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

5 januari 2020 bijgewerkt door: Dagmar l'Allemand, Ostschweizer Kinderspital
Randomised controlled trial in overweight adolescents using a health App.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Saint Gallen
      • St. Gallen, Saint Gallen, Zwitserland, 9006
        • Ostschweizer Kinderspital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

11 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Intervention SG
Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months
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.
Andere namen:
  • Mobile-coach obesity intervention in adolescents
Geen tussenkomst: Control SG
Therapy during 6 months with usual care. 10 therapy visits over 6 months
Actieve vergelijker: Intervention VD
Adapted sport session 1h/week + PathMate-S during 6 months
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.
Andere namen:
  • controles
Geen tussenkomst: Control VD
Adapted sport session 1h/week during 6 months

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body Mass Index
Tijdsspanne: 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.
12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
fitness / physical capability
Tijdsspanne: 12 months
Eurofit-test
12 months
fitness / physical activity
Tijdsspanne: 12 months
accelerometry
12 months
stress reduction, biological measure
Tijdsspanne: 12 months
Cortisol levels in blood
12 months
stress and arousal
Tijdsspanne: 12 months
Self-Assessment Manikin (SAM) Scale
12 months
reduction of chronic stress
Tijdsspanne: 12 months
Trierer Stress Inventar questionnaire (TICS)
12 months
stress and arousal, biophysical measure
Tijdsspanne: 12 months
skin conductance (Nexus 10)
12 months
well-being
Tijdsspanne: 12 months
KIDSCREEN
12 months
waist circumference
Tijdsspanne: 12 months
Waist-to-Height-ratio or SDS according to Fredricks 2005
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Dagmar lAllemand, Prof. MD, Ostschweizer Kinderspital, St. Gallen, Switzerland

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 januari 2017

Primaire voltooiing (Werkelijk)

31 december 2018

Studie voltooiing (Werkelijk)

31 december 2018

Studieregistratiedata

Eerst ingediend

26 juli 2017

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2017

Eerst geplaatst (Werkelijk)

1 september 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 januari 2020

Laatste update ingediend die voldeed aan QC-criteria

5 januari 2020

Laatst geverifieerd

1 januari 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2016-01965

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Obesitas, adolescent

Abonneren