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

Primary Purpose

Obesity, Adolescent

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
PathMate2
PathMateS
Sponsored by
Ostschweizer Kinderspital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Adolescent

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ostschweizer Kinderspital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Intervention SG

Control SG

Intervention VD

Control VD

Arm Description

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

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

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

Adapted sport session 1h/week during 6 months

Outcomes

Primary Outcome Measures

Body Mass Index
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

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

Full Information

First Posted
July 26, 2017
Last Updated
January 5, 2020
Sponsor
Ostschweizer Kinderspital
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1. Study Identification

Unique Protocol Identification Number
NCT03270423
Brief Title
PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Acronym
PM2
Official Title
PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostschweizer Kinderspital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention SG
Arm Type
Active Comparator
Arm Description
Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months
Arm Title
Control SG
Arm Type
No Intervention
Arm Description
Therapy during 6 months with usual care. 10 therapy visits over 6 months
Arm Title
Intervention VD
Arm Type
Active Comparator
Arm Description
Adapted sport session 1h/week + PathMate-S during 6 months
Arm Title
Control VD
Arm Type
No Intervention
Arm Description
Adapted sport session 1h/week during 6 months
Intervention Type
Device
Intervention Name(s)
PathMate2
Other Intervention Name(s)
Mobile-coach obesity intervention in adolescents
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PathMateS
Other Intervention Name(s)
controls
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
fitness / physical capability
Description
Eurofit-test
Time Frame
12 months
Title
fitness / physical activity
Description
accelerometry
Time Frame
12 months
Title
stress reduction, biological measure
Description
Cortisol levels in blood
Time Frame
12 months
Title
stress and arousal
Description
Self-Assessment Manikin (SAM) Scale
Time Frame
12 months
Title
reduction of chronic stress
Description
Trierer Stress Inventar questionnaire (TICS)
Time Frame
12 months
Title
stress and arousal, biophysical measure
Description
skin conductance (Nexus 10)
Time Frame
12 months
Title
well-being
Description
KIDSCREEN
Time Frame
12 months
Title
waist circumference
Description
Waist-to-Height-ratio or SDS according to Fredricks 2005
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dagmar lAllemand, Prof. MD
Organizational Affiliation
Ostschweizer Kinderspital, St. Gallen, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ostschweizer Kinderspital
City
St. Gallen
State/Province
Saint Gallen
ZIP/Postal Code
9006
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25099872
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.
Results Reference
background

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

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