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Obesity, AdolescentPM2NCT03270423

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

A study testing PathMate2 and PathMateS in people with Obesity, Adolescent, run by Ostschweizer Kinderspital at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomised controlled trial in overweight adolescents using a health App. Read more about this study

Who is it for?
Ages 11 to 18 years
Conditions the study is for
Obesity, Adolescent
What is being tested?
PathMate2 and PathMateS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSwitzerland
Study dates
30 Jan 2017to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Ostschweizer Kinderspital

    Sankt Gallen, Canton of St. Gallen, 9006

Other trials in Switzerland

About this study

Randomised controlled trial in overweight adolescents using a health App.

Read the 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.

Being tested
PathMate2, PathMateS
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PathMate2Device

    Also called Mobile-coach obesity intervention in adolescents

    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.

  • PathMateSDevice

    Also called controls

    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.

Study groups in NCT03270423
Study groupRoleWhat they receive
Intervention SGActive comparatorTherapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months
Receives: Device: PathMate2
Control SGNo interventionTherapy during 6 months with usual care. 10 therapy visits over 6 months
Intervention VDActive comparatorAdapted sport session 1h/week + PathMate-S during 6 months
Receives: Device: PathMateS
Control VDNo interventionAdapted sport session 1h/week during 6 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (8)
  1. fitness / physical capability

    Eurofit-test

    Measured: 12 months

  2. fitness / physical activity

    accelerometry

    Measured: 12 months

  3. stress reduction, biological measure

    Cortisol levels in blood

    Measured: 12 months

  4. stress and arousal

    Self-Assessment Manikin (SAM) Scale

    Measured: 12 months

  5. reduction of chronic stress

    Trierer Stress Inventar questionnaire (TICS)

    Measured: 12 months

  6. stress and arousal, biophysical measure

    skin conductance (Nexus 10)

    Measured: 12 months

  7. well-being

    KIDSCREEN

    Measured: 12 months

  8. waist circumference

    Waist-to-Height-ratio or SDS according to Fredricks 2005

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2017
  2. Study start30 Jan 2017
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03270423
Sponsor's protocol ID
2016-01965
Other IDs
2016
Acronym
PM2
Status last verified
Jan 2020
First submitted
26 Jul 2017
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25099872
  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PubMed 38375882

Questions about this trial

What is this clinical trial studying?

A study testing PathMate2 and PathMateS in people with Obesity, Adolescent, run by Ostschweizer Kinderspital at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03270423, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

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