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PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers (PM2)

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ClinicalTrials.gov Identifier: NCT03270423
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dagmar l'Allemand, Ostschweizer Kinderspital

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

Condition or disease Intervention/treatment Phase
Obesity, Adolescent Device: PathMate2 Device: PathMateS Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Study Start Date : January 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Active Comparator: Intervention SG
Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months
Device: PathMate2
No Intervention: Control SG
Therapy during 6 months with usual care. 10 therapy visits over 6 months
Active Comparator: Intervention VD
Adapted sport session 1h/week + PathMate-S during 6 months
Device: PathMateS
No Intervention: Control VD
Adapted sport session 1h/week during 6 months



Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: 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.


Secondary Outcome Measures :
  1. fitness / physical capability [ Time Frame: 12 months ]
    Eurofit-test

  2. fitness / physical activity [ Time Frame: 12 months ]
    accelerometry

  3. stress reduction, biological measure [ Time Frame: 12 months ]
    Cortisol levels in blood

  4. stress and arousal [ Time Frame: 12 months ]
    Self-Assessment Manikin (SAM) Scale

  5. reduction of chronic stress [ Time Frame: 12 months ]
    Trierer Stress Inventar questionnaire (TICS)

  6. stress and arousal, biophysical measure [ Time Frame: 12 months ]
    skin conductance (Nexus 10)

  7. well-being [ Time Frame: 12 months ]
    KIDSCREEN

  8. waist circumference [ Time Frame: 12 months ]
    Waist-to-Height-ratio or SDS according to Fredricks 2005



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270423


Contacts
Contact: Dagmar lAllemand, Prof. MD 0041 71 243 1326 dagmar.lallemand@kispisg.ch
Contact: Dirk Buechter, MD 0041 71 243 1467 Dirk.Buechter@kispisg.ch

Locations
Switzerland
Ostschweizer Kinderspital Recruiting
St. Gallen, Switzerland, 9006
Contact: Dagmar lAllemand, Prof. MD    0041 71 243 1467    dagmar.lallemand@kispisg.ch   
Sponsors and Collaborators
Ostschweizer Kinderspital
Investigators
Principal Investigator: Dagmar lAllemand, Prof. MD Ostschweizer Kinderspital, St. Gallen, Switzerland

Publications:
Responsible Party: Dagmar l'Allemand, Prof. Dr. med., Ostschweizer Kinderspital
ClinicalTrials.gov Identifier: NCT03270423     History of Changes
Other Study ID Numbers: 2016-01965
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Overweight
Pediatric Obesity
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders