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

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

Patrocinadores

Patrocinador principal: Ostschweizer Kinderspital

Fuente Ostschweizer Kinderspital
Resumen breve

Randomised controlled trial in overweight adolescents using a health App.

Descripción detallada

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.

Estado general Completed
Fecha de inicio January 30, 2017
Fecha de Terminación December 31, 2018
Fecha de finalización primaria December 31, 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Body Mass Index 12 months
Resultado secundario
Medida Periodo de tiempo
fitness / physical capability 12 months
fitness / physical activity 12 months
stress reduction, biological measure 12 months
stress and arousal 12 months
reduction of chronic stress 12 months
stress and arousal, biophysical measure 12 months
well-being 12 months
waist circumference 12 months
Inscripción 40
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: PathMate2

Descripción: 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.

Etiqueta de grupo de brazo: Intervention SG

Otro nombre: Mobile-coach obesity intervention in adolescents

Tipo de intervención: Device

Nombre de intervención: PathMateS

Descripción: 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.

Etiqueta de grupo de brazo: Intervention VD

Otro nombre: controls

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 11 Years

Edad máxima: 18 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Dagmar lAllemand, Prof. MD Principal Investigator Ostschweizer Kinderspital, St. Gallen, Switzerland
Ubicación
Instalaciones: Ostschweizer Kinderspital
Ubicacion Paises

Switzerland

Fecha de verificación

January 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Ostschweizer Kinderspital

Nombre completo del investigador: Dagmar l'Allemand

Título del investigador: Prof. Dr. med.

Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: Intervention SG

Tipo: Active Comparator

Descripción: Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months

Etiqueta: Control SG

Tipo: No Intervention

Descripción: Therapy during 6 months with usual care. 10 therapy visits over 6 months

Etiqueta: Intervention VD

Tipo: Active Comparator

Descripción: Adapted sport session 1h/week + PathMate-S during 6 months

Etiqueta: Control VD

Tipo: No Intervention

Descripción: Adapted sport session 1h/week during 6 months

Acrónimo PM2
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov