<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03270423</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01965</org_study_id>
    <nct_id>NCT03270423</nct_id>
  </id_info>
  <brief_title>PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers</brief_title>
  <acronym>PM2</acronym>
  <official_title>PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostschweizer Kinderspital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ostschweizer Kinderspital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomised controlled trial in overweight adolescents using a health App.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problem In Switzerland, 20% of children are overweight and novel methods are urgently needed&#xD;
      to control the epidemic. Foundations of chronic diseases develop during childhood and track&#xD;
      into adulthood obesity in more than 75% of patients, contributing to a significant increase&#xD;
      in public health costs.&#xD;
&#xD;
      Multi-professional programs combining physical activity, nutritional and behavioral&#xD;
      components have positive effects on therapy outcomes and co-morbidities, but these&#xD;
      interventions induce high costs and are time-consuming for health providers, patients and&#xD;
      families, in particular those living in rural regions. In fact, less than 0.2% of overweight&#xD;
      children can participate in these programs. Thus, health information systems (HIS) have not&#xD;
      only the potential to improve outcomes of obesity therapy but also to reduce health costs and&#xD;
      increase access to health care in remote regions. Most HIS have indeed not been evaluated in&#xD;
      this regard.&#xD;
&#xD;
      Preparation work In the PathMate project (SNF grant #135552), a mobile HIS has been developed&#xD;
      for teenagers to support therapy and to prevent obesity in accordance with state-of-the-art&#xD;
      multiprofessional programs and, in contrast to commercially available IT applications, with a&#xD;
      high standard of data protection and safety. The IS effects of this HIS have been&#xD;
      successfully evaluated in first longitudinal studies. In parallel, the impact of&#xD;
      multi-professional therapies in Swiss children as well as potential confounders have been&#xD;
      established in several longitudinal cohort studies with up to two-years follow-up.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      The overall goal of PathMate2 is to assess the impact of HIS services on the degree of&#xD;
      obesity measured by the body mass index (BMI) incl. other health outcomes. Individual and&#xD;
      shared understanding between patients and therapists are assessed as mediating factors.&#xD;
      Specific goals are:&#xD;
&#xD;
        1. to assess the effects of a child-friendly IT-mediated low-threshold intervention under&#xD;
           the supervision of primary care providers and obesity experts, compared to expensive&#xD;
           on-site consultations in highly specialized pediatric obesity centers&#xD;
&#xD;
        2. to automatically capture and process obesity-related biosignals by smart sensors and use&#xD;
           results for immediate feedback for the patients and medical providers based on&#xD;
           permissions and communication patterns and&#xD;
&#xD;
        3. to design evidence-based selfregulation interventions for teenager in their everyday&#xD;
           life by coupling Neuro Information Systems (NeuroIS) services with Smart Health Sensors&#xD;
           (SHS).&#xD;
&#xD;
      Methods HIS services are collaboratively developed by design-science research and evaluated&#xD;
      by medical experts, patients, IS researcher and computer scientists. First, HIS services from&#xD;
      PathMate are enhanced with SHS enabling real-time data analytics on mobile devices and&#xD;
      results can be seen by both therapists and patients. Second, a randomized controlled trial&#xD;
      (RCT) is conducted by a physician in a specialized pediatric obesity center in St. Gall with&#xD;
      the goal to evaluate the effects of the re-designed and improved HIS services on adherence to&#xD;
      therapy of the patient and his parents as well as on BMI and other health outcomes; a second&#xD;
      RCT is conducted in parallel to assess the effects of these services in a community setting&#xD;
      in the French-speaking part of Switzerland.&#xD;
&#xD;
      Importance and impact Building on the preliminary results of the PathMate project it is&#xD;
      expected that the improved HIS services that are going to be designed and evaluated in&#xD;
      PathMate2 have the potential for a significant impact on individual health and the quality of&#xD;
      healthcare systems in general.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>12 months</time_frame>
    <description>Main outcome parameter is Body Mass Index, as BMI-SDS adjusted for gender &amp; 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fitness / physical capability</measure>
    <time_frame>12 months</time_frame>
    <description>Eurofit-test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fitness / physical activity</measure>
    <time_frame>12 months</time_frame>
    <description>accelerometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stress reduction, biological measure</measure>
    <time_frame>12 months</time_frame>
    <description>Cortisol levels in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stress and arousal</measure>
    <time_frame>12 months</time_frame>
    <description>Self-Assessment Manikin (SAM) Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction of chronic stress</measure>
    <time_frame>12 months</time_frame>
    <description>Trierer Stress Inventar questionnaire (TICS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stress and arousal, biophysical measure</measure>
    <time_frame>12 months</time_frame>
    <description>skin conductance (Nexus 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>well-being</measure>
    <time_frame>12 months</time_frame>
    <description>KIDSCREEN</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist circumference</measure>
