PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Condition: Obesity, Adolescent
MeSH terms: Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Randomised controlled trial in overweight adolescents using a health App.
    

Detailed description: 
      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:

        1. 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

        2. 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

        3. 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.
    

Intervention name(s): PathMate2; PathMateS
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Other intervention name(s): Mobile-coach obesity intervention in adolescents; controls
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment