of Switzerland.
Importance and impact Building on the preliminary results of the PathMate project it is expected that the improved HIS services that are going to be designed and evaluated in PathMate2 have the potential for a significant impact on individual health and the quality of healthcare systems in general.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Saint Gallen
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St. Gallen、Saint Gallen、瑞士、9006
- Ostschweizer Kinderspital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Intervention SG
Therapy during 6 months with PathMate2 design.
6 therapy visits + PathMate2 over 6 months
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To improve self-regulation of overweight adolescents and subsequently their weight status, we tested, whether a biofeedback relaxation exercise decreases stress and whether relaxation services as well as sensor data integration implemented in a novel Smartphone App supported intervention have effects on stress, physical activity and weight outcomes.
During the intensive phase of 6 months, patients of the intervention group (IG) are equipped with a smartphone and a specially designed chat App with game character, which encourages them through a virtual coach to achieve daily activity, healty lifestyle or relaxation challenges and earn virtual rewards, to increase adherance to the health information system.
其他名称:
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无干预:Control SG
Therapy during 6 months with usual care.
10 therapy visits over 6 months
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有源比较器:Intervention VD
Adapted sport session 1h/week + PathMate-S during 6 months
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Overweight or obese adolescents of the treatment as-usual group (CG) have monthly visits on site during the intensive phase.
Counseling for physical activity, healthy eating and lifestyle as well as psychosocial wellbeing is provided by a pediatrician.
其他名称:
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无干预:Control VD
Adapted sport session 1h/week during 6 months
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body Mass Index
大体时间:12 months
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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.
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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fitness / physical capability
大体时间:12 months
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Eurofit-test
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12 months
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fitness / physical activity
大体时间:12 months
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accelerometry
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12 months
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stress reduction, biological measure
大体时间:12 months
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Cortisol levels in blood
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12 months
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stress and arousal
大体时间:12 months
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Self-Assessment Manikin (SAM) Scale
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12 months
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reduction of chronic stress
大体时间:12 months
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Trierer Stress Inventar questionnaire (TICS)
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12 months
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stress and arousal, biophysical measure
大体时间:12 months
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skin conductance (Nexus 10)
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12 months
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well-being
大体时间:12 months
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KIDSCREEN
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12 months
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waist circumference
大体时间:12 months
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Waist-to-Height-ratio or SDS according to Fredricks 2005
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12 months
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合作者和调查者
调查人员
- 首席研究员:Dagmar lAllemand, Prof. MD、Ostschweizer Kinderspital, St. Gallen, Switzerland
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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