    <time_frame>12 months</time_frame>
    <description>Waist-to-Height-ratio or SDS according to Fredricks 2005</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity, Adolescent</condition>
  <arm_group>
    <arm_group_label>Intervention SG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control SG</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Therapy during 6 months with usual care. 10 therapy visits over 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention VD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adapted sport session 1h/week + PathMate-S during 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control VD</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Adapted sport session 1h/week during 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PathMate2</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention SG</arm_group_label>
    <other_name>Mobile-coach obesity intervention in adolescents</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PathMateS</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention VD</arm_group_label>
    <other_name>controls</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obesity, BMI &gt; P. 97 (Jenni et al., 2011) or overweight, BMI &gt;P.90, plus risk factors&#xD;
             or co-morbidity&#xD;
&#xD;
          -  ability and parent's permission to use pre-configured study smartphones handed out to&#xD;
             the children&#xD;
&#xD;
          -  readiness to use the personal smartphone number and to spend the sum allocated&#xD;
             exclusively for the study SMS during the 6 months of intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major somatic or psychiatric disease without adequate treatment,&#xD;
&#xD;
          -  weight-relevant medication (antiepileptic drugs, methylphenhydate and similar&#xD;
             medication),&#xD;
&#xD;
          -  inability or lack of parent's or caregivers' permission to use a study smartphone with&#xD;
             a mobile phone contract,&#xD;
&#xD;
          -  lack of informed consent from children and parents and&#xD;
&#xD;
          -  undue consumption of the amount allocated for study SMS for non-study purposes,&#xD;
&#xD;
          -  overuse of smartphone e.g. without night beak for at least 8 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dagmar lAllemand, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ostschweizer Kinderspital, St. Gallen, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ostschweizer Kinderspital</name>
      <address>
        <city>St. Gallen</city>
        <state>Saint Gallen</state>
        <zip>9006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Haug S, Kowatsch T, Castro RP, Filler A, Schaub MP. Efficacy of a web- and text messaging-based intervention to reduce problem drinking in young people: study protocol of a cluster-randomised controlled trial. BMC Public Health. 2014 Aug 7;14:809. doi: 10.1186/1471-2458-14-809.</citation>
    <PMID>25099872</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>January 5, 2020</last_update_submitted>
  <last_update_submitted_qc>January 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ostschweizer Kinderspital</investigator_affiliation>
    <investigator_full_name>Dagmar l'Allemand</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03270423
org study id: 2016-01965
nct id: NCT03270423
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomised controlled trial in overweight adolescents using a health App.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body Mass Index
time frame: 12 months
description: 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.
measure: fitness / physical capability
time frame: 12 months
description: Eurofit-test
measure: fitness / physical activity
time frame: 12 months
description: accelerometry
measure: stress reduction, biological measure
time frame: 12 months
description: Cortisol levels in blood
measure: stress and arousal
time frame: 12 months
description: Self-Assessment Manikin (SAM) Scale
measure: reduction of chronic stress
time frame: 12 months
description: Trierer Stress Inventar questionnaire (TICS)
measure: stress and arousal, biophysical measure
time frame: 12 months
description: skin conductance (Nexus 10)
measure: well-being
time frame: 12 months
description: KIDSCREEN
measure: waist circumference
time frame: 12 months
description: Waist-to-Height-ratio or SDS according to Fredricks 2005
arm group label: Intervention SG
arm group type: Active Comparator
description: Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months
arm group label: Control SG
arm group type: No Intervention
description: Therapy during 6 months with usual care. 10 therapy visits over 6 months
arm group label: Intervention VD
arm group type: Active Comparator
description: Adapted sport session 1h/week + PathMate-S during 6 months
arm group label: Control VD
arm group type: No Intervention
description: Adapted sport session 1h/week during 6 months
intervention type: Device
intervention name: PathMate2
description: 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.
arm group label: Intervention SG
other name: Mobile-coach obesity intervention in adolescents
intervention type: Device
intervention name: PathMateS
description: 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.
arm group label: Intervention VD
other name: controls
criteria: 
gender: All
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: No
last name: Dagmar lAllemand, Prof. MD
role: Principal Investigator
affiliation: Ostschweizer Kinderspital, St. Gallen, Switzerland
facility: 
country: Switzerland
citation: Haug S, Kowatsch T, Castro RP, Filler A, Schaub MP. Efficacy of a web- and text messaging-based intervention to reduce problem drinking in young people: study protocol of a cluster-randomised controlled trial. BMC Public Health. 2014 Aug 7;14:809. doi: 10.1186/1471-2458-14-809.
PMID: 25099872
responsible party type: Principal Investigator
investigator affiliation: Ostschweizer Kinderspital
investigator full name: Dagmar l'Allemand
investigator title: Prof. Dr. med.
mesh term: Overweight
mesh term: Pediatric Obesity
sharing ipd: No