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

Not Applicable

Completed

• Conditions: Obesity, Adolescent

• Registration Number: NCT03270423
• Lead Sponsor: Ostschweizer Kinderspital

Brief Summary

Randomised controlled trial in overweight adolescents using a health App.

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 Timeline

• Study Start: 2017-01-30
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Mass Index	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

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

Trial Locations

Locations (1)

Ostschweizer Kinderspital; 🇨🇭 St. Gallen, Saint Gallen, Switzerland