Clinical trial NCT03270423: PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Official title: PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Lead sponsor: Ostschweizer Kinderspital
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Body Mass Index
timeFrame: 12 months
Secondary outcomes:
measure: fitness / physical capability
timeFrame: 12 months
measure: fitness / physical activity
timeFrame: 12 months
measure: stress reduction, biological measure
timeFrame: 12 months
measure: stress and arousal
timeFrame: 12 months
measure: reduction of chronic stress
timeFrame: 12 months
measure: stress and arousal, biophysical measure
timeFrame: 12 months
measure: well-being
timeFrame: 12 months
measure: waist circumference
timeFrame: 12 months
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Ostschweizer Kinderspital
state: Saint Gallen
Study officials:
affiliation: Ostschweizer Kinderspital, St. Gallen, Switzerland
name: Dagmar lAllemand, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haug S, Kowatsch T, Castro RP, Filler A, Schaub MP. Efficacy of a web- and text messaging-based intervention to reduce problem drinking in young people: study protocol of a cluster-randomised controlled trial. BMC Public Health. 2014 Aug 7;14:809. doi: 10.1186/1471-2458-14-809.