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

5. januar 2020 opdateret af: Dagmar l'Allemand, Ostschweizer Kinderspital
Randomised controlled trial in overweight adolescents using a health App.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

11 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andre navne:
  • Mobile-coach obesity intervention in adolescents
Ingen indgriben: Control SG
Therapy during 6 months with usual care. 10 therapy visits over 6 months
Aktiv komparator: 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.
Andre navne:
  • kontroller
Ingen indgriben: Control VD
Adapted sport session 1h/week during 6 months

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Mass Index
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. januar 2017

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Faktiske)

31. december 2018

Datoer for studieregistrering

Først indsendt

26. juli 2017

Først indsendt, der opfyldte QC-kriterier

30. august 2017

Først opslået (Faktiske)

1. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2016-01965

Plan for individuelle deltagerdata (IPD)

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